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Sunday, June 24
 

8:00am

8:30am

9:00am

10:30am

12:30pm

1:00pm

3:00pm

4:15pm

 
Monday, June 25
 

7:00am

7:30am

8:30am

10:00am

10:15am

10:30am

11:00am

#105: Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model Room 253AB #107: The Metamorphosis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials Room 257AB #108: From Patients and Advocacy Groups to Operations and Beyond: Obtaining and Incorporating Input from Stakeholders in Protocol Design Room 258AB #111: Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics-Driven Approach to Monitor Data Integrity Room 209 #115: Regenerative Medicine Advanced Therapies: Facilitating Product Development and Approval Room 156ABC #117: Beyond Robotics Process Automation: Next Generation Integrated QMS for R&D Room 205C #122: Contracting for Value: From Outcomes-Based Contracts to Bundled Payment Programs: What’s Working and Why Room 252AB #106: Signal Management: Separating Needles From Haystacks Room 253C #109: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials Room 258C #110: Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research Room 208 #112: Scientific Communication Key Message Development, Management, and Dissemination Room 210C #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? Room 151AB #114: A Hot Debate: Perspectives on Benefit and Risk From Patients Across Diseases Room 153ABC #116: Culture: The Link Between Team Culture and Productivity - An Interactive Workshop Room 254AB #118: How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making? Room 205AB #119: ‘Target’ing Pediatric Oncology Development: New Global Pediatric Considerations Under FDARA 2017 Room 204AB #120: FDA Innovation in Pharmaceutical Quality Assessment and Inspection Room 206AB #121: Use of Historical Information in Clinical Trial Design Room 256 #123: Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge Room 157AB #124: Analyzing Innovations Progress in the Gottlieb Era Room 210AB

12:00pm

12:30pm

12:45pm

1:15pm

1:30pm

1:45pm

2:00pm

2:15pm

3:00pm

#141: eSource: The Road to Real World Evidence – Are We There Yet? Room 257AB #147: Facilitating Nonclinical Data-Sharing and Access Across the Industry Room 151AB #148: Essential Project Leadership in Navigating an Evolving Regulatory Landscape in Asia-Pacific Room 258C #152: FDA Expectations for Demonstration of Interchangeability Room 206AB #139: Novel Approaches to Pharmacovigilance Collaboration Room 253C #140: How Inspection-Ready is Your Organization? Room 253AB #142: Mobile Accelerometry in Clinical Trials: Potential Applications and Meaningful Outcomes Room 258AB #143: Applying Artificial Intelligence, Machine Language, Natural Language Processing, and Predictive Models in Clinical Trials to Deliver Value to Stakeholders Room 209 #144: The Evolving Biosimilars Landscape: A Medical Affairs Perspective Room 210C #145: A New Ecosystem: The Nature of Relationships Between Patient Advocacy Groups and Sponsors Room 153ABC #146: Development of Microbiome-Derived Therapeutics Room 156ABC #149: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative Room 205C #150: TFDA Town Hall Room 208 #151: Using Real World Evidence for Regulatory Support: Time to Embrace the Future Room 205AB #153: New Technologies in Pharmaceuticals and Biopharmaceuticals: Opportunities and Regulatory Challenges Room 204AB #154: Bayesian Application in Small-Sized Clinical Trials Room 256 #155: Real World Evidence for Value and Access Room 252AB #157: Courageous Leadership Room 254AB #156: International Regulatory Convergence Room 210AB

4:30pm

4:45pm

5:30pm

 
Tuesday, June 26
 

7:00am

8:00am

#202: Quantifying the Impact of Credentialed Clinical Research Site Professionals on Clinical Trial Conduct Quality Room 257AB #203: Utilizing and Understanding Real World Evidence Solutions to Efficiently Recruit the Most Appropriate Patients and Sites for Clinical Trials Room 258AB #207: Novel Approaches for Accessing the CNS: Nonclinical and Clinical Challenges Room 156ABC #209: Oversight in the Era of E6 (R2) Room 205C #201: Generic Drug Products: Comparison of Safety Profile With Branded Cousin Room 253AB #204: FDA Data Standards Update Room 209 #205: Best Practices for Implementing Lay Summaries and Communicating Results to Patients Room 210C #206: Incorporating Patient Input Into US Food and Drug Administration’s Medical Product Development and Regulatory Decision Making Room 151AB #208: Effective Management of Internal Stakeholders and External Strategic Partners from Multiple Perspectives: Non-Profit, CRO, and Pharmaceutical Industry Room 153ABC #210: Artificial Intelligence: The Future of Regulatory Affairs Room 206AB #211: Update on Collaboration and Trends in Global Companion Diagnostics Room 208 #212: Global Regulatory Strategies for Biosimilars Room 204AB #213: 2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry Room 205AB #214: CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs Room 253C #215: Pediatric and Rare Disease Drug Development Room 256 #216: Early HTA Scientific Advice: Does it Improve Internal Company Decision-Making and Ensure Predictability of HTA Outcome? Room 258C #218: Building Your Brand Room 254AB #217: Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence Room 210AB

9:00am

9:15am

9:30am

9:45am

10:00am

10:30am

#228: Global Clinical Trials: Lessons in Effective Execution Room 258AB #231: Automation with Intelligence: From Standard-Based Solution to Metadata-Driven Automation Room 209 #236: Executives Respond to the State of the Industry Report on Risk-Based Approaches in Clinical Trials: Opportunity or Threat? Room 205C #237: Expanded Access: Where Are We Now? Room 206AB #226: Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities Room 253AB #227: Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible Room 257AB #229: Mobile Reported Outcomes: A Forum on Patient and Caregiver Assessments Room 258C #230: Common Data Model Harmonization for Evidence Generation Room 208 #232: Digital Data and New Technologies to Drive Customer Impact in Medical Affairs, Medical Writing, and Medical Communications Room 210C #233: The Patient's Assessment of the Patient-Focused Drug Development Meeting Initiatives Room 151AB #234: Personalized Medicine Approaches During Early-Phase Clinical Research Room 156ABC #235: The Adventures of Patient Experience in Drug Development Room 252AB #238: The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer? Room 204AB #239: Generic Drug Town Hall Room 205AB #240: Biosimilars: Demonstrating Structural and Functional Similarity Room 253C #241: Time-to-Event Analysis in Clinical Trials Room 256 #242: Unmet Medical Need: Can the Stakeholders Align? Progress to Date Room 153ABC #243: Global Perspectives on Patient Engagement Room 210AB

11:30am

12:00pm

12:10pm

1:10pm

1:15pm

1:30pm

2:00pm

#255: Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations Room 208 #260: Optimizing Clinical Development With Adaptive Trial Designs Room 156ABC #267: Developing and Partnering on Evidence for Outcomes and Value Assessment: Standardizing Measurement for Patient-Centered Care Room 252AB #269A: DIA Regulatory Community Round Table Discussion: Global Regulatory Strategies for Biosimilars Community Zone NE Lobby #251: Risk Management: New Directions Room 253AB #252: Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection Room 257AB #253: Digitizing a Patient-Focused Clinical Trial Experience Room 258AB #254: Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go Room 258C #256: CTD Regulatory Defense Strategies: How Best to Prepare Your Response to Health Authority Queries Room 210C #257: Globalizing and Regionalizing Medical Information Contact Centers Room 209 #258: Reaching the Underserved: Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels Room 151AB #259: Measuring the Impact of Patient Engagement: What to Ask Depends on Who You Ask Room 254AB #261: Project Management Throwdown: How Not to Get Chopped Room 153ABC #262: The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan Room 205C #263: Navigating the Regulatory Landscape of Drug-Device Combination Products Room 204AB #264: Global Development Using Expedited Pathways in Established and Emerging Markets Room 206AB #265: ICH M9 BCS-Based Biowaivers Room 253C #266: User-Friendly Tools for Study Planning and Analysis Room 256 #268: Future of PharmaTech Room 210AB

2:15pm

3:00pm

3:15pm

3:30pm

3:40pm

4:15pm

#284: Using Advocacy Partnerships to Improve Real World Evidence in Clinical Trials Room 151AB #288: Is It Time to Change the Content and Format of Labeling? Room 205AB #293: Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management Room 257AB #294: Sustainable Healthcare Funding Room 258AB #276: Patient Engagement in Pharmacovigilance Room 253AB #277: Pharmacovigilance: No Longer Going it Alone Room 253C #278: Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring Room 252AB #279: Redefining the Site Investigator's Experience Room 153ABC #280: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers Room 254AB #281: Future of Endpoints Room 258C #282: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials Room 209 #283: Evolving Roles and Responsibilities for Medical Affairs Professionals Room 210C #285: Gene Therapy: Advances in Translating Technology Room 156ABC #286: Which Regulatory Project Management Staff at FDA Should You Engage With? When and How? Room 157AB #287: The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team Room 205C #289: Electronic Submissions Demystified Room 204AB #290: Priority Review Vouchers: Here to Stay and Worth the Effort? Room 206AB #291: ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes? Room 208 #292: Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs Room 256

4:30pm

 
Wednesday, June 27
 

7:00am

8:00am

#317: Operationalizing Real World Evidence and Value Room 257AB #319: DIA Clinical Safety and Pharmacovigilance Community Round Table Discussion: Pharmacovigilance: No Longer Going It Alone Community Zone NE Lobby #320: DIA Patient Engagement Community Round Table Discussion: Reaching the Underserved - Methods to Ensure Diversity and Inclusion for Patient Research, Clinical Trials, and Advisory Panels Community Zone NE Lobby #321: PowerUp: Career Transforming Moments Room 157AB #301: Automation in Pharmacovigilance: Doing More With Less Room 253C #302: Risk Communication and Patient Safety: Recent Learnings and New Approaches Room 253AB #303: Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial Room 258C #304: Data and Quality Approaches to Informing Global Investigative Site Selection Room 258AB #305: Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders Room 254AB #306: phactMI: A Collaborative Approach to Advancing the Practice of Medical Information and Enabling Innovative Customer Solutions Room 210C #307: Maintaining Patient Engagement in the Development of Patient-Reported Outcome (PRO) Measures Room 153ABC #308: How Do Patients and Other Multi-Disciplinary Stakeholders Collaborate to Develop Patient Registries which Accelerate Research? Room 151AB #309: Evolution and Harmonization of First-in-Human Guidelines Room 156ABC #310: Becoming Highly Self-Aware: Leading in the Midst of Ambiguity Room 252AB #311: Harnessing the Power of Data and Analytics to Enhance Quality Room 205C #312: Harmonizing Regulatory Science Through the International Council for Harmonisation (ICH) Room 206AB #313: Global Rare Disease Town Hall Room 205AB #314: What Can We Say About Combination Products? Labeling, Advertising and Promotion of Combination Products Room 204AB #315: Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes Room 208 #316: Opportunities for Efficient and Innovative Study Designs Room 256 #318: Value-Based Assessment and Contracting: What Needs to be Done to Make it a Best Practice? Room 210AB

9:00am

9:15am

9:30am

9:45am

10:00am

10:30am

#333: Streamlining Vendor Reconciliation Room 209 #337: Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally Room 156ABC #329: Reducing the Burden of Drug Safety Risk Minimization Programs on the Healthcare System: How Do We Do So and What Has Been Learned to Date? Room 253AB #330: Artificial Intelligence: Robots Taking Over Clinical Research Room 253C #331: Rebuilding or Building a Research Site in the Year 2020 Room 254AB #332: Clinical Data: Let’s Get to the Source and Streamline it to the End Room 208 #335: Collaboration Across the Medical Affairs Ecosystem to Advance Patient Care Room 257AB #336: Addressing the Elephant in the Room: A Hard Look at Metrics, Legal, Payers, and Other Leading Obstacles Facing the Sustainability of Patient Engagement Room 153ABC #338: You've Got Data #now what? Room 157AB #339: Determining Data Integrity: Decoding the Impact of Inspectional Observations Room 258AB #340: Harmonization Beyond ICH Room 206AB #341: New FDA Draft Guidance on Part 11 in Clinical Investigations Room 204AB #342: Sex Considerations in the FDA Drug Review Pipeline: The Where, When, and How Room 205C #343: Innovative Visualization Approaches Room 256 #344: Biosimilar Interchangeability: A Global Perspective Room 205AB #334: Clinical Trial Disclosure: Learnings from EMA Policy 0070, NIH Final Rule, and FDA’s Clinical Data Summary Pilot Program Room 210C #345: Unmet Medical Need: Path Forward – Creating a Commonly Agreed Criteria Globally Room 252AB #346: Precision Medicine, Gene Editing, and Gene Therapy: Current Status and Regulatory Challenges of Integrating Genetic Medicine into Clinical Care Room 210AB

11:30am

12:00pm

12:10pm

12:45pm

1:00pm

1:10pm

1:15pm

1:30pm

2:00pm

#361: A New Way of Authoring and Reviewing Documents for Clinical Development Room 258C #362: Do the Evolution: The Future Role of Clinical Data Management Room 209 #372: AdPromo: Assessing Risk in the Current Regulatory Environment Room 206AB #359: IMEDS: A Collaboration Based on the FDA's Sentinel Initiative Room 253C #360: Implementation of eConsent and Other Digital Clinical Trial Innovations Room 258AB #363: Innovative and Effective Authoring Strategies to Facilitate Accelerated Regulatory Submissions Room 157AB #364: Achieving Customer Centricity to Advance Patient Care Through Innovative Communication Channels Room 210C #365: Engaging the Rare Disease Community to Design Clinical Trials Room 151AB #366: Gene Therapy Clinical Trials: Current Challenges Room 156ABC #367: Real Life Strategies for Collaborative Stakeholder Management Room 252AB #368: Predicting Future Generic Drug Competition: Powering Strategic Planning Using Quantitative Methods and Modeling Room 153ABC #369: Virtual Audits: Do They Achieve the Objective? Room 257AB #370: Clinical Outcome Assessments (COA) Endpoints for Use in Rare and Ultra-Rare Disease Clinical Trials Room 204AB #371: What's New in Health Canada: Updates and New Endeavors Room 205C #373: PMDA Town Hall Room 205AB #374: Modernization and Harmonization of Inspectional Approaches Room 208 #375: Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints Room 256 #376: Courageous Hiring Room 254AB #358: Expedited E2B Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations? Room 253AB

2:15pm

3:00pm

3:15pm

3:25pm

3:30pm

4:00pm

 
Thursday, June 28
 

8:00am

8:30am

9:00am

10:30am

10:45am