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Sunday, June 24
 

8:00am

8:00am

Exhibitor Registration
Sunday June 24, 2018 8:00am - 6:00pm
North Lobby

8:30am

#20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-18-500-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference short courses.
Real world evidence (RWE) has the potential to compliment and extend the safety and effectiveness knowledge of drugs gained from RCTs. This session will discuss key study design principles to guide evaluation of RWE using studies focused on cardiovascular safety assessments.
Back to DIA 2018 Short Courses

Who should attend?

This short course is designed for members of the Clinical Research and Regulatory audiences.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe key epidemiological design principles central to interpreting the quality and validity of RWE studies
  • Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments
  • Recognize when RWE based approaches are of sufficient quality to enable decision making



Speakers
avatar for Alan Brookhart

Alan Brookhart

Professor, Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill
M. Alan Brookhart, Ph.D., is a Professor of Epidemiology at the UNC Gillings School of Global Public Health University of North Carolina at Chapel Hill. Dr. Brookhart’s research has focused on the development and application of innovative epidemiologic study designs, statistical... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Global Chief, Sci Affairs; Sr VP, Head, Center for Advanced Evidence Generation, IQVIA
Nancy Dreyer is the chief scientific officer and global chief of scientific affairs for IQVIA Real-World & Analytic Solutions. She leads the Center for Advanced Evidence Generation, focusing on the use of real-world evidence for regulators, payers, clinicians, and patients using minimally... Read More →
avatar for Mary Jane Geiger

Mary Jane Geiger

Vice President and TA Lead, Drug Development Services, ICON
MJ Geiger is VP & CV lead for ICON’s Drug Development Services providing scientific, operational and therapeutic expertise spanning the development continuum from concept through development to post-approval activities. She is involved in the Cardiac Safety Research Consortium... Read More →
NS

Norman Stockbridge

Director, Division of Cardiovascular and Renal Products, OND, CDER, FDA
Norman Stockbridge received his MD and PhD (Physiology) from Duke University. He has been a part of the FDA/CDER Division of Cardiovascular and Renal Products since 1991, serving as Division Director since 2004.


Sunday June 24, 2018 8:30am - 12:00pm
Room 157C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

8:30am

#21: The IDMP Challenge: Points to Consider for Pharmacovigilance Departments
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-501-L04-P; CME 3.25; IACET 3.25; RN 3.25

The Identification of Medicinal Products (IDMP) is a new industry regulation that pharmaceutical, biologics, and generic companies must comply with in the EU. The main objective of IDMP is to provide the basis for a unique identification of medicinal products. EMA is the first competent authority that has mandated the implementation of IDMP, and other regions (including the US and Japan) are expected to provide their deadlines in the near future. IDMP presents as an enormous challenge for companies to develop data governance standards on medicinal product data, identify sources of product data, harvest data efficiently and curate, review, and submit data to the EMA. During this short course we will present an overview of the current status of IDMP looking at regional implementation plans and timelines and we will look at some of the key challenges associated with IDMP for pharma – including data governance, data sourcing, data collection, and review. In response to some of the data challenges, we will examine various solutions and operating models for addressing IDMP and pay special focus on how IDMP will interface with pharmacovigilance — considering what data the pharmacovigilance department will typically need to provide to support IDMP and the data that the pharmacovigilance department is likely to consume. An additional registration fee is required for all preconference short courses.   Back to DIA 2018 Short Courses  

Who should attend?

This short course is designed for professionals in pharmacovigilance and regulatory affairs professionals.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Analyze the current status of IDMP
  • Identify the various solutions being developed to address IDMP requirements
  • Recognize how the IDMP impacts pharmacovigilance operations



Sunday June 24, 2018 8:30am - 12:00pm
Room 158 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

8:30am

#22: Protocol Co-Design with Patients and Advocates
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-18-502-L04-P; CME 3.25; IACET 3.25; RN 3.25

This course will allow participants to experience multiple activities which encourage active collaboration among patients, trial sponsors, and advocates. Following a brief introduction outlining the benefits of interactive activities with multiple stakeholders, you will engage in several activities:
  • Protocol red lining (individual/partner activity)
  • Design your own protocol (small group activity)
  • Walk the protocol (large group activity)
The first activity asks you to react to a draft protocol individually. You will then share your reactions with a partner representing a different stakeholder group. The second activity encourages collaboration among multiple stakeholders as table teams work to design a protocol that meets the needs of all stakeholders. The third and final activity will have the entire group reacting individually to a sample protocol (represented by posters on the wall), then discuss their reactions and seek consensus. Each activity will be debriefed to not only assess the experience, but to discuss how a similar activity might be applied to your needs. We will conclude by presenting a case-study that outlines the successful application of these methods for trial design. These exercises were designed by clinicians, instructional designers, and experts in patient literacy. They have been used successfully in numerous workshop settings to obtain input on protocol design features and trial recruitment and retention methods. Feedback on the experience from past participants has been very positive. It is our hope that you will leave the workshop with an understanding of how these types of exercises can be designed and executed to encourage collaboration and to design clinical trials that meet the needs of all stakeholders. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

Who should attend?

This short course is designed for individuals responsible for clinical trial design and protocol development; clinical trials operations professionals; advocacy leaders who wish to collaborate with trial sponsors; CRO professionals; patient engagement professionals; advocacy engagement professionals

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Evaluate valuable and detailed input from patients and advocates on clinical trial design
  • Design patient interactions that encourage collaboration among patients, sponsors, and advocacy groups
  • Critique clinical trials to ensure they meet the needs of all stakeholders



Speakers
avatar for Kelly Franchetti

Kelly Franchetti

Global Head Patient Insights and Engagement, ICON, plc
Kelly Franchetti, RN, CCRN, CEN, is the VP of Global Patients Insights and Engagement at Mapi/ICON. Kelly has nearly two decades of direct patient experience, gained in both hospital and industry settings including CROs, healthcare technology, patient research, and hands-on patient... Read More →
MJ

Marsha Jones

Director, Pharmacovigilance, Mapi


Sunday June 24, 2018 8:30am - 12:00pm
Room 159 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

8:30am

#23: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-503-L04-P; CME 3.25; IACET 3.25; RN 3.25

Quality oversight of drugs throughout the product development lifecycle is complex, crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way. This short course takes you through the development of a cross functional quality strategy frame work in an R&D QA organization which, when implemented will coordinate, communicate, and manage quality risks along with business partners throughout the life of a drug product. Using a “Playbook and Game Plan” analogy, we will workshop real-life examples of the quality gates that a drug in development needs to pass through to assure confidence in the quality of the data for submission to regulatory agencies for approvals. The effect and value of this approach will be shown, revealing the positive impact on drug development and the potential for enhanced relationships with regulatory agencies. An additional registration fee is required for all preconference short courses.
Back to DIA 2018 Short Courses  

Who should attend?

This short course is designed for professionals within sponsor, CRO, and regulatory agency organizations interested in research and development, clinical research, and/or clinical quality assurance

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Analyze the positive effect that a cross functional quality strategy (CQS) has on a drug in the development pipeline
  • Identify the framework for a CQS and workshop examples of quality risk mitigations
  • Describe how CQS optimizes quality as a competitive advantage in delivering safe/effective drugs



Speakers
avatar for Victoria Burk

Victoria Burk

Director R&D Quality Assurance, Abbvie
Vicki Burk is the R&D Quality Assurance director of Combination Products and Medical Devices at AbbVie. She leads a team responsible for Design Quality Assurance and the R&D Combination Product and Device Quality System. Vicki is also the business process owner for the R&D Comprehensive... Read More →


Sunday June 24, 2018 8:30am - 12:00pm
Room 160A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

8:30am

#24: Preparing for a US FDA Advisory Committee Meeting
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-504-L04-P; CME 3.25; IACET 3.25; RN 3.25

What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This short course is structured like an actual FDA Advisory Committee meeting, and presents best practices for preparing for meetings. What You Will Learn:
  • What an advisory committee is
  • How an advisory committee is structured
  • Critical factors for advisory committee preparation
  • How to design the most applicable preparation program for your team
  • Top ten "best practices" and "must avoids"
An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

Who should attend?

This course is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Identify the critical success factors in preparing for an advisory committee meeting
  • Outline those factors that are most applicable to your team
  • Design the most effective preparation strategy for your team(s)



Speakers
MA

Martha Arnold

Principal, PharmApprove
Martha Arnold has led over 50 Advisory Committee preparation and pre-submission strategy projects at PharmApprove and possesses over 30 years’ experience in facilitating marketing and regulatory communications for pharmaceutical firms. She works closely with clinical, regulatory... Read More →
avatar for Lisa Peluso

Lisa Peluso

Director, Coaching and Client Engagement, PharmApprove, a member of the NDA Group
Lisa helps development teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped... Read More →


Sunday June 24, 2018 8:30am - 12:00pm
Room 160B Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  • format json
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial

8:30am

#25: Precedent: A Driver of Regulatory Strategy
Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

This course will review regulatory precedent (and the pathway to locate, assess, and integrate) as a global regulatory strategic driver. Precedent case studies will be used to identify challenges when limited information is publicly available and how to interpret precedent. Attendees will engage through analysis of a hypothetical development program and explore the types of questions that would be critical to successfully integrate precedent for regulatory success. An additional registration fee is required for all preconference short courses.

Back to DIA 2018 Short Courses  

Who should attend?

This short course is designed for professionals with basic knowledge in Regulatory (strategy, CMC, regulatory intelligence), Clinical, Project management, competitive intelligence, and business development

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Evaluate global regulatory precedent, assess its value and integrate to drive regulatory strategy decision making and determine what to do when no precedent exists
  • Identify precedent for risk assessment and mitigation planning as well as opportunities for success in approval and lifecycle management



Speakers
avatar for Kimberly Belsky

Kimberly Belsky

Senior Director, Regulatory Affairs, Regulatory Policy and Intelligence, Mallinckrodt Pharmaceuticals
Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals... Read More →
avatar for Robert Kester

Robert Kester

Director, Global Regulatory Affairs, Merck & Co., Inc.
Robert Kester is a Director, Global Regulatory Liaison, in the Oncology & IVD group at Merck & Co. Inc. He has been at Merck for more than five years and began as a Regulatory Liaison focused on developing Rest of World regulatory strategies for cardiovascular and oncology products... Read More →


Sunday June 24, 2018 8:30am - 12:00pm
Room 160C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

8:30am

#27: The Evolving Role of Payers in Drug Development: Pricing, Pharmacoeconomics, and Health Technology Assessment
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-506-L04-P; CME 3.25; IACET 3.25; RN 3.25

Payers play an important role in both national and global health care systems: their decision-making signals to manufacturers their likelihood to support the R&D required for innovative, new medicines. Only a small number of innovative medicines are approved annually. The large proportion of new drug candidates fail during the development, and the average R&D cost per approved new molecular entity is increasing. Providers and payers can be thought of as agents acting on behalf of patients and their covered beneficiaries. Payers are critical in expressing the willingness of health care systems to provide funds to support innovation. Manufacturers must understand, monitor, and anticipate the evolving payer environment to increase the likelihood of regulatory and commercial success for new products. Key tools such as pharmacoeconomic evaluation of cost-effectiveness and budget impact, as well as important processes such as health technology assessment are used in many developed countries. Understanding their varying role in different jurisdictions is critical for pricing and market access negotiations. This short course, which is hosted with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), will introduce participants to the basic economics of drug development, pricing, contracting, and market access. It will address commonly used economic concepts, such as demand, supply, willingness to pay, monopoly, intellectual property, and value. Practical observations will be made on the similarities and differences in how health care systems approach these pricing and access practices and decisions, with an emphasis on the implications for stakeholder incentives. Examples will be used to illustrate key concepts in both routine and special cases. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

Who should attend?

This short course is designed for industry professionals and academics with an interest to learn more about the economic perspective on drug development, incentives for innovation, and how different countries grapple with these difficult health sector resource allocation decisions.

Learning Objectives

  • Explain what makes innovative medicines unique economic inputs into population health including how the patent system relates to the financing of global R&D
  • Discuss in what way prices for innovative medicines are established, how this differs by system, as well as the evolving impact of pharmacoeconomics and health technology assessment
  • Describe how the complex global network of public and private payers judge the value of innovative medicines



  • Speakers
    avatar for Richard Willke

    Richard Willke

    Chief Science Officer, International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
    Dick became ISPOR’s first Chief Science Officer in 2016, where he develops, leads, and supports strategic initiatives related to research, scientific, and content priorities. Prior to ISPOR he worked for 25 years at Pfizer and its legacy companies, where he retired as a vice president... Read More →


    Sunday June 24, 2018 8:30am - 12:00pm
    Room 161 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
    • format json
    • Credit Type ACPE, CME, IACET, RN
    • Tags Tutorial

    8:30am

    #28: Preparing Documents for Disclosure and Public Sharing
    Component Type: Tutorial
    CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-507-L04-P; CME 3.25; IACET 3.25; RN 3.25

    Recent clinical trial transparency regulations have been developed to provide greater access to clinical trial information. As a result, the pharmaceutical industry is changing its approach to responsibly sharing the results of clinical trials and addressing what information needs to be released, when and how, in order to comply with these recent regulations. This short course will focus on the European Medicine Agency’s (EMA) Publication Policy 0070 and the US Department of Health and Human Services (HHS) Final Rule for Section 801 of the US Food and Drug Administration Amendments Act (FDAAA) of 2007. We will discuss how these recent US and EU regulations related to data disclosure are being implemented and will also focus on the application of preparing such documents for disclosure. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

    Who should attend?

    This short course is designed for medical writers who will be preparing documents for disclosure.

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Define what is in scope, the timing, and requirements of the EMA Policy 0070 and HHS Final Rule
    • Discuss how regulatory documents can be prepared for disclosure
    • Apply best practices in developing layperson summaries
    • Discuss the impact of clinical trial disclosure regulations and initiatives on publication deliverables



    Speakers
    avatar for Eileen Girten

    Eileen Girten

    Principal Medical Writer, PRA Health Sciences
    Eileen M. Girten is a Principal Medical Writer with PRA Health Sciences and is experienced in regulatory and publications writing, submissions, and mentoring. She is an Adjunct Assistant Professor at the University of the Sciences in Philadelphia and has taught Regulatory Documentation... Read More →
    avatar for Eileen Girten

    Eileen Girten

    Principal Medical Writer, PRA Health Sciences
    Eileen M. Girten is a Principal Medical Writer with PRA Health Sciences and is experienced in regulatory and publications writing, submissions, and mentoring. She is an Adjunct Assistant Professor at the University of the Sciences in Philadelphia and has taught Regulatory Documentation... Read More →


    Sunday June 24, 2018 8:30am - 12:00pm
    Room 162A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

    8:30am

    #29: Leadership: How to Organize and Lead People in a Work Group
    Component Type: Tutorial
    CE: CME 3.25; IACET 3.25; PDU 3.25 PMI 2166-00217; RN 3.25

    The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This short course addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.
    An additional registration fee is required for all preconference short courses.
    Back to DIA 2018 Short Courses  

    Who should attend?

    This short course is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and want to learn how to exert influence on group behavior. This course will also benefit individuals to whom project managers report.

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Identify the different types of work group structures and be able to predict the quality of work the group will produce
    • Identify ways to correct dysfunctional group dynamics
    • Create and maintain cooperation among team members, including cross-functional teams



    Sunday June 24, 2018 8:30am - 12:00pm
    Room 162B Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
    • format json
    • Credit Type CME, IACET, PMI, RN
    • Tags Tutorial

    9:00am

    #40: Smart, Innovative Risk-Based Auditing: Shifting the Paradigm
    Component Type: Tutorial
    CE: CME 6.50; IACET 6.50; RN 6.50

    ICH E6 R2 states it loud and clear- “the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities.” Time to revise your audit strategy! Join us as we develop audit plans that address quality in a targeted, efficient, nimble, calculated, risk-based manner. Learn to use technology to circumvent governmental travel advisories, weather hazards, resource limitations (auditors, time, budget), etc. without sacrificing audit goals. Garner the experience and expertise of department heads from Data Management, Clinical Operations, Information Technology, etc. to fulfill technical assessment/ oversight requirements. A wide range of audit types [vendor qualification/ re-assessment (CROs, pharmacovigilance, eCOA vendors, etc.), investigator sites, internal process audits (when the department is off-site), trial master files, GLP, etc.] will be discussed. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

    Who should attend?

    This short course is designed for:
    • Quality personnel from sponsor companies, CROs, and vendors
    • Data Managers, Clinical Operations, CRAs, Clinical Scientists, Medical Monitors and other project leaders with ideas on how and what critical to quality data should be presented to auditors
    • Representatives/consultants of companies that provide auditing services

      Learning Objectives

      At the conclusion of this course, participants should be able to:
      • Identify which data is critical to quality using risk-based methodologies
      • Select novel methods to access documents and data when hosting/conducting a qualification, vendor, investigator site, or other GCP audit
      • Develop more comprehensive and cross functional audit plans for oversight activities of vendors and CROs



    Speakers
    avatar for Joanne Malia

    Joanne Malia

    Associate Director, Clinical Documentation Management, Regeneron Pharmaceuticals
    Joanne Malia is Associate Director of Clinical Documentation Management at Regeneron Pharmaceuticals where she drives operational activities related to the implementation and management of an eTMF and associated clinical document management processes. She serves as the business owner... Read More →


    Sunday June 24, 2018 9:00am - 5:00pm
    Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
    • format json
    • Credit Type CME, IACET, RN
    • Tags Tutorial

    9:00am

    #42: Back to the Future: Combination Products in the 21st Century
    Component Type: Tutorial
    CE: ACPE 6.50 Application UAN: 0286-0000-18-516-L04-P; CME 6.50; IACET 6.50; RN 6.50

    As technology advances, so do opportunities for combining different technologies to solve some of the world’s most pressing medical issues. The lines between engineering, chemistry, and advanced biologic processes are becoming blurred – the age of combination products is here. There are significant differences between the development processes for drugs, devices, and biologics. Theoretically, if the product complies with the regulations specific for each component of the combination product, then your company should be covered, right? Not quite! Because the constituent parts of a combination product are regulated using different regulatory standards, this is nearly impossible. Factor in new laws and regulations such as the 21st Century Cures Act (CCA) and the European Medical Device Regulation (MDR), and the complexity of compliance increases further. This short course provides an overview and comparison of drug, device, and biologics regulation in the US and EU, and the intersect that defines how combination products fit within these regulations. It covers pre-market activities including clinical requirements, applicability of Good Manufacturing Practices (GMPs), post-market activities, and labeling requirements. It will also introduce the 21st CCA and the European MDR, and how combination products are impacted by them. The course will be interactive. Case studies will be presented, but you are also encouraged ask questions and share your own examples of challenges and successes. If you are a regulatory professional or project manager new to the field of combination products, or are simply switching disciplines, this course will provide you with the foundation to move forward in your If you are a regulatory professional or project manager new to the field of combination products, or are simply switching disciplines, this course will provide you with the foundation to move forward in your career. An additional registration fee is required for all preconference short courses.  Back to DIA 2018 Short Courses  

    Who should attend?

    This short course is designed for regulatory professionals and project managers who are new to combination products or who have switched disciplines (e.g. drugs to devices, etc.).

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Discuss how combination products fit into the development processes for drugs/biologics and medical devices
    • Identify the unique challenges of premarket and post-market requirements for combination products in the US and EU
    • Discuss how the 21st Century Cures Act and the EU Medical Device Regulation affects combination products



      Speakers
      CB

      Caitlin Bancroft

      Assoc. Regulatory Affairs Consultant, Pharmatech Associates, Inc.
      avatar for Lynn Hansen

      Lynn Hansen

      Director Regulatory Affairs, Pharmatech Associates Inc.


      Sunday June 24, 2018 9:00am - 5:00pm
      Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #000: Emerging Professionals and Student Forum
      Component Type: Forum
      Level: Basic

      This session will explore the opportunities that student membership in the Drug Information Association (DIA) offers. The session will start with an overview of the DIA and its relationship to the global pharmaceutical, device, and therapeutic industries. Students will find that the information and networking opportunities that DIA provides can help shape and guide course and track selections as they proceed through their educational experiences. The session will also include an inter panel discussion on potential careers for students with a scientific and/or health care background.

      Chair

      Raleigh E. Malik, PhD

      Speaker

      Panelist
      Ranjini Prithviraj, PhD

      Panelist
      Nancy Pire Smerkanich, DrSc, MS

      Panelist
      Margaret Richards, PhD, MPH

      Panelist
      Alberto Grignolo, DIAFellow, PhD



      Speakers
      avatar for Alberto Grignolo

      Alberto Grignolo

      Corporate VP PAREXEL Consulting, PAREXEL
      Alberto Grignolo has 36+ years of experience as a regulatory and drug development professional including consulting for pharmaceutical and biotechnology companies. He is a driver of a successful worldwide consulting business and established PAREXEL’s Japan Consulting Services. He... Read More →
      avatar for Raleigh Malik

      Raleigh Malik

      Senior Scientific Liaison, DIA
      Dr. Raleigh Malik is a Sr. Scientist at DIA in Washington, DC, where she supports the advancement of DIA’s global content strategy by providing scientific expertise related to therapeutic drug development and regulatory disciplines. Prior to joining DIA, Dr. Malik supported medical... Read More →
      avatar for Ranjini Prithviraj

      Ranjini Prithviraj

      Sr Managing Editor/Associate Director, DIA Publications, DIA
      Dr. Ranjini Prithviraj is Senior Managing Editor and Associate Director of Publications at DIA, where she provides strategic thought leadership and delivers content that advances DIA’s mission through various media, including traditional journal publications. Prior to DIA, she was... Read More →
      avatar for Margaret Richards

      Margaret Richards

      Executive Director, Scientific Affairs, Real-World Solutions, PRA Health Sciences
      Dr. Meg Richards has over 25 years' experience as an epidemiologist in the public health, biopharmaceutical, and contract research sectors. Prior to joining PRA as Executive Director of Scientific Affairs, Dr. Richards worked for 8 years at Mapi (ICON plc) and PPD-Evidera. Dr. Richards... Read More →
      avatar for Nancy Smerkanich

      Nancy Smerkanich

      Assistant Professor, Clinical Pharmacy; Educational Liaison & Instructor, ICRS, University of Southern California
      Dr. Smerkanich recently completed her doctorate in Regulatory Science on the Implementation of Benefit-Risk Frameworks in Industry. She leads the clinical regulatory courses while continuing to provide regulatory guidance to her academic and industry peers. In her new role at USC... Read More →


      Sunday June 24, 2018 10:30am - 12:00pm
      Commonwealth Room Westin Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      12:30pm

      1:00pm

      #30: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
      Component Type: Tutorial
      CE: CME 3.25; IACET 3.25; RN 3.25

      The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

      Who should attend?

      This short course is designed for professionals involved with clinical and data operations.

      Learning Objectives

      At the conclusion of this short course, participants should be able to:
      • Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology
      • Discuss the use of key tools in the RBM process
      • Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology



      Sunday June 24, 2018 1:00pm - 4:30pm
      Room 160A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
      • format json
      • Credit Type CME, IACET, RN
      • Tags Tutorial

      1:00pm

      #31: Machine Learning in Pharmacovigilance
      Component Type: Tutorial
      CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

      This short course will explore machine learning (ML) and its application within the Regulatory/ Pharmacovigilance (PV) landscape. We will provide a high-level introduction to ML, including tools and project tips. The core of the course will dive deeper into applications within PV, including examples from our work on ICSR identification. We will also discuss what the future of ML in PV could look like, followed by time for questions and open discussion.

      Since machine learning requires resources from across the organization, this course is designed for anyone interested in sponsoring or joining a machine learning project within their organization.
      An additional registration fee is required for all preconference short courses.
      Back to DIA 2018 Short Courses  

      Who should attend?

      This short course is designed for members of Pharma, Academia, Regulators, and Medicine interested in Machine Learning in PV

      Learning Objectives

      At the conclusion of this course, participants should be able to:
      • Identify advances that make ML practical
      • Describe how ML can be applied to the regulatory and PV landscape
      • Develop potential future use cases for ML in PV



      Speakers
      avatar for Robert Ball

      Robert Ball

      Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA
      Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug risks and promoting the safe use of drugs by the American... Read More →
      avatar for Shaun Comfort

      Shaun Comfort

      Associate Director and Senior Safety Science Leader IIDO, Genentech, A Member of the Roche Group
      avatar for Bruce Donzanti

      Bruce Donzanti

      Senior Group Director, Global Pharmacovigilance Innovation Policy, Genentech, A Member of the Roche Group
      Bruce has a PhD in pharmacology with 20+ years experience in the pharma/bio industry, mostly in drug safety but he has also worked in other areas such as pre-clinical research. During the past 5 years, Bruce was Head, Drug Safety at Genentech before transitioning into a new role in... Read More →
      avatar for Mick Foy

      Mick Foy

      Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group, MHRA
      Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 11 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the signal detection system. He is responsible for two major projects to improve drug safety. Firstly a Gates... Read More →


      Sunday June 24, 2018 1:00pm - 4:30pm
      Room 160B Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:00pm

      #33: Quality Tolerance Limits/Issue Management: Taming the Beast of Clinical Development Risk
      Component Type: Tutorial
      CE: ACPE 3.25 Application UAN: 0286-0000-18-509-L04-P; CME 3.25; IACET 3.25; RN 3.25

      Are you ready for ICH E6 (R2)? Have you defined your Quality Tolerance Limits? This highly interactive short course with hands on experience will apply the TransCelerate Issue Management Conceptual Framework as a foundation in setting tolerance limits, managing issues, and applying analytics as part of quality risk management. The short course will begin with a quick review of ICH E6 R1, R2, and the impact to the clinical development enterprise. Following the review, instructors will provide points to consider regarding the principles and benefits of a framework with a proactive approach for end to end management of issues including a triage mechanism (tolerance limits) that is utilized to drive continuous improvement and supports the management of risk. Using hypothetical case studies (developed for this course) you will begin with designing a proactive approach for the management of issues. TransCelerate tools developed during a 24 month journey with a cross function team from pharma industry participating in a TransCelerate Clinical QMS Initiative for Issue Management will be available and utilized for this exercise. Through this hands on experience, you will develop thresholds for triage thereby setting tolerance limits in the hypothetical cases. Next, you will have the experience of developing CAPAs that make a difference and design trending leading to analytics to identify future signals and risks. Lastly you will have an opportunity to learn from the instructor’s approaches to getting started in their institutions. In 3.5 hours, you will leave with knowledge and access to material developed that will enable you to design a framework for management of issues with tolerance limits which could reside in your own organization’s risk management program. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

      Who should attend?

      This short course is designed for Clinical Development team members involved in risk Mgmt., developing risk tolerance and issue Mgmt. at the site, trial, or program level, study monitors, trial managers/specialists, clinical operations personnel or functions involved in the design, implementation, execution, & reporting of clinical activities associated with human research/clinical development, study coordinators/managers, GCP quality/compliance

      Learning Objectives

      At the conclusion of this course, participants should be able to:
      • Implement a framework in which issues are managed, tolerance limits are defined and resulting data can be leveraged to detect new signals/risks and drive continuous improvement
      • Formulate tolerance limits through a proactive issue management framework
      • Define methodology for trending and analytics that will signal potential risks.



      Speakers
      avatar for Tim Grey

      Tim Grey

      Director,R&D Quality Systems, AbbVie, Inc.
      Tim Grey joined AbbVie in December 2013. He is currently Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team. Tim has spent his career developing, applying, and implementing quality systems principles across the GxP product... Read More →


      Sunday June 24, 2018 1:00pm - 4:30pm
      Room 161 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:00pm

      #34: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Effecting Pharmaceutical Development
      Component Type: Tutorial
      CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-510-L04-P; CME 3.25; IACET 3.25; RN 3.25

      Significant changes in Japanese pharmaceutical regulations and procedures are impacting the development of new drugs in Japan as well as global development programs. This short course will describe the major drivers of the regulatory system, including the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW), regulatory procedures during drug development (consultations with PMDA and clinical trial notifications), the integration of Japanese drug development with East Asian and global drug development, orphan drug regulation and J-NDA preparation and review. Several development strategies available to address Japanese requirements for new drug approval, as well as selected post-approval requirements, will be discussed.
      An additional registration fee is required for all preconference short courses.
      Back to DIA 2018 Short Courses  

      Who should attend?

      This short course is designed for professionals involved in regulatory affairs, project management, and clinical development who are involved with global development projects involving Japan.

      Learning Objectives

      At the conclusion of this short course, participants should be able to:
      • Explain the major elements of the Japanese regulatory system
      • Describe the regulatory procedures during development, registration, and post-approval
      • Discuss specific attributes of the Japanese regulatory system and their impact on local and global development strategies



      Speakers
      avatar for Alberto Grignolo

      Alberto Grignolo

      Corporate VP PAREXEL Consulting, PAREXEL
      Alberto Grignolo has 36+ years of experience as a regulatory and drug development professional including consulting for pharmaceutical and biotechnology companies. He is a driver of a successful worldwide consulting business and established PAREXEL’s Japan Consulting Services. He... Read More →
      avatar for Yoshiaki Uyama

      Yoshiaki Uyama

      Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
      Yoshiaki Uyama is currently Office Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for pharmacoepidemiological safety assessment and regulatory science research relating to new drug review and safety... Read More →


      Sunday June 24, 2018 1:00pm - 4:30pm
      Room 159 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
      • format json
      • Credit Type ACPE, CME, IACET, RN
      • Tags Tutorial

      1:00pm

      #35: FDA Advisory Committee Purpose and Noninferiority Case Study: Rivaroxaban
      Component Type: Tutorial
      CE: ACPE 3.25 Application UAN: 0286-0000-18-511-L04-P; CME 3.25; IACET 3.25; RN 3.25

      In this case study the audience will serve as the CDER Cardiorenal Advisory Committee voting on the same questions as on September 2011 (Rivaroxaban for stroke prevention in atrial fibrillation). The case study will follow the following sequence: CDER Advisory Committee structure and function relative to CDER decisions, rivaroxaban pivotal trial summary (Rocket AF), critical video clips from the advisory committee impacting your vote, biostatistics analysis discussion, your vote, and post advisory committee history including realizing the portable device used to measure INR malfunctioned. Particular focal areas in the case will include issues around dose-response, regional heterogeneity in results, and best practices for device use in pivotal clinical trials. General principles on trial design, analysis and interpretation will be illustrated through topic specific video play and interactive in-class discussion. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

      Who should attend?

      This short course is designed for individuals who work in regulatory affairs, clinical development, biostatistics, trial monitoring, clinical investigators, exploratory development, and regulatory agencies.

      Learning Objectives

      At the conclusion of this course, participants should be able to:
      • Evaluate the CDER Advisory Committee value in regulatory decisions
      • Describe the particular concerns regarding pivotal non-inferiority, multi-regional global trial design
      • Analyze the impact of biomarker device performance on pivotal clinical trials



      Speakers
      avatar for William Wang

      William Wang

      Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
      Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →
      avatar for Stephen Wilson

      Stephen Wilson

      Statistical Consultant
      Statistical reviewer/manager at FDA/CDER for more than 30 years; Captain in the USPHS; Retired as Dir. of Div. of Biometrics III/Office of Biostatistics on June 1, 2017; Received a doctorate in Biostatistics from UNC Chapel Hill in 1984; Also worked for the East West Center, the Indonesian... Read More →


      Sunday June 24, 2018 1:00pm - 4:30pm
      Room 162A Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:00pm

      #36: Value Pricing Bootcamp: A Crash Course in How to Use Real World Evidence to Better Measure Outcomes and Evaluate New Innovative Therapies
      Component Type: Tutorial
      CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-512-L04-P; CME 3.25; IACET 3.25; RN 3.25

      In a post Sovaldi world, payers and industry are regularly at loggerheads on price. Payers complain that their budgets are being decimated, whilst industry states that therapies are now more effective and deserve higher prices. Patients, often, are being caught in the middle. This short course will show that the seemingly intractable pricing impasse is driven by our current system of evaluating new treatments based only on 6-9 months of mean response in a clinical trial, with success determined by a statistical 'p-value'. It will highlight examples of how RWE can be better used to facilitate earlier access, measure outcomes, address value long term across the entire health system, and offer more creative pricing solutions to facilitate better patient access. In addition, this short course will address the Pricing, Value, and Access challenges being caused by highly effective targeted therapies such as IO Checkpoint, CAR T, and Gene Therapies. The short course will feature:
      • Pricing and value case-studies based on current clinical therapies such as CAR T, IO checkpoint, and HEP C
      • Interactive workshop discussions on various payment options such as annuity, up front, or pay on performance
      • An overview of the Italian outcomes system of reimbursement and how it has impacted price and access
      • Real-time cost and outcomes modeling to test and aid discussions on various options to stakeholders
      • Horizon scanning discussions on the impact of cures in areas such as Duchene Muscular Dystrophy, Viral Therapies, or Alzheimer’s which may arrive in 3 5 years: How can we plan now? What should we do differently?
      An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

      Who should attend?

      This short course is designed for Regulators, Insurance (Payers) both National and Private, HTAs, Industry Access Managers (both Large Pharma and Biotech), Health IT Providers, VCs and Fund managers, Patient Advocates.

      Learning Objectives

      At the conclusion of this course, participants should be able to:
      • Compare short and long term outcomes and their impacts on budgets
      • Discuss and evaluate different pricing scenarios in group settings
      • Demonstrate use cases for RWE in pricing and reimbursemen



      Speakers
      avatar for Luca Pani

      Luca Pani

      Former, AIFA; Professor, Department of Psychiatry and Behavioral Sciences, University of Miami
      Luca Pani is Professor of Clinical Psychiatry, Department of Psychiatry and Behavioral Sciences, University of Miami, and Executive Director for Global Medical Innovation, NeuroCog Trials, USA. As former Director General of the Italian Medicines Agency (AIFA) and member of the CHMP... Read More →
      avatar for Duane Schulthess

      Duane Schulthess

      Managing Director, Vital Transformation
      Duane is the Managing Director of Vital Transformation who consults to National health authorities, blue chip multi-national organisations, governments, and stakeholder groups on healthcare policy and technology. He is a regular speaker at many leading international conferences, and... Read More →


      Sunday June 24, 2018 1:00pm - 4:30pm
      Room 162B Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:00pm

      #37: Data Visualization in the Life Sciences
      Component Type: Tutorial
      CE: ACPE 3.25 Application UAN: 0286-0000-18-513-L04-P; CME 3.25; IACET 3.25; RN 3.25

      Traditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues. First and foremost, with the high cost of conducting translational clinical research, it is common to collect as much data as possible on as many endpoints as possible. This phenomenon is further reinforced due to our limited understanding of biological mechanisms and pathways, including the potential genomic underpinnings of a disease or treatment response. For example, we may have a clear understanding for how a novel therapy induces an efficacious response, but there is typically limited knowledge into the downstream effects of the drug to other body systems. A second challenge to communication lies in the increased use of sensitivity analyses to assess the consistency and robustness of study results to varying assumptions. Given the volume of data to review and the variety of analyses to perform, it should come as no surprise that clear insight is often out of reach. In this environment, the traditional means of data summary – tables and listings – are ineffective for gaining insight; visualization is the key to effective communication for the modern clinical trialist. Ben Shneiderman stated that “the purpose of visualization is insight.” Therefore, the goal of this short course is to describe data visualization techniques to aid in the understanding and communication of results from applications in clinical trials and genomics research. Numerous practical illustrations and examples from the literature will be presented. To be accessible to a wide audience, this course will focus on principles and interpretation, and limit technical jargon. At least 2/3 of the course will focus on case studies specific to clinical trials, while the remainder will be spent on examples in genomics. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

      Who should attend?

      This short course is designed to be accessible to a wide audience, it will focus on principles, limit technical jargon, and interpret numerous examples of data visualization using data from the life sciences literature. The audience may include any individual interested in developing their skills for more efficient interpretation and communication of various aspects of study design and analysis.

      Learning Objectives

      At the conclusion of this course, participants should be able to:
      • Describe the transition from traditional methods of data analysis to visual approaches
      • Interpret life science data using one or more data visualizations
      • Assess the strengths and limitations of various graphical techniques
      • Explain the “data story” of numerous clinical research examples using data visualization techniques



      Speakers
      avatar for Kelci Miclaus

      Kelci Miclaus

      Advanced Analytics R&D Senior Manager, SAS Institute Inc., JMP Division
      Kelci Miclaus is Advanced Analytics Sr. Manager for JMP Life Sciences division at SAS Institute. She manages the R&D development team and develops statistical features for JMP Genomics and JMP Clinical software. She joined SAS in 2006 and holds a PhD in Statistics with a biomedical/genetics... Read More →
      avatar for Richard Zink

      Richard Zink

      Director of Statistical Services, TARGET Pharmasolutions Inc.
      Richard C. Zink is Director of Statistics at TARGET PharmaSolutions, an innovative company that generates real-world insights for several diseases, primarily in hepatology and gastroenterology. He is Associate Editor for Therapeutic Innovation and Regulatory Science, and holds a Ph.D... Read More →


      Sunday June 24, 2018 1:00pm - 4:30pm
      Room 160C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #001: Effective Use of Social Media
      Component Type: Workshop
      Level: Basic

      During this workshop, we will focus on Twitter and LinkedIn but also discuss Facebook, Snapchat, and Instagram. We will look at a specific tool for social media management and talk about best practices for incorporation of social media, personally and professionally. We will also look at what guidance the FDA has provided about social media use.

      Learning Objectives

      Discuss the various types of social media (Twitter, LinkedIn, Facebook,Snapchat, Instagram);Differentiate which are best used for what messaging; Identify how to craft the message for maximum exposure.

      Chair

      Robin Whitsell


      Speakers
      avatar for Robin Whitsell

      Robin Whitsell

      President, Whitsell Innovations, Inc
      Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, she has 20 years’ experience, specializing in medical writing and regulatory submission strategies. Prior to founding WI, Ms. Whitsell was the assistant director of preclinical... Read More →


      Sunday June 24, 2018 3:00pm - 4:00pm
      Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      4:15pm

      #002: The Power of Networking
      Component Type: Workshop
      Level: Basic

      This workshop will include personality assessments and discussion of the role that plays in networking. Introvert, extrovert, centrovert (ambivert) and how these types interact and network will be demonstrated. Practice situations will be employed for people to see how to network while at the conference. There will be networking exercises designed to show how closely connected we are in our industry.

      Learning Objectives

      Discuss personality types and how to apply that to networking; Describe the benefits of networking; Recognize the responsibilities of networking.

      Chair

      Chris Matheus, MBA

      Speaker

      Facilitator
      Michelle Esposito



      Speakers
      ME

      Michelle Esposito

      Director, Institutional Services & Sites, Advarra
      Michelle Esposito is Director of Institutional Services and Sites at Advarra, where she provides new and existing clients with guidance and support in working with the IRB. With over 15 years’ experience in B2B sales and marketing, Michelle has honed her networking and relationship... Read More →
      avatar for Chris Matheus

      Chris Matheus

      President, Matheus BD Connections
      Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical technology companies. Chris establishes strong working relationships customers and has built a significant... Read More →


      Sunday June 24, 2018 4:15pm - 5:30pm
      Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
       
      Monday, June 25
       

      7:00am

      7:30am

      Annual Meeting Orientation
      Component Type: Social Event
      Meet long-time Annual Meeting attendees and learn what they get out of the meeting each year, flag can’t miss sessions and content, and discover how you can maximize the value of your time at DIA 2018.




      Monday June 25, 2018 7:30am - 8:15am
      Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      7:30am

      Coffee and Light Refreshments
      Component Type: Social Event




      Monday June 25, 2018 7:30am - 8:30am
      North Lobby

      8:30am

      #100: Opening Plenary Session and Keynote Speaker
      Component Type: Session
      Level: Intermediate
      CE: ACPE 0.50 Knowledge UAN: 0286-0000-18-517-L04-P; CME 0.50; IACET 0.50; RN 0.50

      Join us for the DIA 2018 Global Annual Meeting Keynote Address

      Keynote speaker Dr. Volkow will discuss the need for development of new molecules and formulations, technologies for stimulation of the brain and neurocircuitry, advances in biofeedback, and unique opportunities for wireless and mobile technologies to assist in pain management. She will also emphasize the importance of public-private partnerships in addressing these issues and how to get involved.

      Learning Objectives

      Discuss the need for development of new molecules and formulations, technologies for stimulation of the brain and neurocircuitry, advances in biofeedback, and unique opportunities for wireless and mobile technologies to assist in pain management; Identify the importance of public-private partnerships in addressing addiction issues and how to get involved.

      Chair

      Barbara Lopez Kunz, MSc

      Speaker

      All Hands on Deck: Using Science to Help Solve the Opioid Crisis
      Nora Volkow, MD



      Speakers
      avatar for Barbara Lopez Kunz

      Barbara Lopez Kunz

      Global Chief Executive, DIA
      avatar for Nora Volkow

      Nora Volkow

      Director, National Institute on Drug Abuse, National Institutes of Health (NIH)


      Monday June 25, 2018 8:30am - 10:00am
      Ballroom Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
      • format json
      • Credit Type ACPE, CME, IACET, RN
      • Tags Session

      10:00am

      Coffee Break
      Component Type: Social Event




      Monday June 25, 2018 10:00am - 11:00am
      Exhibit Hall

      10:00am

      Exhibit Hall Open
      Monday June 25, 2018 10:00am - 6:00pm
      Exhibit Hall

      10:00am

      Student Poster Session
      Component Type: Poster Presentation




      Speakers
      JC

      Jacqueline Chen

      Student, University of Southern California
      MH

      Mark Hanna

      PharmD Candidate, St. John's University
      My name is Mark Hanna, and I am a rising P4 pharmacy student at St. John's University. I wish to pursue a fellowship after graduating with my PharmD in 2019.
      SH

      Sydney Hoiseth

      Student, Bedford High School
      NH

      Noreen Hussain

      Touro College of Pharmacy
      Noreen Hussain is currently a student at the Touro College of Pharmacy. She anticipates completing her PharmD in 2019.
      avatar for Nina A. Johnson

      Nina A. Johnson

      PharmD Candidate 2019, Western New England University College of Pharmacy
      I am PharmD Candidate for 2019 with experience in pharmacovigilance, in pursuit of a career in the pharmaceutical industry. During my pharmacy professional program, I have interned as an ORISE fellow in the CDER Office of Clinical Pharmacology and with Shire in both Safety Analytics... Read More →
      avatar for Nahae Kim

      Nahae Kim

      Undergraduate Researcher, University of Southern California
      Hannah Kim is an upcoming 3rd year undergraduate at the University of Southen California. Currently, she is researching with the USC International Center for Regulatory Science. After graduating in 2019, she hopes to pursue her PharmD.
      CM

      Cezar Manansala

      Graduate School of Pharmacy, Centro Escolar University
      avatar for Alexander Agyei Marfo

      Alexander Agyei Marfo

      Student, Touro College of Pharmacy
      Highly motivated, self-driven, and passionate healthcare professional with excellent written and verbal communication skills. Possess solution driven ways of leading and supporting projects and demonstrated cross-functional influence and impact. Team player with good interpersonal... Read More →
      avatar for Katherine St. Martin

      Katherine St. Martin

      Graduate Student, DrSc Regulatory Science Program, University of Southern California (USC)
      Katherine St. Martin, MS, RAC (US) is a doctoral student in University of Southern California’s regulatory science program. She serves as the Principal Regulatory Specialist for the National Marrow Donor Program (NMDP), a non-profit facilitating unrelated stem cell donation. Prior... Read More →
      BM

      Bijan Motamedi

      Doctor of Pharmacy Candidate, 2020, USC School of Pharmacy
      KN

      Kathleen Nagle

      Global Study Manager, Rutgers University
      Since 2013, I have been building my career in the clinical research field. I began as a study coordinator and have progressed to a project manager with Covance Central Laboratory Services. I recently completed my Masters of Science degree from Rutgers School of Health Professions... Read More →
      JN

      Justine Nasejie

      Lecturer, University of Kwazulu-Natal
      I recently graduated with a PhD in Statistics at the University of KwaZulu-Natal and currently employed as a Lecturer in the School of Statistics and Actuarial science at the University of the Witwatersrand.
      avatar for Henrietta Ofuluozor

      Henrietta Ofuluozor

      Student, Touro College of Pharmacy NY
      An international student with a Bachelor's degree in Chemistry and Biology from the University of West Georgia and about 3 years of pharmaceutical industry experience in analytical method validation and quality control testing of Active Pharmaceutical Ingredients (API). Currently... Read More →
      MA

      Muntazir Ali Sayed

      Medical Student, RCSM Government Medical College; CPR General Hospital
      I am a Medical Student from India. I will soon be a doctor. I feel myself to be efficient, productive, committed, enthusiastic and hard-working in whatever I do. In short the word 'Sedulous' fits best to describe my personality. Apart from academic excellence, I have always been very... Read More →
      NT

      Nicole Tsao

      PhD Candidate, University of British Columbia
      SV

      Shannon Vaffis

      Graduate Research Assistant/PhD Student, University of Arizona
      CV

      Christian Vogt

      PharmD Student, Husson University School of Pharmacy
      JW

      John Wageh

      Pharmacy Student, Rutgers University
      John Wageh is a PharmD Candidate at Ernest Mario School of Pharmacy. John has extensive experiences in both community and hospital pharmacy as well as at a an organic synthesis research lab. He is interested in pursuing a residency post-graduation to hone his clinical knowledge and... Read More →
      avatar for Casey Walker

      Casey Walker

      Student, Howard University College of Pharmacy
      I am a rising 3rd year pharmacy student and the student chapter president of DIA at Howard University. My interest in the pharmaceutical industry is rooted in patient engagement. After completing pharmacy school, I aspire to become a Medical Science Liaison.
      RW

      Ryan Wolfe

      Student Pharmacist, Touro College of Pharmacy
      AX

      Annie Xie

      Undergraduate Student, University of Southern California
      Annie Xie is an upcoming 3rd year undergraduate pursuing a B.S. in Pharmacology and Drug Development at the University of Southern California. She currently serves as a USC School of Pharmacy SURF fellow at the USC International Center for Regulatory Science.
      ZY

      Zhuyifan Ye

      student, University of Macau
      MY

      Millicent Yeboah-Awudzi

      Graduate Assistant and PhD Student, Louisianna State University
      TZ

      Tianqi Zhang

      PhD Candidate, University of Macau
      avatar for Enav Zusman

      Enav Zusman

      Student, University of British Columbia


      Monday June 25, 2018 10:00am - 6:00pm
      Posters Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:15am

      #101: PAREXEL International Innovation Theater: Innovation’s Greater Purpose - How Technology Can Increase Commercial Success
      Component Type: Session

      Join PAREXEL and Microsoft to explore how new technology innovations can increase commercial success of your treatments, and provide value to the patient by delivering successful therapies. Learn how your clinical studies can be optimized to run smarter by aligning people, processes, and technology. See how todays cloud-based solutions reduce risk and ensure data compliance.

      Chair

      PAREXEL International


      Speakers
      avatar for Xavier Flinois

      Xavier Flinois

      President, PAREXEL Informatics, PAREXEL
      Xavier Flinois leads PAREXEL’s technology services business and is a member of PAREXEL’s Business Review Committee, the company’s most senior leadership group with extended responsibilities for the company technology and clinical trial supply logistics activities. Mr. Flinois... Read More →


      Monday June 25, 2018 10:15am - 10:45am
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:15am

      #102: Deloitte Innovation Theater: Engage. Innovate. Execute. - How Digital Technologies are Transforming Clinical Development
      Component Type: Session

      The biopharma sector is under pressure to develop innovative and targeted new medicines that demonstrate therapeutic value to patients in need. The current R&D model is not sustainable and clinical development lacks the digital technology infrastructure and integration to leverage the wealth of information available to innovate in patient care. Join Deloitte as we discuss the strategies, technology, and partnerships necessary to build a scalable, sustainable digital R&D footprint. Learn how digital technologies can transform clinical development by increasing the types, amount, and quality of data collected in trials; generate valuable insights from that data; enhance the patient and investigator experience; and improve clinical trial productivity.

      Chair

      Deloitte Consulting


      Speakers
      RS

      Raveen Sharma

      VP, Life Sciences, ConvergeHEALTH by Deloitte


      Monday June 25, 2018 10:15am - 10:45am
      Theater 2 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:15am

      #103: Networking Do's and Don'ts
      Component Type: Workshop
      Level: Basic

      Discussion and demonstration of the usefulness and need for networking.

      This Engage and Exchange will be a follow-up to the Sunday workshop on networking.

      Learning Objectives

      Discuss the importance of preparation when networking; Identify common mistakes; Determine appropriate strategies.

      Chair

      Chris Matheus, MBA

      Speaker

      Details of Networking
      Michelle Esposito



      Speakers
      ME

      Michelle Esposito

      Director, Institutional Services & Sites, Advarra
      Michelle Esposito is Director of Institutional Services and Sites at Advarra, where she provides new and existing clients with guidance and support in working with the IRB. With over 15 years’ experience in B2B sales and marketing, Michelle has honed her networking and relationship... Read More →
      avatar for Chris Matheus

      Chris Matheus

      President, Matheus BD Connections
      Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical technology companies. Chris establishes strong working relationships customers and has built a significant... Read More →


      Monday June 25, 2018 10:15am - 11:00am
      E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #104: LinkedIn Review
      Component Type: Session
      Level: Basic
      CE: IACET 0.50

      There are a few different subscription types to LinkedIn. Which one is best suited to an individual depends on how they will use it. The types will be reviewed as well as identifying the types of professionals who use them. Examples of good profiles will be shown and a description of what makes a good profile will be presented.

      Learning Objectives

      Describe best practices for a LinkedIn profile; Assess examples of good and bad profiles; Identify changes to improve your own profile.

      Chair

      Tom McPhatter


      Speakers
      avatar for Tom McPhatter

      Tom McPhatter

      Director, Business Development, Whitsell Innovations, Inc
      Tom McPhatter is responsible for driving client engagement at Whitsell Innovations. He has a broad background in sales, management, and leadership in multiple market verticals and geographies. Tom has led successful efforts in many complicated and intensely competitive service environments... Read More →


      Monday June 25, 2018 10:30am - 11:00am
      Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #105: Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model
      Component Type: Session
      Level: Basic
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-518-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will discuss how the Cardiac Safety Research Consortium’s collaborative, precompetitive approach has significantly advanced the field of cardiac safety in medical product development. Industry, academia, and regulatory perspectives will be provided.

      Learning Objectives

      Discuss the concept and implementation of Public-Private Partnerships; Recognize the importance of cardiac safety considerations throughout new drug development; Describe new approaches to regulatory science in cardiac safety.

      Chair

      Rick Turner, DrSc, PhD

      Speaker

      The Cardiac Safety Research Consortium: Current Accomplishments and Future Goals
      Mitchell W. Krucoff, MD

      New Approaches to Regulatory Science in Cardiac Safety
      Norman Stockbridge, MD, PhD

      The Comprehensive In-Vitro Proarrhythmia Assay (CiPA)
      Philip T. Sager, MD



      Speakers
      avatar for Mitchell Krucoff

      Mitchell Krucoff

      Professor of Medicine/Cardiology, Duke University
      Dr. Mitchell W. Krucoff is Professor of Medicine/Cardiology at Duke University. He serves as Director of the Cardiovascular Devices Unit and the eECG Core Laboratory at the Duke Clinical Research Institute (DCRI) and is a special government employee of the United States FDA, from... Read More →
      PS

      Philip Sager

      Adjunct Professor, Stanford University
      Philip T. Sager, M.D, FACC, FAHA, FHRS is an Adjunct Professor at the Stanford University, the previous chair of the FDA Cardio-Renal Advisory Committee and an Executive Comm. member of the Cardiac Safety Research Consortium. He is a member of the ICH E14 QT Group and is on the Steering... Read More →
      NS

      Norman Stockbridge

      Director, Division of Cardiovascular and Renal Products, OND, CDER, FDA
      Norman Stockbridge received his MD and PhD (Physiology) from Duke University. He has been a part of the FDA/CDER Division of Cardiovascular and Renal Products since 1991, serving as Division Director since 2004.
      avatar for Rick Turner

      Rick Turner

      President, Turner Consulting and Communications LLC
      J. Rick Turner, PhD, DSc, is an experimental research scientist, and currently President, Turner Consulting & Communications LLC. He is a member of the Cardiac Safety Research Consortium’s Executive Committee, and an active participant in many aspects of the Science of Cardiac Safety... Read More →
      avatar for Rick Turner

      Rick Turner

      Expert Consultant, DRT Strategies, Inc.
      J. Rick Turner, PhD, DSc, is an experimental research scientist, and currently President, Turner Consulting & Communications LLC. He is a member of the Cardiac Safety Research Consortium’s Executive Committee, and an active participant in many aspects of the Science of Cardiac Safety... Read More →


      Monday June 25, 2018 11:00am - 12:00pm
      Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #107: The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials
      Component Type: Forum
      Level: Basic
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-520-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will examine the promise of virtual trials to address challenges of traditional site-based models by examining the evolving roles of study stakeholders, patients, investigators, and study managers, and how they improve study performance

      Learning Objectives

      Describe the potential promise, benefits, and considerations of virtual clinical trials to address challenges to clinical trial conduct and participation; Define the evolution of stakeholder roles, existing and new, and the interplay between them, in virtual/direct to patient clinical trials; Apply insights to inform virtual trial design and planning.

      Chair

      Josh Rose, MBA

      Speaker

      Panelist
      Angela Botto-van Bemden, PhD

      Panelist
      Jeff Kingsley, DO, MBA

      Panelist
      Christina M. Markus, JD

      Panelist
      Robert Goldman, PhD



      Speakers
      avatar for Angela Botto-van Bemden

      Angela Botto-van Bemden

      Director, OA Programs, Arthritis Foundation
      TBD- MCT Stakeholder Perceptions project, CTTI
      avatar for Robert Goldman

      Robert Goldman

      Head, Global Medical Affairs, Sunovian
      avatar for Jeff Kingsley

      Jeff Kingsley

      Chief Executive Officer, IACT Health
      Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and twelve wholly owned and integrated clinical research offices. The companies conduct phase Ib through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology... Read More →
      CM

      Christina Markus

      Partner/Attorney, King & Spalding LLP
      avatar for Josh Rose

      Josh Rose

      Vice President, Global Head of Strategy, IQVIA
      As Vice President and Global Head of Strategy for the R&D Solutions business unit at IQVIA, Josh Rose is responsible for building the overarching strategy for the clinical development business, establishing and governing strategic initiatives, and leading the identification of acquisition... Read More →


      Monday June 25, 2018 11:00am - 12:00pm
      Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #108: From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-521-L04-P; CME 1.00; IACET 1.00; RN 1.00

      Too often sponsors resort to obtaining input from their most important stakeholder, the patient, only after their study is not enrolling to plan. Improving the quality of health outcomes, the goal of our collective efforts, can only happen if we keep those receiving our treatments involved in the life of the process. Led by a practicing physician, this session will provide real life examples of effective collaboration with advocacy groups, sites, and CROs to inform and help develop a protocol that be of interest to and will benefit the patient.

      Learning Objectives

      Describe best practices for obtaining and incorporating input from key stakeholders in protocol design; Discuss strategies for collaborating with advocacy groups; Identify protocol development best practices including template creation, facilitating review, and finalization strategies.

      Chair

      Andrea Lukes, MD, MHS

      Speaker

      Best Ways to Partner with Advocacy Group: From a CRO Perspective
      Clint Dart, MS

      The Advocacy Group's Voice
      Michelle Witkop, DrSc



      Speakers
      avatar for Clint Dart

      Clint Dart

      Senior Director, Biometrics, Health Decisions
      Clint is responsible for the oversight of Biometrics (statistics) and Medical Writing at Health Decisions and have over 21 years of clinical trial experience. He is the principle investigator of the statistical and clinical coordinating center that HD runs for the NICHD. He is responsible... Read More →
      avatar for Andrea Lukes

      Andrea Lukes

      Co-Founder, OB/GYN, Carolina Research and Wellness Clinic
      Dr. Andrea S. Lukes is a board-certified OB/GYN, a Fellow of The American College of Obstetricians and Gynecologists and an expert on clinical development of women’s health products in indications across the female lifecycle. As the Chief Medical Officer, Dr. Lukes advises Health... Read More →
      avatar for Michelle Witkop

      Michelle Witkop

      Head of Research, National Hemophilia Foundation
      As the Head of Research, Dr. Witkop, a Doctor of Nursing Practice, leads the National Hemophilia Foundation’s research initiatives. Previously the lead practitioner at the Northern Regional Bleeding Disorders Center in Traverse City MI, she is the 2015 recipient of the Nurse of... Read More →


      Monday June 25, 2018 11:00am - 12:00pm
      Room 258AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #111: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-524-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will describe approaches for implementation of a data integrity tool such as the Playbook, management of identified issues, lessons learned and next steps.

      Learning Objectives

      Describe a proven solution to implement a cross-functional technical approach to perform audit trail reviews for ensuring data integrity; Identify lessons learned and best practices.

      Chair

      Nareen Katta, MBA, MS

      Speaker

      Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics Driven Approach to Monitor Data Integrity
      Nareen Katta, MBA, MS

      Data Integrity: It's Not Just for Clinical Data
      Gene Vinson



      Speakers
      NK

      Nareen Katta

      Director, Data Sciencies, Abbvie
      Nareen Katta works as a Director, Clinical Analytics in Data Science organization at AbbVie. Nareen has over 15 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the analytics strategy in support of Risk Based... Read More →
      avatar for Gene Vinson

      Gene Vinson

      Senior Director, Global Data Technologies, Biometrics, Syneos Health
      Gene Vinson has over 15 years’ experience in a clinical research organization (CRO) and is currently the Senior Director of Global Data Technologies in Biometrics at Syneos Health. Gene has lead the implementation of multiple EDC Systems and is an expert in the implementation of... Read More →


      Monday June 25, 2018 11:00am - 12:00pm
      Room 209 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #115: Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-528-L04-P; CME 1.00; IACET 1.00; RN 1.00

      Regenerative medicine therapies include certain cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products, including genetically modified cellular therapies and gene therapies that produce durable effects. Challenges in the development of these products range from establishing a consistent manufacturing process to demonstrating efficacy in clinical trials. This session will address the regulatory framework for regenerative medicine products, Regenerative Medicine Advanced Therapy designation, and will also suggest potential pathways sponsors can take to address issues related to manufacturing and clinical trial design.

      Learning Objectives

      Describe the regulatory framework for regenerative medicine products; Identify potential pathways sponsor can take for issues related to manufacturing and clinical trial design.

      Chair

      Peter W. Marks, MD, PhD

      Speaker

      Regenerative Medicine Advanced Therapy Designation Pathway
      Tejashri Purohit-Sheth, MD

      Advancements in Product Manufacturing: Lessons Learned from Developing Cellular Therapies
      Robert W. Mays, PhD

      Preclinical Program Development to Support Early-Phase Clinical Trials
      Jane S. Lebkowski, PhD

      EMA Approach to Regulating Advanced Therapies
      Marie-Helene Pinheiro, PharmD

      Panelist
      Iwen Wu, PhD

      Panelist
      Donald Wright Fink, PhD

      Panelist
      Joshua Hare, MD, FACC



      Speakers
      DF

      Donald Fink

      Cell Therapies Branch, Division of Cellular and Gene Therapies, OTAT, CBER, FDA
      Presently, Dr. Fink is engaged in overseeing an extensive portfolio of applications that includes hematopoietic, mesenchymal, cord blood, placenta-derived, and pluripotent stem cell-derived cellular products. His current appointment is as Expert Regulatory Biologist with specific... Read More →
      avatar for Joshua Hare

      Joshua Hare

      Founding Director, Interdisciplinary Stem Cell Institute; Professor of Medicine, University of Miami
      Dr. Joshua Hare directs the Interdisciplinary Stem Cell Institute at the University of Miami. He is a pioneer advancing stem cell therapeutics through first-in-human clinical trials. He's published multiple clinical trials investigating mesenchymal stem cells in patients with heart... Read More →
      avatar for Jane Lebkowski

      Jane Lebkowski

      President of Research and Technology, Regenerative Patch Technologies
      Jane Lebkowski has been actively involved in the development of cell and gene therapies since 1986 and is President of R&D at Regenerative Patch Technologies, a biotechnology firm developing composite stem cell-based implants for geographic atrophy. Jane Lebkowski also served as Chief... Read More →
      avatar for Peter Marks

      Peter Marks

      Director, Center for Biologics Evaluation and Research, FDA
      Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
      RW

      Robert W. Mays

      Vice President of Regenerative Medicine and Head of Neuroscience Programs, Athersys, Inc.
      Dr. Mays is the Head of Neuroscience and VP of Regenerative Medicine at Athersys, Inc. He is focused on the company's proprietary stem cell product, MultiStem®, and its applications in Regenerative Medicine. Dr. Mays was the Principal Investigator of the published MASTERS clinical... Read More →
      avatar for Marie-Helene Pinheiro

      Marie-Helene Pinheiro

      Industry Stakeholder Liaison, Corporate Stakeholders Department, European Medicines Agency (EMA)
      Marie-Helene Pinheiro currently the Industry Stakeholder Liaison within the Corporate Stakeholders Department, at the European Medicines Agency. She is responsible for coordinating the Agency’s interaction with industry stakeholder organisations, for human and veterinary medicines... Read More →
      TP

      Tejashri Purohit-Sheth

      Director/DCEPT, Office of Tissues and Advanced Therapies, CBER, FDA
      Dr. Purohit-Sheth is the Director for the Division of Clinical Evaluation and Pharmacology Toxicology (DCEPT) in CBER’s Office of Tissues and Advanced Therapies. Her division is responsible for oversight of clinical, pharmacology/toxicology, and clinical pharmacology reviews for... Read More →
      IW

      Iwen Wu

      Branch Chief of Pharmacology and Toxicology 2, OTAT, CBER, FDA
      She has previously held positions as a Pharmacology/Toxicology Team Lead and Reviewer. Prior to joining CBER, she was a lead reviewer in the Renal Devices Branch at the Center for Devices and Radiological Health and a Commissioner’s Fellow at FDA. She completed her Ph.D. in Biomedical... Read More →


      Monday June 25, 2018 11:00am - 12:00pm
      Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #117: Beyond Robotics Process Automation: Next Generation Integrated QMS for R&D
      Component Type: Forum
      Level: Advanced
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-529-L04-P; CME 1.00; IACET 1.00; RN 1.00

      In this forum, our panel will present an overview of current quality management system (QMS) trends, novel digital approaches to connecting data through the QMS bottom-up process framework, as well as implemented digital use cases. The use case discussions will include a global pharmaceutical company and a global CRO. In detail, the panel will describe the methodology of implementing an integrated, cross-functional, process centric, digital QMS. Further, the panel will conclude the forum by describing and discussing the operational benefits/efficiencies, regulatory obligations and lessons learned in designing and implementing a digital process and customer focused QMS/QRM system.

      Learning Objectives

      Review and discuss current QMS/QRM systems and practices; Describe next generation technologies to enable data integrations in legacy systems based on process/procedure management; Discuss the benefits of integrating the QMS and QRM together.

      Chair

      Christina R. Morris

      Speaker

      Panelist
      Ed Chase

      Panelist
      Brad Haby

      Panelist
      Kimberly Tableman, MSc



      Speakers
      EC

      Ed Chase

      Senior Director, Life Sciences, Pegasystems
      BH

      Brad Haby

      Sr. Director, Data Science, PRA Health Sciences
      Brad Haby is currently the Sr. Dir of Data Science at PRA Health Sciences. Brad has built Business Intelligence and Data Science teams from the ground up at PRA. He received his degree in Electrical Eng. from Texas A&M Univ. before becoming a Process Engineer in Semiconductor manufacturing... Read More →
      CM

      Christina Morris

      Senior Manager, Life Science Advisory, Ernst & Young, LLP
      Christina has over 17 years of clinical research experience, including over 12 years in pharma in clinical operations, training, quality auditing and quality management systems. She has establish R&D and Consumer Quality Management System to enabled consistent process improvement... Read More →
      avatar for Kimberly Tableman

      Kimberly Tableman

      Head, Digital Clinical Trials, PCPS, GSK


      Monday June 25, 2018 11:00am - 12:00pm
      Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #122: Contracting for Value: From Outcomes-Based Contracts to Bundled Payment Programs: What’s Working and Why
      Component Type: Forum
      Level: Basic
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-534-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will explore the challenges and opportunities with demonstrating value to different stakeholders and using big data, analytics, and outcomes to develop, implement, and transform value and outcomes-based programs that touch payers, industry, and providers.

      Learning Objectives

      Discuss the macro forces driving and impeding value-based contracts for payers, industry and providers; Describe methods of understanding risk and tracking performance under a value based contract for different stakeholders; Describe new models that focus on partnership and leverage data and advanced analytics to understand patient populations; Identify areas of risk and how to mitigate those risks.

      Chair

      Richard Gliklich, MD

      Speaker

      Payer Perspective
      Jim Clement, MHA

      Industry Perspective
      Robert Duffield, II, JD

      Provider View
      Thomas Renshaw



      Speakers
      avatar for Robert Duffield

      Robert Duffield

      Counsel, Novo Nordisk A/S
      Robert P. Duffield, II is currently Counsel for Market Access at Novo Nordisk based in Plainsboro, NJ. He advises on a variety of matters impacting the global pharmaceutical industry, but focuses primarily on managed markets issues including contracting strategy. He supports Novo... Read More →
      avatar for Richard Gliklich

      Richard Gliklich

      Chief Executive Officer, OM1
      Dr. Richard Gliklich is the CEO of OM1, Inc., an AI and big data company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale University... Read More →
      avatar for Thomas Renshaw

      Thomas Renshaw

      Senior Director, Business Solutions, Apexus, LLC


      Monday June 25, 2018 11:00am - 12:00pm
      Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #106: Signal Management: Separating Needles From Haystacks
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-519-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The session will discuss signal management throughout the lifecycle and how to transition from the pre-approval to the post approval setting. In the post-approval setting, we will concentrate on signal management requirements in EudraVigilance and provide some examples of how companies are addressing the requirements.
      The speakers have broad experience and represent the perspectives of CROs, large pharma and small biotech companies.

      Learning Objectives

      Describe the key elements of a signal management process throughout the lifecycle; Identify the requirements of signal management in EudraVigilance and formulate best practices.

      Chair

      William Gregory, PhD

      Speaker

      Experiences with the EVDAS Requirements
      Uwe Trinks, DrSc, PhD

      From Clinical Trial to Post-Marketing Signal Management: A Continuum
      Rosa A. Piccirillo, MD

      Latest Initiatives with Signal Detection and Management at MHRA
      Mick Foy



      Speakers
      avatar for Mick Foy

      Mick Foy

      Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group, MHRA
      Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 11 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the signal detection system. He is responsible for two major projects to improve drug safety. Firstly a Gates... Read More →
      avatar for William Gregory

      William Gregory

      Safety and Risk Management, Pfizer Inc
      He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
      RP

      Rosa Piccirillo

      Senior Director and Global Head, Medical Safety, Core Safety Services, IQVIA
      Dr. Piccirillo is a Sr. Director Medical Safety at IQVIA. Dr. Piccirillo has experience in clinical trial development and implementation, with special focus on safety reviews, post-marketing surveillance, signal detection, risk management, reference safety information review-updates... Read More →
      UT

      Uwe Trinks

      Partner and Director, Foresight Group, An IQVIA Company
      Dr. Trinks is a Partner at Foresight Group International AG with 30 years of experience in Pharmaceutical R&D holding senior postions in R&D IT at Ciba-Geigy and Novartis and as CIO of Sentrx. He received a PhD in organic chemistry from the Swiss Federal Institute of Technology (ETH... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #109: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-522-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Panelists will discuss how they have implemented recommendations from CTTI’s Mobile Clinical Trials projects to advance the use of mobile technology in clinical trials, as well as how others can adopt these strategies.

      Learning Objectives

      Describe recommendations for successfully incorporating mobile technology in regulatory submission trials; Identify approaches for developing novel endpoints, overcoming legal and regulatory barriers, and incorporating mobile devices in clinical trials while accounting for site and patient perspectives; Discuss opportunities to implement recommendations in attendee organizations.

      Chair

      Robert A. DiCicco, PharmD

      Speaker

      Panelist
      Cynthia Geoghegan

      Panelist
      Philip Coran, JD, MBA

      Panelist
      Jan Hewett, BSN, JD



      Speakers
      avatar for Philip Coran

      Philip Coran

      Principal, Global Compliance and Strategy, Medidata Solutions
      Phil Coran is a Principal of Global Compliance & Strategy at Medidata. Prior to joining Medidata, Phil was at Pfizer for 12 years in the Medical Quality Assurance and Internal Audit groups. From 1999-2001, Phil was an IT Risk Consultant at Deloitte & Touche & Arthur Andersen accounting... Read More →
      avatar for Robert DiCicco

      Robert DiCicco

      Executive Consultant, TransCelerate Biopharma Inc.
      Rob DiCicco is an executive consultant for TransCelerate. He is the Executive Sponsor for the Common Protocol Template Project and was one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over 25 years of experience in clinical development. His... Read More →
      avatar for Cynthia Geoghegan

      Cynthia Geoghegan

      Patient Representative, Patients and Partners LLC
      A patient advocate and cancer survivor with decades of health policy, communications and non-profit leadership experience, Cindy Geoghegan founded Patient & Partners to ensure that the patient perspective is represented throughout industry, academic, government and non-profit efforts... Read More →
      avatar for Jan Hewett

      Jan Hewett

      Regulatory Counsel for Policy, OSI, CDER, FDA
      Jan Hewett is currently Regulatory Counsel (Policy) at the FDA (CDER – Office of Scientific Investigations). Before joining OSI, Jan served in various HRPP & IRB Director, Snr. Grants & Contracts and Clinical Research Nurse Coordinator roles. She has also served as a member of the... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #110: Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-523-L04-P; CME 1.25; IACET 1.25; RN 1.25

      While healthcare is rapidly adapting to the digital era, the basic systems and processes for conducting clinical studies to assess new medical treatments are still based on the legacy of a separate, paper-based, parallel process. EDC helped, but still was based on collecting data in a separate, siloed process disconnected from general healthcare practices.
      Given the priorities of the FDA to incorporate real-world evidence from EHRs as eSource, coupled with industry pressure to reduce cost and time to market while reducing the burden on sites, the emergence and adoption of HL7 FHIR as a universal standard API that can make healthcare data readily available in a standard format for research purposes provides a provocative lever for reimagining research.

      This session will examine the current state, readiness, and opportunities for applying FHIR to dramatically transform the research process.

      Learning Objectives

      Discuss the basics of FHIR APIs, how they support goals of 21st Century Cures, and what FHIR can do for a variety of research-related use cases; Describe how experienced implementers worked with FHIR, and how the FHIR community is working to achieve interoperability among providers, investigators, researchers and patients.

      Chair

      Wayne R. Kubick, MBA

      Speaker

      Fast Healthcare Interoperability Resources: An Evolving Data Standard for Interoperability in the Life Sciences Industry
      Kunal Dubey, MBA

      eSource and FHIR: The TransCelerate Experience
      Jesper Kjaer, MS



      Speakers
      KD

      Kunal Dubey

      Healthcare Consultant, Citius Tech Healthcare Technology Pvt. Ltd.
      Kunal has worked in Healthcare IT sector for over 7 years. Over the course, he has advised leading pharmaceutical and clinical trial companies on data integration, analysis and interoperability. Kunal has worked with leading IT companies as a consultant helping their clients map technologies... Read More →
      JK

      Jesper Kjaer

      Manager, Novo Nordisk A/S
      Depart. Manager within Clinical Systems, Data and Trial Management (CSDTM) at Novo Nordisk A/S. The team is driving market research of and provides guidance internally on mHealth, patient facing technologies and eSource from eHR. Active member of the TransCelerate eSource and Patient... Read More →
      avatar for Wayne Kubick

      Wayne Kubick

      Chief Technology Officer, HL7 International
      Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #112: Scientific Communication Key Message Development, Management, and Dissemination
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-525-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will provide solutions for optimizing key message development and disclosure, including input/output links, data-to-message mapping, and awareness/access details important for strategic alignment of scientific narrative.

      Learning Objectives

      Share scientific key message and narrative development, management, and disclosure processes; Define the cross-functional inputs and outputs of medical/scientific key message development, including the role of advisory board relationships and workshops in message development; Summarize improved and expanded awareness to key messages, including new methods to communicate complex medical information to maximize their value.

      Chair

      David B. Clemow, PhD

      Speaker

      Scientific Narrative Development: Medical Message Inputs and Disclosure Outputs
      David B. Clemow, PhD

      The Advisory Board ‘Laboratory’ for Key Message Development
      Kristine Jolliffe

      Innovating Medical Communications: Transformative Approaches for Adding Value Through Improved Medical Decision-Making
      Wesley Portegies, MBA



      Speakers
      avatar for David Clemow

      David Clemow

      Advisor, Scientific Communications Information Strategy, Eli Lilly and Company
      David is an Advisor Scientific Communications Information Strategy at Eli Lilly and Company with over 20 years of regulatory, publication, and promotional scientific communications experience in the pharmaceutical industry. His work has included document authoring, team management... Read More →
      avatar for Kristine Jolliffe

      Kristine Jolliffe

      Director, Scientific Content, Six Degrees Medical Consulting
      Kristine Jolliffe, PhD is Director, Scientific Content at Six Degrees Medical Consulting, a leader in global medical communications. Kristine specializes in strategic communication and the effective use of advisory boards in the areas of chronic endocrine and cardiovascular disease... Read More →
      avatar for Wesley Portegies

      Wesley Portegies

      Chief Executive Officer, Medicalwriters.com
      Wesley has 10+ years’ experience as a marketing manager in the medical industry. He has successfully launched several products in the pharmaceutical and medical device market and has a great passion for Medical Communications. Wesley prides himself as being a motivated, strategic... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 210C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #113: Patient-Focused Medicines Development: Where It has Led Us to Today, What Challenges Remain, and What Do We Still Need to Do to Achieve Success?
      Component Type: Forum
      Level: Basic
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-526-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Using a multi-disciplinary approach, we will take a dynamic look at the experience of those involved in patient engagement, across stakeholder groups representing different regions, to understand how we have collectively moved the needle. As organizations have embarked upon efforts and implemented initiatives, we will provide a bird’s eye view of the impact of patient engagement across various stakeholders.

      Learning Objectives

      Describe how patient engagement has evolved across stakeholder groups in the past few years; Discuss the impact of collective approaches on patient engagement in medicines development lifecycle; Apply key learnings from collective approaches in their own efforts; Describe recent achievements in patient engagement and identify remaining challenges.

      Chair

      Lode Dewulf, MD, FFPM

      Speaker

      Panelist
      David Gray

      Panelist
      Sarah Krug, MS, MSc

      Panelist
      Pamela Tenaerts

      Panelist
      Lisa Cone



      Speakers
      avatar for Lisa Cone

      Lisa Cone

      Patient, Parkinson's Disease Foundation Initiative
      Now retired from corporate leadership roles, Lisa Cone leverages her personal experience as a person with Parkinson’s Disease and her professional experiences working with healthcare providers as a Patient Advocate. She was chosen to be a member of the 2014 PatientsLikeMe (PLM... Read More →
      avatar for Lode Dewulf

      Lode Dewulf

      Chief Patient Officer, Servier
      Lode recently joined Servier as Chief Patient Officer, reporting to the CEO, because the Patient IN strategy is a core pillar of Servier’s transformation process RiSe. Lode, a physician with 30y global industry experience, is a known global leader and trusted reference for the development... Read More →
      avatar for David Gray

      David Gray

      Senior Director, Pfizer Inc
      David Gray is a Drug Discovery team leader based in Cambridge, MA. He's focused mainly in the Neuroscience and Pain, with experience spanning early preclinical "idea" stage to large scale global development of clinical candidates. Additional areas of interest include effectively incorporating... Read More →
      avatar for Sarah Krug

      Sarah Krug

      Chief Executive Officer, CANCER101
      Sarah Krüg is CEO of CANCER101, the founder of Health Collaboratory, and the ED of the Society for Participatory Medicine. She serves on the board of NORD and previously held the position of Global Education Director as well as Patient Advocacy Relations at Pfizer. She also established... Read More →
      avatar for Pamela Tenaerts

      Pamela Tenaerts

      Executive Director, Clinical Trials Transformation Initiative (CTTI)
      Dr. Tenaerts provides senior level oversight of CTTI and directs efforts to effectively engage all stakeholders to improve conduct of clinical trials. She is a member of PCORI's CTAP expert post-award subcommittee and MIT Collaborative Initiatives Clinical Trials Process Expert Advisory... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 151AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
      • Level Beginner
      • format json
      • Credit Type ACPE, CME, IACET, RN
      • Tags Forum

      11:00am

      #114: A Hot Debate: Perspectives on Benefit and Risk From Patients Across Diseases
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-527-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session provides a look at how regulators, companies, and patients can work together to discuss the benefits and risks of emerging products that can lead to better patient outcomes.

      Learning Objectives

      Describe how regulators incorporate patient preferences into benefit/risk assessment; Identify how international efforts are building methodology for patient preferences and input into development, using case study examples.

      Chair

      Deborah E. Collyar

      Speaker

      Benefit- Risk Communication: Lessons from Patients
      Dinah Duarte, PharmD, MSc

      PREFERing to Advocate for Patient Preferences
      Rebecca A. Noel, DrPH



      Speakers
      avatar for Deborah Collyar

      Deborah Collyar

      President, Patient Advocates In Research (PAIR)
      Deborah Collyar is a leader in patient advocacy, utilizing successful business, leadership and IT skills to bridge gaps between science, research, medicine and patients. Her advocacy work encompasses diseases, programs and policies at grassroots, national and international levels... Read More →
      avatar for Dinah Duarte

      Dinah Duarte

      Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
      Senior assessor at Scientific Evaluation Unit (Portuguese Regulatory Authority - INFARMED). Expert member at European Medicines Agency (EMA). Current Committee for Orphan Medicinal Products member. Representative in ENCePP (European Network Centres Pharmacoepidemiology & Pharmacovigilance... Read More →
      avatar for Rebecca Noel

      Rebecca Noel

      Global Benefit-Risk Lead, Global Patient Safety, Eli Lilly and Company
      Rebecca (Becky) Noel is currently the Global Leader for Benefit-Risk Assessment at Eli Lilly and Company. Since joining Lilly in 2002, Becky has been extensively involved in leading the development of systematic approaches to benefit-risk assessment, both internally at Lilly and externally... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 153ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #116: Culture: The Link Between Team Culture and Productivity - An Interactive Workshop
      Component Type: Workshop
      Level: Intermediate
      CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000220; RN 1.25

      This workshop will allow participants to clearly articulate what culture is, how it impacts productivity, and how they can influence teams, management, and stakeholders.

      Learning Objectives

      Identify opportunities for influencing team behavior and ways of working together more effectively to drive productivity; Describe a culture call to action to implement within their teams.

      Chair

      Nancy Slater, MBA

      Speaker

      Facilitator
      Carrie Furin

      Facilitator
      Nancy Watanabe



      Speakers
      avatar for Carrie Furin

      Carrie Furin

      Manager, Clinical Trial Management, Eli Lilly and Company
      Carrie is a Manager with Eli Lilly and Company overseeing Clinical Trial Managers on Oncology trials. She has over 10 years of drug development experience in clinical operations and project management. Carrie has led teams across multiple therapeutic areas and phases, which has provided... Read More →
      NS

      Nancy Slater

      Senior Director, AbbVie, Inc.
      Nancy Slater, MBA, PMP is Senior Director, Portfolio Program Management Therapeutic Area Head for Virology and General Medicines at AbbVie. Nancy has over 24 years of Project Management experience in drug development, strategic process improvement initiatives and global lifecycle... Read More →
      NW

      Nancy Watanabe

      Senior Director, BeiGene, Inc.


      Monday June 25, 2018 11:00am - 12:15pm
      Room 254AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #118: How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making?
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-530-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Why has the utilization of real-world data to assess efficacy lagged relative to the application of real-world safety data? Important questions must be addressed concerning efficacy data quality, endpoint surrogacy, and overall study design. This session will bring together global regulators, healthcare technologists, and drug developers to tackle the practical challenges, so that real world evidence can be more optimally incorporated into regulatory decision making.

      Learning Objectives

      Identify how real-world data must be collected, analyzed and reported in order to be useful in regulatory decision-making beyond the post-market safety surveillance setting.

      Chair

      Jeffrey N. Stuart, PhD, RAC

      Speaker

      EMA Perspective
      Tânia Teixeira, PharmD

      Regulatory Perspective
      Nikolai Constantin Brun, MD, PhD

      Patient Perspective
      Jeff Allen, PhD

      FDA Perspective
      Jacqueline A. Corrigan-Curay, JD, MD



      Speakers
      avatar for Jeff Allen

      Jeff Allen

      President and Chief Executive Officer, Friends of Cancer Research
      Jeff Allen is President and CEO of Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments... Read More →
      avatar for Nikolai Brun

      Nikolai Brun

      Chief Medical Officer, Director of Division for Medical Evaluation and Biostats, Danish Medicines Agency
      MD, PhD Background and experience in the Clinical field and afterwards in research and development of pharmaceuticals in the Biotech and Pharmaceutical Industry for 17 years with a long list of publications in high-impact journals. 1.5 years as Medical Director responsible for Medical... Read More →
      avatar for Jacqueline Corrigan-Curay

      Jacqueline Corrigan-Curay

      Director, Office of Medical Policy, CDER, FDA
      Dr. Corrigan-Curay brings to the position a unique legal, scientific policy, and clinical background with expertise in risk and scientific assessment, and clinical trial design and oversight. Before joining FDA, she served as supervisory medical officer with the Immediate Office of... Read More →
      avatar for Jeffrey Stuart

      Jeffrey Stuart

      Global Regulatory Director, Oncology, Immunology, and InVitro Diagnostics, Merck & Co., Inc.
      Jeff Stuart is a Regulatory Affairs Certified professional whose current interests include immunooncology and precision medicine. He has served as a speaker, session organizer, and steering committee member for several DIA events and has authored numerous scientific publications... Read More →
      TT

      Tânia Teixeira

      EMA Liaison Official at FDA, European Medicines Agency (EMA)
      Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #119: ‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-531-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The new requirements in FDARA Title V will substantially impact the conduct of pediatric oncology research globally. This session will explore the pediatric provisions in FDARA Title V, assess feasibility challenges in pediatric oncology drug development, and how they may be impacted by the new provisions in law, and will assess the potential global impact of FDARA. Session will include an interactive, global Q&A session with the audience and panel.

      Learning Objectives

      Describe and explain the new provisions in FDARA 2017 Title V that will impact global pediatric oncology development going forward; Analyze the implications and assess the impact of these new provisions on global pediatric oncology development.

      Chair

      Melodi J McNeil, MS, RPh

      Speaker

      Industry Perspective
      Christina Bucci-Rechtweg, MD

      FDA Perspective
      Lynne P. Yao, MD

      EMA Perspective
      Agnès Saint-Raymond, MD



      Speakers
      avatar for Christina Bucci-Rechtweg

      Christina Bucci-Rechtweg

      Global Head, Pediatric and Maternal Health Policy, Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation
      Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 16 yrs of experience in Clinical Development and Regulatory Policy... Read More →
      avatar for Melodi McNeil

      Melodi McNeil

      Director, AbbVie, Inc.
      Melodi J. McNeil, R.Ph., M.S. Ms. McNeil is currently a Director in AbbVie’s Rockville, Maryland Regulatory Policy and Intelligence office. She identifies, assesses, and comments on proposed regulatory policies, and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
      avatar for Agnès Saint-Raymond

      Agnès Saint-Raymond

      Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
      MD, Paediatrician. Chef de Clinique in Paediatrics@Necker-Enfants-Malades Hospital (Paris 1985-90). Pharma industry 1990-95. French Medicines Agency (ANSM) 1995-99 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. EMA 2000-current. EMA Head of Paediatric Medicines, Orphan Medicines... Read More →
      avatar for Lynne Yao

      Lynne Yao

      Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA
      Lynne Yao, MD, is the Director, Office of New Drugs, Division of Pediatric and Maternal Health in the Center for Drug Evaluation and Research, US Food and Drug Administration. The Division of Pediatric and Maternal Health oversees quality initiatives within the Office of New Drugs... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #120: FDA Innovation in Pharmaceutical Quality Assessment and Inspection
      Component Type: Session
      Level: Basic
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-532-L04-P; CME 1.25; IACET 1.25; RN 1.25

      FDA’s Office of Regulatory (ORA) and Office of Pharmaceutical Quality (OPQ) within CDER work closely together to provide “one quality for voice” for products including new drugs, biotechnology products, generic drugs, and over-the-counter drugs. Many changes and innovation have occurred since the 2015 stand up of OPQ and the 2017 program alignment within ORA. This session will discuss some of the innovative approaches being used within OPQ and ORA to provide more focused and patient relevant quality assessments, promote review efficiency and innovation for generic drugs and to integrate quality assessment and inspection.`

      Learning Objectives

      Identify the ongoing FDA initiatives to modernize and integrate the quality assessment and inspection processes for drugs.

      Chair

      Christine M. V. Moore, PhD

      Speaker

      Modernization of Quality Assessment of Generic Drugs
      Susan M. Rosencrance, PhD

      Patient-Focused Quality Within OPQ: Clinically Relevant Specifications and Quality Overall Summary
      Ashley Boam, MS

      Progress in Integration of Inspection and Quality Assessment
      Alonza Cruse



      Speakers
      avatar for Ashley Boam

      Ashley Boam

      Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
      Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies & standards related to drug product quality, including... Read More →
      avatar for Alonza Cruse

      Alonza Cruse

      Director, Office of Pharmaceutical Quality Operations, ORA, OGROP, FDA
      Director, Office of Pharmaceutical Quality Operations within FDA’s Office of Regulatory Affairs (ORA), responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic, working in conjunction with FDA Centers: CDER and CVM. Alonza is also leading... Read More →
      avatar for Christine Moore

      Christine Moore

      Global Head and Executive Director, GRACS CMC - Policy, Merck Research Laboratories
      Christine Moore is the Global Head and Executive Director of CMC Policy at Merck. She joined Merck in 2016 after 11 years in various positions at FDA, including Acting Office Director of the ONDQA and OPF. Throughout here career, Christine has been at the forefront of development... Read More →
      avatar for Susan Rosencrance

      Susan Rosencrance

      Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA
      Dr. Susan Rosencrance currently serves as the Director for the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality (OPQ). In this capacity, she directs procedures and processes for evaluating and assessing drug product quality of both brand name and generic drug... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #121: Use of Historical Information in Clinical Trial Design
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-533-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The use of historical controls in clinical trials may be an alternative method to assess the efficacy of a new drug. Challenges that arise from the use of historical controls, as well as methods for overcoming those challenges, will be discussed.

      Learning Objectives

      Determine whether the use of a historical control is Determine whether the use of a historical control is appropriate for their clinical trial design; Discuss how to analyze endpoints and interpret results from clinical trials that use a historical control.

      Chair

      Sara Jimenez, PhD

      Speaker

      Efforts to Combine Data Across Companies
      Edward Bowen, MA, MBA, MS

      Using Historical Data to Transform Clinical Trials: Statistical Considerations
      Jessica Lim, MA

      Converging Lines of Evidence: Using Modern Structural Meta-analysis to Advance Multisite Knowledge Discovery - A Case Study
      Andrew Wilson, PhD, MS



      Speakers
      avatar for Edward Bowen

      Edward Bowen

      Lead, Placebo as Standard of Care Workstream, TransCelerate BioPharma
      Ed Bowen is the Head of R&D Data Science at GSK, where he leads a team of data scientists and machine learning engineers in leveraging large-scale, distributed systems in building, testing and validating analytics, statistical models, and machine learning models. These models and... Read More →
      avatar for Sara Jimenez

      Sara Jimenez

      Mathematical Statistician, OB, OTS, CDER, FDA
      Sara Jimenez is a mathematical statistician in the Division of Gastroenterology and Inborn Errors Products at the FDA’s Center for Drug Evaluation and Research. She performs regulatory reviews of clinical trial submissions and contributes to data standards efforts within the division... Read More →
      avatar for Jessica Lim

      Jessica Lim

      Director, Clinical Statistics, GlaxoSmithKline
      Jessica Lim leads a team of HIV clinical statisticians at GSK. She is also the Scientific Application subteam lead on the TransCelerate Placebo/Standard of Care data sharing initiative. Jessica received her MA in Biostatistics from UC Berkeley and has experience in the pharmaceutical... Read More →
      avatar for Andrew Wilson

      Andrew Wilson

      Director, Pharmacoepidemiology and Statistics RWDS, PAREXEL
      I lead the pharmacoepidemiology & statistics initiatives within Real World Data Services at PAREXEL. To be part of the real world evidence movement, it is essential we embrace the data generation process, and keep data context as all-important. Real world data typically comes from... Read More →


      Monday June 25, 2018 11:00am - 12:15pm
      Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #123: Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge
      Component Type: Session
      Level: Basic
      CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-698-L04-P; CME 1.50; IACET 1.50; RN 1.50

      Part 1 of the DIA-CIRS Workshop

      Unmet medical need drives decisions across value chain from investment and prioritization to approval timelines and access discussions but is very vaguely defined. Learn why interpretation matters and how decision makers view the concept.

      Learning Objectives

      Demonstrate how unmet medical need is defined in different countries or regions; Identify how different stakeholders perceive unmet medical need; Discuss the scope of what is defined as unmet medical need based on situational context, issues, concerns, and dilemmas each stakeholder faces in prioritization

      Chair

      Lawrence Eugene Liberti, PhD, RPh, RAC

      Speaker

      FDA Definition and How it is Interpreted in Decision-Making
      Larry Bauer, MA, RN

      Unmet Medical Need in Economic Evaluation
      Karen Lee

      Patients View on How the Concept Works
      Marc M. Boutin, JD



      Speakers
      avatar for Larry Bauer

      Larry Bauer

      Regulatory Scientist, Rare Diseases Program, Office of New Drugs, CDER, FDA
      Larry Bauer is a Regulatory Scientist in the Center for Drug Evaluation and Research, Office of New Drugs Immediate Office (CDER, OND IO) in the Rare Diseases Program. He provides regulatory expertise internally and externally regarding FDA laws, regulations, guidances and policies... Read More →
      avatar for Marc Boutin

      Marc Boutin

      Chief Executive Officer, National Health Council (NHC)
      Boutin has been a leading voice for greater patient involvement, starting with the development of new drugs to regulatory oversight of health care delivery. Under his leadership, the NHC has convened a broad range of stakeholders to effectively implement strategies and public policy... Read More →
      KL

      Karen Lee

      Director, Health Economics, Canadian Agency For Drugs & Technologies In Health (CADTH)
      avatar for Lawrence Liberti

      Lawrence Liberti

      Executive Director, Centre for Innovation in Regulatory Science (CIRS)
      For the past 38 years, Mr Liberti has worked in the fields of regulatory affairs and clinical R&D. Since 2009 he has served as the Executive Director of CIRS (formerly the CMR International Institute for Regulatory Science), an independent, division of Clarivate Analytics. He ireceived... Read More →


      Monday June 25, 2018 11:00am - 12:30pm
      Room 157AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:00am

      #124: Analyzing Innovations Progress in the Gottlieb Era
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-535-L04-P; CME 1.50; IACET 1.50; RN 1.50

      FDA Commissioner Scott Gottlieb has advanced an ambitious plan to modernize drug development and FDA’s approach to regulation. He has taken bold new approaches to streamline clinical trials, engage in efficient, risk-based regulation, and advance innovation.

      Gottlieb is focused on transformative innovations that hold the promise of both significantly impacting disease and reducing overall health care costs.

      How is the agency’s approach impacting innovation? Is it making a difference? Are further changes needed? What does the future of drug development look like under Gottlieb? Where are the key opportunities for collaboration between FDA and industry?

      This DIAmond Session will bring together top regulatory thought leaders from FDA, industry and the venture capital world, for an interactive, forward-looking discussion of FDA’s modernization plan and its impact on development of innovative therapies.

      Learning Objectives

      Describe FDA’s Medical Innovation Development Plan; Identify implications for the future of drug development under Commissioner Gottlieb; Plan for impact of regulatory changes on drug development and business plans.

      Chair

      Nancy Bradish Myers, Esq, JD

      Speaker

      Panelist
      Sandra A. Milligan, DIAFellow, JD, MD

      Panelist
      Kathy Hibbs

      Panelist
      Doug Cole, MD



      Speakers
      DC

      Doug Cole

      Managing Partner, Flagship Pioneering
      KH

      Kathy Hibbs

      Chief Legal and Regulatory Officer, 23andMe
      avatar for Sandra Milligan

      Sandra Milligan

      Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories
      Sandra Milligan serves as senior vice president and head of Global Regulatory Affairs and Clinical Safety at Merck. She is a graduate of George Washington University School of Medicine and Georgetown University Law Center. Sandy served on DIA’s board from 2011 to 2017, served on... Read More →
      avatar for Nancy Myers

      Nancy Myers

      President and Founder, Catalyst Healthcare Consulting, Inc
      Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA’s Commissioner’s Office and held senior positions at PhRMA, BIO and... Read More →


      Monday June 25, 2018 11:00am - 12:30pm
      Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      12:00pm

      Luncheon Service
      Component Type: Social Event




      Monday June 25, 2018 12:00pm - 2:00pm
      Exhibit Hall

      12:30pm

      #126: EU Global Data Protection Regulation and Impact on US Companies
      Component Type: Session
      Level: Intermediate
      CE: IACET 0.50

      In May 2018, the EU Global Data Protection Regulation goes into production. Data Privacy and the rights of the participating human test subjects have been greatly increased, and pertain to any company who runs trials in the EU. This content hub will briefly expose attendees to the new regulation, and then interactively discuss implementation steps to remain compliant.

      Learning Objectives

      Describe the new EU regulation and its effect on USA companies; Discuss the implementation of key items by May 2018 and how required fees for non-compliance are sizeable.

      Chair

      Terry Katz, MS


      Speakers
      TK

      Terry Katz

      Director, Global Data Management and Statistics, Merck Animal Health
      Terry Katz is Head of Data Management and Statistics at Merck Animal Health. Previously he was Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician, and Certifications... Read More →


      Monday June 25, 2018 12:30pm - 1:00pm
      Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      12:30pm

      #125: Organizational Change and Knowledge Management for Cybersecurity Threats
      Component Type: Workshop
      Level: Basic

      This workshop will discuss how to apply organizational change management principles to both prepare and respond to cyberattacks. Teams must manage the company culture and behavior in addition to the technology, infrastructure, devices and processes.

      Learning Objectives

      Deploy up front table top and red team exercises to prepare your organization for a potential cyber attack; Implement knowledge management and after action reviews to improve future outcomes; Apply organizational change management principles to minimize risky human behaviors and initiate new guidelines/procedures for infrastructure and devices to reduce the risk of a breach.

      Chair

      Diane Cooney, MBA


      Speakers
      avatar for Diane Cooney

      Diane Cooney

      Senior Consultant, CGI
      Diane Cooney of CGI started her career as a writer, before moving into consulting. With communication as her foundation, Diane’s interest evolved into understanding how strategy impacts planning and performance, and how culture influences our perception of our world. Her consulting... Read More →


      Monday June 25, 2018 12:30pm - 1:30pm
      E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      12:45pm

      #127: IQVIA Innovation Theater: Re-imagine Clinical Development with Human Data Science
      Component Type: Session

      The world of clinical development has changed, with demands that extend beyond traditional research & development and regulatory approval for new drugs. Explore a better, more strategic clinical development approach powered by human data science. Case studies feature innovative models that are helping biopharma accelerate timelines and optimize outcomes.

      Chair

      IQVIA


      Speakers
      avatar for IQVIA

      IQVIA

      IQVIA
      avatar for Natalia Balko Kotchie

      Natalia Balko Kotchie

      Head, Analytics Center of Excellence, IQVIA
      Natalia Balko leads the Analytics Center of Excellence within R&D Solutions for IQVIA. In this role she is responsible for innovation, development, and delivery of new analytic solutions globally, which underpin IQVIA’s next generation approach to clinical development. The solutions... Read More →
      avatar for Cynthia Verst

      Cynthia Verst

      President, R&D Design and Delivery Innovation, IQVIA
      Dr. Cynthia L. Verst, President of Design and Delivery Innovation for Research and Development Solutions at IQVIA, is responsible for accelerating growth through innovative solutions powered by rich data assets, advanced predictive analytics, integrated technology capabilities, and... Read More →


      Monday June 25, 2018 12:45pm - 1:15pm
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      12:45pm

      #128: PPD Innovation Theater: Reimagining Study Planning and Feasibility to Create More Efficient Clinical Trials
      Component Type: Session

      Traditional study planning, driven by the number of sites estimated to achieve enrollment, is filled with inefficiencies and significant delays. Together with a key client, PPD’s Accelerated Enrollment Solutions business unit pioneered a new way to integrate the site network into study design to drastically reduces startup times and increases consistency/quality of data and study conduct. This new model is helping bring a lipid-lowering therapy with potential to change millions of lives to market in unprecedented timelines. This case study presentation highlights:

      • Shared sense of purpose and accountability across this program to deliver for the greater good and impact to global healthcare system
      • Change management on a global- and industry- scale to change the longstanding approach to study startup
      • Collaboration to generate evidence: unified to overcome obstacles and nimble to develop new approaches
      • The combination of patient data, modeling, direct marketing, predictive analytics to identify qualified patients and deliver enrollment volume and certainty

      This unique approach illustrates how a sponsor and CRO can come together to change the face of drug development.

      Chair

      PPD, Inc.


      Speakers
      avatar for Tammy D’Lugin-Monroe

      Tammy D’Lugin-Monroe

      Executive Director and Global Operations Lead, Accelerated Enrollment Solutions, PPD
      Tammy D’Lugin-Monroe is executive director and global operations lead for accelerated enrollment solutions with Acurian-PPD. She leads and directs the PatientAdvantage enrollment solution across all therapeutic areas, divisions and business units to ensure that those recruiting... Read More →
      avatar for PPD, Inc.

      PPD, Inc.

      Pharmaceutical Product Development, Inc
      avatar for Peter Wijngaard

      Peter Wijngaard

      Executive Vice President and Chief Development Officer, The Medicines Company
      Peter is Executive Vice President and Chief Development Officer at The Medicines Company. Peter has extensive experience in the areas of global project leadership, business development, medical affairs, and pharmaceutical marketing. Previously, Peter led European Medical Affairs and... Read More →


      Monday June 25, 2018 12:45pm - 1:15pm
      Theater 2 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:15pm

      #129: Using Quality-Inspired Dashboards to Track Patient Engagement
      Component Type: Session
      Level: Intermediate
      CE: IACET 0.50

      Dashboards are important for measuring sustained progress of patient engagement initiatives against goals and benchmarks. Commonly used in Quality and Operations areas, the application of dashboards in Patient Engagement is just emerging. Participants will discuss challenges of conceiving, establishing and maintaining dashboards to measure patient engagement initiatives in clinical development. Participants will share examples such as diversity among study participants, patient-centric protocol design changes, and site engagement. Those interested in attending are encouraged to bring their own examples to share.

      Learning Objectives

      Discuss metrics to track in a patient engagement dashboard; Identify sources of data for benchmarking initiatives and measuring their performance; Describe patient engagement dashboard formats.

      Chair

      Mary Stober Murray, MBA


      Speakers
      avatar for Mary Murray

      Mary Murray

      Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb
      As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and underserved populations. Mary has co-chaired DIA-PEC... Read More →


      Monday June 25, 2018 1:15pm - 1:45pm
      Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:30pm

      #130: PAREXEL International Innovation Theater: The Innovation Imperative: The Future of Drug Development
      Component Type: Session

      The Economist Intelligence Unit will unveil its independent research findings titled, “The Innovation Imperative: The Future of Drug Development.” Commissioned by PAREXEL, the report shows how four key innovations consistently improve industry success metrics such as enrollment rates, regulatory approval, and payer adoption. However, despite their quantifiable positive impact, their adoption appears low. The reasons for this “adoption lag” and potential solutions will be discussed.

      Chair

      PAREXEL International


      Speakers
      avatar for Alberto Grignolo

      Alberto Grignolo

      Corporate VP PAREXEL Consulting, PAREXEL
      Alberto Grignolo has 36+ years of experience as a regulatory and drug development professional including consulting for pharmaceutical and biotechnology companies. He is a driver of a successful worldwide consulting business and established PAREXEL’s Japan Consulting Services. He... Read More →
      avatar for David Humphreys

      David Humphreys

      Head of Health Policy, EIU Healthcare, The Economist Intelligence Unit
      David Humphreys is the Head of the Health Policy Practice for The Economist Intelligence Unit (EIU) Healthcare consulting division. He supports clients across the healthcare ecosystem by conducting evidence based analysis and health policy impact through the EIU’s clinical, macro... Read More →


      Monday June 25, 2018 1:30pm - 2:00pm
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:30pm

      #131: Covance Innovation Theater: Evidence-Based Approaches to Accelerating Patient Recruitment and Improving Patient Retention
      Component Type: Session

      Successful delivery of clinical study enrollment requires the ability to match the study protocol inclusion/exclusion criteria with the locations of sizeable clusters of potentially matching patients. Combining these insights with longitudinal investigator performance, demographic and capacity measures, one is able to quickly and precisely recruit matching patients onto a clinical study. During our presentation we will share how we leverage our proprietary data sets to accelerate patient recruitment, increase the pool of potential participants, optimize your study design and improve patient retention.

      Chair

      Covance Inc.


      Speakers
      avatar for Gabriela Feldberg

      Gabriela Feldberg

      Head of Feasibility, Recruitment & Engagement, Covance
      avatar for Covance Inc.

      Covance Inc.

      Covance Inc.


      Monday June 25, 2018 1:30pm - 2:00pm
      Theater 2 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:45pm

      #132: New Approaches, Novel Endpoints, and Next-Generation Trials
      Component Type: Workshop
      Level: Intermediate

      Using a case study, we will illustrate CTTI recommended practices for selecting, developing, and including technology-derived endpoints in regulatory trials. Participants can apply best practices learned to other scenarios, including their own work.

      Learning Objectives

      Describe approaches to identifying mobile technology-derived outcome measures that are most valuable and warrant development; Review approaches for optimizing the efficiency of technology-derived novel endpoint development; Discuss how to include and position technology-derived novel endpoints to be most impactful.

      Chair

      Jennifer C Goldsack, MA, MBA

      Speaker

      Facilitator
      Jessie Bakker, PhD, MS

      Facilitator
      Daniel Rollings Karlin, DrMed, MA, FAPA

      Facilitator
      Komathi Stem, MS



      Speakers
      JB

      Jessie Bakker

      Senior Manager, Clinical Trials, Philips Respironics
      avatar for Jennifer Goldsack

      Jennifer Goldsack

      Senior Project Manager, Clinical Trials Transformation Initiative (CTTI)
      Jen Goldsack is a Senior Project Manager at the Clinical Trials Transformation Initiative (CTTI). Jen leads two projects within CTTI's Mobile in Clinical Trials (MCT) Program; the MCT Novel Endpoints, and MCT Mobile Devices projects.
      DK

      Daniel Karlin

      Head of Clinical, Informatics, and Regulatory Strategy, Pfizer Inc
      Dan is the Head of Clinical, Informatics, and Regulatory Strategy for Digital Medicine and Pfizer Innovation Research Lab, where he manages strategy for multiple aspects of Pfizer’s collaborative digital measurement and endpoint development efforts. Dan is board certified in Psychiatry... Read More →
      KS

      Komathi Stem

      Founder and Chief Executive Officer, monARC Bionetworks
      Komathi Stem, MS is passionate about transforming drug development by rethinking the way clinical trials are designed & executed. As an entrepreneurial systems thinker, she is focused on sparking an ecosystem change that accelerates research through greater collaboration across the... Read More →


      Monday June 25, 2018 1:45pm - 2:45pm
      E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:45pm

      #133: DIA Good Clinical Practices and QA Community Round Table Discussion: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity
      Component Type: Forum

      Join DIA GCP and QA Community for a round table discussion tied to session # 111 Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics Driven Approach to Monitor Data Integrity (Monday, June 25th)

      To include special guests from the session: Nareen Katta and Gene Vinson.

      Chair

      Terry Katz, MS


      Monday June 25, 2018 1:45pm - 2:45pm
      Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:45pm

      #134: DIA Medical Writing Community Round Table Discussion: Scientific Communication Key Message Development, Management, and Dissemination
      Component Type: Forum

      Join DIA MW Community for a round table discussion tied to session # 112 Scientific Communication Key Message Development, Management, and Dissemination (Monday, June 25th)

      To include special guests from the session: David clemow, Kristine Joliffe, and Wesley Portegies.

      Chair

      David B. Clemow, PhD


      Speakers
      avatar for David Clemow

      David Clemow

      Advisor, Scientific Communications Information Strategy, Eli Lilly and Company
      David is an Advisor Scientific Communications Information Strategy at Eli Lilly and Company with over 20 years of regulatory, publication, and promotional scientific communications experience in the pharmaceutical industry. His work has included document authoring, team management... Read More →


      Monday June 25, 2018 1:45pm - 2:45pm
      Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #135: On the Soapbox: Right to Try
      Component Type: Session
      Level: Intermediate
      CE: IACET 0.50

      Issues surrounding gravely ill patients who have exhausted all possible treatment options are amongst the most heart-wrenching, complex bioethical and legal challenges of our time. The “Right to Try” movement seeks to ameliorate these issues by stating that terminally-ill patients have the right to save their own lives, by requesting access to experimental interventions early in clinical development. Despite significant questions regarding whether such laws would effectively provide greater access to experimental drugs than is already allowed under often-ignored federal regulation, and a host of troubling provisions embedded in the legislation, nearly 40 states have enacted Right to Try laws, and 2 notable federal bills recently passed the House and Senate, setting the stage for a potential national “Right to Try.”

      In addition to illuminating this fascinating and unique case study in political advocacy, this talk will examine the emotional, legal, medical, and ethical dimensions raised by the Right to Try movement.

      Learning Objectives

      Analyze practical, ethical, operational and regulatory considerations that factor into evaluating patient requests for pre-approval (compassionate use) access to experimental interventions; Identify the key provisions in state and federal RTT laws, and describe the benefits and potential harms central and ancillary portions of these laws; Appraise the current climate giving rise to the vast demand for pre-approval access, and propose measures that could ameliorate the field.

      Chair

      Beth E. Roxland, JD, MA


      Speakers
      avatar for Beth Roxland

      Beth Roxland

      Senior Consultant On Law, Health Policy, and Ethics
      Beth E. Roxland is an Attorney and Bioethicist with unique experience across industry, law, government & academia. She's a Senior Consultant on Law, Health Policy and Ethics to law firms, life science entities, and professional & patient groups. She was previously Johnson & Johnson's... Read More →


      Monday June 25, 2018 2:00pm - 2:30pm
      Room 157AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #136: Drug Safety: A Continuum Approach Linking Pre-Market and Post-Market Safety Assessment
      Component Type: Session
      Level: Intermediate
      CE: IACET 0.50

      Pharmaceutical Drug Safety is of paramount importance to drug manufacturers, payers, regulators, and the society as a whole as it attracts public attention more so than effectiveness. While there have been significant efforts in monitoring safety thru internal safety groups within the drug manufacturers and independent external committees in the clinical development phase, not a lot of these pre-marketing safety information may be historically translated into a robust pharmacovigilance (PV) and safety monitoring plan in the post-marketing arena. The EMA GVP regulations encourage good PV planning during clinical development but at this stage have not offered recommendations. In order to provide more clarity into potentially suspected safety issues during the clinical trials, follow-up post-marketing real world evidence (RWE) studies could be undertaken. On behalf of the DIA/ASA Biopharm Safety Evaluation Scientific Working Group, currently focusing on safety monitoring during development, it would be important to discuss the possibility of bridging with the post-marketing safety planners in an informal interactive dialogue with subject matter experts in the PV, RWE and Safety area to plan for future collaborations in this important aspect of life-cycle of pharmaceutical drugs.

      Learning Objectives

      Explain the planning objectives of the ASA Biopharm/DIA Safety Monitoring Assessment Scientific Working Group (SWG); Discuss ways to bridge pre-marketing safety planning recommendations of this SWG to safety planning in post-marketing.

      Chair

      Susan Duke, MSc


      Speakers
      avatar for Susan Duke

      Susan Duke

      Mathematical Statistician, OB, OTS, CDER, FDA
      Susan became involved in safety related industry-widegraphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG. She is currently a Mathematical Statistician reviewer in CDER and co-leads a cross-functional safety monitoring WG co-sponsored by DIA and ASA Biopharm... Read More →


      Monday June 25, 2018 2:00pm - 2:30pm
      Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:15pm

      #137: DiagnoSearch Life Sciences Innovation Theater: Disruptive Innovation - ‘Wide-Angle-Data’ - Intuitive Algorithms and Artificial Intelligence for Real-time Safety and Risk Management
      Component Type: Session

      Conventional approach to identification of patient safety triggers in clinical trials is cumbersome and often interspersed with delays which can potentially lead to diminished regulatory compliance. An integrated platform with intuitive algorithms and artificial intelligence can facilitate prompt signal detection, complete signal adjudication and comprehensive real-time risk management. ‘Wide-Angle-Data’ platform achieves exactly that goal with advanced analytics and goes a step ahead.

      Chair

      DiagnoSearch Life Sciences



      Monday June 25, 2018 2:15pm - 2:45pm
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:15pm

      #138: SAS Institute Innovation Theater: Real World Evidence - Better, Faster, More!
      Component Type: Session

      Want to efficiently move from Real World Data to Real World Insights? Join us to learn how to effectively leverage your RWE investment.

      Chair

      SAS Institute Inc.


      Speakers
      avatar for Sherrine Eid

      Sherrine Eid

      Principal Industry Consultant, SAS Institute Inc.
      Sherrine Eid is an Industry Consultant with Health and Life Sciences at SAS. She has over 20 years of experience in Real-World Evidence, Epidemiology and Biostatistics. Previous positions include both private sector and public service roles, including work for USAID, CDC, the City... Read More →
      avatar for SAS Institute Inc.

      SAS Institute Inc.

      SAS Institute Inc


      Monday June 25, 2018 2:15pm - 2:45pm
      Theater 2 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #141: eSource: The Road to Real World Evidence – Are We There Yet?
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-538-L04-P; CME 1.00; IACET 1.00; RN 1.00

      The arrival of wearables and big data, felt like clinical research would change overnight. But has it? This session will consider a variety of real world sources, how they are/could change the way we do trials, and ask when will the real world vision will deliver.

      Learning Objectives

      Describe different forms of eSource, how data can be acquired. and what it could deliver; Discuss barriers, regulatory, process, technical – and methods to break them down; Identify how eSources may radically change our industry, for the better.

      Chair

      Jonathan Palmer

      Speaker

      Panelist
      Daniel Rollings Karlin, DrMed, MA, FAPA

      Panelist
      Matthew Moyer, MBA, MS, PMP

      Panelist
      Jeremy Wyatt, MBA



      Speakers
      DK

      Daniel Karlin

      Head of Clinical, Informatics, and Regulatory Strategy, Pfizer Inc
      Dan is the Head of Clinical, Informatics, and Regulatory Strategy for Digital Medicine and Pfizer Innovation Research Lab, where he manages strategy for multiple aspects of Pfizer’s collaborative digital measurement and endpoint development efforts. Dan is board certified in Psychiatry... Read More →
      avatar for Matthew Moyer

      Matthew Moyer

      Director, Merck & Co., Inc.
      Matt has 15 years of pharmaceutical development experience with Merck, and is Director of Clinical Supply Technology. He leads Merck’s clinical supply innovation efforts, incorporating new digital and enabling technologies to drive improved clinical trial execution, and more informed... Read More →
      JP

      Jonathan Palmer

      Senior Director, Product Strategy, Digital Trials, Oracle Health Sciences
      Jonathan leads Product Strategy for Digital Trials within Oracle’s Health Sciences Global Business Unit. He is responsible for defining, and delivering, new innovative Digital/mHealth solutions. He has spent over 20 years within Oracle’s Clinical business teams delivering solutions... Read More →
      avatar for Jeremy Wyatt

      Jeremy Wyatt

      CTO, ActiGraph
      Jeremy Wyatt is the CTO at ActiGraph, a leading global provider of physical activity and sleep monitoring solutions for the pharmaceutical and academic industries. ActiGraph's ecosystem of of medical-grade physical activity monitors and cloud software ensure clients are collecting... Read More →


      Monday June 25, 2018 3:00pm - 4:00pm
      Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #147: Facilitating Nonclinical Data-Sharing and Access Across the Industry
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-545-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will present an overview of the SEND components required for US FDA applications and provide a foundational understanding of how to review regulatory applications for SEND compliance. This session will present the core capabilities, use cases, and principles driving the Toxicology Data Sharing Initiative.

      Learning Objectives

      Identify the SEND components required for US FDA applications; Apply this knowledge to review regulatory applications for SEND compliance; Assess technical and operational framework for sharing preclinical toxicology and background control data; Evaluate core principles guiding data sharing and collaboration amongst preclinical consortium participants.

      Chair

      William Houser

      Speaker

      BioCelerate Toxicology Data-Sharing Initiative: Development of a Centralized, Searchable Preclinical Data Repository
      William Houser

      US Regulatory Compliance With the Standard For Exchange of Nonclinical Data (SEND)
      Kaitlyn Nicole Riffel, MSc



      Speakers
      avatar for William Houser

      William Houser

      Capability Manager, Bristol-Myers Squibb
      William Houser is a senior research scientist for Bristol-Myers Squibb, where he has 25+ years of experience in nonclinical toxicology. He is a core team member on the BioCelerate projects for Toxicology Data and Background Control Data Sharing. For the last 10 years he has been developing... Read More →
      avatar for Kaitlyn Riffel

      Kaitlyn Riffel

      Consultant, Scientific Consulting, Cardinal Health Regulatory Sciences
      Kaitlyn Riffel is a Consultant of Global Regulatory Affairs for Cardinal Health Regulatory Sciences (CHRS) where she consults on drug, device, and biologic development. Kaitlyn holds a Master of Science in Integrative Pharmacology from Michigan State University College of Osteopathic... Read More →


      Monday June 25, 2018 3:00pm - 4:00pm
      Room 151AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #148: Essential Project Leadership in Navigating an Evolving Regulatory Landscape in Asia-Pacific
      Component Type: Session
      Level: Intermediate
      CE: CME 1.00; IACET 1.00; PDU 1.00 PMI 2166-000221; RN 1.00

      Regulatory agencies in Asia-Pacific region are taking various initiatives and proactive approaches to promote global drug development to the industries. Such initiatives are supported by recent changes in regulatory requirements resulting an increased number of Asian-based biopharmaceutical and biotechnology companies planning and conducting clinical trials that involved countries in the North America, Europe and Asia-Pacific, in addition to country of origin in Asia. Despite there are many global and local CROs accessible by sponsors in different countries and regions, one common challenge encountered lies with the proficiency of project leadership competencies in that such competencies are directly and indirectly determining the success and failure of a project from planning to smooth execution.
      This session will outline changes of regulatory landscape and requirements in representing developed and developing markets : (1) Japan (regenerative medicine and orphan drug development)
      (2) Southeast Asia (regulatory changes in clinical trial review and approval).
      Core elements of project leadership competencies that must have in effective project management will be covered in the presentations which will benefit to attendees.

      Learning Objectives

      Discuss the changes of regulatory landscape and requirements in selection countries in Asia-Pacific region; Describe the challenges encountered in the project planning and management under an evolving regulatory landscape; Identify core project leadership competencies must have in an effective project management.

      Chair

      Hwee Hwee Tey

      Speaker

      Balancing Unity and Individuality: Leadership Skills for Managing Culturally Divergent Clinical Teams
      Brian Malkin, JD

      The Regulatory Landscape and Development Pathways of Regenerative Medicine and Orphan Drugs in Japan
      Gregg Mayer, PhD

      Including the APAC Region into a Global Study:An Operational Perspective
      Winnie Lim, MSc



      Speakers
      WL

      Winnie Lim

      Manager Clinical Operations - Asia, Aurinia Pharmaceuticals Inc.
      Early in her career, Winnie worked in a translational research facility in the discovery of genetic biomarkers. She developed an interest for and transitioned into, clinical development and operations and has been working in the industry for the last 6 years gaining experience in... Read More →
      avatar for Brian Malkin

      Brian Malkin

      Counsel, Arent Fox LLP
      Brian has more than 24 years of food and drug law practice and over 13 years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian's regulatory experience includes all types of FDA-regulated products... Read More →
      avatar for Gregg Mayer

      Gregg Mayer

      President, Gregg L. Mayer Company, Inc.
      Gregg received his BA and PhD from the University of California, Berkeley. After serving as President at Berkeley Antibody Company, and Vivigen, Inc., Gregg studied at Keio University in Tokyo. He then joined the San Francisco office of McKinsey & Company, later leaving to establish... Read More →
      HH

      Hwee Hwee Tey

      Head of Project Management & Regulatory Affairs, CMIC Asia-Pacific, Pte. Ltd.
      HweeHwee is the Head of Project Management & Regulatory Affairs in CMIC APAC Services & is also responsible for the Company’s clinical operations within Southeast Asia. HweeHwee holds a bachelor’s degree in Microbiology from National University of Singapore. Following her clinical... Read More →


      Monday June 25, 2018 3:00pm - 4:00pm
      Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #152: FDA Expectations for Demonstration of Interchangeability
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-549-L04-P; CME 1.00; IACET 1.00; RN 1.00

      Biological products which are biosimilars of reference products are not automatically interchangeable under FDA guidelines. This session will detail our current understanding of FDA expectations for demonstration of interchangeability of a biological product with a reference product with regards to study designs, duration of switches, PK/PD immunogenicity sampling, statistical analysis, and product presentation considerations.

      Learning Objectives

      Compare and contrast biosimilarity versus interchangeability; Describe an overview of FDA expectations for demonstration of interchangeability; Describe standalone versus combined interchangeability study designs.

      Chair

      Kamali Chance, PhD, MPH, RAC

      Speaker

      FDA Overview of Considerations in Demonstrating Interchangeability With a Reference Product
      Leah Christl, PhD

      Industry Perspective of the FDA Interchangeability Guidance
      Hillel Cohen, PhD



      Speakers
      avatar for Kamali Chance

      Kamali Chance

      Chief Regulatory Officer, Biosciences Corporation
      Dr. Chance has extensive regulatory strategy/ regulatory affairs experience working for a Clinical Research Organization and pharmaceutical and biopharmaceutical companies. She advises pharmaceutical and biotechnology companies in the development of region specific and/or global regulatory... Read More →
      avatar for Leah Christl

      Leah Christl

      Associate Director for Therapeutic Biologics, TBBT, OND, CDER, U.S. Food and Drug Administration (FDA)
      Dr. Christl is the Director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs in the FDA's CDER. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for biosimilar... Read More →
      avatar for Hillel Cohen

      Hillel Cohen

      Executive Director, Scientific Affairs, Sandoz Inc.
      Hillel Cohen is Executive Director at Sandoz, helping explain policies to the healthcare community, patient advocacy groups, & health authorities. Current areas of focus include switching, substitution, interchangeability & safety. He led Sandoz efforts for the first biosimilar presentation... Read More →


      Monday June 25, 2018 3:00pm - 4:00pm
      Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #139: Novel Approaches to Pharmacovigilance Collaboration
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-536-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Following the success of its clinical initiatives, TransCelerate launched its first pharmacovigilance projects in 2017, which are now actively engaging with health authorities and delivering both near-term and long-term value. This session will feature a panel of leaders from TransCelerate’s pharmacovigilance teams, as they discuss the future of pharmacovigilance (challenges associated with globalization, data automation, new PV requirements, etc.) and discuss initiatives that TransCelerate has undertaken to address these challenges.

      Learning Objectives

      Describe expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space; Discuss strategies to address pharmacovigilance challenges.

      Chair

      Jose Vega, MD

      Speaker

      Industry Collaboration to Improve Patient Safety: TransCelerate’s Long-Term Vision to Address Pharmacovigilance Challenges
      Jose Vega, MD

      Evaluating the Value of Safety Information Data Sources: Gathering Evidence to Illustrate a Hierarchy of Value
      Peter Verdru, MD

      Interpretation of PV Regulations
      Ajay B. Singh, MD

      Value of Safety Information Data Sources
      Jeremy Jokinen, PhD, MS

      FDA Perspective
      Gerald J. Dal Pan, MD, MHS



      Speakers
      avatar for Jeremy Jokinen

      Jeremy Jokinen

      Senior Director, Decision Sciences, AbbVie, Inc.
      Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, statisticians, and data managers developing novel approaches and methodologies to improve patient safety. Jeremy has over 20 years... Read More →
      avatar for Gerald Dal Pan

      Gerald Dal Pan

      Director, Office of Surveillance and Epidemiology, FDA
      Dr. Dal Pan is the Director of the Office of Surveillance and Epidemiology in FDA’s CDER, where he is responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. He is involved in both... Read More →
      AS

      Ajay Singh

      Team Leader, Safety Evaluation and Risk Management, GlaxoSmithKline
      Ajay is a nephrologist by training and currently serves as a team leader in the Safety Evaluation and Risk Management group at GSK.
      avatar for Jose Vega

      Jose Vega

      Vice President, Chief Safety Officer, Merck & Co., Inc.
      José M. Vega is Vice President, Global Clinical Safety and Pharmacovigilance (GCS&PV) and Chief Safety Officer at Merck Research Laboratories (MRL). He also serves as Executive Sponsor of the TransCelerate Pharmacovigilance initiatives and as Merck's representative on the Clinical... Read More →
      avatar for Peter Verdru

      Peter Verdru

      Vice President, Head of Patient Safety, UCB Biopharma S.P.R.L.
      Peter Verdru, MD was trained as neurologist and joined UCB in 1997. He is heading the global Patient Safety team since 2015. Prior to his current role, Peter was heading the Therapeutic Area CNS in Medical Affairs and Clinical Development.


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #140: How Inspection-Ready is Your Organization?
      Component Type: Session
      Level: Basic
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-537-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will provide an overview of the current state of regulatory inspections – what is their current focus, as well as how inspections align and can vary between regulatory agencies. The MHRA will present a summary on the most common inspection findings as well as guidance on how best to address. Core elements of a comprehensive pharmacovigilance system will be reviewed to detail how one’s organization can achieve and maintain an “Inspection-ready” state. The Pharmacovigilance System Master File (PSMF) is a foundational element that can be invaluable in achieving this goal as it can support the safety governance model to reassure stakeholders the company’s ability to protect patient safety while meeting both global and regional requirements. A detailed review of the key PSMF components and their ability to align with inspectors’ requests will be discussed. Additionally, the session will feature real-world examples of how organizations are able to demonstrate their inspection readiness.

      Learning Objectives

      Describe the focus of MHRA inspections versus other regulators, such as FDA; Discuss best practices for establishing a fit-for-purpose quality system that meets global PV requirements; Define the core elements for inspection ready; Identify how to utilize the Pharmacovigilance System Master File (PSMF) as an effective inspection readiness tool; List real-world examples of inspection findings and inspection readiness.

      Chair

      Annette S. Williams, MBA, RPh

      Speaker

      Inspection Readiness: How Prepared are Your Systems for Global Regulatory Inspections?
      Shelley Gandhi, MS

      One Pharmacovigilance System to Satisfy FDA and MHRA’s Inspections
      Anil K. Hiteshi, RAC

      Inspection Readiness: MHRA Inspectorate Perspective
      Joanna Harper



      Speakers
      avatar for Shelley Gandhi

      Shelley Gandhi

      Strategic Advisor, NDA Group
      Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
      avatar for Joanna Harper

      Joanna Harper

      Expert Inspector, GPvP, Inspectorate, Enforcement and Standards, Medicines and Healthcare products Regulatory Agency (MHRA)
      Jo joined the MHRA Inspectorate in 2007, having worked for 15 years in the pharma industry. Throughout 2010-2012, she led the inspectors' contribution to the Implementing Regulation and specific statutory guidance GVP Modules in support of the pharmacovigilance legislation changes... Read More →
      avatar for Anil Hiteshi

      Anil Hiteshi

      Vice President, Global Regulatory Affairs, QA, PV and Drug Safety, and CDM, Spectrum Pharmaceuticals, Inc.
      I am currently the Vice President of Regulatory Affairs, Quality Assurance and Pharmacovigilance at Spectrum Pharmaceuticals and have over 30 years of experience in the industry. I have previously worked at Anabolic Pharmaceuticals, McGaw Laboratories (now B. Braun), ICN Pharmaceuticals... Read More →
      avatar for Annette Williams

      Annette Williams

      Vice President, Lifecycle Safety, IQVIA
      Annette Williams, R.Ph, is Vice President of PV Services at IQVIA, encompassing global Safety Operations (case processing and regulatory reporting), Project Management, and Safety Systems. Williams leads the exploration and adoption of innovative technologies to streamline how Lifecycle... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #142: Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes
      Component Type: Workshop
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-540-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This interactive workshop seeks to continue the recent discussions on wearables and patient-focused outcomes in clinical trials. We will discuss the applicability and suitability of mobile sensor technology to various types of studies and the relevance of sensor-derived outcomes to clinical decision-making. Physical activity, in particular walking, plays a major role as a potential patient-oriented, sensor-derived outcome measure in a broad range of diseases. Valid and reliable methods to assess physical activity are currently developed and/or refined. One example is the actibelt® system, which is a 3D accelerometer hidden in a belt-buckle combined with a set of algorithms, that measures clinical relevant outcomes such as walking speed in the real world. The suitability of various devices will be discussed. Participants will be encouraged to share their previous experience with wearables and/or smartphone applications and discuss the current usage of mobile sensors in clinical trials. The core part of the workshop will be a practical session during which participants can wear different sensors and perform various exercises that illustrate how the devices are used and what data are generated (various walk and/or balance tests, normal activities of daily living). Participants are encouraged to be creative and probe the usability and applicability of this technology. The workshop will finish with an interactive discussion on the regulatory aspects of sensor-derived outcomes and their suitability as pivotal endpoints. This can include a brainstorm on solutions to alleviate current shortfalls in the clinical practice or to complement established endpoints, depending on the application of interest. We aim to also discuss the available and forthcoming evidence for the validity of sensor-derived outcomes, which could wind up into a list of next steps to be taken towards regulatory acceptance of these outcomes as pivotal endpoints in clinical trials.

      Learning Objectives

      Identify opportunities and challenges of mobile sensor-technology as a method to assess physical activity in clinical trials; Discuss the clinical relevance of candidate endpoints derived from accelerometer data and discuss the usage of sensor-derived outcomes as pivotal endpoints; Facilitate decisions on the use of mobility sensors in their specific field of application.

      Chair

      Martin Daumer, DrSc

      Speaker

      Facilitator
      Bill Byrom, PhD

      Facilitator
      Bernd Grimm, PhD

      Facilitator
      Kate Lyden, PhD



      Speakers
      avatar for Bill Byrom

      Bill Byrom

      Vice President, Product Strategy and Innovation, CRF Health
      Bill serves as a Senior Director within Product Innovation at ICON, focusing on harnessing new technologies for clinical trials. He has worked in the Pharma industry for over 25 years and is the author of 60+ publications and an industry textbook on electronic Patient Reported Outcomes... Read More →
      avatar for Martin Daumer

      Martin Daumer

      Scientific Director, Sylvia Lawry Centre For Multiple Sclerosis Research - The Human Motion Institute
      Dr Martin Daumer: Director of the SLCMSR e.V. - The Human Motion Institute in Munich and managing director of the IT company, Trium Analysis Online GmbH. He is also Honorary Professor for Telemedicine and Clinical Applications of Computational Medicine at the Technical University... Read More →
      avatar for Bernd Grimm

      Bernd Grimm

      Senior Engineer, Sylvia Lawry Centre, The Human Motion Institute
      As a former lecturer of Applied Mechanics at Bath University, UK and biomedical engineer for implant design, Dr. Bernd Grimm directed the orthopaedic research foundation and coordinated clinical research at Zuyderland, training hospital of Maastricht University NL. Since 2004 he's... Read More →
      avatar for Kate Lyden

      Kate Lyden

      Clinical Research Scientist, PAL Technologies Ltd.
      Kate Lyden is a research scientist with an expertise in measuring physical behavior with wearable sensors. Kate works as part of the research & development team for PALTechnologies and serves as Adjunct Faculty to the Kinesiology Department at The University of Massachusetts. Kate’s... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 258AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #143: Applying Artificial Intelligence, Machine Language, Natural Language Processing, and Predictive Models in Clinical Trials to Deliver Value to Stakeholders
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-541-L04-P; CME 1.25; IACET 1.25; RN 1.25

      With the focus on acceleration of drug development, the ever increasing complexity of clinical trials is driving companies to look for possibilities in leveraging artificial intelligence/machine learning and predictive analytics. Clinical trial protocols are written by and for humans, often with ambiguity that presents challenges to machine reading and understanding. Patient data and lack of uniform data standards are also challenges to overcome for artificial intelligence machines. This session will cover how the combination of machine learning methods and big data technology leads to high performance patient outcome optimization and clinical trial solutions that deliver value to multiple stakeholders.

      Learning Objectives

      Apply artificial intelligence, machine learning, natural language processing, and predictive analytics in clinical trial solutions to discover the nuances in clinical protocols and EHR data; Identify how these innovations enable pharma to achieve patient centricity, cost reduction, and improved productivity in the trial process

      Chair

      Prasanna Rao

      Speaker

      Application of Artificial intelligence and Machine Learning in Clinical Trials
      Sunil Agarwal, MS

      Why Big Data and Machine Learning will Change the Paradigm for Demonstrating and Delivering Value to Multiple Stakeholders
      Costas Boussios, PhD



      Speakers
      avatar for Sunil Agarwal

      Sunil Agarwal

      Associate Vice President and Practice Lead, Pharma R&D, HCL America Inc.
      Business process and technology executive with 21+ Years of global experience in the Life Sciences industry. Sunil’s strength and success is in bridging the gap between business users and technologists. Sunil started his career in Clinical Operations with a CRO in Germany. Since... Read More →
      avatar for Costas Boussios

      Costas Boussios

      Vice President, Data Science, OM1
      Costas Boussios, PhD, is Vice President of Data Science at OM1, where he leads research and development of OM1's Machine Learning solutions. Prior to OM1, Dr. Boussios has led Data Science at Mitra Capital LLC, the top performing equity market neutral fund of 2015, Cignifi Inc and... Read More →
      avatar for Prasanna Rao

      Prasanna Rao

      Offering Leader, Clinical Trial Transformation, IBM Watson Health
      Prasanna Rao is an Offering Leader for Clinical Trials Transformation at IBM Watson Health. He has over 25 years of experience in Technology, Data Warehousing, BI & Analytics, with 10 years in Healthcare&Life Sciences. In his previous role as an Architect at Watson Health, he was... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 209 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #144: The Evolving Biosimilars Landscape: A Medical Affairs Perspective
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-542-L04-P; CME 1.25; IACET 1.25; RN 1.25

      No matter what position a company plays in the biopharmaceutical market (innovator or not), biosimilars will bring new challenges. The key challenge companies must face is how they will adapt their product development and commercialization strategies to be successful. Manufacturers have started to realize that biosimilars require not only a unique development pathway but also a more tailored go-to-market approach.
      While much has been said about the need to modify the commercial support required for biosimilars, the role of medical affairs and how it needs to evolve to guide biosimilar product development strategy is yet to be defined. Similarly, the role of medical affairs in shaping defense strategies in the face of biosimilar competition has not been explored.
      This session will analyze three key challenges to the development and commercialization of biosimilars: 1) regulatory uncertainty; 2) development complexity; and 3) lack of stakeholder confidence and will discuss how medical affairs is uniquely positioned to help manufacturers address these challenges and how this function can evolve to better serve pharmaceutical companies.

      Learning Objectives

      Describe the three key challenges to biosimilars development and commercialization; Discuss how medical affairs is uniquely positioned to help address those challenges; Identify how medical affairs is organized in this growing field.

      Chair

      Bryan Katz, MBA

      Speaker

      Medical Affairs Perspective
      Richard Markus, MD, PhD

      Panelist
      Javier Coindreau

      Panelist
      Christiane L. Arsever, MD



      Speakers
      CA

      Christiane Arsever

      US Medical Affairs, Strategy Leader - Biosimilars, Merck & Co., Inc.
      Dr. Arsever received her B.A. and M.D. from the Univ. of Michigan in Ann Arbor, completed her residency in internal medicine at Northwestern University Med. Center in Chicago, and a research fellowship in Rheumatology at Univ. of Michigan Medical Center. Dr. Arsever has been at Merck... Read More →
      JC

      Javier Coindreau

      Vice President, Biosimilars Global Medical Affairs Lead, Pfizer Inc
      avatar for Bryan Katz

      Bryan Katz

      Managing Director, Syneos Health
      Bryan is a product development specialist with more than 20 years of experience across the pharma/ life sciences industry. With projects spanning integrated [clinical-commercial] program planning, deal and transformation strategy, Bryan has delivered over $1bn in accretive enterprise... Read More →
      avatar for Richard Markus

      Richard Markus

      Vice President, Global Development, Amgen Inc.
      Richard Markus is Vice President, Global Development at Amgen, where he leads development activities for the Biosimilar Business Unit. He received his BS degree from the University of California, Los Angeles (UCLA) and his MD/PhD at the University of Southern California, where he... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 210C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #145: A New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-543-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This interactive session will convene three distinct patient advocacy groups (PAGs) who will discuss how their unique business models are being used to build long-term relationships with sponsors. The session will also describe how PAGs resource, fund and execute interactions and collaborations with sponsors and discuss opportunities, challenges and solutions arising from the business side of patient engagement, such as maintaining independence, understanding potential conflicts of interest and ensuring transparency

      Learning Objectives

      Identify three distinct patient advocacy group (PAG) business models being used to build long-term relationships with sponsors; Describe how PAGs resource, fund and execute interactions and collaborations with sponsors; Discuss opportunities, challenges and solutions arising from the business side of patient engagement, such as maintaining independence and ensuring transparency.

      Chair

      Kristin Voorhees, MA

      Speaker

      The Business of Patient Engagement
      Alice Bast

      Necessary Relationships: The Effect of Pharmaceutical Relationships on Rare Disease Patient Advocacy Organizations
      Katie Jensen, MPA

      A Day in the Life: Making Patient Engagement Real
      Suzanne Schrandt, JD



      Speakers
      avatar for Alice Bast

      Alice Bast

      CEO, Beyond Celiac
      Alice Bast is CEO of Beyond Celiac, an organization that accelerates patient-centered research. She engages with government, researchers and industry, serving on the National Advisory Council for AHRQ and as a member of the Digestive Disease National Coalition, plus others. Alice... Read More →
      avatar for Katie Jensen

      Katie Jensen

      Development Director, The LAM Foundation
      Katie is a nonprofit development professional with over 5 years experience in rare disease patient advocacy organizations. She is focused on strategic patient engagement, advocacy, fundraising, and innovative ways to amplify the patient voice. Katie holds her Master's in Public Administration... Read More →
      avatar for Suzanne Schrandt

      Suzanne Schrandt

      Director, Patient Engagement, Arthritis Foundation
      Suz Schrandt, JD, is Patient Engagement Director at the Arthritis Foundation. She was previously Deputy Director, Patient Engagement for PCORI, where she helped to launch key efforts including the Engagement Rubric. Schrandt's patient engagement focus stems from her own rheumatological... Read More →
      avatar for Kristin Voorhees

      Kristin Voorhees

      Senior Manager, Patient Advocacy, Ultragenyx Pharmaceutical
      Kristin recently joined Ultragenyx Pharmaceutical as Senior Manager, Patient Advocacy where she supports, educates, and empowers the rare disease community and strives to make a positive difference in the lives of patients, caregivers and families. She is trained in health communications... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 153ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #146: Development of Microbiome-Derived Therapeutics
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-544-L04-P; CME 1.25; IACET 1.25; RN 1.25

      In addition to human cells, our bodies contain an even greater number of microbial cells, collectively referred to as the human microbiome. The majority of these reside in the gastrointestinal tract. Over the past several years, it has become clear that the microbiome within the human body impacts and regulates not only the function of the gut, but also many aspects of clinically relevant biology, including the immune system, liver, and brain, and can also influence carcinogenesis. Approaches to drug development involving modulating the function of the microbiome include both small molecules (e.g. probiotics), as well as the direct transfer of microbial cells. This session will highlight some of the current approaches to targeting the microbiome using cell transfer, as well as a discussion of the regulatory landscape for microbiome targeted drug development.to be developed.

      Learning Objectives

      Illustrate two approaches to modulating microbiome function; Describe the medical, regulatory, and operational challenges to microbiome targeted therapies.

      Chair

      Philip Brooks, PhD

      Speaker

      FDA Perspective
      Taruna Khurana, PhD, MS

      Applying Principles of Rational Drug Development to Living Medicines
      Aoife Brennan, MD

      The Next Generation of Clinical Trials: Lessons from the Hurdles of the Microbiome
      Zain Kassam, MD, MPH



      Speakers
      avatar for Aoife Brennan

      Aoife Brennan

      Interim President and Chief Executive Officer, Synlogic
      Aoife is Chief Medical Officer at Synlogic Inc., where she leads clinical development, operations, and regulatory affairs. Previously she was VP and Head of the Rare Disease Innovation Unit at Biogen where her work resulted in the approval of ALPROLIXTM, ELOCTATETM and SPINRAZATM... Read More →
      avatar for Philip Brooks

      Philip Brooks

      Program Director, Office of Rare Diseases Research & Div of Clinical Innovation, NIH, National Center for Advancing Translational Sciences (NCATS)
      ZK

      Zain Kassam

      Executive Vice President, Clinical Development and Translational Medicine, Finch Therapeutics Group
      Dr Zain Kassam is a Co-founder and Executive VP, Clinical Development & Translational Medicine at Finch Therapeutics Group, a microbiome therapeutics spin out of OpenBiome, the world’s first stool bank for fecal transplants. He is also a founding team member and former CMO at OpenBiome... Read More →
      TK

      Taruna Khurana

      Regulatory Biologist, Office of Vaccines Research and Review, CBER, USFDA
      Dr. Taruna Khurana did her doctoral research in Cell and Molecular Biology at University of Cologne, Germany, followed by postdoctoral fellowships at NIH and FDA. She had joined the Office of Vaccines Research and Review, CBER, FDA as a Research Reviewer in 2009. Currently, she is... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #149: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Application UAN: 0286-0000-18-546-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The Clinical Trials Transformation Initiative (CTTI) and the FDA evaluated methods to prospectively build quality into the scientific and operational design of clinical trials (quality by design). Applying the CTTI quality-by-design recommendations and principles permits organizations to prioritize the most critical aspects of a trial’s quality; identify non-essential activities that can be eliminated to streamline trial conduct and oversight; and develop appropriate plans to define, avoid, mitigate, monitor, and address important errors. This session will provide a brief overview of the CTTI project and recommendations and speakers will describe their experience with implementing a quality-by-design approach in clinical trials.

      Learning Objectives

      Identify recommendations and lessons learned from the CTTI quality by design project; Describe strategies for implementing a quality by design approach to trial design and conduct.

      Chair

      Annemarie Forrest, MPH, MS, RN

      Speaker

      Case Study: How a Large Pharma Company Integrates QbD into Clinical Development
      Julie Dietrich, MS

      A Collaborative Approach to Applying QbD in a CV Outcomes Trial: Lessons Learned
      Sabrina Comic-Savic, MD, MPH



      Speakers
      SC

      Sabrina Comic-Savic

      Vice President, Quality Assurance, The Medicines Company
      avatar for Julie Dietrich

      Julie Dietrich

      Director, Clinical Development, Amgen Inc.
      Julie Dietrich is a Director in Amgen’s Center for Design & Analysis (CfDA). The CfDA partners with product teams to design optimized clinical programs and implement innovative solutions. Julie also heads the Patient Experience Program for Amgen’s Clinical Technology & Experience... Read More →
      JD

      Julie Dietrich

      Director, Clinical Development, Amgen Inc.
      Julie Dietrich is a Director in Amgen’s Center for Design & Analysis (CfDA). The CfDA partners with product teams to design optimized clinical programs and implement innovative solutions. Julie also heads the Patient Experience Program for Amgen’s Clinical Technology & Experience... Read More →
      AF

      Annemarie Forrest

      Director of Projects, Clinical Trials Transformation Initiative (CTTI)
      Annemarie Forrest is the Director of Projects for CTTI. Ms. Forrest provides senior operational leadership for core activities such as project management, site management, personnel management, financial performance, regulatory compliance, information systems, and process improve... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #150: TFDA Town Hall
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-547-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The safety, quality, and effectiveness of drugs are closely entwined with our daily lives and health. The Taiwan Food and Drugs Administration (TFDA) has played a crucial role in promoting public health and continued to enhance a comprehensive drugs safety management system. During this forum, TFDA will share the updated information of regulatory management of drug development, challenges of MRCT implementation, the application of real world evidence, and innovative biotechnological medicine.

      Learning Objectives

      Discuss an overview of TFDA expectations for regulatory management of drug development; Describe the challenges in conducting and analyzing MRCT data and in applying real-world data in regulatory decision making; Describe the latest development of biotechnological medicine.

      Chair

      Shou-Mei Wu, PhD

      Speaker

      TFDA Perspective on Regulatory Management of Drug Development
      Shou-Mei Wu, PhD

      Global Challenges in Conducting MRCT and Interpreting Data
      James Chih-Hsin Yang, MD, PhD

      Using Real World Evidence in Regulatory Decision-Making
      Churn-Shiouh Gau, PhD, MS

      The Development of Pharmaceutical Industry in Taiwan
      Annie Tsu-Hui Liu



      Speakers
      avatar for Churn-Shiouh Gau

      Churn-Shiouh Gau

      Executive Director, Center For Drug Evaluation, Taiwan
      Dr. Churn-Shiouh Gau is the Executive Director of Center for Drug Evaluation, Taiwan and the adjunct professor of School of Pharmacy, National Taiwan University. She has more than 20 years experience on drug evaluation specialized in CMC. She was the project leader for the establishing... Read More →
      avatar for Annie Tsu-Hui Liu

      Annie Tsu-Hui Liu

      Director, Office of Science and Technology, Executive Yuan
      Dr. Tsu-Hui Annie Liu is currently the Director of Biotechnology, Health, Medicine and Agriculture Division, Office of Science and Technology, Executive Yuan, Taiwan. Dr. Liu has more than 20 years of broad experience in biotechnology related field from basic research, drug development... Read More →
      avatar for Shou-Mei Wu

      Shou-Mei Wu

      Director General, TFDA
      avatar for James Chih-Hsin Yang

      James Chih-Hsin Yang

      Director, Department of Oncology, NTU Hospital
      Dr. Yang’s research focuses on lung cancer treatment and the mechanism of multidrug resistance of chemotherapy therapy and targeted therapy. Dr. Yang is a global leader in lung cancer clinical studies, especially in the new drug development in EGFR mutant lung cancer. He published... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #151: Using Real World Evidence for Regulatory Support: Time to Embrace the Future
      Component Type: Session
      Level: Basic
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-548-L04-P; CME 1.25; IACET 1.25; RN 1.25

      As mandated under the 21st Century Cures Act, in December 2018, the FDA is scheduled to issue a draft framework and guidance for evaluating real world evidence (RWE) to help support the approval of a new indication for an already approved drug, and to help support or satisfy post approval study requirements. This session will examine the latest FDA thinking and global experience in terms of decision support for label expansions and other regulatory decisions.

      Learning Objectives

      Describe the latest FDA thinking about the use of real world evidence (RWE) for regulatory decision making as a supplement to or in lieu of traditional RCT; Apply this knowledge to product development to generate the RWE most likely to be used by regulators; Recognize how to get better ROI from RWE by understanding the differential roles of clinical and surrogate outcomes.

      Chair

      Nancy Dreyer, DIAFellow, PhD, MPH, FISPE

      Speaker

      Lessons from Approval of a Drug to Treat Metastatic Merkel Cell Carcinoma
      Tarek Hammad, MD, PhD, MS, MSc, FISPE

      FDA Perspective
      Tamy Kim, PharmD

      Rethinking the Process for Post-Market Requirements
      Andrew Robertson, JD, PhD



      Speakers
      avatar for Nancy Dreyer

      Nancy Dreyer

      Global Chief, Sci Affairs; Sr VP, Head, Center for Advanced Evidence Generation, IQVIA
      Nancy Dreyer is the chief scientific officer and global chief of scientific affairs for IQVIA Real-World & Analytic Solutions. She leads the Center for Advanced Evidence Generation, focusing on the use of real-world evidence for regulators, payers, clinicians, and patients using minimally... Read More →
      avatar for Tarek Hammad

      Tarek Hammad

      Head, Signal Detection, Benefit-Risk Assessment, Global Drug Safety Innovation, EMD Serono, Inc.
      Dr. Hammad joined EMD Serono in 2017 as Head of Signal Detection and Benefit Risk Assessment. Prior to that, he was an Executive Dir of Pharmacoepidemiology in Merck. Previously, he has had a distinguished career with US FDA, most recently as Deputy Dir, Div of Epi, CDER. He is nationally... Read More →
      avatar for Tamy Kim

      Tamy Kim

      Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER, FDA
      Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →
      AR

      Andrew Robertson

      Head, Global Regulatory Science and Policy, NA, Sanofi
      Andrew Robertson is the Head of Regulatory Science and Policy NA at Sanofi, where he heads up regulatory policy initiatives in the US and Canada. Andrew has more than 14 years of collective experience working in life sciences, policy and law, and has authored multiple peer-reviewed... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #153: New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-550-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The session is intended to have a broad look at technology innovations and interactions with regulatory authorities in this area. The two key themes of continuous manufacturing and advanced therapy medicinal products are chosen to illustrate recent innovations. Topics included are: quality attributes, control strategy and advanced analytical methods, including PAT applications.The session will address both small and large molecules and give examples of complex biologicals, e.g. Gene and Cell therapy and CAR-T cells applications. Regulatory challenges for implementation of new technologies will be addressed, including possibilities for effective interaction with regulatory authorities.

      Learning Objectives

      Identify recent technological developments and regulatory challenges in their implementation; Describe continuous manufacturing and how complex biological products are characterized and control strategies are developed; Discuss possibilities for interaction with regulatory authorities on development of innovative products

      Chair

      Peter Richardson, PhD

      Speaker

      Global Approval and Acceptance of Continuous Manufacturing: Regulatory Opportunities
      Leslie Weiss, MBA, RPh

      Regulatory Challenges and Solutions for New Technology Development
      Lucy Chang, PhD

      Innovative Manufacturing for Cell and Gene Therapies
      Michael Havert, PhD



      Speakers
      avatar for Lucy Chang

      Lucy Chang

      Director, Merck & Co., Inc.
      Dr. Chang received her Ph.D. from University of Connecticut and has worked in various biopharm companies including Sanofi, GSK, Pfizer and Teva. She is currently the Director of Global Regulatory CMC, providing regulatory leadership, oversight and strategy to a team of Regulatory... Read More →
      avatar for Michael Havert

      Michael Havert

      Biologist/CMC Reviewer, Gene Therapy Branch, OTAT, CBER, FDA
      Mike has been a CMC Reviewer in the Gene Therapy Branch since 2004. Gene Therapies are a diverse group of new technologies that include genetically modified viruses and cells. Mike’s recent accomplishments include serving as BLA Chair for a genetically modified autologous T-cell... Read More →
      avatar for Peter Richardson

      Peter Richardson

      Head of Quality, Specialised Scientific Disciplines Department, European Medicines Agency (EMA)
      Dr Richardson is a pharmacist, with a Ph.D. in pharmaceutics from The Queens University, Belfast. He worked in industry in the area of formulation research and on drug delivery and controlled release systems for small and large molecules. He has worked for the UK MHRA as a pharmaceutical... Read More →
      avatar for Leslie Weiss

      Leslie Weiss

      Director, CMC Regulatory Affairs, Janssen Research and Development LLC
      Leslie Weiss, Director of CMC RA at Janssen R&D, leads a team responsible for managing new registrations and post approval changes for a diverse product portfolio. Leslie’s team received the first FDA approval for a batch to CM process switch. She continues to partner with global... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #154: Bayesian Application in Small-Sized Clinical Trials
      Component Type: Session
      Level: Advanced
      CE: ACPE 1.25 Application UAN: 0286-0000-18-551-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The use of historical data demonstrates value and efficiency in designing clinical trials, especially in nonconfirmatory trials. This session presents an overview of theoretical framework, case studies in exploratory situations, and future directions.

      Learning Objectives

      Describe the use of historical information on controls in rare disease and pediatric settings; Discuss the challenges and concerns in design of confirmatory trials; Analyze industry and regulatory point of view and potentially pilot solutions.

      Chair

      Fei Wang, PhD

      Speaker

      Incorporating Adult Study Data into Pediatric Clinical Trials: Is Bayesian Borrowing the Solution?
      James Travis, PhD

      Approaches to Medical Device Evaluation Using Real-World Evidence
      Sharon-Lise Normand

      Bayesian Applications for Extrapolation from Adult to Pediatric Data
      Amy Xia, PhD



      Speakers
      SN

      Sharon-Lise Normand

      Professor of Health Care Policy (Biostatistics), Harvard Medical School
      Sharon-Lise Normand, Professor of Health Care Policy, Department of Health Care Policy at Harvard Medical School & Professor, Department of Biostatistics, Harvard School of Public Health focuses on the development of statistical methods for health services & outcomes research, including... Read More →
      avatar for James Travis

      James Travis

      Staff Fellow, OB, OTS, CDER, FDA
      James Travis is a mathematical statistician in the Division of Biostatistics in the FDA’s Center for Drug Evaluation and Research. He is a member of the Pediatric Review committee and a reviewer for the Division of Anesthesia, Analgesia, and Addition Products. He received his PhD... Read More →
      FW

      Fei Wang

      Senior Manager, Biostatistics, Amgen
      As a statistician, Dr. Wang has worked in both academia and pharmaceutical industry. Her research focuses on statistical methods for Bayesian design and hierarchical modeling, including applications for clinical trials in drug development, medical device evaluation, and health outcomes... Read More →
      avatar for Amy Xia

      Amy Xia

      Executive Director, Biostatistics, Amgen Inc.
      Amy Xia is Executive Director, Head of Design and Innovation in the Center for Design and Analysis at Amgen. Her research interests include Bayesian and adaptive design, meta-analysis and innovative approaches in drug development. Amy is an ASA Fellow. She currently serves as Vice-Chair... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #155: Real World Evidence for Value and Access
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-552-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Increasing availability of real-world data (RWD) and real-world evidence (RWE) has created justifiable excitement for stakeholders. The applications of RWD and RWE seem limitless – from trial optimization, directing R&D spend, and defining risk-sharing arrangements and value. Also, the role of RWD and RWE is becoming increasingly important to drug development and patient safety and has been cited as a significant priority of the FDA. Yet, there is still a lot of work to be done before the use of RWD and RWE is widespread and truly impactful. The session will explore this potential as well as the areas for further exploration, alignment, methods, and infrastructure development. Also, the session will present a study conducted by Tufts Center for the Study of Drug Development that examines current RWE data uses, sources of data, how data is being integrated and operational approaches supporting RWD use.

      Learning Objectives

      Discuss the potential advantages and challenges, as well as return on investment, in using real-world data (RWD) and real world evidence (RWE); Assess the application of RWD and RWE for clinical research, value-based payment arrangements, and post-market safety surveillance; Describe emerging practices and definitions.

      Chair

      Marianne Hamilton Lopez, PhD, MPA

      Speaker

      The Use of Real World Evidence and Data in Clinical Research and Post-Marketing Safety Applications
      Mary Jo Lamberti, PhD, MA

      How Real World Evidence is Rapidly Changing Drug Development and Value Demonstration
      Charles Makin, MBA, MS



      Speakers
      avatar for Mary Jo Lamberti

      Mary Jo Lamberti

      Associate Director of Sponsored Research, Research Assistant Professor, Tufts Center for the Study of Drug Development
      Mary Jo Lamberti leads multi-company sponsored research studies at the Tufts Center for the Study of Drug Development (CSDD). She has extensive experience conducting research on biopharmaceutical industry practices and trends affecting contract research organizations and investigative... Read More →
      avatar for Marianne Hamilton Lopez

      Marianne Hamilton Lopez

      Research Director, Value-Based Payment Reform, Duke-Margolis Center For Health Policy
      Marianne Hamilton Lopez, PhD, MPA is Research Director of Value-Based Payment Reform at the Duke-Robert J. Margolis, MD, Center for Health Policy. She focuses on value-based payment models for medical products; oversees a multi-stakeholder Consortium; and partners with faculty and... Read More →
      CM

      Charles Makin

      Vice President and Global Head, RWE and Late Phase Research, ICON plc
      Charles Makin leads ICON’s late phase research unit, one of the industry’s largest teams dedicated to RWE generation and analysis. In over 15 years in RWE, HEOR and drug commercialization, Mr. Makin has developed and implemented drug value, safety and effectiveness roadmaps for... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #157: Courageous Leadership
      Component Type: Workshop
      Level: Intermediate
      CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000233; RN 1.25

      Skills for overcoming the impact that fear of failure can have are important to learn. This workshop will focus on decision making, the power of the leader's shadow, and the importance of deliberate leadership choices.

      Learning Objectives

      Define what is meant by courageous leadership; Describe how courageous decisions improve the workplace; Recognize courageous communication situations.

      Chair

      Michael Williams


      Speakers
      avatar for Michael Williams

      Michael Williams

      Managing Partner, Facio Consulting Group and Associates
      Michael Williams, a sales executive with a record of exceeding goals. He led a successful career with GlaxoSmithKline culminating as VP for the medical groups then moved to Sanofi Pharmaceuticals as VP of Sales for hospitals and long term care accounts. He was the Managing Director... Read More →


      Monday June 25, 2018 3:00pm - 4:15pm
      Room 254AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      #156: International Regulatory Convergence
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-553-L04-P; CME 1.50; IACET 1.50; RN 1.50

      The objective of the forum is to highlight leadership from international regulatory agencies on the fight against antimicrobial resistance, including efforts such as the Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR), the tripartite EMA-FDA-PDMA meetings, bilateral EMA-FDA initiatives and the cooperation with WHO (including PAHO), OIE and Codex Alimentarius.

      We intend to show how international regulatory authorities cooperate to ensure global coordination of research activities, convergence on regulatory requirements for the approval of antibacterial agents, support to discussions on new business models for antibacterial agents, on alternative therapeutics approaches to antibiotics, and on prevention of resistance across regions, including antimicrobial stewardship following the One Health approach.

      Learning Objectives

      Describe how international regulatory authorities cooperate and collaborate, and the public health, economic, and political drivers for that cooperation; Describe how international regulatory agencies seek to set the strategic direction and priorities for the various regulatory initiatives.

      Chair

      Agnès Saint-Raymond, MD

      Speaker

      The Fight Against Antimicrobial Resistance: A One Health Approach
      Ivo Claassen, PhD, MSc

      Panelist
      Guido Rasi, MD

      Panelist
      Tatsuya Kondo, MD, PhD

      Panelist
      Julio Sánchez Y Tépoz

      Panelist
      Pierre Sabourin, MBA

      Panelist
      Donald Prater, DVM



      Speakers
      avatar for Ivo Claassen

      Ivo Claassen

      Head of Veterinary Medicines Division, European Medicines Agency (EMA)
      Dr Claassen is a biomedical scientist by training and obtained his PhD in Virology and Immunology at the Erasmus University in Rotterdam.He started his career in different positions related to R&D,production,QA/QC and regulatory aspects of human and veterinary medicines.For the past... Read More →
      avatar for Tatsuya Kondo

      Tatsuya Kondo

      Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
      Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
      DP

      Donald Prater

      Assistant Commissioner for Food Safety Integration, OC, FDA
      avatar for Guido Rasi

      Guido Rasi

      Executive Director, European Medicines Agency (EMA)
      Professor Guido Rasi has been Executive Director of EMA since November 2011 and was Director-General of AIFA from 2008 to 2011. He was made full professor of microbiology at the University of Rome 'Tor Vergata' in 2008. He had a teaching experience at the University of California... Read More →
      avatar for Pierre Sabourin

      Pierre Sabourin

      Assistant Deputy Minister, Health Products and Food Branch, Health Canada
      Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch at Health Canada in 2016. He was the Senior Vice-President at Canada Mortgage and Housing Corporation (CMHC) from 2013 – 2014. From 2010 to 2013, he held the position of Vice-President... Read More →
      avatar for Agnès Saint-Raymond

      Agnès Saint-Raymond

      Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
      MD, Paediatrician. Chef de Clinique in Paediatrics@Necker-Enfants-Malades Hospital (Paris 1985-90). Pharma industry 1990-95. French Medicines Agency (ANSM) 1995-99 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. EMA 2000-current. EMA Head of Paediatric Medicines, Orphan Medicines... Read More →
      JS

      Julio Sánchez Y Tépoz

      Federal Commissioner, COFEPRIS


      Monday June 25, 2018 3:00pm - 4:30pm
      Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      4:30pm

      Opening Reception
      Monday June 25, 2018 4:30pm - 6:00pm
      Exhibit Hall

      4:30pm

      Opening Reception
      Component Type: Social Event




      Monday June 25, 2018 4:30pm - 6:00pm
      Exhibit Hall

      4:45pm

      #158: Advanced Clinical Innovation Theater: Preparing for the Next Generation of Clinical Research
      Component Type: Session

      Recent technological innovations are transforming global industries. Within clinical research, improvements in the way we collect, share, store, aggregate and analyze trial data have been demonstrated, but how can research organizations adopt new innovations while keeping up with the growing pace of change?

      Join us for a dynamic discussion about the industry’s most promising innovations, and strategies for clinical development organizations to lead change. Learn about how cross-industry collaboration is already impacting new therapy discovery and research practices, and how organizations can successfully prepare for the next generation of clinical research.

      Chair

      Advanced Clinical


      Speakers
      avatar for Cheryle Evans

      Cheryle Evans

      Sr. Vice President, Clinical and Medical Operations, Advanced Clinical


      Monday June 25, 2018 4:45pm - 5:15pm
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      4:45pm

      #159: ArisGlobal Innovation Theater: A Clinical Perspective - How Cognitive E-2-E Pharma Platforms can Transform Productivity in Pharma - Introducing LifeSphere from Clinical to Regulatory
      Component Type: Session

      Quality platforms in GMP, GCP, GVP and Good Regulatory Practice assure quality but data provision is often inconsistent. ‘Silo thinking’ across departments has led to disconnected platforms, defining their own standards, creating weak Data Governance. ArisGlobal solves this problem differently, with unified, cross-domain solutions, driven by industry-transforming cognitive computing. LifeSphere Clinical is set to transform Pharma with a process driven approach and ‘Industry Standard Practices’.

      Chair

      ArisGlobal, LLC


      Speakers
      avatar for Vitthal Gouri

      Vitthal Gouri

      Director – Clinical Solutions, ArisGlobal
      Mr. Vitthal Gouri has around 18+ years of experience in the information technology industry, and played various leadership roles in the areas of production development, architecture, product management and profession services. He has extensively contributed to the architecture and... Read More →


      Monday June 25, 2018 4:45pm - 5:15pm
      Theater 2 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      5:30pm

      #160: Cognizant Innovation Theater - Powering New Possibilities for Site-Sponsor Collaboration with the Shared Investigator Platform in partnership with TransCelerate
      Component Type: Session

      Cognizant’s Shared Investigator Platform (SIP) revolutionizes the collaboration between Sponsors and Sites across clinical trials. SIP enables increased efficiency and a unified experience for:
    • Sponsor Companies with savings through shared system investment and maintenance costs
    • Clinical Sites with a single point of access for site personnel to interact with multiple sponsors
      Learn about the time-saving SIP features and future roadmap for clinical trials, designed with Sites and for Sites.


    • Chair

      Cognizant Technology Solutions Corporation


      Speakers
      avatar for Cognizant Technology Solutions Corporation

      Cognizant Technology Solutions Corporation

      Cognizant Technology Solutions Corporation
      avatar for Beenu Kapoor

      Beenu Kapoor

      Sr.Director - Consulting, Life Sciences, Cognizant
      avatar for Krupa Patel

      Krupa Patel

      Head of Business Enablement Organization, Merck & Co., Inc.
      Krupa Patel is a Head of Business Enablement Organization within Global Clinical Trial Operations at Merck & Co., Inc. Her team is responsible for validation, implementation and ongoing management of clinical systems that support business processes. She was also a Co-Lead for Shared... Read More →


      Monday June 25, 2018 5:30pm - 6:00pm
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      5:30pm

      #161: Appian Innovation Theater: Moving beyond Cloud with Digital Transformation to Unify Process, Connect Data, and Turbocharge Innovation
      Component Type: Session

      Conducting and managing a successful, safe clinical trial is complicated. With massive data and complex processes at the core, it’s no surprise innovation is challenging yet very promising in the context of successful trials.

      Chair

      Appian


      Speakers
      avatar for Troy Bryenton

      Troy Bryenton

      VP IT, R&D Solutions, Clinical Operations Business Solutions, IQVIA
      avatar for Evi Cohen

      Evi Cohen

      VP, Life Sciences Sales, Appian


      Monday June 25, 2018 5:30pm - 6:00pm
      Theater 2 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
       
      Tuesday, June 26
       

      7:00am

      Coffee and Light Refreshments
      Component Type: Social Event




      Tuesday June 26, 2018 7:00am - 8:00am
      North Lobby

      7:00am

      Attendee, Speaker, and Exhibitor Registration
      Tuesday June 26, 2018 7:00am - 5:15pm
      North Lobby

      8:00am

      #202: Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-555-L04-P; CME 1.00; IACET 1.00; RN 1.00

      In this session, representatives from the Association of Clinical Research Professionals (ACRP) and the Tufts Center for the Study of Drug Development (Tufts CSDD) will present novel data quantifying the impact of properly trained and credentialed – or “certified” – site professionals as it pertains to quality outcomes in clinical trial studies. Based on a joint ACRP/Tufts CSDD global survey this session will present key findings on: • Whether properly trained and credentialed site staff have any impact to trial quality performance factors such as reduced levels of protocol deviations, queries, monitoring visits, audit findings, non-enrolling sites, etc. • Whether credentialed site staff have any impact to staff productivity factors such as job satisfaction and reduced levels of turnover rates, etc.

      Learning Objectives

      Describe the growing need and importance to ensure quality performance of clinical research site staff; Discuss the impact of properly trained and credentialed professionals on clinical trial quality; Describe industry initiatives designed to enhance the quality and competency of clinical research site staff.

      Chair

      Kenneth A. Getz, DIAFellow, MBA

      Speaker

      Update on Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality
      Beth Harper, MBA

      Assessing the Impact of Credentialing on Clinical Trial Quality and Performance
      Suzanne Caruso



      Speakers
      SC

      Suzanne Caruso

      Vice President, Clinical Solutions, WCG
      avatar for Kenneth Getz

      Kenneth Getz

      Director of Sponsored Research Programs and Associate Professor, Center For the Study of Drug Development, Tufts University School of Medicine
      Kenneth A. Getz directs research programs on drug development management strategy and practice. He is also the chair of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. Ken is also the founder... Read More →
      avatar for Beth Harper

      Beth Harper

      Workforce Innovation Officer, ACRP
      Beth is currently serving as the Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Beth received her... Read More →


      Tuesday June 26, 2018 8:00am - 9:00am
      Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #203: Utilizing and Understanding Real World Evidence Solutions to Efficiently Recruit the Most Appropriate Patients and Sites for Clinical Trials
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Application UAN: 0286-0000-18-556-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will examine the use of real world evidence for optimal insight into site and patient recruitment. We will discuss ways in which pharmacy, medical claim, consumer and lab data can be used to improve outcomes on clinical trials. Detailed methods and case studies will be presented by key opinion leaders in each of these areas.

      Learning Objectives

      Discuss using geo-targeting to identify where the highest volumes of patients and prescribers can be found; Identify how these tools can be used to select ideal locations for study sites and patients; Discuss ways to further refine and target study populations to find patients for any particular disease state or desired patient population.

      Chair

      Nancy Mulligan

      Speaker

      Heat Maps: Using PBM Data, Predictive Modeling, Medical Expertise in Understanding, Targeting and Conducting Effective Patient Recruitment Strategies
      Nancy Mulligan

      Using Consumer Data to Improve Patient Segmentation and Targeting for Clinical Trials Recruitment
      Andrew Kress

      Clinical Trial Patient Recruitment
      David M. Freeman, MA, MBA



      Speakers
      DF

      David Freeman

      General Manager, Information Ventures, Quest Diagnostics Inc.
      David Freeman is the General Manager of Information Ventures, an informatics business within Quest Diagnostics, where he is responsible for building Quest’s data and analytics solutions and partnerships, with particular focus on both the therapeutic and care continuums. David has... Read More →
      avatar for Andrew Kress

      Andrew Kress

      Chief Executive Officer, HealthVerity, Inc.
      Andrew is the CEO of HealthVerity, a company that operates a healthcare data marketplace using novel technologies to connect data at the patient level from a broad set of external data partners. Previously, he was SVP, Healthcare Value Solutions for IMS Health, responsible for real... Read More →
      avatar for Nancy Mulligan

      Nancy Mulligan

      Executive Director, Patient & Physician Services, United BioSource Corporation (UBC)
      Ms. Mulligan has more than 20 years of experience in medical and pharmaceutical communications. In her current position, Ms. Mulligan designs and executes aggressive, multi-media initiatives and site-based programs for various stakeholders. Ms. Mulligan is responsible for program... Read More →


      Tuesday June 26, 2018 8:00am - 9:00am
      Room 258AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #207: Novel Approaches for Accessing the CNS: Nonclinical and Clinical Challenges
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-560-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will highlight new approaches in CNS-targeted therapeutics. These approaches to identify and develop therapies able to reach the CNS and address specific genetic perturbations are being pioneered in rare disease, and require disciplined approaches to study designs and execution.

      Learning Objectives

      Design studies for advanced treatment modalities, with focus on CNS therapeutics. Identify and address hurdles in pre-clinical evaluation, identification of appropriate patients, and administration of treatments crossing or bypassing the blood brain barrier: Describe target engagement and biologic impact.

      Chair

      Richard Scheyer, MD

      Speaker

      Novel Approaches to Confirming CNS Penetration and Target Engagement
      Richard Scheyer, MD

      Nonclinical Models Supporting Orphan Drug Designations in Rare Neurodegenerative Conditions
      Dinah Duarte, PharmD, MSc

      Novel Central Nervous System Delivery Methods in the Era of Targeted Therapeutics
      William Elmquist, PharmD, PhD



      Speakers
      avatar for Dinah Duarte

      Dinah Duarte

      Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
      Senior assessor at Scientific Evaluation Unit (Portuguese Regulatory Authority - INFARMED). Expert member at European Medicines Agency (EMA). Current Committee for Orphan Medicinal Products member. Representative in ENCePP (European Network Centres Pharmacoepidemiology & Pharmacovigilance... Read More →
      avatar for William Elmquist

      William Elmquist

      Director, Brain Barriers Research; Distinguished Prof, Dept. of Pharmaceutics, Univerity of Minnesota
      His research has studied the influence of active efflux transporters in the blood-brain barrier (BBB) on CNS drug distribution. An important project currently underway is examining the determinants of anticancer drug permeability in the blood-brain barrier to improve the treatment... Read More →
      avatar for Richard Scheyer

      Richard Scheyer

      Vice President, Medical Affairs, Medpace
      Dr. Richard Scheyer is VP Medical Affairs at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from... Read More →


      Tuesday June 26, 2018 8:00am - 9:00am
      Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #209: Oversight in the Era of E6 (R2)
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Application UAN: 0286-0000-18-562-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will outline the characteristics that define common outsourcing models and expose their corresponding risk/benefit ratio with regard to sponsor and CRO oversight. Case studies of proven solutions within each model will be presented and linked to recommendations to achieve enhanced oversight in the era of E6 (R2).

      Learning Objectives

      Discuss the risk/benefit ratio with regard to sponsor and CRO oversight in common outsourcing models; Identify methods to implement improved and more efficient approaches to clinical trial oversight.

      Chair

      Melissa Bomben, MS

      Speaker

      Outsourcing Models
      Cristin MacDonald, PhD

      Panelist
      Lauren Curtiss



      Speakers
      avatar for Melissa Bomben

      Melissa Bomben

      Vice President, Strategic Resourcing, Syneos Health
      Melissa Bomben is Vice President, Strategic Resourcing with Syneos Health, an organization purpose-built to achieve a singular goal: Biopharmaceutical Acceleration. As an operational leader with over 20 years of experience, Melissa works directly with pharmaceutical development organizations... Read More →
      avatar for Lauren Curtiss

      Lauren Curtiss

      GCP Inspection Lead, Merck & Co., Inc.
      Lauren Curtiss is a GCP Inspection Lead within the Global Clinical Trial Operations department at Merck & Co., Inc. In this role, Lauren leads the preparation, notification, conduct and follow-up of Health Authority GCP inspections related to clinical studies sponsored by Merck worldwide... Read More →
      avatar for Cristin MacDonald

      Cristin MacDonald

      Executive Director, Client Delivery, The Avoca Group
      Dr. Crissy MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across Avoca. Crissy has 12 years of pharmaceutical industry experience with expertise in clinical research... Read More →


      Tuesday June 26, 2018 8:00am - 9:00am
      Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #201: Generic Drug Products: Comparison of Safety Profile With Branded Cousin
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-554-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This forum will discuss how FDA interprets generic drug regulation and safety reporting requirements along with review practices, ethics considerations, and guidance and labeling development to monitor and ensure generic drug safety.

      Learning Objectives

      Summarize how pre- and post-market elements of generic drug safety and surveillance integrate understanding of critical clinical elements of performance; Compare risk/benefit considerations for patients versus healthy volunteers in bioequivalence (BE) studies and effects on enrollment criteria and safety monitoring.

      Chair

      Howard Chazin, MD, MBA

      Speaker

      FDA Perspective
      Karen B. Feibus, MD

      Academic Perspective
      Aaron Kesselheim, JD, MD, MPH

      Industry Perspective
      Kiran Krishnan, PhD



      Speakers
      avatar for Howard Chazin

      Howard Chazin

      Director, Clinical Safety Surveillance Staff, Office of Generic Drugs, CDER, FDA
      Dr. Chazin joined FDA in 2002 and is the Director of the Clinical Safety Surveillance Staff in the Office of Generic Drugs. He leads a multidisciplinary team tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug product quality... Read More →
      KF

      Karen Feibus

      Lead Medical Officer, CSSS, Office of Generic Drugs, CDER, FDA
      I practiced obstetrics and gynecology for 9 years before joining FDA as a medical officer (MO). I worked in the Office of Nonprescription Products for 3 years and then served as Lead MO of OND's Maternal Health Team for 5 years. I joined the Veterans Administration as the Office of... Read More →
      AK

      Aaron Kesselheim

      Associate Professor of Medicine, Brigham and Women's Hospital/Harvard Medical School
      Dr. Kesselheim is an internist, lawyer, and faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Within the Division, Aaron created and leads the Program On Regulation, Therapeutics, And Law (www.PORTALresearch.org), an interdisciplinary... Read More →
      KK

      Kiran Krishnan

      Senior Vice President, Global Regulatory Affairs, Apotex Inc
      Kiran Krishnan is the Senior Vice President for Global Regulatory Affairs at Apotex. He has over 15 years of experience in the generic pharmaceutical industry. Dr. Krishnan’s areas of expertise include formulation development, process development, validation, intellectual property... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #204: FDA Data Standards Update
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-557-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will implement a joint data standards strategy, with supporting action plan. The action plan is now a PDUFA VI commitment to industry. The strategy will be facilitated by the rules, regulations, and guidances that authorize FDA to require electronic standardized data in regulatory submissions. Supported by a data standards governance, the strategy’s key data standards goals and objectives fall into the following areas: pre-market review, post-market safety, and pharmaceutical quality.
      The session will present the joint strategy, action plan, and updates such as SDTM / ADaM / SEND, therapeutic area standards, technical rejection of submissions, IDMP, and ICSRs. In addition, updates on the technical conformance guides and other technical specifications will be presented.

      This session will provide updates on the data standards in development, supported and required and have an impact on sponsor's electronic submissions to the FDA.

      Learning Objectives

      Explain the key data standards and impact on industry; Describe the key points of the FDA data standards strategy; Demonstrate an understanding of the data standards action plan and its projects.

      Chair

      Ron D. Fitzmartin, DIAFellow, PhD, MBA

      Speaker

      CDER Perspective
      Mary Ann Slack

      CBER Perspective
      Virginia Hussong



      Speakers
      avatar for Ron Fitzmartin

      Ron Fitzmartin

      Senior Advisor, Office of Strategic Programs, CDER, FDA
      Ron Fitzmartin is Senior Advisor in the Office of Strategic Programs in CDER. In this role Ron provides regulatory guidance and technical support regarding electronic submissions and standardized study data to industry and reviewers. Recent areas of focus have included: Standardized... Read More →
      avatar for Virginia Hussong

      Virginia Hussong

      Chief, Data Standards Program, CBER, FDA
      Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data... Read More →
      avatar for Mary Ann Slack

      Mary Ann Slack

      Acting Director, Office of Strategic Programs, CDER, FDA
      Ms. Slack has over 30 years’ technology and informatics experience implementing informatics solutions to business problems. Since joining FDA in 2003, she has been engaged in data standards development efforts in CDISC, HL7 and ISO in support of Agency needs. Ms. Slack is an FDA... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 209 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #205: Best Practices for Implementing Lay Summaries and Communicating Results to Patients
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Application UAN: 0286-0000-18-558-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Chief concerns from regulators and patient/public/advocate communicates are that trial results summaries (lay language summaries) are non-promotional, unbiased and not misleading. This session presents case studies and reviews strategies to address these concerns in lay summary content including: narrative content, visual content, process and policy and review.

      Learning Objectives

      Evaluate strategies to ensure lay language summaries are non-promotional, unbiased and not misleading; Analyze case studies to identify key takeaways to develop your own internal lay summaries program and processes.

      Chair

      Behtash Bahador

      Speaker

      Preparing for the Clinical Trial Report Lay Summary
      Barry Drees, PhD

      Beyond Lay Summaries: A Vision for Comprehensive Post-Trial Communications
      Paulo Moreira

      Promotional and Misleading Lay Summaries: Addressing the Elephant in the Room
      Behtash Bahador



      Speakers
      avatar for Behtash Bahador

      Behtash Bahador

      Senior Manager, Quality and Compliance, CISCRP
      Behtash Bahador is a Senior Manager at the non-profit CISCRP. With a background in health communication, Behtash leads quality and compliance assurance on CISCRP’s program that provides non-promotional and unbiased trial results summaries in an easy-to-understand format for patients... Read More →
      BD

      Barry Drees

      Senior Partner, Trilogy Writing & Consulting
      Barry Drees holds a PhD in Genetics from the University of California, San Francisco. He joined Hoechst AG Frankfurt in 1989 as a medical writer and is a past president of the European Medical Writers Association (EMWA) and is a former Editor-in-Chief of EMWA. His current position... Read More →
      avatar for Paulo Moreira

      Paulo Moreira

      Vice President, Global Clinical Operations, Head of External Innovation, EMD Serono, Inc.
      Paulo Moreira is a Clinical Development executive with 25+ years of experience in Clinical R&D. He has been with EMD Serono for the last 17 years. Presently serves as the Head of GCO External Innovation overseeing Clinical Innovation and Patient Centricity in Clinical Operations... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 210C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #206: Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-559-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This will discuss the FDA's history of including patient's voice in the regulatory process and current or new efforts that may be more advanced. How has their view of patient engagement changed? Evolution of the Patient Representative Program and Patient Engagement Advisory Council, for example. Engage in dialogue with the FDA and provide considerations for next steps, including from sponsor and patient.

      Learning Objectives

      Describe current and upcoming FDA efforts to advance the incorporation of patient input into medical product development and FDA’s regulatory decision-making; Discuss regulatory and methodological considerations that must be addressed in order to realize the full potential for patient input to support medical product development and evaluation.

      Chair

      Pujita Vaidya, MPH

      Speaker

      How FDA Involves Patients and Advocates
      Andrea Furia-Helms, MPH

      Partnering for Patients: A Regulatory Framework to Advance Patient-Focused Drug Development
      Eleonora Ford, PhD

      Panelist
      Theresa Mullin, PhD

      Panelist
      Anindita Saha

      Panelist
      Telba Irony, PhD



      Speakers
      EF

      Eleonora Ford

      Global Regulatory Affairs and Policy, Amgen Inc.
      Dr. Eleonora Ford currently serves as a Director, Global Regulatory and R&D Policy at Amgen, with a focus on Patient Focused Drug Development and Innovative Clinical Trial Design. She received her Ph.D. in Chemistry from King’s College London, UK and served as a postdoctoral researcher... Read More →
      AF

      Andrea Furia-Helms

      Patient Representative Program, Office of Health and Constituent Affairs, OC, FDA
      avatar for Telba Irony

      Telba Irony

      Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA
      Telba Irony is Deputy Director of the Office of Biostatistics and Epidemiology at CBER. She joined FDA to implement the use of Bayesian statistics for the regulation of medical devices, and led the Decision Analysis initiative at CDRH including Bayesian statistics, benefit-risk determinations... Read More →
      avatar for Theresa Mullin

      Theresa Mullin

      Associate Director for Strategic Initiatives, CDER, FDA
      As CDER Associate Director for Strategic Initiatives Dr. Mullin leads development of long-range goals and implementation plans for international drug regulatory harmonization and standardization to increase regulatory clarity and efficiency; effective integration of the patient’s... Read More →
      avatar for Anindita Saha

      Anindita Saha

      Director, External Expertise and Partnerships, OCD, CDRH, FDA
      Anindita Saha is the Director of External Expertise and Partnerships (EEP) in FDA/CDRH. Ms. Saha leads CDRH’s Patient Preference Initiative and helps coordinate MDUFA IV efforts in patient engagement and science. Ms. Saha is leading research projects in patient preferences and patient-reported... Read More →
      PV

      Pujita Vaidya

      Acting Director, Decision Support and Analysis Team, OSP, CDER, FDA
      Pujita Vaidya serves as the Acting Director for the Decision Support and Analysis Team in the Office of Strategic Programs, in CDER at the U.S. FDA. She has been with FDA since 2012 and is the operations lead on CDER’s Patient-Focused Drug Development initiative. Pujita holds a... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 151AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #208: Effective Management of Internal Stakeholders and External Strategic Partners from Multiple Perspectives: Non-Profit, CRO, and Pharmaceutical Industry
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Application UAN: 0286-0000-18-561-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000222; RN 1.25

      Drug development has become an increasingly complex process due to rising costs, increased regulations, and the need to collaborate with essential internal and external stakeholders. Companies are embracing strategies to mitigate the risks of these costly and time sensitive development programs. This has resulted in an increasing number of companies in-licensing products and outsourcing development activities. Therefore, effective stakeholder management is an essential component of any successful drug development project. This forum will include three panelists who are experts in managing the collaborations and strategies for the biotech/pharmaceutical drug development process. This includes stakeholders such as business partners, non-profit consortiums, academia, key opinion leaders, and patient advocacy groups. Panelists will share their experiences and through case studies demonstrate some of the challenges they face in their individual unique settings. These challenges include how each business segment (advocacy, CRO, and medical affairs), define key stakeholders and how they developed plans to manage expectations and achieve project goals within set timeline and budget parameters.

      Learning Objectives

      Define stakeholders and recognize different levels of stakeholders; Identify key stakeholders and stakeholders in various settings from different perspectives; Recognize the similarities and differences of stakeholders in different settings; Identify risks and mitigation strategies; Develop a stakeholder management plan.

      Chair

      Jing Li, MBA, MS, PMP

      Speaker

      Stakeholder Management: From Non-Profit and Industry/Academic/Government Consortium
      Debora Merrill, MBA

      Stakeholder Management: From CRO Perspective
      Steven Innaimo, MS

      Stakeholder Management: From Sponsor Medical Affairs Perspective
      Stephen Apple, MD



      Speakers
      SA

      Stephen Apple

      Senior Medical Director, Mitsubishi Tanabe Pharma America
      Dr. Apple has over 20 years of experience both nationally and internationally in all major segments of health care delivery: as a provider, educator, managed care consultant, and as a medical director Dr. Apple is currently Senior Medical Director for Mitsubishi Tanabe Pharma America... Read More →
      avatar for Steven Innaimo

      Steven Innaimo

      Head, Program Management Office, Covance
      Steve Innaimo is the head of the Covance Program Management Office and possesses more than 25 years of drug development experience in the pharma, biotech and CRO settings. Steve began his career as molecular biologist developing novel targeted gene therapies. During his 22 years with... Read More →
      avatar for Jing Li

      Jing Li

      Head of Program Management Office, Castle Creek Pharmaceuticals
      Jing Li is the Head of Program Management Office at Castle Creek Pharmaceuticals, responsible for managing all R&D programs under development. Jing is a passionate leader with strong management skills. Jing has 20 years of direct project management experience in large pharma, mid-size... Read More →
      DM

      Debora Merrill

      Vice President, COPD Biomarker Qualification Consortium, COPD Foundation
      As VP, COPD Biomarker Qualification Consortium (CBQC) for the COPD Foundation, Debbie focuses on integrating pharma, academic and government partners to qualify novel biomarkers and clinical outcome assessment tools supporting development of novel COPD therapies. Prior to that, Debbie... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 153ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #210: Artificial Intelligence: The Future of Regulatory Affairs
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Application UAN: 0286-0000-18-563-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will focus on the various aspects of artificial intelligence (AI) currently incorporated in regulatory processes as well a futuristic look at what it can do for the RA function. Case studies and lessons learned on AI pilots within the biopharma and medical device industry will be highlighted as well as FDA's perspective on the future of AI.

      Learning Objectives

      Identify obstacles in developing an artificial intelligence pilot for regulatory decision making; Discuss lessons learned on a large pharma's groundbreaking artificial intelligence pilot; Analyze the integration of artificial intelligence into regulatory processes including information management.

      Chair

      Linda Bowen, MSc, RAC

      Speaker

      Regulatory 2.0: The Future of Regulatory Affairs and Advanced Technologies
      Oliver Steck

      Exploring New Ways of Working Using Artificial Intelligence: Proof of Concept Pilot
      Dany De Grave

      FDA Update
      Bakul Patel, MBA, MS



      Speakers
      avatar for Linda Bowen

      Linda Bowen

      Assistant Professor, Temple University
      Linda has 35 years experience in the BioPharma Industry, of which 25 years were spent in regulatory affairs. She consults on regulatory policy & intelligence issues and is an Associate Professor in the Temple University RAQA Program. She was previously Head of US Regulatory Policy... Read More →
      avatar for Dany De Grave

      Dany De Grave

      Senior Director, Innovation Programs & External Networks, Sanofi Pasteur
      Dany is an engineer trained in biology with 20+ years of industry experience at GSK and Sanofi Pasteur. In various positions he supported R&D, clinical, manufacturing and global regulatory submissions. He currently leads the implementation of various cognitive and other innovative... Read More →
      avatar for Bakul Patel

      Bakul Patel

      Associate Director for Digital Health, Office of the Center Director, CDRH, FDA
      Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical... Read More →
      avatar for Oliver Steck

      Oliver Steck

      Principal, Deloitte & Touche LLP
      Oliver Steck is a Principal in Deloitte & Touche’s Regulatory & Operational Risk Advisory practice. He has over 20 years experience as a management consultant in the life science industry and helped global clients to optimize their organizations and processes in respect of regulatory... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #211: Update on Collaboration and Trends in Global Companion Diagnostics
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-564-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Regulatory representatives from Japan, US, and EU will discuss the latest trends and challenges they face in the area of companion diagnostics, and will also discuss potential collaboration opportunities and their value from the scientific and regulatory point of view.

      Learning Objectives

      Describe the latest trends in regulations related to companion diagnostics; Discuss common challenges and possible global collaboration opportunities.

      Chair

      Karen D. Weiss, MD, MPH

      Speaker

      PMDA Perspectives on Companion Diagnostics Development in Japan
      Reiko Yanagihara, PhD

      FDA Perspective
      Yun-Fu Hu, PhD

      EMA Perspective
      Marie-Helene Pinheiro, PharmD



      Speakers
      YH

      Yun-Fu Hu

      Deputy Director, Division of Molecular Genetics and Pathology, CDRH, FDA
      Dr. Hu is currently the Deputy Director of the Division of Molecular Genetics and Pathology in the Office of In Vitro Diagnostics and Radiological Health at FDA. He received his M.S. and Ph.D. degrees from the Ohio State University. He joined FDA in 2009 and was promoted to Associate... Read More →
      avatar for Marie-Helene Pinheiro

      Marie-Helene Pinheiro

      Industry Stakeholder Liaison, Corporate Stakeholders Department, European Medicines Agency (EMA)
      Marie-Helene Pinheiro currently the Industry Stakeholder Liaison within the Corporate Stakeholders Department, at the European Medicines Agency. She is responsible for coordinating the Agency’s interaction with industry stakeholder organisations, for human and veterinary medicines... Read More →
      avatar for Karen Weiss

      Karen Weiss

      Vice President, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
      Karen Weiss MD, MPH is the VP for Regulatory Policy and Intelligence for Janssen Pharmaeutical Companies of J&J. She joined J&J in January 2012 after a 22 year career at the US FDA, where she served in a number of postions, within first CBER and then CDER. Before joining FDA, Karen... Read More →
      avatar for Reiko Yanagihara

      Reiko Yanagihara

      Deputy Review Director, Office of In Vitro Diagnostics, Pharmaceuticals and Medical Devices Agency (PMDA)
      Dr. Reiko Yanagihara is Deputy Review Director of Office of in vitro Diagnostics in Pharmaceuticals & Medical Devices Agency (PMDA). She joined PMDA in 2009 and served as reviewer in the area of biopharmaceuticals, biosimilars and in vitro diagnostics. She is responsible for leading... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #212: Global Regulatory Strategies for Biosimilars
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Application UAN: 0286-0000-18-565-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The number of approvals of biosimilars has increased significantly in both EU and USA over the last three years. However, for some originators there are still only a few biosimilar versions available and up until now there was no overall significant reduction in price in USA as compare to EU. Due to the complexity of biosimilar development, it is not surprising that the biggest and most advanced biotechnological companies remain the major players in the biosimilar field and on average it still takes up to 10 years to develop a biosimilar. Why is there reduced competition from smaller companies from emerging markets? Why do smaller companies seem to struggle when developing biosimilar products for the global market? What obstacles are preventing smaller companies from entering the EU and USA to help drive down the price of expensive originator biologics? The goal of this session is to explore these major questions using case studies of three biosimilars development of the same monoclonal antibody developed in emerging markets

      Learning Objectives

      Discuss components of a successful regulatory strategy that can reduce biosimilar development time and get to market sooner; Identify common mistakes in biosimilar development that significantly increase time of overall development.

      Chair

      Oxana Iliach, PhD

      Speaker

      The Evolving Regulatory Guidelines for Biosimilars and Biologics
      Brittany Scott

      Industry Perspective: Developing Biosimilars and Biologics in a Crowded Market
      Yatika Kohli, PhD

      Health Canada Perspective
      Agnes V. Klein, MD



      Speakers
      avatar for Oxana Iliach

      Oxana Iliach

      Senior Director Regulatory Affairs, Biosimilars Center of Excellence, IQVIA
      Oxana Iliach, PhD is a Sr. Director Regulatory Affairs at the Biosimilars Center of Excellence, IQVIA. She works with the team of dedicated professionals to develop and implement practical and creative strategies for biosimilars development from selection of target product to bringing... Read More →
      avatar for Agnes Klein

      Agnes Klein

      Senior Medical Advisor, Health Canada
      Agnes V. Klein MD is currently the Senior Medical Advisor in the Director General's Office, in the Biologics and Genetic Therapies Directorate. Dr. Klein trained in Endocrinology at UofT and has interests in multiple aspects of drug development and medical bioethics. Dr. Klein is... Read More →
      avatar for Yatika Kohli

      Yatika Kohli

      Vice President, Regulatory Affairs, Medicago Inc
      Dr. Yatika Kohli is a candid professional of strategic foresight & business acumen with over 15 years of experience in leading R2L activities in a fast-paced, high growth environment at global bio-pharma companies. She has expertise in developing global regulatory & clinical strategy... Read More →
      avatar for Brittany Scott

      Brittany Scott

      Creative Director, Addison Whitney
      As creative director, Brittany provides creative vision through innovative verbal and visual solutions. With more than 15 years experience, she has worked with a wide range of companies, specializing in pharmaceuticals. Prior to Addison Whitney, Brittany worked for Wells Fargo and... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #213: 2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-702-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The dynamics of the US healthcare market are shifting. Retailers are entering the world of healthcare in unorthodox ways; in one of the more prominent market shifts, we have seen a growing interest in consolidation between retail pharmacies and health plans. At the same time, Silicon Valley technology companies are looking to bring disruptive approaches to critical aspects of healthcare delivery. Shifts are also occurring on the public payer side; for example, new CMS policies will change the way states administer their Medicaid programs. How will all of these market changes impact biopharma innovators and patients? Come and hear from a range of experts about what’s triggering these market shifts, how they could affect care delivery, and what the future of healthcare may look like.

      Learning Objectives

      Recognize shifts in the healthcare market that may signal important changes in care delivery or access to treatments; Appraise the potential impact and how biopharmaceutical and device stakeholders might strategize to prepare for such changes.

      Chair

      Nancy Bradish Myers, Esq, JD

      Speaker

      Panelist
      Larry Kocot, JD

      Panelist
      Darshak Sanghavi, MD

      Panelist
      Rick Weissenstein, MA



      Speakers
      LK

      Larry Kocot

      Principal, National Leader of the Center for Healthcare Regulatory Insight, KPMG
      Larry Kocot is a Principal at KPMG, LLP and National Leader of KPMG’s Center for Healthcare Regulatory Insight. The Center follows health care regulatory and policy trends driving health care transformation and industry convergence and the broader implications of operating in a... Read More →
      avatar for Nancy Myers

      Nancy Myers

      President and Founder, Catalyst Healthcare Consulting, Inc
      Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA’s Commissioner’s Office and held senior positions at PhRMA, BIO and... Read More →
      DS

      Darshak Sanghavi

      Chief Medical Officer and Senior Vice President of Translation, Optum Labs
      RW

      Rick Weissenstein

      Managing Director, Health Care Services and Pharmaceutical Policy, Cowen Washington Research Group
      Rick Weissenstein is part of the Cowen Washington Research Group and is responsible for analyzing health care policy issues and emerging trends in the federal and state legislative, regulatory, and legal arenas. He was formerly the Washington Bureau Chief for Modern Healthcare ma... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #214: CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-567-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Major regions have put in place regulatory processes to support development with the aim of delivering new medicines to patients by accelerated pathways. Reducing the clinical development timeline also impacts on the time available for manufacturing process development. Industry has proposed a number of areas where risk based approaches may be adopted to expedite delivery of a commercial product. In the EU, unmet medical need has utilized the PRIME procedure and designated more advanced therapy medicines for early access support. In the US a number of small and large molecules have also been given Breakthrough status. Experiences of how quality development / CMC has been a factor in delivering these products will be addressed in the session.

      Learning Objectives

      Recognize regulatory mechanisms for early access for unmet needs; Identify how quality and manufacturing development falls on the critical path; Describe where there are opportunities to modify development and control strategies on a risk basis, e.g. using prior knowledge.

      Chair

      Peter Richardson, PhD

      Speaker

      Taking the Leap: CMC Strategies for Supporting External Clinical Studies for a Breakthrough Therapy Designation Product
      Christine Kolz, PhD

      CMC Challenges for Breakthrough Therapies
      Ronald Imhoff, MS

      CMC Challenges and Opportunities for the Expedited Development Program
      T. G. Venkateshwaran, PhD



      Speakers
      avatar for Ronald Imhoff

      Ronald Imhoff

      Senior Director, CMC Regulatory Affairs, Janssen Biologics
      Ronald Imhoff is senior director of global regulatory affairs - CMC at Janssen based in Leiden, The Netherlands and is responsible for leading a global team of regulatory affairs-CMC professionals. His team provides strategy for multiple biological products and vaccines at all stages... Read More →
      avatar for Christine Kolz

      Christine Kolz

      Associate Director, Global Regulatory CMC, Pfizer Inc
      Christine is an Associate Director of Regulatory CMC, with 20 years of experience at Pfizer, responsible for developing and executing regulatory CMC strategies for a portfolio of small molecule products spanning early clinical phases through registration. Christine completed an NIH... Read More →
      avatar for Peter Richardson

      Peter Richardson

      Head of Quality, Specialised Scientific Disciplines Department, European Medicines Agency (EMA)
      Dr Richardson is a pharmacist, with a Ph.D. in pharmaceutics from The Queens University, Belfast. He worked in industry in the area of formulation research and on drug delivery and controlled release systems for small and large molecules. He has worked for the UK MHRA as a pharmaceutical... Read More →
      avatar for T. Venkateshwaran

      T. Venkateshwaran

      Associate Vice President and Global Head CMC Biologics, Medical Devices and Comb, Merck & Co., Inc.
      T.G. Venkateshwaran (TG) currently serves as an associate vice president - Chemistry, Manufacturing & Controls Biologics and Combination Products, GRACS,Merck. TG joined Merck in November 2015 and has 18 years of pharmaceutical industry experience in R&D, quality, regulatory and manufacturing... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #215: Pediatric and Rare Disease Drug Development
      Component Type: Session
      Level: Advanced
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-568-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will highlight some of the new drugs approved in the last few years for rare disease and the statistical approaches used. Regulatory, industry and patient perspectives will be shared and approaches proposed that are realistic based upon needs of patients and scientific rigor necessary. Additionally, for drugs approved where there were significant differences of opinion, regulatory, industry, and patient perspectives will be shared on experience of these marketed products post-approval and whether post-marketing studies supported the treatment to be efficacious and safe.

      Learning Objectives

      Identify approaches to design and analyze data for studies for developing new medical products for rare diseases; Describe how use of historical controls can help show therapeutic benefit in rare diseases.

      Chair

      Munish Mehra, PhD

      Speaker

      The Use of Historical Controls From Register Data in Randomized Clinical Trials in Rare Diseases
      Thomas Zwingers

      Challenges and Strategies: Cases Studies for Pediatric Rare Disease Clinical Trials
      Yeh-Fong Chen, PhD



      Speakers
      avatar for Yeh-Fong Chen

      Yeh-Fong Chen

      Mathematical Statistician, Office of Translational Sciences, CDER, FDA
      Dr. Yeh-Fong Chen is the statistical team leader supporting the Division of Gastroenterology and Inborn Errors Products at the Division of Biometrics III at US Food and Drug Association. She joined FDA in 2000 immediately after graduation with a PhD degree in Statistics from the University... Read More →
      avatar for Munish Mehra

      Munish Mehra

      Executive Director, Tigermed Co., Ltd.
      Munish Mehra, is a Sr. Biostatistician and drug development expert who heads up Tigermed's India operations. During a career spanning over 30 years, Dr. Mehra, setup Biometrics operations in China for a US CRO, started a SMO in India and helped grow two multinational CRO’s, one... Read More →
      TZ

      Thomas Zwingers

      Director of Consultancy, CROS DE Gmbh
      Thomas Zwingers was CEO of estimate, a CRO for statistical consultancy and analysis, from 1992 to 2011. Then he joined CROS NT with headquarters in Verona, Italy, as Head of the consultancy department. His main expertise are Designing of study protocols, adaptive designs in oncology... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #216: Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome?
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-569-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Health technology assessment (HTA) scientific advice is now more critical for companies to take to help them develop the right evidence package. This session will look to bring findings from current studies which have been undertaken to identify the type of advice taken and how this affects the development program as well as case study perspective from a company and an agency on what they believe are the potential issues but also how to define a successful scientific advice meeting.

      Learning Objectives

      Identify different strategic approaches for obtaining relevant HTA advice on evidence development and reimbursement; Recognize the problems of initiating and seeking HTA advice by companies and how effective use can support a positive HTA recommendation; Define measures of success of a scientific advice meeting from the different stakeholders perspectives.

      Chair

      Neil McAuslane, PhD, MSc

      Speaker

      Early Scientific Advice from HTA Agencies: How Does the Effective Use of the Various Kinds of Advice Support a Positive HTA Recommendation?
      Neil McAuslane, PhD, MSc

      Early HTA Scientific Advice: What’s in it For the Agency?
      Amy Sood, PharmD

      How Can This Aid Companies in Their Development of New Medicines and How Would a Successful Scientific Meeting be Defined?
      Matthew Lamb, PharmD, RPh



      Speakers
      avatar for Matthew Lamb

      Matthew Lamb

      Vice President, Regulatory Affairs, Inflammation and Immunology, Celgene Corporation
      Matthew is Vice President, Regulatory Affairs, at Celgene. He has 20 years of experience in the pharmaceutical industry working within Regulatory Affairs, Clinical Pharmacology and Project Leadership. Matthew previously was Vice President, Regulatory Affairs and Project Leadership... Read More →
      avatar for Neil McAuslane

      Neil McAuslane

      Director, Centre For Innovation In Regulatory Science (CIRS)
      Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (CIRS, previously CMR International) and works in the area of regulatory and HTA strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology... Read More →
      avatar for Amy Sood

      Amy Sood

      Manager, Scientific Advice Program, Canadian Agency For Drugs & Technologies In Health (CADTH)
      Amy Sood is the Manager for the Scientific Advice Program at the Canadian Agency for Drugs and Health Technologies in Health (CADTH). She has been an integral part of early scientific advice since the launch of the program at CADTH. Amy received her Bachelor of Science in Pharmacy... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #218: Building Your Brand
      Component Type: Workshop
      Level: Basic

      Personal branding is the practice of people marketing themselves and their careers as brands. The personal-branding concept suggests instead that success comes from self-packaging. Personal branding is essentially the ongoing process of establishing a prescribed image or impression in the mind of others about yourself. Marketing textbooks define the personal brand in this way: "Your brand is a perception or emotion, maintained by somebody other than you, that describes the total experience of having a relationship with you." Attendees will work on their own or be presented with a skill set of a fictitious person and create a brand. They will identify criteria to feature.

      Learning Objectives

      Define and describe a personal brand; Identify attributes to feature in a personal brand; Demonstrate an example of a self-branding.

      Chair

      Chris Matheus, MBA

      Speaker

      Facilitator
      Danielle Baxter, MA



      Speakers
      avatar for Danielle Baxter

      Danielle Baxter

      Director, Business Development, Paragon Global CRS
      Danielle began her career as an assistant professor of rhetoric at Indiana University, teaching public speaking courses as well as business and professional communications through the Kelley School of Business. Since then, she has worked as a marketing consultant with clients specializing... Read More →
      avatar for Chris Matheus

      Chris Matheus

      President, Matheus BD Connections
      Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical technology companies. Chris establishes strong working relationships customers and has built a significant... Read More →


      Tuesday June 26, 2018 8:00am - 9:15am
      Room 254AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      8:00am

      #217: Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence
      Component Type: Forum
      Level: Advanced
      CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-570-L04-P; CME 1.50; IACET 1.50; RN 1.50

      The last several years have seen increasing effort to better understand when and how real-world data and evidence could better support a wide range of regulatory decisions. And while sponsors, researchers, policymakers, and regulatory agencies continue to develop real world evidence (RWE) frameworks to achieve that express aim, guiding principles are emerging related to the selection of adequate real-world data sources and appropriate study designs within specific regulatory contexts: How do specific characteristics related to disease area, data source, or analytical method affect questions around maintaining randomization? When can well-done observational studies suffice for generating actionable evidence? Are we nearing truly proof-of-concept pilot opportunities?

      Speakers
      avatar for Paul Bleicher

      Paul Bleicher

      Chief Executive Officer, OptumLabs
      Paul Bleicher, MD, PhD, is CEO of OptumLabs, a collaborative research and innovation center. Previously, he was CMO for Humedica, a next-generation clinical informatics company. He founded Phase Forward, which helped bring clinical trials from paper to the web. Dr. Bleicher holds... Read More →
      avatar for Jacqueline Corrigan-Curay

      Jacqueline Corrigan-Curay

      Director, Office of Medical Policy, CDER, FDA
      Dr. Corrigan-Curay brings to the position a unique legal, scientific policy, and clinical background with expertise in risk and scientific assessment, and clinical trial design and oversight. Before joining FDA, she served as supervisory medical officer with the Immediate Office of... Read More →
      avatar for Cathy Critchlow

      Cathy Critchlow

      Vice President, Center for Observational Research, Amgen Inc.
      Dr. Critchlow leads Amgen’s Center for Observational Research, providing strategic leadership to the design & conduct of observational studies for multiple stakeholders. Their Real World Data Platform with data for 160M patients uses a common data model and visualization/analytic... Read More →
      avatar for Gregory Daniel

      Gregory Daniel

      Deputy Director and Clinical Professor, Duke-Margolis Center For Health Policy
      Dr. Gregory Daniel is Deputy Director and Clinical Professor in the Duke-Robert J. Margolis Center for Health Policy. Dr. Daniel directs the DC-based office and leads its pharmaceutical and medical device policy portfolio aimed at developing strategies for improving development and... Read More →
      avatar for Pall Jonsson

      Pall Jonsson

      Associate Director Research and Development, National Institute for Health and Care Excellence (NICE)
      Dr Jonsson heads Research and Development UK's National Institute for Health and Care Excellence (NICE). He leads NICE's contribution to a portfolio of international research projects, in areas including big data and real-world evidence. Dr Jonsson has a PhD in biochemistry from University... Read More →


      Tuesday June 26, 2018 8:00am - 9:30am
      Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
      • Level Advanced
      • format json
      • Credit Type ACPE, CME, IACET, RN
      • Tags Forum

      9:00am

      Coffee Break
      Component Type: Social Event




      Tuesday June 26, 2018 9:00am - 10:30am
      Exhibit Hall

      9:00am

      Professional Poster Session 1
      Component Type: Poster Presentation




      Speakers
      JB

      Jasmine Benger

      Research Services Project Manager, CISCRP
      KB

      Kia Bryant

      Epidemiologist, Centers For Disease Control and Prevention (CDC)
      avatar for Magdalena Bujar

      Magdalena Bujar

      Project Manager, Centre For Innovation In Regulatory Science (CIRS)
      Magda Bujar is a Project Manager at CIRS. She received her undergraduate degree in Biochemistry from the University of Bristol and a Master of Science in Biochemical Engineering from the University College London. At CIRS, Magda’s scope of responsibilities covers the Global Development... Read More →
      EB

      Emer Byrne

      Digital Strategy Consultant, Accenture
      DC

      Diane Carozza

      Managing Senior Engagement Consultant, Medidata Solutions
      XC

      Xiangchen Cui

      Senior Director, Alkermes Inc.
      Xiangchen (Bob) Cui, Senior Director, Head of Statistical Programming Department of Alkermes, Inc., has 19-year experience with 10+ years in managing various levels of programmers.He has very strong hands-on SAS skills for clinical trial reporting and tool development, and track record... Read More →
      MC

      Maria Cusano

      Novartis Institute of Biomedical Research
      MC

      Maria Cusano

      Novartis Institute of Biomedical Research
      MC

      Michael Cushion

      Global Solutions Manager, IQVIA
      AD

      Amit Dang

      Founder and CEO, Marksman Healthcare Solutions LLP
      SD

      Sameen Desai

      Director, PV Innovation, Celgene
      AF

      Aaron Fleishman

      Strategic Consultation and Advocacy Outreach, BBK Worldwide
      Aaron Fleishman leads the Social Innovation and Advocacy Engagement teams at BBK Worldwide, the global leader in patient recruitment. Aaron’s team works directly with pharmaceutical sponsors, advocacy organizations, and patient thought leaders to create award-winning, innovative... Read More →
      EG

      Ellyn Getz

      Senior Manager of Development & Community Engagement, CISCRP
      EH

      Erik Hansen

      Clinical Study Manager, PRA Health Sciences
      Erik Hansen is a Clinical Study Manager at PRA Health Sciences in Salt Lake City, Utah. He has worked at PRA for 8 years, beginning in Quality Assurance and continuing as Project Supervisor before progressing to his current managerial position. He has co-authored several publications... Read More →
      KH

      Kathleen Hoffman

      Writer/Editor, Inspire
      YL

      Young Lan Hong

      CRA, ASAN Medical Center
      I'm working at Asan Medical Center as a Project Manager of Clinical trials.
      BJ

      Brad Jordan

      Director, Global Regulatory and R&D Policy, Amgen
      TK

      Tanveer Khan

      Manager, Pharmacovigilance, IQVIA
      Tanveer Khan is registered pharmacist, he has completed his Masters in Pharmacy with Pharmacology as specialization from NMIMS Mumbai. He has more than 10 years of experience in the field of Drug Safety and Pharmacovigilance. He holds a position of Manager, Pharmacovigilance at IQVIA... Read More →
      RL

      Ryan Lanier

      Associate Director, Consulting, Analgesic Solutions
      NM

      Nicola Mathieson

      Global Medical Manager Hematology / Nephrology, Sandoz Biopharmaceuticals
      avatar for Sanjeev Miglani

      Sanjeev Miglani

      Founder and Director at AWINSA Life Sciences, AWINSA Life Sciences
      Sanjeev is an MD in Internal Medicine and has more than 16 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities for... Read More →
      CN

      Cambrey Nguyen

      Drug Information Specialist; Clinical Assistant Professor, Drug Information, University of Kansas School of Pharmacy
      Cambrey Nguyen earned a Pharm.D. from the University of Kansas School of Pharmacy in 2012. After graduation, she worked for Walgreens then moved into the pharmaceutical industry as a Medical Information Specialist at ProPharma Group. At ProPharma Group, she managed clients that specialized... Read More →
      BR

      Barbara Rusin

      Regulatory Compliance Manager, MMS Holdings Inc.
      TS

      Toshiki Saito

      Director, Department of Regenerative Medicine, National Hospital Organization Nagoya Medical Center
      MS

      Monika Schneider

      Research Associate, Duke-Margolis Center For Health Policy
      ES

      Erin Sizemore

      Lead Epidemiologist, Data Mgt & Implementation Team, Div of TB Elimination, Centers For Disease Control and Prevention (CDC)
      avatar for Meredith Smith

      Meredith Smith

      Global Risk Management Officer, Global Patient Safety, Amgen Inc.
      Meredith Smith is Global Risk Management Officer, Global Patient Safety & Labeling at Amgen, Inc. where she leads a team of scientists responsible for medicinal product benefit-risk assessment and risk management. Trained as a health services researcher, Dr. Smith has over 15 years... Read More →
      BS

      Beth Stockstill

      Associate Director, IQVIA
      YT

      Yu-Chun Teng

      Project manager, TFDA/Center for Drug Evaluation, Taiwan
      RT

      Rajan Thumar

      Jr. Consultant, Regulatory Affairs, Syner-G Pharma Consulting, LLC
      ST

      Stelios Tzellos

      Consultant, IQVIA
      LW

      Lynn Webster

      Vice President, Scientific Affairs, PRA Health Sciences


      Tuesday June 26, 2018 9:00am - 4:00pm
      Posters Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      9:00am

      Exhibit Hall Open
      Tuesday June 26, 2018 9:00am - 5:00pm
      Exhibit Hall

      9:15am

      #219: FDA Warning Letters on Data Integrity
      Component Type: Session
      Level: Basic
      CE: IACET 0.50

      Data integrity continues to be a hot topic as seen in the regulatory inspections and resulting FDA warning letters. Case studies / select samples of warning letters on data integrity, computer system validation, electronic records, and audit trail will open up discussions for data integrity, data life cycle, and ALCOA principles.

      Learning Objectives

      Describe the current trends of FDA Warning Letters on Data Integrity, with exposure to case studies; Discuss data integrity, and general requirements on data life cycle and ALCOA principle.

      Chair

      Anu Virkar, MA, MS


      Speakers
      avatar for Anu Virkar

      Anu Virkar

      Vice President, Quality and Compliance, eClinical, Merge eClinical, An IBM Watson Health
      Anu Virkar, MS, MA, PMP is the VP of Q&C. Anu has been in the SQA field for over 23 years, & has focused on clinical trial mgmt and Med device industry for over 15 yrs. She has extensive experience in software QA, SDLC, project mgmt as well as policy development, implementation. She... Read More →


      Tuesday June 26, 2018 9:15am - 9:45am
      Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      9:30am

      #220: Brexit: Practical Real-World Solution Planning
      Component Type: Workshop
      Level: Basic

      This Engage and Exchange workshop will be a discussion on impacts of Brexit on regulatory issues facing pharmaceutical sector, areas of work that will be affected and when to take action. The participants will be exchanging best practices and finding practical solutions to the upcoming regulatory challenges.

      Learning Objectives

      Discuss the uncertainties around Brexit and the real-world regulatory challenges of Brexit; Describe and come up with practical solutions to the real-world scenarios that the UK withdrawal from EU will create; Discuss how to strategically plan for and prepare license transfers, variations, clinical trials and supply chains affected by Brexit.

      Chair

      Parastoo Karoon, PhD, MS

      Speaker

      MHRA Perspective
      Mick Foy



      Speakers
      avatar for Mick Foy

      Mick Foy

      Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group, MHRA
      Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 11 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the signal detection system. He is responsible for two major projects to improve drug safety. Firstly a Gates... Read More →
      PK

      Parastoo Karoon

      Principal Consultant, PAREXEL International
      Dr Parastoo Karoon - PhD, Principal Consultant PAREXEL, provides advice on drug development & submission strategies, interactions with Regulatory Authorities & regulatory issues. She performs gap analysis, due diligence, scientific advice, MAA & variation. With 12 years of experience... Read More →


      Tuesday June 26, 2018 9:30am - 10:30am
      E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      9:30am

      #221: DIA Regulatory Community Round Table Discussion: Artificial Intelligence: The Future of Regulatory Affairs
      Component Type: Forum

      Join DIA RA Community for a round table discussion tied to session # 210 Artificial Intelligence: The Future of Regulatory Affairs (Tuesday, June 26th)

      To include special guests from the session: Linda Bowen, Oliver Steck, Dany De Grave, and Bakul Patel.

      Chair

      Linda Bowen, MSc, RAC


      Tuesday June 26, 2018 9:30am - 10:30am
      Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      9:30am

      #222: DIA Patient Engagement Community Round Table Discussion: New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors
      Component Type: Forum

      Join DIA PE Community for a round table discussion tied to session # 145 New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors (Monday, June 25th)

      To include special guests from the session: Katie Jensen, Kristen Voorhees, Alice Bast, and Suzanne Schrandt.

      Chair

      Mary Stober Murray, MBA


      Speakers
      avatar for Mary Murray

      Mary Murray

      Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb
      As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and underserved populations. Mary has co-chaired DIA-PEC... Read More →


      Tuesday June 26, 2018 9:30am - 10:30am
      Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      9:45am

      #223A: On the Soapbox: Blockchain and Genomics
      Component Type: Session
      Level: Intermediate



      Chair

      Dennis Grishin, MS


      Speakers
      DG

      Dennis Grishin

      Chief Scientific Officer and Co-Founder, Nebula Genomics
      I am a PhD candidate in genetics and genomics at Harvard Medical School in the laboratory of Prof. George Church. I am also co-founder and chief scientific officer at Nebula Genomics. Our goal is to incentivize personal genome sequencing by reducing costs and addressing privacy concerns... Read More →


      Tuesday June 26, 2018 9:45am - 10:15am
      Room 157AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      9:45am

      #223B: Covance Innovation Theater: Case Study - Driving Clinical Transformation Through a Next-Generation of Data Integration and Analytic Technologies with a GlaxoSmithKline-Covance Partnership
      Component Type: Session

      With a mandate to improve company-wide performance through greater adoption of digital technologies, GSK embarked on a series of technology initiatives to provide study teams with timely and integrated access to all clinical trial data to improve operational performance and accelerate decision making. This presentation will walk the audience through GSK’s vision and discuss the technological and cultural reasons that led GSK to select Covance Xcellerate Informatics to enable that vision.

      Chair

      Covance Inc.


      Speakers
      avatar for Dimitris Agrafiotis

      Dimitris Agrafiotis

      Chief Data Officer and Head of Technology Products, Covance
      Dimitris Agrafiotis, PhD, FRSC, is Chief Data Officer and Head of Technology Products at Covance. He has over 25 years of experience in pharmaceutical R&D that spans venture-funded biotech, large pharma and the CRO industry, and is an internationally recognized thought leader with... Read More →
      avatar for Covance Inc.

      Covance Inc.

      Covance Inc.
      avatar for Kimberly Tableman

      Kimberly Tableman

      Head, Digital Clinical Trials, PCPS, GSK


      Tuesday June 26, 2018 9:45am - 10:15am
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      9:45am

      #224: Veeva Systems Innovation Theater: Global Industry Report - New Findings from the 2018 Unified Clinical Operations Survey
      Component Type: Session

      The Veeva 2018 Unified Clinical Operations Survey examines the industry’s progress in reducing system and process complexity to improve study execution. By gathering the experiences and opinions of clinical operations professionals from around the globe, the goal of the research is to understand the challenges and advances in today’s clinical operating model. The annual survey has been expanded to include trends in optimizing the clinical operating environment including EDC, eTMF, CTMS, and study start-up.

      Chair

      Veeva Systems, Inc.


      Speakers
      avatar for Mike Burton

      Mike Burton

      Director, Value Engineering, Veeva
      avatar for Veeva Systems, Inc.

      Veeva Systems, Inc.

      NA
      Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →


      Tuesday June 26, 2018 9:45am - 10:15am
      Theater 2 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:00am

      #225: Building a Dynamic Presentation: Rethinking Audience Engagement
      Component Type: Session
      Level: Basic
      CE: IACET 0.50

      Death by Powerpoint seems to be the hallmark of scientific communication, the smaller the font the better. However, research has shown that audiences understand and engage more if the presenter conveys information in stories and imagery. This interactive presentation will discuss new strategies for presentations.

      Learning Objectives

      Discuss the best uses of Powerpoint; Describe how storytelling and imagery can enhance audience engagement; Identify the effective presentation strategies.

      Chair

      Robin Whitsell


      Speakers
      avatar for Robin Whitsell

      Robin Whitsell

      President, Whitsell Innovations, Inc
      Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, she has 20 years’ experience, specializing in medical writing and regulatory submission strategies. Prior to founding WI, Ms. Whitsell was the assistant director of preclinical... Read More →


      Tuesday June 26, 2018 10:00am - 10:30am
      Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #228: Global Clinical Trials: Lessons in Effective Execution
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-572-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will feature distinguished speakers who have proven incredibly successful in executing global clinical trials for critical products. They will speak to real challenges with global trials and how to overcome such challenges based on their firsthand experience.

      Learning Objectives

      Describe the common obstacles faced in executing an effective global clinical trial; Demonstrate strategy and tactics for overcoming obstacles; Identify through global clinical trial case studies how strategy and implemented tactics ensured sufficient enrollment, engagement, data collection, and logistics as well as appropriate ethics review, consent and community involvement.

      Chair

      Mitchell Parrish, JD, RAC

      Speaker

      Site Network Perspective
      Kathy Lenhard

      CRO Perspective
      Jason Ezzelle, MT



      Speakers
      JE

      Jason Ezzelle

      Chief Commercial and Government Contracts Officer, Pharm-Olam
      Jason began his research career in a clinical microbiology laboratory before moving into the CRO industry where he served in both operational and business roles with increasing responsibility. In his more than 20 year career in clinical research he has worked on the ground in 17 different... Read More →
      avatar for Kathy Lenhard

      Kathy Lenhard

      President, Panamerican Clinical Research
      Kathy has more than 30 years of drug, vaccine,and biologic development. Additionally, Kathy is owner of PanAmerican Clinical Research with offices in Queretaro, Mexico, offering Clinical Operations expertise.
      avatar for Mitchell Parrish

      Mitchell Parrish

      VP of Legal and Regulatory Affairs, Quorum Review; Kinetiq
      Mitchell Parrish, JD, RAC, CIP, leads the Kinetiq legal and regulatory teams, driving consultation on pressing issues impacting clinical trials and innovative medical research. In prior roles he has provided regulatory, compliance, and transactional services to leading manufacturers... Read More →


      Tuesday June 26, 2018 10:30am - 11:30am
      Room 258AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #231: Automation with Intelligence: From Standard-Based Solution to Metadata-Driven Automation
      Component Type: Session
      Level: Basic
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-575-L04-P; CME 1.00; IACET 1.00; RN 1.00

      This session will discuss the challenges in managing the standard adoption, the potential points for automation through utilizing robotic process automation and artificial intelligence and the maturity model for metadata driven automation.

      Learning Objectives

      Discuss challenges in streamlining the process for automation in clinical data transformation and standardization; Describe how to leverage the development of technologies in robotic process automation and artificial intelligence for automation; Define how to display automation maturity model to transform standard base solution into metadata driven automation

      Chair

      Hanming H Tu, MSc

      Speaker

      Rapid Transformations to Standard Data Models via Automation and Machine Learning
      Silas McKee, MSc

      The Growing Impact of Big Data and Emerging Technologies: Increased Commercial Visibility, Efficiency, Outcomes, and Safety
      David Kiger

      The Perfect Partnership: Machine Learning and CDISC
      Kevin Lee, MS



      Speakers
      avatar for David Kiger

      David Kiger

      Chief Commercial Officer, BioClinica
      David runs GTM departments for global sales, corporate marketing and commercial operations. David was the former VP Product Strategy and Marketing at PAREXEL Informatics where he led launches in all areas of patient, clinical, and regulatory technologies. David lives in the San Francisco... Read More →
      KL

      Kevin Lee

      Director of Data Science, ClinData Insight
      Kevin Lee is Director of Data Science at Clindata Insight. Kevin has been supporting pharmaceutical industry nearly 20 years as a data-driven solution architecture including CDISC standards, Big Data and Machine Learning. He is also a current member of the data standards team at CDISC... Read More →
      SM

      Silas McKee

      Technology Consulting Manager, Accenture
      Silas has worked within Life Sciences R&D for over 6 years. His experience has largely focused on projects supporting clinical R&D including analytics, data warehousing, and clinical data standards (CDISC). Silas received a B.A in Chemistry from Hamilton College and an M.S. in Chemistry... Read More →
      HT

      Hanming Tu

      Vice President, Clinical IT and Database Administration, Frontage Laboratories, Inc.
      * MS, MCRP * VP, Clinical IT & Database Administration (DBA) at Frontage * Manager, DBA in Accenture Life Science Cloud * Director, Clinical IT in Octagon Research * Over 15 years of pharmaceutical and clinical IT experience * Oracle Certified Professional (OCP) and DBA Master from... Read More →


      Tuesday June 26, 2018 10:30am - 11:30am
      Room 209 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #236: Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat?
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-580-L04-P; CME 1.00; IACET 1.00; RN 1.00

      Part didactic presentation, part lively debate and discussion among an executive panel, dive deep into the state of risk in clinical trials and explore our data on risk assessment and risk-based approaches to clinical trial oversight and execution.

      Learning Objectives

      Identify the most recent information regarding the state of the industry for familiarity, use, impact and satisfaction with risk assessment and risk-based approaches in clinical research; Develop new perspectives on how to shape their individual and organizational perspectives and positioning with respect to changing regulatory requirements and evolving risk landscape.

      Chair

      Dennis Salotti, MBA, MS

      Speaker

      Panelist
      Neil McCullough

      Panelist
      Elizabeth Luczak, MBA



      Speakers
      avatar for Elizabeth Luczak

      Elizabeth Luczak

      Vice President, R&D Quality Assurance, Vertex Pharmaceuticals
      Elizabeth is Vice President of R&D Quality Assurance at Vertex Pharmaceuticals. Prior to joining Vertex, she has held positions of increasing scope and responsibility within quality/compliance across a number of biopharma organizations; her most recent experience was at Covance/LabCorp... Read More →
      avatar for Neil McCullough

      Neil McCullough

      Executive Vice President, Clinical Quality and Compliance, ICON Clinical Research
      Dr. McCullough has vast experience leading global quality and compliance teams within the industry. His expertise in quality assurance, regulatory affairs, risk-based auditing, continuous improvement, and project management are relied upon by PPD and its clients to achieve high quality... Read More →
      avatar for Dennis Salotti

      Dennis Salotti

      Vice President, Operations, The Avoca Group
      Dennis Salotti is Vice President of Operations at The Avoca Group and leads the strategy and execution of Avoca’s industry-leading research practice and Diligent™, the clinical research industry’s first centralized platform for clinical service provider prequalification. Mr... Read More →


      Tuesday June 26, 2018 10:30am - 11:30am
      Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #237: Expanded Access: Where Are We Now?
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-581-L04-P; CME 1.00; IACET 1.00; RN 1.00

      Expanded Access is a reality in today’s clinical development environment. An Expanded Access Program (EAP) is a formal plan under which preapproval access to an investigational drug is provided to a group of patients. There are practical issues relevant to EAP decision making, particularly around implementation considerations. There are a multitude of considerations of when to initiate an Expanded Access Protocol and guidance on the proper exit strategy. Some, but not all, pharmaceutical companies have embraced EAPs. This session will provide valuable insight into the considerations, risks and commitments that will enable a company to decide whether it is right to go ‘all in’.

      Learning Objectives

      Describe the complex considerations faced by a clinical team when deciding whether to embark on an Expanded Access Program; Describe risks, ethical considerations of an Expanded Access Program; Review key considerations for a thoughtful and responsible exit strategy.

      Chair

      Anne B Cropp, PharmD

      Speaker

      Stakeholder Tools to Facilitate Patients Access: A Trade-Off of Uncertainties?
      Richard Huckle, MSc

      Global Patient Access Process
      Sarah Alummootil

      Global Patient Access Process: Advocate Perspective
      Jennifer McNary



      Speakers
      avatar for Sarah Alummootil

      Sarah Alummootil

      Expanded Access Coordinator, Early Access Care
      Sarah Alummootil joined Early Access Care as an Expanded Access Coordinator in 2017. In this ever adapting pharmaceutical industry, Sarah strives to prioritize the patient during their interaction with each stage of the drug development process. Prior to Early Access Care, Sarah was... Read More →
      avatar for Anne Cropp

      Anne Cropp

      Chief Scientific Officer, Early Access Care
      RH

      Richard Huckle

      Principal Consultant, Pope Woodhead
      Regulatory affairs professional with drug development experience spanning 25 years in the consulting/CRO industry and biotech/pharma companies. With a broad technical understanding of pre-clinical, quality, clinical and regulatory procedures. Richard leads Pope Woodhead’s (now Huron... Read More →
      avatar for jennifer McNary

      jennifer McNary

      Manager, J McNary Consulting
      Jenn McNary is the mother of two young men with a rare disease and a consultant in the biotechnology space with an expertise in caregiver/patient engagement, including bringing the patient voice to drug development and solving barriers to access. Her other activities include serving... Read More →


      Tuesday June 26, 2018 10:30am - 11:30am
      Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #226: Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities
      Component Type: Session
      Level: Advanced
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

      Regulatory agencies have conducted real-world studies of postmarketing safety concerns to inform their regulatory decision-making and explored safety surveillance methods using real-world data. This session will discuss the approach of the FDA, EMA, Health Canada, and PMDA, the challenges faced in exploring new methods and designing and conducting these studies, and future areas of research, including opportunities for international collaborative research.

      Learning Objectives

      Describe how regulatory agencies have used real-world data for safety surveillance and studies of post-marketing safety concerns; Discuss future areas of research by regulatory agencies using real-world data, including opportunities for international collaborative research.

      Chair

      Michael D. Blum, MD, MPH

      Speaker

      Regulator’s Utilization of Real-World Data in Pharmacovigilance Activities
      Yoshiaki Uyama, PhD

      FDA's Sentinel Program
      Michael D. Nguyen, MD

      EMA Perspective
      Agnès Saint-Raymond, MD

      Improving the Use of Real World Evidence in the Regulatory Environment: Where Are We Heading in Canada?
      Rhonda Kropp, BSN, MPH



      Speakers
      avatar for Michael Blum

      Michael Blum

      Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA
      Michael Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in FDA CDER. He is a pediatric infectious diseases specialist. Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in... Read More →
      RK

      Rhonda Kropp

      Director General, Marketed Health Products Division, Health Canada
      Rhonda Kropp is currently the Director General for the Marketed Health Products Directorate in the Health Products and Food Branch of Health Canada. She is responsible for the oversight of the vigilance of marketed health products in Canada, including ensuring Canadians and health... Read More →
      MN

      Michael Nguyen

      FDA Sentinel Program Lead, FDA
      Michael D. Nguyen, MD is the FDA Sentinel Program Lead and Deputy Director of the Regulatory Science Staff in the Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research (CDER). He oversees the day-to-day management of the Sentinel Program for the Agency... Read More →
      avatar for Agnès Saint-Raymond

      Agnès Saint-Raymond

      Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
      MD, Paediatrician. Chef de Clinique in Paediatrics@Necker-Enfants-Malades Hospital (Paris 1985-90). Pharma industry 1990-95. French Medicines Agency (ANSM) 1995-99 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. EMA 2000-current. EMA Head of Paediatric Medicines, Orphan Medicines... Read More →
      avatar for Yoshiaki Uyama

      Yoshiaki Uyama

      Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency (PMDA)
      Yoshiaki Uyama is currently Office Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for pharmacoepidemiological safety assessment and regulatory science research relating to new drug review and safety... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #227: Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible
      Component Type: Forum
      Level: Intermediate
      CE: CME 1.25; IACET 1.25; RN 1.25

      TransCelerate BioPharma common protocol template (CPT) was first released in December 2015. It was updated in 2017 based on collaboration with NIH-FDA to align templates from both organizations. Since the initial release CPT has been downloaded over 3,700 times by several hundred unique clinical research organizations including Pharma, CROs, academic institutions and health authorities. In 2016 the project initiated proof of concept programs, using the technology enhanced CPT, with the aim of demonstrating automated reuse of protocol information for critical activities such as eCRF generation and registry posting. The session will focus on the development of prototypes which deliver high value applications of a machine readable protocol. In addition, a model which describes traceability from protocol to report will be described. Current applications of the technology enabled edition of the CPT will also be presented.

      Learning Objectives

      Discuss the benefits of digital data flow, including accelerating time to study start up; Describe how the technology enabled edition of the CPT delivers automated traceability; Discuss future opportunities for implementation.

      Chair

      Robert A. DiCicco, PharmD

      Speaker

      Panelist
      Richard (Reb) Buckley, JD, MBA

      Panelist
      Jeff Beeler

      Panelist
      Michel Rider, DrMed



      Speakers
      avatar for Jeff Beeler

      Jeff Beeler

      Client Executive, Watson Health, IBM Watson Health
      RR

      Richard (Reb) Buckley

      Clinical Innovation, TransCelerate Program Lead, Operations Center of Excellence, Pfizer Inc
      Reb works in the Clinical Innovation group for Pfizer. In his position he focuses on leading initiatives that will transform the conduct of clinical trials in the industry. Since 2012, Reb has worked as the Program Lead at Pfizer for the TransCelerate initiatives. Through his Program... Read More →
      avatar for Robert DiCicco

      Robert DiCicco

      Executive Consultant, TransCelerate Biopharma Inc.
      Rob DiCicco is an executive consultant for TransCelerate. He is the Executive Sponsor for the Common Protocol Template Project and was one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over 25 years of experience in clinical development. His... Read More →
      MR

      Michel Rider

      Managing Director, Life Sciences Cloud Strategy, Accenture


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #229: Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Application UAN: 0286-0000-18-573-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This forum will be a set of case studies and discussion to create an open space for sharing the successes and learnings from the use of mobile apps and technology in clinical trials.

      Learning Objectives

      Define opportunities and challenges of mobile as a data collection methodology in clinical trials and real world evidence; Demonstrate experiential learning with case studies from panelists and audience members; Identify potential pathways for greater inclusion of mobile assessments while maintaining regulatory compliance and content validity.

      Chair

      Christopher Jones, PhD

      Speaker

      Patient Perspective
      Christine McSherry, BSN, RN

      Panelist
      Michelle K White, PhD

      Panelist
      Reenie McCarthy

      Panelist
      Linsey Walker, MS



      Speakers
      CJ

      Christopher Jones

      Executive Vice President, iTakeControl
      Chris has over twenty years of experience growing businesses and advising organizations through innovation and the adoption of digital technology in the biotech industry. He leads iTakeControl's platform design, client delivery services, and consults on real-world evidence and registry... Read More →
      RM

      Reenie McCarthy

      Chief Executive Officer, Stealth BioTherapeutics
      avatar for Christine McSherry

      Christine McSherry

      Executive Director, Jett Foundation
      Christine McSherry is the executive director of Jett Foundation, a non-profit dedicated to Duchenne muscular dystrophy, and the co-founder of Casimir Trials, a CRO that designs patient, caregiver, and observer reported outcomes that support regulatory approval and reimbursement. Christine... Read More →
      LW

      Linsey Walker

      Senior Clinical Trial Manager, Sarepta Therapeutics
      Linsey Walker is a Senior Clinical Trial Manager at Sarepta Therapeutics.
      MW

      Michelle White

      Senior Scientist, Optum
      Michelle K White, PhD, is VP and Sr. Scientist at Optum Patient Insights, where she leads a team of health-related quality of life patient-reported outcomes scientists. She has conducted dozens of patient-focused studies using qualitative and quantitative research designs to evaluate... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #230: Common Data Model Harmonization for Evidence Generation
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will discuss how to facilitate the use of real-world data (RWD) sources (e.g., claims, EHRs, registries, electronic patient-reported outcomes (ePRO) to support evidence generation for regulatory and clinical decision making.

      Learning Objectives

      Discuss how to use real-world data to support evidence generation for regulatory and clinical decision making.

      Chair

      Mitra Rocca, MSc

      Speaker

      Unlocking Real-World Value from EHRs: FDA's Harmonization of CDMs for Real World Evidence
      Michael A. Ibara, PharmD

      Common Data Models: Implementation and Use
      Jeffrey Brown, PhD, MA

      Industry Perspective
      Christian G. Reich, DrMed



      Speakers
      JB

      Jeffrey Brown

      Associate Professor, Department of Population Medicine, Harvard Pilgrim Health Care Institute/Harvard Medical School
      Dr. Brown is an Associate Professor in the Department of Population Medicine, Harvard Medical School and the Harvard Pilgrim Health Care Institute. His primary research activities involve new approaches to facilitate large-scale multi-institutional research and the use of distributed... Read More →
      avatar for Michael Ibara

      Michael Ibara

      Managing Partner, Fathom Digital Healthcare Consulting
      20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →
      CR

      Christian Reich

      Vice President, Real World Evidence Systems, IQVIA; Principal Investigator, IQVIA
      Christian Reich is VP, Real World Insights at IQVIA, leading a team offering standardized analytics across a large global network of observational data. He is also Principal Investigator at the OHDSI collaborative, which focuses on creating comprehensive evidence about disease, healthcare... Read More →
      avatar for Mitra Rocca

      Mitra Rocca

      Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA
      Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #232: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications
      Component Type: Session
      Level: Basic
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-576-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will discuss technology-driven approaches to supporting creation/production of different clinical and/or regulatory documents.

      Learning Objectives

      Discuss technology-driven approaches to support the creation/production of different clinical and/or regulatory documents.

      Chair

      Madhavi Gidh-Jain, PhD

      Speaker

      Artificial Intelligence for the Clinical Study Report
      Madhavi Gidh-Jain, PhD

      Understand the Unknown: How Health Specific Cognitive Services Accelerate Innovation by Unlocking New Insights
      Tim Wolfe, MBA

      Generating Narratives Using Structured Content Principles
      Shailesh Shah, MS



      Speakers
      avatar for Madhavi Gidh-Jain

      Madhavi Gidh-Jain

      Senior Director, Head Medical Writing (US), Sanofi
      Dr. Madhavi Gidh-Jain has experience since 1997 in designing, writing, and reviewing clinical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. Her work at various pharmaceutical and biotech companies includes process management... Read More →
      SS

      Shailesh Shah

      Practice Director, Electronic Content and Business Process Management, ArborSys Group
      Shailesh has 20+ years of experience in the software development industry in various technical roles. He has a wealth of knowledge in Enterprise Content Management areas in highly regulated industries like pharmaceuticals and life sciences with recent focus on structured authoring... Read More →
      TW

      Tim Wolfe

      Senior Offering Manager, Watson Health Cognitive Services, IBM Watson Health
      Tim Wolfe is a Product Manager at Watson Health building common AI and cognitive services to support the full product portfolio. He applies natural language processing and machine learning to healthcare and life sciences. Before IBM, Tim worked at the Bill and Melinda Gates Foundation... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 210C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #233: The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-577-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This forum will review lessons learned from the Patient-Focused Drug Development meetings held to date, including externally-led meetings, and provide patient perspectives on their experiences and what has changed in their field as a result. Representation will include both rare, life threatening and chronic disease communities, as well as FDA.

      Learning Objectives

      Appraise recent examples of FDA’s current efforts to incorporate the patient perspective into regulatory decision-making; Discuss implementation of patient engagement provisions in 21st Century Cures Act and PDUFA VI; Evaluate current proposals of methods collecting patient experience data.

      Chair

      James E. Valentine, JD, MHS

      Speaker

      FDA Perspective on the Value and Potential of PFDD
      Theresa Mullin, PhD

      Experience From an FDA-Led PFDD Meeting - NTM Case Study
      Amy Leitman, JD

      Experience From an Externally-Led PFDD Meeting; TSC Case Study
      Steven L. Roberds, PhD



      Speakers
      avatar for Amy Leitman

      Amy Leitman

      Director of Policy & Advocacy, NTM Info & Research
      A native of Canada, Amy moved to Miami, Florida to pursue her undergraduate studies and law degree at the University of Miami. She has more than 17 years’ experience in both the private and nonprofit sectors. Amy handles policy and legislative issues impacting NTMir, patients, or... Read More →
      avatar for Theresa Mullin

      Theresa Mullin

      Associate Director for Strategic Initiatives, CDER, FDA
      As CDER Associate Director for Strategic Initiatives Dr. Mullin leads development of long-range goals and implementation plans for international drug regulatory harmonization and standardization to increase regulatory clarity and efficiency; effective integration of the patient’s... Read More →
      avatar for Steven Roberds

      Steven Roberds

      Chief Scientific Officer, Tuberous Sclerosis Alliance
      Steve leads the development and implementation of the TS Alliance's scientific strategy. He partners with basic, translational and clinical scientists to advance new treatments for tuberous sclerosis complex, including creation of the TSC Preclinical Consortium and Biosample Repository... Read More →
      avatar for James Valentine

      James Valentine

      Attorney, Hyman, Phelps & McNamara, PC
      James Valentine is an associate at Hyman, Phelps & McNamara, a law firm in Washington, DC. There he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Prior... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 151AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #234: Personalized Medicine Approaches During Early-Phase Clinical Research
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-578-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Recent advances in molecular screening, gene sequencing and microarray technology have not only accelerated the identification of novel biomarkers, but are also rapidly revolutionizing the field of personalized medicine, particularly in the oncology arena. As an example, next-generation sequencing is routinely used in early-phase clinical research for the detection of genetic mutations that are associated with disease. Using these novel methodologies, potentially significant mutations and biomarkers can be distinguished from those that are less likely to be significant at an early stage of development. Specifically, this session will discuss some of the novel approaches currently being used to identify and qualify novel biomarkers for tumor targeting and efficacy. Case examples highlighting the clinical use of novel biomarkers will also be presented. Finally, a number of the regulatory concerns and challenges in leveraging novel biomarker technology for early clinical development will also be discussed.

      Learning Objectives

      Identify cutting-edge methods for shifting through genomic data to identify mutations that have the most potential for clinical significance; Describe some real-word applications of biomarker technology in early clinical development; Discuss the regulatory implications of utilizing biomarkers in drug development.

      Chair

      David J. Pepperl, PhD

      Speaker

      From PDX to the Clinic: A Biomarker Story
      Pavan Kumar, PhD

      Regulatory Considerations for Companion Diagnostic Development
      Sabah Malek

      Biomarkers as an Integral Part of Modern Drug Discovery and Development
      Jannik N. Andersen, PhD, MSc



      Speakers
      avatar for Jannik N. Andersen

      Jannik N. Andersen

      Vice President, Head of Research, Xios Therapeutics
      Jannik has multidisciplinary background in chemical engineering (M.Sc) and human biology (Ph.D). He has spent his professional career working in drug discovery in pharma (Novo Nordisk & Merck), Biotech (XTuit Pharmacuticals & Xios Therapeutics) and at leading university hospitals... Read More →
      PK

      Pavan Kumar

      Director of Biomarkers and Companion Diagnostics, H3 Biomedicine, Inc.
      Pavan has been part of the Biomarkers and Diagnostics industry for over 10 years, and is currently responsible for development and execution of clinical biomarker and translation strategies for multiple oncology programs, with special emphasis on liquid biopsies and multiplexed biomarker... Read More →
      avatar for Sabah Malek

      Sabah Malek

      Director, Regulatory Affairs, Oncology Business Group, Eisai Inc.
      Within Eisai, Sabah’s responsibilities include developing and delivering effective regulatory strategies to support development of therapeutics, especially those utilizing biomarkers or companion diagnostics (CDx) and managing global regulatory submissions. Prior to this, Sabah... Read More →
      avatar for David Pepperl

      David Pepperl

      Senior Consultant and Nonclinical Group Leader, Biologics Consulting
      Dr. David Pepperl is a Sr. Consultant and nonclinical group leader at Biologics Consulting in Alexandria, VA, and has 20 years’ experience in nonclinical development of drugs and biologics. With a background in both pharmacology/toxicology and cell and molecular biology, Dr. Pepperl... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #235: The Adventures of Patient Experience in Drug Development
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-579-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000223; RN 1.25

      Sponsors constantly brainstorm ways to become more customer centric. This session presents an overview of the clinical trial experience methods created to capture and improve the experiences of patients and sites in clinical studies.

      Learning Objectives

      Identify areas of importance and specific pain points for patients and site personnel within the experience maps; Describe ways in which clinical trial teams can use the knowledge from the maps and other examples to make future clinical trials more customer centric; Discuss what project/program managers can do to enable trial designs that improve site, investigator, and patient experiences.

      Chair

      Abby Jeske, PharmD

      Speaker

      Mapping the Patient and Site Experience During a Clinical Trial
      Abby Jeske, PharmD

      How Patient Advisory Boards Can Help Teams Elicit Feedback
      Tanja Keiper, DrSc

      Patient Perspective
      T.J. Sharpe, PMP



      Speakers
      avatar for Abby Jeske

      Abby Jeske

      Clinical Project Manager, Eli Lilly and Company
      Former Clinical Research Coordinator at a CRO that specialized in PI and PII PK/PD and dermatology trials. Received a PharmD from Samford University in Birmingham, AL. Currently working at Eli Lilly and Company as a Clinical Project Management Consultant supporting Early Phase Oncology... Read More →
      avatar for Tanja Keiper

      Tanja Keiper

      Director, GCO Clinical Applications & Innovation, Merck KGaA
      Tanja Keiper, molecular biologist by training, holds a doctoral thesis in internal medicine and is since 2005 working in the healthcare industry in various positions in R&D. She joined Merck KGaA in 2007 and is since 2014 member of Global Clinical Operations External Innovation/Clinical... Read More →
      avatar for T.J. Sharpe

      T.J. Sharpe

      Patient Advocate, Starfish Harbor LLC
      T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 blog. He was diagnosed in August 2012 with melanoma tumors in multiple organs, four weeks after his son was born, undergoing six surgeries and four immunotherapy treatments over two... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #238: The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer?
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-582-L04-P; CME 1.25; IACET 1.25; RN 1.25

      2017 was a big year for devices in Europe and US. Last year an overview of the new regulations was presented but it was clear that many questions remained in both US and EU about how the new regulations would affect the way medical devices are manufactured, tested and sold. The transition period in EU is now one year further along…have we had the enabling acts promised? Do they make life easier? What is still missing? Has the confusion been allayed by meaningful guidance? Is your supply chain sufficiently controlled? Are your MAIDs in compliance? In US, how is MDUFA IV shaping the devices market in the US? Have the new FDA user fees for de novo medical device registrations impacted manufacturers’ plans for commercialization of cutting-edge products in the US? Is the reduced fee for small-businesses for de novo applications too high for some prospective US medical device market companies? This session will review what has been seen to date and will consider what may be yet to come as we negotiate the many pitfalls and hurdles facing device manufacture, registration and commercialization in the forthcoming years.

      Learning Objectives

      ACompare how your organization is managing the change to the new EU regulations; Recognize what changes the MDUFA IV regulations have already made and identify what areas may continue to change; ; Identify areas within your organization that need to change to comply with the new regulations; Interpret the new regulations and guidance to benefit individual working environments.

      Chair

      Angela Stokes, MS

      Speaker

      Industry Perspective
      Theresa Jeary, MSc

      Industry Perspective
      LeeAnn L Chambers, MS



      Speakers
      LC

      LeeAnn Chambers

      Principal Research Scientist, Global Regulatory Affairs, CMC - Devices, Eli Lilly and Company
      LeeAnn Chambers has been a Regulatory Affairs professional at Eli Lilly and Company for 21 years. She assists teams in developing global registration strategies for medical devices and drug / device combination products. She has guided the preparation of device content in US IND... Read More →
      avatar for Theresa Jeary

      Theresa Jeary

      Head of Notified Body, Lloyds Register Quality Assurance (LRQA)
      Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments... Read More →
      avatar for Angela Stokes

      Angela Stokes

      Senior Director, Global Regulatory Consulting, Syneos Health
      Angela Stokes has over 27 years experience in the pharmaceutical and medical device industry in a variety of Regulatory Affairs based roles, most recently as Senior Director Global Regulatory Consulting at INC Research. She is experienced in medicinal product and medical device development... Read More →
      avatar for Angela Stokes

      Angela Stokes

      Senior Director, Global Regulatory Consulting, Syneos Health
      Angela Stokes has over 27 years experience in the pharmaceutical and medical device industry in a variety of Regulatory Affairs based roles, most recently as Senior Director Global Regulatory Consulting at INC Research. She is experienced in medicinal product and medical device development... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #239: Generic Drug Town Hall
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This forum will include information related to the implementation, policy, and regulatory science updates related to the Generic Drug User Fee Amendments (GDUFA).

      Learning Objectives

      Recognize challenges inherent to implementing the Generic Drug User Fee Amendments (GDUFA); Discuss policies impacting generic drug development, regulatory review, oversight, inspections and facilities assessments; Describe an update on regulatory science initiatives for complex generic drug products; Discuss opportunities for industry to move toward improved generic application approvability, related to the FDA Commissioner’s actions to improve access to affordable medicines.

      Chair

      Kathleen Uhl, MD

      Speaker

      Panelist
      Maryll Toufanian, JD

      Panelist
      Robert A. Lionberger, PhD

      Panelist
      Susan M. Rosencrance, PhD

      Panelist
      Ashley Boam, MS

      Panelist
      Alonza Cruse



      Speakers
      avatar for Ashley Boam

      Ashley Boam

      Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
      Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies & standards related to drug product quality, including... Read More →
      avatar for Alonza Cruse

      Alonza Cruse

      Director, Office of Pharmaceutical Quality Operations, ORA, OGROP, FDA
      Director, Office of Pharmaceutical Quality Operations within FDA’s Office of Regulatory Affairs (ORA), responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic, working in conjunction with FDA Centers: CDER and CVM. Alonza is also leading... Read More →
      avatar for Robert Lionberger

      Robert Lionberger

      Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA
      Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads implementation of the GDUFA science and research commitments. ORS also provides pre-submission advice on complex generics through pre-ANDA... Read More →
      avatar for Susan Rosencrance

      Susan Rosencrance

      Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA
      Dr. Susan Rosencrance currently serves as the Director for the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality (OPQ). In this capacity, she directs procedures and processes for evaluating and assessing drug product quality of both brand name and generic drug... Read More →
      avatar for Maryll Toufanian

      Maryll Toufanian

      Acting Director, FDA Office of Generic Drug Policy, FDA
      Maryll W. Toufanian, J.D., serves as Acting Director of FDA’s Office of Generic Drug Policy (OGDP), which provides oversight and direction in the development of policies concerning all aspects of generic drugs, and advises the generic drug program on application-specific policy... Read More →
      avatar for Kathleen Uhl

      Kathleen Uhl

      Director, Office of Generic Drugs, CDER, FDA
      Kathleen Uhl, MD currently serves as the Director for the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). This office is responsible for the review and approval of Abbreviated New Drug Applications (ANDAs) and... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 205AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #240: Biosimilars: Demonstrating Structural and Functional Similarity
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-584-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Biosimilar products continue to advance, with many companies investing in this field. The biosimilarity paradigm is based on reducing clinical and non-clinical data to the extent possible, based on robust comparison of the biosimilar product versus the authorized reference medicine. This session will look at the quality foundation for building the biosimilarity exercise and elaborate on experiences gained with authorized products and those in development. The utility of physicochemical and bioassays for characterization will be highlighted with a focus on monoclonal antibodies as example.

      Learning Objectives

      Discuss analytical and functional assays used to develop a biosimilar monoclonal antibody; Identify how robust quality characterization data may enable reduction of clinical requirements; Describe an awareness of technical challenges and regulatory thinking related to biosimilarity at quality level.

      Chair

      T. G. Venkateshwaran, PhD

      Speaker

      Biosimilar Development: The Product Defines the Process
      Richard Markus, MD, PhD

      Industry Perspective
      Rajesh Ullanat

      Building a Strong Analytical Foundation to Support Biosimilarity
      Christopher Downey, PhD



      Speakers
      CD

      Christopher Downey

      Review Chief, OBP, OPQ, CDER, FDA
      Christopher (Chris) Downey is a Review Chief in FDA/CDER’s Office of Biotechnology Products (OBP). He was been with FDA since 2012, and currently oversees CMC reviews of therapeutic proteins, including new molecular entities and biosimilars. He received his PhD in Biochemistry from... Read More →
      avatar for Richard Markus

      Richard Markus

      Vice President, Global Development, Amgen Inc.
      Richard Markus is Vice President, Global Development at Amgen, where he leads development activities for the Biosimilar Business Unit. He received his BS degree from the University of California, Los Angeles (UCLA) and his MD/PhD at the University of Southern California, where he... Read More →
      RU

      Rajesh Ullanat

      Head, Global Biologics Scientific Affairs, Mylan Pharmaceuticals
      Dr Ullanat has significant experience in key senior management positions leading multi-functional teams associated with Biopharmaceutical R&D. Dr Ullanat has significant experience related to Global Biosimilar development especially with respect to EMA and US-FDA and has led regulatory... Read More →
      avatar for T. Venkateshwaran

      T. Venkateshwaran

      Associate Vice President and Global Head CMC Biologics, Medical Devices and Comb, Merck & Co., Inc.
      T.G. Venkateshwaran (TG) currently serves as an associate vice president - Chemistry, Manufacturing & Controls Biologics and Combination Products, GRACS,Merck. TG joined Merck in November 2015 and has 18 years of pharmaceutical industry experience in R&D, quality, regulatory and manufacturing... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #241: Time-to-Event Analysis in Clinical Trials
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-585-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will present statistical methods for analyzing adverse events with a focus on time to occurrence of the first adverse event. Speakers will discuss practical implications of the analysis of AE data in clinical trials and give illustrative examples. The topic of competing risks (e.g., non-event-related death) that preclude the observation of the event of interest will be discussed and two methodologies will be proposed.

      Learning Objectives

      Discuss current problems and solutions for analysis of time-to-event data; Identify new insights and a novel approach for the analysis of drug safety data with the presence of competing risks; Describe extensions to efficacy endpoints.

      Chair

      Brenda Crowe, PhD

      Speaker

      The Challenges of Analyzing Drug Safety Data with Competing Risk Events and Some Thoughts
      William Wang, PhD

      Academic Perspective
      Tim Friede



      Speakers
      avatar for Brenda Crowe

      Brenda Crowe

      Senior Research Advisor, Global Statistical Sciences, Eli Lilly and Company
      Brenda Crowe is a Senior Research Advisor at Eli Lilly and Company (Lilly) where she leads a Safety Analytics team. She obtained a PhD in Statistics from the University of Toronto in 1997 and has 20 years of pharmaceutical industry experience.
      TF

      Tim Friede

      Professor of Biostatistics and Chair, Department of Medical Statistics, University Medical Center Goettingen
      Since 2010 Tim Friede is Professor of Biostatistics at the University Medical Center Göttingen (Germany) where he leads the Department of Medical Statistics. He graduated in mathematics from the Karlsruhe University and obtained a PhD from the Heidelberg University. In 2001 he joined... Read More →
      avatar for William Wang

      William Wang

      Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
      Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →


      Tuesday June 26, 2018 10:30am - 11:45am
      Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #242: Unmet Medical Need: Can the Stakeholders Align? Progress to Date
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-700-L04-P; CME 1.50; IACET 1.50; RN 1.50

      Part 2 of the DIA-CIRS Workshop

      Unmet medical need definition has been attempted to detangle by different groups. Different elements of a possible criteria is presented as a background for the discussion on Day 3.

      Learning Objectives

      Describe criteria currently used and identify a core list of criteria that should be used to identify and prioritize unmet medical need; Discuss what constitutes an unmet medical need and determine universal agreement on key characteristics

      Chair

      Inkatuuli Heikkinen, MSc

      Speaker

      How Should Unmet Medical Needs be Addressed in the US?
      Kenneth I. Kaitin, PhD

      Criteria Developed Between Stakeholders in Europe in the DIA Working Group
      Claudine Sapède, PharmD, MSc

      CIRS Experience and Outcomes of Stakeholder Discussions
      Lawrence Eugene Liberti, PhD, RPh, RAC



      Speakers
      IH

      Inkatuuli Heikkinen

      Senior Scientist, DIA
      Inkatuuli leads DIA EMEA Scientific Content Development and engages with over 500 volunteers annually. She has a policy background, with academic degrees in public policy and health and pharmacoeconomics. Prior to DIA, Inkatuuli worked as a policy consultant in various organisations... Read More →
      avatar for Kenneth Kaitin

      Kenneth Kaitin

      Director Tufts Center for the Study of Drug Development; Professor of Medicine, Tufts University School of Medicine
      Kenneth Kaitin is Professor and Director of the Tufts Center for the Study of Drug Development at Tufts University School of Medicine. He’s also Advisory Professor at Shanghai Medical College, Fudan University. Dr. Kaitin writes and speaks regularly on drug development issues, and... Read More →
      avatar for Lawrence Liberti

      Lawrence Liberti

      Executive Director, Centre for Innovation in Regulatory Science (CIRS)
      For the past 38 years, Mr Liberti has worked in the fields of regulatory affairs and clinical R&D. Since 2009 he has served as the Executive Director of CIRS (formerly the CMR International Institute for Regulatory Science), an independent, division of Clarivate Analytics. He ireceived... Read More →


      Tuesday June 26, 2018 10:30am - 12:00pm
      Room 153ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      10:30am

      #243: Global Perspectives on Patient Engagement
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-586-L04-P; CME 1.50; IACET 1.50; RN 1.50

      In Europe and North America, patient engagement in drug development is now expected, though not perfect. In this session, a panel of patient, industry, and regulator stakeholders will discuss the thinking and initiatives in other global regions to give patients a voice. We will look beyond Europe and North America to explore the thinking and efforts in other regions to engage patients in the medical product lifecycle. What efforts are underway or emerging to give patients a voice? What cultural, societal, and economic factors drive current thoughts and practices? Who are the influencers who are encouraging change? A diverse panel representing patient groups, regulators and industry from regions such as Asia and Latin America will talk about current experience, hopes, and aspirations for patient engagement worldwide.

      Learning Objectives

      Describe current practices for patient engagement in drug development and regulation in regions such as Asia and Latin America; Compare and contrast perspectives of patient, industry, and regulator stakeholders within these regions; Discuss cultural, societal, and other factors playing a role in views, practices, and emerging trends on patient engagement in these regions.

      Chair

      Mathieu Boudes, PhD

      Speaker

      Panelist
      Junko Sato, PhD

      Panelist
      Jan Nissen, BSN, MBA

      Panelist
      Durhane Wong-Rieger

      Panelist
      Young Jack Lee, PhD

      Panelist
      Jieun Lee



      Speakers
      avatar for Mathieu Boudes

      Mathieu Boudes

      PARADIGM Coordinator, European Patients' Forum
      Mathieu Boudes, PhD, joined the European Patients’ Forum (EPF) in 2018 as coordinator of the PARADIGM project, a public-private partnership financed by the Innovative Medicines Initiative and co-led by EPF and EFPIA (European Federation of Pharmaceutical Industries and Associations... Read More →
      avatar for Young Jack Lee

      Young Jack Lee

      Chief Executive Officer, LSK Global PS
      Dr. Young Jack Lee is a experienced biostastician. He started the biostatistics career at the US NIH, his last position being an NIH Biometry Branch Chief. He returned to Korea in 1999 to teach and started LSK Global PS, a full service Korean CRO in 2000. His company with 320 employees... Read More →
      JL

      Jieun Lee

      Assistant Director, Ministry of Food and Drugs Safety
      avatar for Jan Nissen

      Jan Nissen

      Vice President, Patient Innovation, Merck & Co., Inc.
      Jan leads three areas within Patient Innovation at Merck: Patient Insights, Patient & Consumer Experience, and Patient and Caregiver Alliances & Advocacy, and leads Patient Engagement roles in support of priority markets. Jan has been in the pharmaceutical industry for 32 years. The... Read More →
      avatar for Junko Sato

      Junko Sato

      Office Director, Office of International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA)
      She joined the agency in 1998. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs and international area for 6yrs. She also worked in U.S.FDA as a guest reviewer 2002-2003, and in EMA as the Japan Liaison Officer, 2012-2014. She is actively involved... Read More →
      avatar for Durhane Wong-Rieger

      Durhane Wong-Rieger

      President and Chief Executive Officer, Canadian Organization For Rare Disorders
      Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board... Read More →


      Tuesday June 26, 2018 10:30am - 12:00pm
      Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      11:30am

      Luncheon Service
      Component Type: Social Event




      Tuesday June 26, 2018 11:30am - 1:30pm
      Exhibit Hall

      12:00pm

      #244: Yes, No, Maybe: Sharing Health and Other Data for Research - Enthusiasm and Concern from the Patient Community
      Component Type: Workshop
      Level: Intermediate

      Technology facilitates the collection of data for research. Patients want to participate in research but have concerns about misuse of their data. We will come to an understanding of the concerns and develop a framework for addressing them.

      Learning Objectives

      Identify areas of enthusiasm and concern for patients in regards to the collection and sharing of health-related and other data in the course of research. Formulate frameworks for prioritizing and addressing the concerns of patients in study design, implementation, and communications. Propose next steps for future activities and collaboration.

      Chair

      Sara Loud, MBA, MS


      Speakers
      avatar for Sara Loud

      Sara Loud

      Chief Operating Officer, Accelerated Cure Project
      As COO of Accelerated Cure Project, Sara Loud ensures delivery of research resources to scientists studying multiple sclerosis. Passionate about the integration of people into “people-powered” research, Sara combines a love of technology, business expertise, and social enterprise... Read More →


      Tuesday June 26, 2018 12:00pm - 1:00pm
      E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      12:00pm

      DIA Community Luncheon
      Component Type: Social Event

      Attend the DIA Community Luncheon to celebrate the many exciting contributions DIA Community members have made throughout the year to improve global healthcare and to congratulate our emerging professional winners from DIA's Leader of Tomorrow challenge and the student poster competition.  

      Please note: seating is limited.




      Tuesday June 26, 2018 12:00pm - 1:30pm
      Ballroom Lobby 3 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      12:10pm

      #245: IQVIA Innovation Theater: Real World Evidence to Enhance Drug Development
      Component Type: Session

      Increase efficiencies and value throughout the life cycle of your drug by leveraging innovative designs with unparalleled real-world data, advanced analytics and technology. Rethink evidence generation with study designs tailored to your research questions and stakeholder needs.

      Chair

      IQVIA


      Speakers
      avatar for Nancy Dreyer

      Nancy Dreyer

      Global Chief, Sci Affairs; Sr VP, Head, Center for Advanced Evidence Generation, IQVIA
      Nancy Dreyer is the chief scientific officer and global chief of scientific affairs for IQVIA Real-World & Analytic Solutions. She leads the Center for Advanced Evidence Generation, focusing on the use of real-world evidence for regulators, payers, clinicians, and patients using minimally... Read More →
      avatar for IQVIA

      IQVIA

      IQVIA


      Tuesday June 26, 2018 12:10pm - 12:55pm
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      12:10pm

      #246: AMPLEXOR Innovation Theater: How Regulatory Information Will Become Part of Your Company Big Data Architecture
      Component Type: Session

      Holistic Big Data in Regulatory requires combined management of Product Master Data and Regulatory Intelligence, allowing end-to-end automation of processes including configurable interfaces enabling at-the-source data management. Complexity is the main exponential cost driver and the major compliance risk. Reduction of complexity contributes to higher compliance and reduces costs. Such approach can change the paradigm from compliance being cost of doing business and turn compliance into value.

      Chair

      AMPLEXOR


      Speakers

      Tuesday June 26, 2018 12:10pm - 12:55pm
      Theater 2 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:10pm

      #247: BioClinica Innovation Theater: Transformational Trends in Investigator Site Payments 2018
      Component Type: Session

      Bioclinica will present key findings from 2018 industry market research highlighting trends in investigator site payments site payments, operational efficiencies and technology adoption. Learn if a shift in outsourcing of site payments is on the horizon, plus hear industry perspectives on financial operational objectives and the impact on site relationships.

      Chair

      BioClinica


      Speakers
      MH

      Meghan Harrington

      VP & Head FLS, Bioclinica


      Tuesday June 26, 2018 1:10pm - 1:55pm
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:10pm

      #248: Veeva Systems Innovation Theater: Tufts Research - Strategies from Data Management Leaders to Speed Clinical Trials
      Component Type: Session

      Learn how top pharmas and CROs plan to speed database build and data collection, see their early results and future priorities. This in-depth research from Tufts follows their industrywide eClinical Landscape Study examining the major causes of database build delays and their impact on trial cycle times.

      Chair

      Veeva Systems, Inc.


      Speakers
      avatar for Kenneth Getz

      Kenneth Getz

      Director of Sponsored Research Programs and Associate Professor, Center For the Study of Drug Development, Tufts University School of Medicine
      Kenneth A. Getz directs research programs on drug development management strategy and practice. He is also the chair of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. Ken is also the founder... Read More →
      avatar for Veeva Systems, Inc.

      Veeva Systems, Inc.

      NA
      Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →


      Tuesday June 26, 2018 1:10pm - 1:55pm
      Theater 2 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:15pm

      #249: Global Evolution in Regulatory Science and Medicine: Novel Modalities and Intersection with Rare Disease Development
      Component Type: Workshop
      Level: Intermediate

      We explore the rapid advancements in science and medicine leading to new complexities in the drug development ecosystem for rare diseases. Also, we examine and deliberate on the heterogeneous nature of regulatory frameworks globally for the treatment

      Learning Objectives

      Discuss the intersection of precision medicine and rare disease drug development, including potential challenges; Explain, in general terms, about the global regulatory policy issues facing rare disease drug development.

      Chair

      Nina S. Cauchon, PhD, RAC


      Speakers
      NC

      Nina Cauchon

      Regulatory Affairs - CMC, Amgen Inc.
      Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She was a lead for early phase & commercial programs, including both small molecules & biologics. She is chair of the AAPS CMC Community, and is active on the ISPE Expedited Regulatory Pathways workstream. Her... Read More →


      Tuesday June 26, 2018 1:15pm - 2:00pm
      E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      1:30pm

      #250: Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials
      Component Type: Session
      Level: Intermediate
      CE: IACET 0.50

      The DIA Study Endpoints Community has convened a working group to drive the science around the use of wearable technology and the development of study endpoints from wearables data. Broad adoption of wearables and sensors for objective data capture in pivotal studies is being impeded by the absence of standards. In this discussion, participants will evaluate and provide feedback on proposed solutions intended to address this challenge.

      Learning Objectives

      Review and discuss the current work of Study Endpoint Community’s Wearables Work Group, and the Standards Work Stream; Evaluate the the adoption of wearables and sensors for objective data capture in clinical trials.

      Chair

      Jennifer C Goldsack, MA, MBA

      Speaker

      Facilitator
      Susan Marie Vallow, MA, MBA, RPh

      Facilitator
      Marie McCarthy, MBA, MS

      Facilitator
      Paul O'Donohoe, MS



      Speakers
      avatar for Jennifer Goldsack

      Jennifer Goldsack

      Senior Project Manager, Clinical Trials Transformation Initiative (CTTI)
      Jen Goldsack is a Senior Project Manager at the Clinical Trials Transformation Initiative (CTTI). Jen leads two projects within CTTI's Mobile in Clinical Trials (MCT) Program; the MCT Novel Endpoints, and MCT Mobile Devices projects.
      MM

      Marie McCarthy

      Senior Director of Product Innovation, ICON plc
      Marie Mc Carthy, Director of Product Innovation, is part of the multidisciplinary Innovation Team at ICON PLC. Her previous role was that of EU Sales and Marketing Manager with Philips Respironics, building awareness of the value of Actigraphy endpoints among Clinicians and Researchers... Read More →
      PO

      Paul O'Donohoe

      Scientific Lead, eCOA and Mobile Health, Medidata Solutions
      Paul O’?Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company?s scientific expertise for electronic clinical outcome assessments and mobile health in clinical trials, and supports... Read More →
      SV

      Susan Vallow

      Vice President, eCOA Solutions, Medavante-Prophase
      Sue Vallow leads the development of patient-facing technologies for clinical trials at MedAvante. Sue is a measurement scientist with over 20 years’ experience in outcomes research and specializes in measuring the patient perspective along with technology. She was GSK’s Senior... Read More →


      Tuesday June 26, 2018 1:30pm - 2:00pm
      Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #255: Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

      Electronic health records (EHRs) are a valuable tool for clinical research and can serve as the source of information in clinical trials. EHR data can be used for protocol design and feasibility, patient recruitment, identification of sites and investigators, monitoring adverse drug events, patient outcomes improvement and other aspects of clinical research. However, EHRs are designed to meet healthcare needs.In order to use EHRs for clinical research, there is a need to develop guidances, enhance existing data standards and conduct projects. This session will focus on the ongoing projects led by various stakeholders (FDA, biopharmaceuticals, electronic health records and electronic data capture vendors, academic medical centers, and standards development organization). This session will discuss the current state of the guidance developed by FDA focusing on the "Use of Electronic Health Record Data in Clinical Investigations".

      Learning Objectives

      Describe the ongoing efforts at FDA, industry, and academia leveraging electronic health records (EHRs) in clinical investigations.

      Chair

      Mitra Rocca, MSc

      Speaker

      Utilizing EHR Data: How to Enable More Efficient Digital Data Gathering Practices to Benefit Patients, Sites, and Sponsors
      Aman Thukral, DrSc, MBA, MPharm

      eSource, Interoperability, and the Problem of 'Second Order Heterogeneity' in Clinical Research: A Real-World Implementation
      Michael A. Ibara, PharmD

      Structured Sourcing of EHR Data for Process and Quality Improvements in the I-SPY 2 Trial
      Adam L Asare, PhD



      Speakers
      avatar for Adam Asare

      Adam Asare

      Chief Data Officer, Quantum Leap Healthcare Collaborative
      Adam Asare has over 15 years’ experience in academic and industry developing clinical and research information systems. As the Quantum Leap Healthcare Collaborative Chief Data Officer, he oversees efforts for process re-engineering and quality improvement of clinical trials and... Read More →
      avatar for Michael Ibara

      Michael Ibara

      Managing Partner, Fathom Digital Healthcare Consulting
      20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →
      avatar for Mitra Rocca

      Mitra Rocca

      Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA
      Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →
      avatar for Aman Thukral

      Aman Thukral

      Assistant Director, AbbVie, Inc.
      Aman Thukral is an Assistant Director, Strategy & Innovation in Development Operations at AbbVie. He has over ten years of experience in clinical development, technology planning & business-technology alignment. In his current role, he is responsible for eClinical strategy, piloting... Read More →


      Tuesday June 26, 2018 2:00pm - 3:00pm
      Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #260: Optimizing Clinical Development With Adaptive Trial Designs
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

      Early-phase adaptive clinical trials combine multiple clinical objectives into one study to deliver high-quality data and substantial time and cost savings compared to a traditional approach involving several single-purpose studies. A biopharmaceutical developer needs to design a clinical strategy from product inception to regulatory approval that is tailored to meet clinical and regulatory expectations and is time- and cost-effective. This roadmap must detail the strategies for general clinical development, study design and operational execution and focus on a target product profile (TPP) that provides the product development team with valuable and measurable deliverables as well as the objectives for and guidance on the clinical development plan. The importance of having an in-depth understanding of adaptive clinical trial design and logistics is critical.

      This interactive session will provide the framework for scientifically robust and efficient early-phase clinical drug development. Working with cross-functional teams and developing appropriate operational infrastructure for all stakeholders, including drug developers, clinical research organizations (CROs) and investigator sites, will also be highlighted.

      Learning Objectives

      Identify strategies to reduce timelines and reduce unnecessary human exposure while increasing potential for successful outcomes; Describe how to leverage accruing data to constantly fine tune the clinical trial and decision making; Identify multiple clinical objectives by thoughtful planning and management to be efficient and cost effective.

      Chair

      Stanley C McDermott

      Speaker

      Adaptive Trial Designs for Early Phase Clinical Development
      Jignesh Patel

      The Range of Flexibility Being Shown in Clinical Trial Designs at the FDA in Oncology With Emphasis on Adaptive Trials
      Mark Thornton, MD, PhD, MPH



      Speakers
      avatar for Stanley McDermott

      Stanley McDermott

      Managing Director, Clinical Research, Cardinal Health Regulatory Sciences
      Dr. McDermott has responsibilities for clinical research consultants providing clinical strategy, design and operations services. He also leads clinical development programs. He has experience with clinical development strategy, planning, execution and reporting; clinical trial design... Read More →
      JP

      Jignesh Patel

      Senior Director, Data Services, Clinical Pharmacology and PK, Early Dev Services, PRA Health Sciences
      MT

      Mark Thornton

      Senior Clinical Consultant, Biologics Consulting
      Mark Thornton, MD, MPH, PhD brings 25 years of FDA and industry experience. He has gained or granted approval of 4 BLAs and his specialties are immuno- and molecularly target-based oncology therapies and companion diagnostics. Dr. Thornton has expertise in Regulatory strategies such... Read More →


      Tuesday June 26, 2018 2:00pm - 3:00pm
      Room 156ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #267: Developing and Partnering on Evidence for Outcomes and Value Assessment: Standardizing Measurement for Patient-Centered Care
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-602-L04-P; CME 1.00; IACET 1.00; RN 1.00

      Developing and partnering on evidence needs is critical for the success of value-based care. This session will present results from multi-stakeholder efforts focused on delivering standardized outcomes and value assessment that are patient centric.

      Learning Objectives

      Describe how outcomes and value are currently assessed and why standardization of measurement is necessary to support value-based care; Discuss how key stakeholders can partner on evidence needs; Identify how standardization is derived from and ultimately supports patient-centered care and how it can be automated with new health IT-driven approaches.

      Chair

      Richard Gliklich, MD

      Speaker

      Standardized Outcomes Measurement
      Elise Berliner, PhD

      Patient Perspective
      Cara Kraft



      Speakers
      EB

      Elise Berliner

      Director, Technology Assessment Program, Agency For Healthcare Research and Quality (AHRQ)
      Elise Berliner, Ph.D., is the Director of the Technology Assessment Program at AHRQ which provides technology assessments to Medicare to inform coverage decisions and other policy issues. Prior to joining AHRQ, Dr. Berliner worked as a consultant on cost-effectiveness and outcomes... Read More →
      avatar for Richard Gliklich

      Richard Gliklich

      Chief Executive Officer, OM1
      Dr. Richard Gliklich is the CEO of OM1, Inc., an AI and big data company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale University... Read More →
      CK

      Cara Kraft

      Director of Research and Evaluation, Allergy & Asthma Network
      Cara Kraft is the Director of Research and Evaluation for the Allergy & Asthma Network. She is a Registered Respiratory Therapist and Certified Asthma Educator. Cara oversees the implementation of the Network’s prospect and research functions. She has worked closely with patients... Read More →


      Tuesday June 26, 2018 2:00pm - 3:00pm
      Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #269A: DIA Regulatory Community Round Table Discussion: Global Regulatory Strategies for Biosimilars
      Component Type: Forum

      Join DIA RA Community for a round table discussion tied to session # 212 Global Regulatory Strategies for Biosimilars (Tuesday, June 26th)

      To include special guests from the session: Oxana Illiach, Agnes Klein, and Yatika Kohl.

      Chair

      Linda Bowen, MSc, RAC


      Tuesday June 26, 2018 2:00pm - 3:00pm
      Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #251: Risk Management: New Directions
      Component Type: Session
      Level: Advanced
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will hear from experts involved in digital risk minimization programs. They will describe how, following a Pharmacovigilance Risk Assessment Committee (PRAC) assessment report, a pilot was initiated to assess the feasibility and operational impact of developing and implementing digital additional risk minimization measures. The session will describe how a digital approach can support tool currency, continuous availability, and educational effectiveness. It will also cover aspects of internal vision development, global and local cross-functional collaboration, tool design, regulatory authority interactions, and the critical importance of change management.

      Learning Objectives

      Identify opportunities for developing digital risk-benefit communications; Describe the organizational aspects of developing digital strategies from the lessons of ongoing programs; Describe the key impacts on people, process and tech in the move to utilise digital approaches for REMS and risk minimization that could be applied to their own organizations.

      Chair

      Carla Perdun Barrett, PharmD

      Speaker

      Organizing for Digital Risk Minimization
      Helen Edelberg, MD, MPH, FACP

      Preparing for Digital in Benefit-Risk Management: Get Ready for the Revolution
      Mark Perrott, PhD



      Speakers
      avatar for Carla Barrett

      Carla Barrett

      Senior Director, Risk Management, PRA Health Sciences
      Dr. Carla Barrett is Senior Director, Risk Management at PRA Health Sciences. Carla has 18 years of pharmaceutical industry experience (Wyeth, Pfizer, Allergan) in the strategic and operational aspects of pharmacovigilance risk management programs, Carla received her Bachelor of Science... Read More →
      avatar for Helen Edelberg

      Helen Edelberg

      Head of Medical Safety Assessment, Innovative Medicines & Global Safety Risk Mgt, Bristol-Myers Squibb
      Dr Helen Edelberg is Head of Med Safety Assmt for Innovative Med & Gbl Safety Risk Mgmt, which provides authoritative expertise on development & execution of rigorous & innovative risk mgmt strategies at BMS. A strategic & innovative biopharmaceutical exec & physician with ~20 years... Read More →
      avatar for Mark Perrott

      Mark Perrott

      Head of Development Consulting, Pope Woodhead
      Mark is Head of Development Consulting at PopeWoodhead where he leads a team of Benefit-Risk and Risk Minimisation professionals. He joined PW in November 2016 and his 20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI and Foresight... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #252: Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-588-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will explore select endpoints FDA has already accepted in traditional clinical trials but which are now collectable using mobile technology in lieu of traditional means to obtain marketing approval, and the timing/options to engage FDA.

      Learning Objectives

      Describe select endpoints FDA has already accepted in traditional clinical trials which may lend themselves to data collection using digital/mobile technology in clinical trials for marketing approval; Evaluate the challenges faced in adapting these endpoints to use of mobile technology; Apply this information to engage with the FDA early in your product development; Discuss the challenges.

      Chair

      Wayne Amchin, MA, MPA, RAC

      Speaker

      Clinical Trials Using Mobile Technology
      Mintu Turakhia, MD, MS

      FDA Perspective
      Bakul Patel, MBA, MS

      Industry Perspective
      Stephen Amato, PhD



      Speakers
      avatar for Stephen Amato

      Stephen Amato

      Director, Clinical Innovation, Pfizer Inc
      Dr. Stephen Amato is a Director of Clinical Innovation within Global Product Development at Pfizer, where he is working to drive clinical innovation by leveraging digital tools and mobile technologies to make clinical trial participation more engaging, informative and less burdensome... Read More →
      avatar for Wayne Amchin

      Wayne Amchin

      Senior Consumer Safety Officer, DCRP, ODE I, OND, CDER, FDA
      Wayne manages the pulmonary arterial hypertension (PAH) portfolio, which includes many drug-device combination products, along with other therapeutic areas. He is the winner of the FDA’s Innovation Lab 1st Prototype Challenge for Mobile Apps, and he is developing the first mobile... Read More →
      avatar for Bakul Patel

      Bakul Patel

      Associate Director for Digital Health, Office of the Center Director, CDRH, FDA
      Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical... Read More →
      avatar for Mintu Turakhia

      Mintu Turakhia

      Executive Director, Center for Digital Health; Chief of EP, Palo Alto VA, Stanford University
      Mintu Turakhia M.D. M.A.S. is an Associate Professor of Medicine at Stanford University. He is Director of Cardiac Electrophysiology at the VA Palo Alto Health Care System and Executive Director of the Stanford Center for Digital Health, where he oversees a large research portfolio... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #253: Digitizing a Patient-Focused Clinical Trial Experience
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-589-L04-P; CME 1.25; IACET 1.25; RN 1.25

      During this interactive session, leaders from TransCelerate Member Companies will candidly share their experiences collaborating to create solutions that will bring about innovative change, and address some of our industry’s greatest challenges.

      Learning Objectives

      Discuss the four key initiatives that, using innovative digital efforts, has to potential to transform clinical trials; Recognize how the use of patient technologies, eConsent, eLabels, and electronic health records can advance clinical research.

      Chair

      Kelley Erb, PhD

      Speaker

      Panelist
      Stephen Yates, PhD

      Panelist
      Wayne R. Kubick, MBA

      Panelist
      T.J. Sharpe, PMP



      Speakers
      avatar for Kelley Erb

      Kelley Erb

      Lead for TransCelerate’s Novel Digital Endpoints; Director, Digital Medicine, Pfizer Inc
      At Pfizer, Kelley serves as project leader for multiple digital medicine programs aimed at developing, validating, and implementing novel digital endpoints for asset teams across the portfolio. At TransCelerate, he leads the novel digital endpoints team focused on delivering pre-competitive... Read More →
      avatar for Wayne Kubick

      Wayne Kubick

      Chief Technology Officer, HL7 International
      Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →
      avatar for T.J. Sharpe

      T.J. Sharpe

      Patient Advocate, Starfish Harbor LLC
      T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 blog. He was diagnosed in August 2012 with melanoma tumors in multiple organs, four weeks after his son was born, undergoing six surgeries and four immunotherapy treatments over two... Read More →
      avatar for Stephen Yates

      Stephen Yates

      Clinical Program Director, UCB Bioscience, Inc.
      Stephen Yates a Clin Prog Dir and Head, Pt Engagement Strategy with UCB Biosciences, Inc. He provides strategy for Ph2 through 4 clinical studies focused in neurology and metabolic disease. Stephen also provides oversight of UCB’s strategy for patient engagement throughout the development... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 258AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #254: Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-590-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Master protocol studies include basket study, umbrella study, platform study, and etc. It provides possibilities to shorten R&D timelines, reduce R&D costs, and improve probability of success if designed and implemented properly. One of the primary key success factors for a master protocol study is the “real-time” collection and analysis of data with high quality to enable “real-time” decision making. Risk-based monitoring (RBM) provides an opportunity to address the needs of data currency and data quality by integrating data-driven risk assessment, statistical monitoring, and data analytics. However there are certain challenges to implement RBM for a master protocol study, due to the more complex design and dynamic nature.
      The session will discuss the opportunity, challenges, and potential ways to apply RBM for a master protocol study.

      Learning Objectives

      Describe components of a master protocol study and the unique challenges for implementation; Identify the key success factors and challenges to apply risk-based monitoring for a master protocol study.

      Chair

      Rachael Cui Song, MBA

      Speaker

      Applying Risk-Based Monitoring to Operationally Complex Studies: Opportunities for Improved Quality and Flexibility
      Mary Arnould, BSN, MSN

      ICH E6 (R2): A Miracle Pill for Clinical Research
      Stephen Young, MSc



      Speakers
      avatar for Mary Arnould

      Mary Arnould

      Director, Clinical Science Operations, Astellas Pharma Global Development, Inc.
      Mary has been in the pharmaceutical industry for over 20 years. She began her career as a site monitor and monitored studies in numerous therapuetic areas. Mary managed site monitors for over 10 years. She has been supporting the implementation of Risk Based Monitoring at Bristol... Read More →
      avatar for Rachael Song

      Rachael Song

      Senior Project Manager - Hematology/Oncology, PPD
      Rachael is currently global Project Leader for Oncology clinical trials with focus on Immuno-Oncology and master protocol studies. She has experiences in compound-level clinical planning and design, study-level operational planning and strategy development, and program implementation... Read More →
      avatar for Stephen Young

      Stephen Young

      Chief Operations Officer, CluePoints
      As Head of Operations for CluePoints, Steve is primarily responsible for ensuring successful customer adoption of the CluePoints solution. He worked for three bio-pharm companies over a span of 15 years, leading the successful enterprise roll-out of EDC at both J&J and Centocor. Steve... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 258C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #256: CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Application UAN: 0286-0000-18-592-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Addressing questions posed to your company by a health authority during the review of your marketing application (ie, reg defense) is a critical and often overlooked part of the process leading to approval of your product. This session will equip the audience with authoring strategies that have worked well to develop robust and timely responses to Health Authority questions. Case studies will be used to demonstrate how these processes have been applied effectively on large response projects, and real-life examples of tools and processes that have been used to manage these activities will also be discussed.

      Learning Objectives

      Develop a strategy that effectively plans and coordinates authoring teams to prepare responses in a timely manner; Discuss the pros and cons of resourcing for handling regulatory responses; Identify some of the key potential conflicts between regulatory defense and other ongoing activities; Demonstrate a plan for triaging and rapidly responding to regulatory defense queries.

      Chair

      Frank Hubbard, PhD

      Speaker

      Field Tested Strategies for How Best to Prepare Responses to Health Authority Questions
      Julia Forjanic Klapproth, PhD

      Finding the Right Balance of Preparation and Structure for Regulatory Defense
      Steve Sibley, MS



      Speakers
      avatar for Frank Hubbard

      Frank Hubbard

      President, Global Regulatory Writing Solutions, Inc.
      Following a 14-year career in the Medical Communications Science group at AstraZeneca, I founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. Given my previous... Read More →
      avatar for Julia Forjanic Klapproth

      Julia Forjanic Klapproth

      President, Trilogy Writing & Consulting
      Julia has a PhD in Developmental Neurobiology and has worked as a medical writer since 1997. She has been President of EMWA twice and is an experienced trainer of medical writers. In 2002, Julia co-founded Trilogy Writing & Consulting, a company specialised in providing medical writing... Read More →
      SS

      Steve Sibley

      Vice President, Global Submissions and Submissions Leadership, Synchrogenix, a Certara Company
      With a career spanning more than 25 years in the pharmaceutical industry, Mr. Sibley has extensive regulatory writing experience across Modules 1-5, with project and team leadership roles on more than 50 submissions. His experience is truly global, having worked in project teams encompassing... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 210C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #257: Globalizing and Regionalizing Medical Information Contact Centers
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-593-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This sessions will discuss how globalization of medical contact centers continues to be a focus and a critical investment across the industry. Medical information professionals working with emerging markets have a challenging task of providing consistent scientific information and quality of service to all regions. However, globalization of any service cannot be successful without a well-organized strategic plan and understanding of potential risks.

      Learning Objectives

      Describe structural approach that differentiates global and local contact centers; Identify the expertise required for a compliant medical information management system; Discuss the methodology to take into account the variance in linguistic and operational coverage.

      Chair

      Christopher J Keenan

      Speaker

      Globalizing and Regionalizing Medical Information Contact Centers
      Christopher J Keenan

      Globalizing and Regionalizing Medical Information Contact Centers
      Philippe Sorel Takam, PharmD, MSc, RPh

      Regionalizing Medical Information: Bringing Global Standards to Regional Needs
      Sabine Lischka-Wittmann, DrSc



      Speakers
      avatar for Christopher Keenan

      Christopher Keenan

      Head, Worldwide Medical Customer Engagement, Bristol-Myers Squibb
      A senior business leader with solid record of leading top performing business units and producing results that have positive impact on the bottom line and customer experience. Diverse worldwide management and operations expertise within financial services, insurance and pharmaceutical... Read More →
      avatar for Sabine Lischka-Wittmann

      Sabine Lischka-Wittmann

      Director Medical Information Europe, Lilly Deutschland GmbH
      Sabine Lischka-Wittmann, PhD is currently the European Medical Information Director for Eli Lilly & Company. She was previously the Senior Manager of the Medical Information and Medical Liaisons teams in Germany. Sabine is a highly experienced Medical Information manager: she has... Read More →
      avatar for Philippe Sorel Takam

      Philippe Sorel Takam

      Associate Director, Global Medical Information, Primevigilance Ltd
      Phil is a qualified pharmacist with over 15 years of experience in the healthcare and pharmaceutical arena. He has gained extensive expertise in clinical affairs and medical affairs throughout his career, with leadership roles to successfully plan and execute multiple medical scientific... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 209 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #258: Reaching the Underserved: Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-594-L04-P; CME 1.25; IACET 1.25; RN 1.25

      A look at experiences and lessons learned from the autoimmune and neurology fields.

      Learning Objectives

      Identify common challenges and pitfalls in recruiting underserved patients for research activities; Discuss best practices for recruiting and engaging with diverse groups of patients in activities such as patient insights research and clinical trials; Apply effective models of collaboration and education to address challenges around engaging underrepresented groups in research.

      Chair

      Hollie Schmidt, MS

      Speaker

      Strengthening the Bridge Between Diverse Patient Populations and the Clinical Trial Journey
      Yaritza Peña

      Strength in Diversity: How a Multi-Stakeholder Partnership Network is Addressing Minority Underrepresentation in MS Research
      Hollie Schmidt, MS



      Speakers
      avatar for Kelly Franchetti

      Kelly Franchetti

      Global Head Patient Insights and Engagement, ICON, plc
      Kelly Franchetti, RN, CCRN, CEN, is the VP of Global Patients Insights and Engagement at Mapi/ICON. Kelly has nearly two decades of direct patient experience, gained in both hospital and industry settings including CROs, healthcare technology, patient research, and hands-on patient... Read More →
      avatar for Yaritza Peña

      Yaritza Peña

      Research Analyst, Tufts Center For the Study of Drug Development
      Yaritza Peña's research focuses primarily on drug development trends, outsourcing, and patient recruitment and retention. Ms. Peña received a BS from Bentley University in Economics with a concentration in Information Design and Corporate Communications. She has experience conducting... Read More →
      avatar for Hollie Schmidt

      Hollie Schmidt

      Vice President of Scientific Operations, Accelerated Cure Project
      Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 151AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #259: Measuring the Impact of Patient Engagement: What to Ask Depends on Who You Ask
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-704-L04-P; CME 1.25; IACET 1.25; RN 1.25

      Meaningful engagement with patients is planned with a purpose, and as it is more fully integrated into the medical product life cycle, measuring its impact is increasingly important. Patients, sponsors, and regulators want to know if their expected outcomes have been achieved. How to measure the impact of patient engagement depends on your viewpoint. In this session, stakeholders discuss their perspectives on the outcomes they might expect from patient engagement and what types of measures can signal achievement. A case example of evaluating the impact of a patient engagement effort from the dual perspectives of patient satisfaction and clinical development deliverables will be examined.

      Learning Objectives

      Describe the relationship of expected outcomes of patient engagement to impact measurements; Identify one outcome of patient engagement that is important to each key stakeholder; Discuss possible measures to assess the impact of patient engagement from the perspective of each key stakeholder.

      Chair

      Roslyn F Schneider

      Speaker

      Thank You! The Power of Gratitude to Improve Clinical Development Quality
      Mary Stober Murray, MBA

      Patient Engagement
      Ellen Coleman, MPH, MS

      Patient Perspective
      Suzanne Schrandt, JD



      Speakers
      avatar for Ellen Coleman

      Ellen Coleman

      President & CEO, MK&A
      Ellen Coleman is Senior Vice President at MK&A, a global industry consulting firm specializing in patient and healthcare stakeholder engagement strategies (www.mkanda.com). She brings considerable experience with patients who have chronic and life-threatening illnesses such as cancer... Read More →
      avatar for Ellen Coleman

      Ellen Coleman

      President & CEO, MK&A
      Ellen Coleman is President & CEO at MK&A, a global industry consulting firm specializing in patient and healthcare stakeholder engagement strategies (www.mkanda.com). She brings considerable experience with patients who have chronic and life-threatening illnesses such as cancer and... Read More →
      avatar for Mary Murray

      Mary Murray

      Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb
      As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and underserved populations. Mary has co-chaired DIA-PEC... Read More →
      avatar for Roslyn Schneider

      Roslyn Schneider

      Global Patient Affairs Lead, Pfizer Inc
      Roz leads Global Patient Affairs at Pfizer, a hub of patient centricity, driving integration of patient experiences and perspectives across the company and the product lifecycle. She held roles in Medical Affairs, Medical Strategy and Medicine Development for twelve years at Pfizer... Read More →
      avatar for Suzanne Schrandt

      Suzanne Schrandt

      Director, Patient Engagement, Arthritis Foundation
      Suz Schrandt, JD, is Patient Engagement Director at the Arthritis Foundation. She was previously Deputy Director, Patient Engagement for PCORI, where she helped to launch key efforts including the Engagement Rubric. Schrandt's patient engagement focus stems from her own rheumatological... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 254AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #261: Project Management Throwdown: How Not to Get Chopped
      Component Type: Forum
      Level: Basic
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-596-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000224; RN 1.25

      This forum will be a debate format with three speakers providing point-counter-point perspectives on the topic of what makes a good project manager.

      Learning Objectives

      Describe the critical competencies and attributes that will differentiate high performing project managers in the future workplace.

      Chair

      Kemi Yusuf, MBA, PMP

      Speaker

      What Makes the Master Project Manager?
      Eva M. Finney, PhD, PMP

      Technical Specialty? Certifications? School of Hard Knocks? The Mix of Qualifications That Makes the Best Program Manager
      Dan Tierno, MA, MBA

      Project Management 2030: Anatomy of an Exceptional Project Manager
      Kemi Yusuf, MBA, PMP



      Speakers
      avatar for Eva Finney

      Eva Finney

      Director, Global Project & Alliance Management, Merck & Co., Inc.
      Eva M. Finney, Ph.D., PMP, is Director, Global Project and Alliance Management at Merck, where she has been a Project Manager for 15 years. She has managed multiple development programs from early to late stage, including several NDA submissions leading to successful product approvals... Read More →
      avatar for Dan Tierno

      Dan Tierno

      Strategic Implementation Manager, Bayer
      Mr. Dan Tierno has over 20 years of experience in the pharmaceutical and biotech industry. Mr. Tierno has spoken on training scientists for rare disease therapeutic development, innovations in drug development and clinical trials, commercialization of cell and gene therapies as well... Read More →
      avatar for Kemi Yusuf

      Kemi Yusuf

      Senior Director, Office of the PST and PPS Portfolio Management, Abbvie
      Kemi Yusuf is the Senior Director, Office of the Product Safety Team (PST) and PPS Portfolio Management within AbbVie’s PV organization. She oversees the Program Office which drives high-priority strategic initiatives & process improvement projects. She also oversees the project... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 153ABC Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #262: The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-597-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session shares how group of sponsors, CROs,and RBM/data analytic vendors have explored centralized monitoring data/metric use and describes a centralized monitoring plan template that supports implementation of centralized monitoring.

      Learning Objectives

      Explain how centralized monitoring supports the quality management approach of ICH E6 (R2); Describe some key items to consider as you develop your centralized monitoring plan.

      Chair

      Linda B. Sullivan, MBA

      Speaker

      Sponsor Perspective
      Nurcan Coskun, PhD, MSc

      RBM Data Analytic Vendor Perspective
      Keith Dorricott

      CRO Perspective
      Olgica Klindworth



      Speakers
      avatar for Nurcan Coskun

      Nurcan Coskun

      Global Risk Based Monitoring Program and Technology Solutions Manager | MC2, Medtronic International Trading Sàrl
      20 years of clinical research experience with contributing in roles such as Clinical Research Manager , Global Clinical Operations Oncology Group Leader, Project Leader, Clinical Monitoring Manager and recently as Global Risk Based Monitoring and Technology Solutions Manager. Her... Read More →
      avatar for Keith Dorricott

      Keith Dorricott

      MCC Ambassador; Director, Dorricott Metrics and Process Improvement Ltd.
      Keith Dorricott is Director, Dorricott MPI Ltd. and a Ambassador for the Metrics Champion Consortium. He has a background in manufacturing from Kodak Ltd. He has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master... Read More →
      avatar for Olgica Klindworth

      Olgica Klindworth

      Associate Director, Data Analytics, PPD, Inc.
      Ms. Klindworth is the AD, Data Analytics at PPD, Inc. She has over 14 years of experience in the clinical research, mostly in data management. Olgica joined PPD's Data Analytics group in 2014, and since then helped build the cross-functional team, implement analytical and centralized... Read More →
      avatar for Linda Sullivan

      Linda Sullivan

      Co-Founder and President, Metrics Champion Consortium LLC
      Ms Sullivan is Co-Founder & President of the Metrics Champion Consortium, an industry association dedicated to the adoption of standardized, consensus-based performance metrics. She has been a featured speaker at Risk-Based Quality Management & Clinical Trial Oversight industry meetings... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #263: Navigating the Regulatory Landscape of Drug-Device Combination Products
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-598-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The focus of the session will be on understanding the regulatory challenges and key success factors for development and lifecycle management of drug-device combination products in light of the evolving global regulatory requirements for these products.

      Learning Objectives

      Describe the changing global regulatory landscape for combination products; Discuss development approaches to meet these requirements throughout the lifecycle of the combination product; Identify the success factors that will help minimize the risk associated with these regulatory challenges, thereby reducing the likelihood of agency request for information during the review period.

      Chair

      Rebecca Lipsitz, PhD

      Speaker

      FDA Perspective
      John Barlow Weiner, JD

      Industry Perspective
      Kirsten H. Paulson, MS, RAC

      Industry Perspective
      Demetra Macheras, MBA



      Speakers
      avatar for Rebecca Lipsitz

      Rebecca Lipsitz

      Associate Director, Janssen
      Rebecca Lipsitz is an Associate Director in Janssen’s Global Regulatory Policy and Intelligence office. She advises and develops policy on a broad range of FDA-related regulatory issues. Her portfolio areas include Immunology, Infectious Disease, Vaccines, Precision Medicine, Combination... Read More →
      avatar for Demetra Macheras

      Demetra Macheras

      Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, Inc.
      Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S. and Canada regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and final regulatory... Read More →
      avatar for Kirsten Paulson

      Kirsten Paulson

      Senior Director, Global CMC Medical Devices, Pfizer Inc
      Kirsten Paulson is Sr. Director, Worldwide Regulatory CMC and Medical Device Lead at Pfizer. Previously, she was the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD RA Medical Device and Diagnostics group. She began her career as an FDA reviewer... Read More →
      avatar for John Weiner

      John Weiner

      Associate Director for Policy, FDA
      John Barlow Weiner is the Associate Director for Policy in the Office of Combination Products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA's Office of Chief Counsel and in private practice. He received a BA from Princeton University and a JD with honors... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #264: Global Development Using Expedited Pathways in Established and Emerging Markets
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-599-L04-P; CME 1.25; IACET 1.25; RN 1.25

      FFDA, EMA, and PMDA have well-established pathways for approval of innovative products that are for unmet medical needs. Some emerging markets are establishing such pathways as well. This session will discuss how governments accelerate the access of such type of products in the emerging markets as well as in established markets. What are the challenges and opportunities that regulators and industry face around the world when filing for expedited approval of a product that is for high unmet need, where access is a priority for patients?

      Learning Objectives

      Identify how expedited pathways work in established markets and how emerging markets are developing new pathways to expedite approval of products for high unmet medical need; Describe how regulators and industry shared their experiences with these pathways and market prioritization; Compare the differences when the review is independent or when using pathways such as mutual reliance and mutual recognition.

      Chair

      Maria Cristina Mota Pina, MBA

      Speaker

      ANVISA Perspective
      Jarbas Barbosa, MD, PhD

      Facilitated Regulatory Pathways in Maturing Agenices: The Benefits of Reliance and Alignment
      Lawrence Eugene Liberti, PhD, RPh, RAC

      Update on the Status of Expedited Pathways in the Mature Markets
      Alberto Grignolo, DIAFellow, PhD

      EFPIA Position Paper: White Paper on Reliance and Expedited Pathways in Emerging Markets
      Denise Bonamici, MSc



      Speakers
      avatar for Jarbas Barbosa

      Jarbas Barbosa

      Director- President, Agência Nacional De Vigilância Sanitária (ANVISA)
      Jarbas Barbosa da Silva Jr. is a public health physician and epidemiologist, with national and international experience in public health, epidemiology applied to health services, health surveillance, prevention and control of diseases and illnesses, and management of health systems... Read More →
      avatar for Denise Bonamici

      Denise Bonamici

      Head of Regulatory Science and Policy - LATAM, Sanofi
      More than 20 years of experience in Regulatory Affairs setting regulatory strategies and managing a diverse portfolio. She is member of major Industry Associations and has a network of strong relationships with Regulatory Agencies. In her role as Head of Regulatory Science & Policy... Read More →
      avatar for Alberto Grignolo

      Alberto Grignolo

      Corporate VP PAREXEL Consulting, PAREXEL
      Alberto Grignolo has 36+ years of experience as a regulatory and drug development professional including consulting for pharmaceutical and biotechnology companies. He is a driver of a successful worldwide consulting business and established PAREXEL’s Japan Consulting Services. He... Read More →
      avatar for Lawrence Liberti

      Lawrence Liberti

      Executive Director, Centre for Innovation in Regulatory Science (CIRS)
      For the past 38 years, Mr Liberti has worked in the fields of regulatory affairs and clinical R&D. Since 2009 he has served as the Executive Director of CIRS (formerly the CMR International Institute for Regulatory Science), an independent, division of Clarivate Analytics. He ireceived... Read More →
      avatar for Maria Cristina Mota Pina

      Maria Cristina Mota Pina

      Director, Scientific Regulatory Policy and Intelligence - Latin America, AbbVie, Inc.
      Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for Latin America. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 206AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #265: ICH M9 BCS-Based Biowaivers
      Component Type: Session
      Level: Intermediate
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-600-L04-P; CME 1.25; IACET 1.25; RN 1.25

      The ICH M9 Expert Working Group has developed a preliminary draft of a harmonized guideline for BCS-Based Biowaivers that focuses on standardizing Biopharmaceutics Classification System criteria for demonstrating solubility, permeability/absorption, other pharmacological attributes and in vitro comparative dissolution. This session will provide a summary of the objectives for establishing a harmonized guideline that will be applicable globally and highlight current contentious issues to be resolved including: • Solubility: Highest Strength vs. Highest Therapeutic Dose • Permeability: Applicability of in vitro data (Caco-2) • Dissolution Comparability: Establishing Harmonized Conditions & Methodology Criteria • Formulation Similarity: Product Composition Applicability & Influence of Excipients This session will highlight regional challenges and differences and opportunities for harmonized reconciliation.

      Learning Objectives

      Describe the current challenges related to biowaivers and the progress and potential of the future ICH M9 guideline.

      Chair

      Roger Nosal, PhD

      Speaker

      ICH M9 BCS Based Biowaivers: Progress and Challenges
      Roger Nosal, PhD

      Revisiting Classification Criteria for Demonstrating Solubility, Permeability, and Comparative Dissolution
      Paul Seo, PhD

      Regional Challenges for Comparative Dissolution and Post-Approval Changes: Excipients
      Talia Flanagan, PhD



      Speakers
      TF

      Talia Flanagan

      Associate Principal Scientist, Biopharmaceutics, AstraZeneca
      Talia is Associate Principal Scientist in Biopharmaceutics in AstraZenecas Product Development group. She has extensive experience of developing biopharmaceutics and clinically relevant dissolution strategies in development and post-approval settings. Talia is EFPIA Deputy Topic Lead... Read More →
      avatar for Roger Nosal

      Roger Nosal

      Vice President, Global CMC, Pfizer Inc
      Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →
      avatar for Paul Seo

      Paul Seo

      Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA
      Paul has worked for the FDA for over 13 years, and has gained experience in the Office of Generic Drugs, Office of Pharmaceutical Science, and Office of New Drug Quality Assessment. He currently oversees the direction and review processes of the Division of Biopharmaceutics in the... Read More →


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #266: User-Friendly Tools for Study Planning and Analysis
      Component Type: Session
      Level: Basic
      CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-601-L04-P; CME 1.25; IACET 1.25; RN 1.25

      This session will describe some novel tools for study planning an analysis. It will include use of open-source tools such as R and Shiny to plan, organize and execute the reporting of clinical trial data. Speakers will also show examples of self-service interactive visual tools that can be used during study design period.

      Learning Objectives

      Describe and demonstrate a novel report analysis plan process that uses using modern R/Shiny/Markdown technology to plan, execute and report clinical trial data; Identify examples of reusable self-service tools and show that they can help improve operational efficiency and communication.

      Chair

      Brenda Crowe, PhD

      Speaker

      ShinyRAP: A Workflow for Analysis Planning, Organization, and Reporting Using Shiny
      Xiao Ni, PhD

      Empower Your Physicians and Enhance Communication Via Self-Service Tools
      Rebeka Revis, MS

      R Shiny Review Tools
      Jonathon J. Vallejo, PhD



      Speakers
      avatar for Brenda Crowe

      Brenda Crowe

      Senior Research Advisor, Global Statistical Sciences, Eli Lilly and Company
      Brenda Crowe is a Senior Research Advisor at Eli Lilly and Company (Lilly) where she leads a Safety Analytics team. She obtained a PhD in Statistics from the University of Toronto in 1997 and has 20 years of pharmaceutical industry experience.
      XN

      Xiao Ni

      Group Head, Biostatistics, Novartis Institute for Biomdical Research
      Xiao is a disease area lead statistician in early clinical development and an R/Shiny expert at Novartis. Through his 10-year career in pharma industry, Xiao has championed using visual analytic methods and tools (e.g. Shiny, Spotfire, JMP etc) in drug development. He received training... Read More →
      RR

      Rebeka Revis

      Statistician, Eli Lilly and Company
      Rebeka Revis has been a statistical analyst at Eli Lilly and Company for 5 years. Her focus is primarily in safety visualizations. She uses Spotfire with R integration to create interactive visualizations for data reviews and provides internal training to people on how to create and... Read More →
      JV

      Jonathon Vallejo

      Mathematical Statistician, OB, OTS, CDER, FDA
      Jonathon Vallejo is a statistical reviewer in the Office of Hematology and Oncology Products at FDA. He is the co-leader of the R Users group at FDA and has authored an R package for internal use at FDA. He is also active in the development and maintenance of Shiny apps at FDA.


      Tuesday June 26, 2018 2:00pm - 3:15pm
      Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:00pm

      #268: Future of PharmaTech
      Component Type: Forum
      Level: Intermediate
      CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-603-L04-P; CME 1.50; IACET 1.50; RN 1.50

      What is PharmaTech? How is the pharmaceutical and biotech industry evolving with new technologies, such as artifical intelligence (AI) and block chain? How will the business model be impacted? Are there lessons learned from other industries?

      This DIAmond session will examine how innovative technologies in drug development are impacting the pharmaceutical and biotech industry.

      Learning Objectives

      Define the concept of PharmaTech and describe it's impact on new technologies and business models; Identify how the pharmaceutical and biotech industry will be impacted by innovative technologies, such as artificial intelligence, in drug development.

      Chair

      Patrick K Brady, PharmD

      Speaker

      Panelist
      Dave Meyers

      Panelist
      Dina Katabi, PhD

      Panelist
      Sudip Parikh, PhD

      Panelist
      Henry "Skip" Francis, MD



      Speakers
      avatar for Patrick Brady

      Patrick Brady

      Regulatory Policy and Intelligence, Bayer
      Dr. Patrick Brady is Vice President, Regulatory Affairs at Bayer. In this role, he leads Bayer’s global regulatory policy and intelligence activities. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and regulatory... Read More →
      avatar for Henry Francis

      Henry Francis

      Director for Data Mining and Informatics Evaluation and Research, OTS, CDER, FDA
      Dr. Francis is the Director of the Data mining and Informatics Evaluation and Research Group in the Office of Translational Sciences, CDER, FDA.In that capacity he directs a trans-disciplinary group of senior sciences to test, create and operate data analysis program facilitating... Read More →
      avatar for Dina Katabi

      Dina Katabi

      Professor, MIT
      Dina Katabi is the Andrew & Erna Viterbi Professor of Electrical Engineering and Computer Science, and the director of the MIT center for wireless networks and mobile computing. Katabi is a MacArthur Fellow, and an ACM Fellow. She received the ACM Grace Murray Hopper Award in 2013... Read More →
      DM

      Dave Meyers

      National Director, US Life Sciences, Microsoft
      Dave Meyers is National Director - US Life Sciences at Microsoft; focused on strategy, business development, and the solutions portfolio in pharma, genomics and precision medicine. He joined Microsoft in 1997 - held various technical, program management, and product development positions... Read More →
      avatar for Sudip Parikh

      Sudip Parikh

      Senior Vice President and Managing Director, DIA Americas, DIA


      Tuesday June 26, 2018 2:00pm - 3:30pm
      Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      2:15pm

      #269B: Avoiding Rejection on your "First Date" with EMA Policy 0070
      Component Type: Workshop
      Level: Advanced

      This interactive session is an opportunity for participants to share and compare cross-industry experience with the first marketing authorization submissions made public under EMA Policy 0070, and to learn best practices for working with the Agency.

      Learning Objectives

      Identify challenges with the implementation of EMA Policy 0070; Describe how to avoid common mistakes and missteps that could lead to invalidation of the draft or final document redaction package; Discuss best practices for responding to and gaining agreement with the Agency's redaction conclusions for the anonymization report and justification tables.

      Chair

      Jo Anne-Marie Blyskal, MS


      Speakers
      avatar for Jo Anne-Marie Blyskal

      Jo Anne-Marie Blyskal

      Head of Global Regulatory Medical Writing, Teva Pharmaceuticals


      Tuesday June 26, 2018 2:15pm - 3:15pm
      E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:00pm

      Refreshment Break
      Component Type: Social Event




      Tuesday June 26, 2018 3:00pm - 4:15pm
      Exhibit Hall

      3:15pm

      #270: DIA Medical Writing Community Round Table Discussion: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications
      Component Type: Forum

      Join DIA MW Community for a round table discussion tied to session # 227 Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications (Tuesday, June 26th)

      To include special guests from the session Maghavi Gidh-Jain and Tim Wolfe.

      Chair

      David B. Clemow, PhD


      Speakers
      avatar for David Clemow

      David Clemow

      Advisor, Scientific Communications Information Strategy, Eli Lilly and Company
      David is an Advisor Scientific Communications Information Strategy at Eli Lilly and Company with over 20 years of regulatory, publication, and promotional scientific communications experience in the pharmaceutical industry. His work has included document authoring, team management... Read More →


      Tuesday June 26, 2018 3:15pm - 4:15pm
      Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:15pm

      #271: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Risk Management - New Directions
      Component Type: Forum

      Join DIA CSP Community round table discussion tied to session # 251 Risk Management: New Directions (Tuesday, June 26th)

      To include special guests from the session: helen Kathryn Edelberg and Mark Perrott.

      Chair

      Catherine Baldridge, MS


      Speakers
      avatar for Catherine Baldridge

      Catherine Baldridge

      Clinical Safety and Pharmacovigilance, PV Compliance, Indivior


      Tuesday June 26, 2018 3:15pm - 4:15pm
      Community Zone NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:30pm

      Annual Meeting of Members
      Component Type: Social Event




      Tuesday June 26, 2018 3:30pm - 3:45pm
      DIA Booth #1519 Exh Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:30pm

      #273: DIA Insights: Latest Global Healthcare Coverage and How to Get Published
      Component Type: Session
      Level: Basic
      CE: IACET 0.50

      Global Forum is DIA’s monthly, online magazine, and YOUR go-to resource for the latest in global healthcare product development. This content hub will bring together readers, writers, and editors for the first time since the magazine’s January 2018 digital redesign. Attendees will meet staff and editorial leadership to learn about DIA Insights and how to get published. Join them to learn more, suggest and discuss topics and articles of interest, and how to contribute your expertise to DIA’s global healthcare community.

      Learning Objectives

      Identify how to meet with editors to learn about global and regional healthcare topics and how to get published.

      Chair

      Alberto Grignolo, DIAFellow, PhD

      Speaker

      Panelist
      Ranjini Prithviraj, PhD

      Panelist
      Alberto Grignolo, DIAFellow, PhD



      Speakers
      avatar for Alberto Grignolo

      Alberto Grignolo

      Corporate VP PAREXEL Consulting, PAREXEL
      Alberto Grignolo has 36+ years of experience as a regulatory and drug development professional including consulting for pharmaceutical and biotechnology companies. He is a driver of a successful worldwide consulting business and established PAREXEL’s Japan Consulting Services. He... Read More →
      avatar for Ranjini Prithviraj

      Ranjini Prithviraj

      Sr Managing Editor/Associate Director, DIA Publications, DIA
      Dr. Ranjini Prithviraj is Senior Managing Editor and Associate Director of Publications at DIA, where she provides strategic thought leadership and delivers content that advances DIA’s mission through various media, including traditional journal publications. Prior to DIA, she was... Read More →


      Tuesday June 26, 2018 3:30pm - 4:00pm
      Content Hub NE Lobby Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:30pm

      #272: LinkedIn Profile Exchange Review
      Component Type: Workshop
      Level: Basic

      A LinkedIn profile and presence is important for industry communications. Done right, it shows your credibility, experience and references. The purpose of this Engage and Exchange is to present on the good and bad of LinkedIn profiles and to evaluate each others.

      Learning Objectives

      Discuss a review LinkedIn profiles; Identify good and bad examples of profiles; Identify changes to improve your own profile.

      Chair

      Chris Matheus, MBA

      Speaker

      LinkedIn Overview
      Tom McPhatter



      Speakers
      avatar for Chris Matheus

      Chris Matheus

      President, Matheus BD Connections
      Chris has over 20 years of experience in clinical research business development. He has focused on clinical trial technologies while working in large CROs and smaller eclinical technology companies. Chris establishes strong working relationships customers and has built a significant... Read More →
      avatar for Tom McPhatter

      Tom McPhatter

      Director, Business Development, Whitsell Innovations, Inc
      Tom McPhatter is responsible for driving client engagement at Whitsell Innovations. He has a broad background in sales, management, and leadership in multiple market verticals and geographies. Tom has led successful efforts in many complicated and intensely competitive service environments... Read More →


      Tuesday June 26, 2018 3:30pm - 4:15pm
      E and E Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:40pm

      #274: WIRB-Copernicus IRB Group Innovation Theater: Clinical Research Sites: Your Competitive Battleground for Study Success
      Component Type: Session

      Fundamental to a study's success if the ability to make the right decisions at the right time. With new insights into the investigator landscape, and performance data on 140k investigators, WCG is helping clients open sites to recruitment 30% faster than traditional methods of site start-up. We'll unfold site success factors such as: therapeutic experience, feasibility rates, competing studies, contract timelines, and enrollment history to help set your study up for success from the start.

      Chair

      WIRB-Copernicus Group


      Speakers
      SC

      Suzanne Caruso

      Vice President, Clinical Solutions, WCG


      Tuesday June 26, 2018 3:40pm - 4:10pm
      Theater 1 Exhibit Hall Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

      3:40pm