DIA 2018 Global Annual Meeting: Full Schedule

11:00am EDT

#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

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States

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 and standards related to drug product quality, including... Read More →

Alonza Cruse

Director, Office of Pharmaceutical Quality Operations, ORA, OGROP, FDA, United States

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 →

Christine Moore

Executive Director, External Advocacy and Standards, Organon & Co., United States

Christine Moore is a founding member of Organon where she leads Global External Advocacy and Standards, with oversight for new GMP-related policy, analytical standards and compendial affairs. Christine started her career as a process development engineer, after which she moved to... Read More →

Susan Rosencrance

Acting Director, Office of Generic Drugs, CDER, FDA, United States

Susan Rosencrance, Ph.D., serves as the Acting Director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER). From 2015 to 2022, Dr. Rosencrance served as the Director of the Office of Lifecycle Drug Products within CDER’s Office of Pharmaceutical... Read More →

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

10: RegCMC-Product Quality, Session

Level Beginner
Featured Topics Regulatory Agency Presenters, Generics
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Featured Topics Regulatory Agency Presenters,Generics
Credit Type ACPE, CME, IACET, RN
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3:00pm EDT

#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

Lucy Chang

Exceutive 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 Executive Director of Global Regulatory CMC, providing regulatory leadership, oversight and strategy to a team of Regulatory... Read More →

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 →

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 →

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 EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

10: RegCMC-Product Quality, Session

Level Intermediate
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Credit Type ACPE, CME, IACET, RN
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8:00am EDT

#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

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 →

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 →

Peter Richardson

Head of Quality, Specialised Scientific Disciplines Department, European Medicines Agency (EMA)

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 EDT
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Featured Topics ExUS Regulatory
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Featured Topics ExUS Regulatory
Credit Type ACPE, CME, IACET, RN
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10:30am EDT

#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

Critical Quality Attributes and Biosimilars Development
Rajesh Ullanat

Building a Strong Analytical Foundation to Support Biosimilarity
Christopher Downey, PhD

Speakers

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 →

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 →

Rajesh Ullanat

Head, Global Biologics Research and Development, 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 →

T. Venkateshwaran

Associate Vice President and Global Head CMC Biologics, Medical Devices and Comb, Merck & Co., Inc.

Tuesday June 26, 2018 10:30am - 11:45am EDT
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Featured Topics Biosimilars
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Featured Topics Biosimilars
Credit Type ACPE, CME, IACET, RN
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2:00pm EDT

#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

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 →

Roger Nosal

Vice President, Head of Global CMC, Pfizer Inc, United States

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 ICH, PhRMA, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees... Read More →

Paul Seo

Director, Division of Biopharmaceutics, ONDP, OPQ, CDER, FDA

Paul has worked for the FDA 15 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 review processes in the Division of Biopharmaceutics, Office of New Drug Products, as... Read More →

Tuesday June 26, 2018 2:00pm - 3:15pm EDT
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Featured Topics Regulatory Agency Presenters
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Featured Topics Regulatory Agency Presenters
Credit Type ACPE, CME, IACET, RN
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8:00am EDT

#315: Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-634-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interactive discussion will take on the complex problem of managing global post-approval CMC changes. Countries and regions have specific timelines for review an approval of changes, and it's not just approval we need, it's approval in the right order to make implementation of the change worthwhile.

Learning Objectives

Evaluate post-approval changes differently and identify the best strategies to gain approval and implement changes rapidly.

Chair

Leonard Lescosky

Speaker

Compliance and Change Control: Checking that the Manufacture/CMC is Maintained in Accord with the Terms of the License
Peter Lassoff, PharmD

Changing Landscape of Managing CMC Post-Approval Changes: Challenges Now and How Global Regulations Impacts Us Going Forward
Pascha Clark-Higgs, RAC

Pharmacopoeia Harmonization and Global Compendial Compliance
J. Mark Wiggins, MS

Speakers

Pascha Clark-Higgs

Associate Director, Regulatory Development Solutions, CMC, PPD

Pascha Clark-Higgs has over 18 years of experience within the pharmaceutical industry. Pascha has held various roles within regulatory affairs and analytical development from start-up to large pharmaceutical companies supporting development and commercialization of brand and generic... Read More →

Peter Lassoff

Vice President and Head, Global Regulatory Affairs, IQVIA

Peter Lassoff is Vice President and Head of Global Regulatory Affairs at IQVIA. In his role, he works with global clients in the pharmaceutical, medical device, cosmetic, nutrition and other industries on regulatory strategy and implementation to ensure their products are placed on... Read More →

Leonard Lescosky

Vice President, Regulatory Operations and CMC, AbbVie, Inc.

Len joined AbbVie in December 2011. Len has more than 30 years of pharmaceutical experience with more than 20 in regulatory. He has held various positions at Thompson Hine LLP, Corus (Gilead), Solvay, Pfizer, Warner Lambert and Parke Davis. Len holds a law degree from Georgia State... Read More →

J. Mark Wiggins

Director, Compendial Compliance and Advocacy, Merck & Co., Inc.

J. Mark Wiggins is Director, Compendial Compliance and Advocacy at Merck, with >30 years experience in the pharmaceutical industry. His responsibilities include reviewing compendial changes from around the world to ensure ongoing compliance and establishing public quality standards... Read More →

Wednesday June 27, 2018 8:00am - 9:15am EDT
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

10: RegCMC-Product Quality, Session

Level Advanced
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Credit Type ACPE, CME, IACET, RN
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2:00pm EDT

#374: Modernization and Harmonization of Inspectional Approaches

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-671-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss industry challenges, needs and feedback regarding international efforts currently underway to harmonize global inspection schemes.

Learning Objectives

Discuss the latest efforts to harmonize global inspection schemes.

Chair

Stephen Mahoney

Speaker

An Industry Perspective: Inspection Management - Fire Drill or Readiness?
Joanne Spallone

Reforming FDA's Enforcement Process
Howard Sklamberg, JD, MA

International Inspections Issues and Successful Remediation
Thomas J. Cosgrove, JD

Speakers

Thomas Cosgrove

Partner, Covington & Burling LLP

Tom Cosgrove is a partner in Covington’s Food, Drug and Device Practice Group. He joined Covington in 2017 from the Food and Drug Administration (FDA), where he was a senior official charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients... Read More →

Stephen Mahoney

Executive Director, Global Compliance Policy and External Collaboration Americas, Genentech, A Member of the Roche Group, United States

Stephen Mahoney is an Executive Director in Global Quality and Compliance at Genentech, Inc. In this role, he advises senior leaders on critical regulatory and manufacturing matters. Previously, Stephen served as a Compliance Officer in the FDA's Center for Drug Evaluation and Research... Read More →

Howard Sklamberg

Partner, Health Group, Akin Gump Strauss Hauer & Feld LLP

Howard Sklamberg is a partner in Akin Gump’s health care and life sciences practice. From 2014 to April 2017, he was FDA’s Deputy Commissioner for Global Regulatory Operations & Policy, where he oversaw FDA quality and safety efforts, including development of standards, field... Read More →

Joanne Spallone

Global Head, Franchise QA Operations and Strategy, Novartis Pharmaceuticals Corporation

Joanne has spent over 37 years in the pharmaceutical industry and approximately 25 years in clinical/pharmactovigilance quality assurance functions. She has managed QA/Audit functions with responsibility for both GCP and Pharmacovigilance activities. Currently, she heads Global Development... Read More →

Wednesday June 27, 2018 2:00pm - 3:15pm EDT
Room 208 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

10: RegCMC-Product Quality, Session

Level Beginner
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Credit Type ACPE, CME, IACET, RN
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