4th FDA/PQRI Conference on Advancing Product Quality

Use this color guide as a reference:

Track #1 Novel Approaches to Improve Treatment Outcome and Patient Safety

Track #2 Emerging Technologies and Patient Centricity in Early Drug Development

Track #3 Novel Manufacturing Technologies and Challenges for the Production of Patient-Centric Drug Products

Day 1 – Tuesday, April 9, 2019
7:30 – 8:30 AM REGISTRATION
8:30 – 10:15 AM Plenary Session 8:30 – 8:45 AM Welcome – *Mehran Yazdanian, PhD, Senior Director of Scientific Strategy and Operations, Teva Pharmaceuticals 8:45 – 9:15 AM Keynote – Advancing Drug Product Quality – Patrizia Cavazzoni, MD, Deputy Director for Operations, CDER, US Food and Drug Administration 9:15 – 9:45 AM Innovating to Accelerate the Delivery of Transformative Therapies to Patients – Stephanie Krogmeier, PhD, Vice President, Global Regulatory CMC Strategy, Vertex Pharmaceuticals, Inc. 9:45 – 10:15 AM Pharmaceutical Product Development: Evolving Regulatory Landscape – Lawrence Yu, PhD*, Deputy Director, Office of Pharmaceutical Quality, CDER, US Food and Drug Administration
10:15 -10:45 AM Coffee Break
	Track #1: *Novel Approaches to Improve Treatment Outcome and Patient Safety*	Track #2: *Emerging Technologies and Patient Centricity in Early Drug Development*	Track #3: *Novel Manufacturing Technologies and Challenges for the Production of Patient-Centric Drug* *Products*
10:45 AM – 12:30 PM	Session 1: Complex Generics – Challenges and Opportunities Session Introduction Moderator: Wenlei Jiang, FDA Considerations for Biologics and Non-biological Complex Drugs Daan Crommelin, Utrecht University An Overview of Complex Drug Substances and Complex Formulations – A Quality Perspective Katherine Tyner, FDA Overview of Complex Generics – Regulatory Perspective on Bioequivalence Jeff Jiang, FDA Panel Discussion (above speakers)	Session 1: Early Drug Development: A Vision for the Future Moderator: *Geoffrey Wu, FDA* Early Drug Development: A Regulatory Perspective *Ramesh Sood, FDA* Accelerating Drug Development Using Small Scale, Data Intensive, Iterative Design Approaches *Greg Troup, Merck & Co., Inc.* Challenges and Opportunities with Patient-Centric Drug Product Design: Industry Perspectives *Matthew Burke, GlaxoSmithKline* Panel Discussion (above speakers)	Session 1: Novel Manufacturing Technologies and Challenges for Cell and Gene Therapies Moderator: *Michael Skidmore, Pharmaceutical Quality Consulting, Inc.* Regulatory Expectations for Cell and Gene Therapies *Ramjay Vatsan, FDA* Setting the Standard in Gene Therapy Manufacturing *Palani Palaniappan, Sarepta* Testing Strategies for Ex-vivo Gene Therapies *Michael Havert, bluebird bio* Panel Discussion (above speakers)
12:30 –1:30 PM Lunch
1:30 PM – 3:15 PM	Session 2: Developments in Biopharm Characterization of Injectable and Implantable Products Moderator: *Nan Zheng, FDA* Physicochemical Characterization of Nanomedicines *Jeffrey Clogston, Nanotechnology Characterization Laboratory* Challenges and Considerations in the Development and Validation of In Vitro Drug Release Testing for Intravaginal Rings *Karl Malcolm, Queen’s University Belfast* Complex Injectable and Implantable Drug Products: Bioequivalence Considerations *Wenlei Jiang, FDA* Panel Discussion (above speakers)	Session 2: Designing for Delivery: Drug Discovery and the Early Development Interface Moderator: *Diane Paskiet, West Pharmaceutical Services* Value-Driven Drug Development *Christopher Breder, FDA* Discovering and Developing Non-Traditional Drug Modality Molecules with Optimal Pharmaceutical Properties *Mike Hageman, University of Kansas* Designing for Delivery: The Use of Mathematical Modeling *Ronald Iacocca, Eli Lilly and Company* Panel Discussion (above speakers)	Session 2: Implementation and Regulatory Impact of Continuous Manufacturing (Part I) Moderator: *Bob Meyer, Merck & Co., Inc.* In Silico Modeling Approaches Towards Robust Design, Specification Setting and Establishing Control Strategies – Bio/Pharma Industry Perspective *Cenk Undey, Amgen* Perspective on the Validation of Computational Models for Establishing Control Strategies *Thomas O’Connor, FDA* PAT for Model Based Design, Optimization, Monitoring and Control of Continuous Manufacturing *Thomas De Beer, Ghent University, Belgium* Panel Discussion (above speakers)
3:15 – 3:45 PM Coffee Break
3:45 PM – 5:30 PM	Session 3: A Novel Approach for Overcoming Barriers to Improve Patient Access for Topical Drugs Moderator: *Filippos Kesisoglou, Merck & Co., Inc.* In Vitro Release and Q3 Measurements for Semisolid Drug Products *Flavian Rădulescu, Carol Davila University of Medicine and Pharmacy* The Premise of a Topical Drug Classification System as an Alternative to Clinical Endpoint Bioequivalence Studies *Vinod Shah, Pharmaceutical Consultant* Bioequivalence of Topical Products: Scientific Considerations *Tannaz Ramezanli, FDA* Panel Discussion (above speakers)	Session 3: Drug Device Combination Products – Emerging Technologies & the Evolving Regulatory Landscape Moderator: *Ajit Narang, Genentech* Drug Device Combination Products: Evolving Global Regulatory Landscape *Susan Neadle, Johnson & Johnson* Emerging Drug-Device Combinations: A Digitally Enhanced Patient Experience *Kristina Lauritsen, FDA* Inhaled Product Advances for Aerosolization, Breath Coordination and Patient Monitoring *Alan Watts, Savara Pharmaceuticals* Panel Discussion (above speakers)	Session 3: Implementation and Regulatory Impact of Continuous Manufacturing (Part II) Moderator: *Pramod Kotwal, Merck & Co., Inc.* Transforming Biopharmaceutical Production Through the Deployment of Next Generation Manufacturing: Opportunities and Challenges *Arthur Hewig, Amgen* Continuous Manufacturing – Framing a Future for Patients *Paul Collins, Eli Lilly and Company* Novel Technologies to Support Patient Centric Product Development: FDA Perspective *Sharmista Chatterjee, FDA* Panel Discussion (above speakers)
5:30 – 7:00 PM Reception
Day 2 – Wednesday, April 10, 2019
7:30 – 8:00 AM Continental Breakfast
8:00 – 10:00 AM Plenary Session Track Summaries from Day 1 8:00 – 8:40 AM Track #1 Summary 8:40 – 9:20 AM Track #2 Summary 9:20 – 10:00 AM Track #3 Summary
10:00 AM – 10:30 AM Coffee Break –
	Track #1 Novel Approaches to Improve Treatment Outcome and Patient Safety	Track #2 Emerging Technologies and Patient Centricity in Early Drug Development	Track #3 Novel Manufacturing Technologies and Challenges for the Production of Patient-Centric Drug Products
10:30 – 12:15 PM	Session 4: Predictive Approaches to Gain Insight into the Clinical Performance of Inhaled Medicines Moderator: *Mehran Yazdanian, Teva* Biopharmaceutical Classification of Inhaled Medicines: Development of an iBCS *Jayne E. Hastedt, PhD, JDP Pharma Consulting* Modeling Aspects Related to Inhaled Medicines *Per Bäckman, Emmace Consulting* Regulatory and Scientific Challenges in Establishing Bioequivalence for Generic Orally Inhaled Drug Products *Bing Li, FDA* Panel Discussion (above speakers)	Session 4: Development Considerations for Evolving Non-Traditional Drug Modalities Moderator: *Allen Templeton, Merck & Co., Inc.* Unlocking the Promise of Immunoncology and Combination Therapies *Rubi Burlage, Merck & Co., Inc.* Delivery of Nucleic Acid Sequences in Mammalian Cells Mediated by Phosphorothioate DNA or RNA Transporter Elements *Serge Beaucage, FDA* Developing Next Generation Technologies in the Context of a Public Private Partnership *Kelvin Lee, NIIMBL/University of Delaware* Panel Discussion (above speakers)	SESSION 4: Regulatory Submission Lifecycle Management Moderator: *Susan Rosencrance, FDA* Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: ICH Q12 *Andrew Chang, NovoNordisk* The Concept and Proposed Global Applicability and Benefit of PACMP (Post-Approval Change Management Protocol) *Mahesh Ramanadham, FDA* Established Conditions and its Application *Bhagwant Rege, FDA* Panel Discussion (above speakers)
12:15 – 1:15 PM Lunch
1:15 PM – 3:00 PM	Session 5: Enabling Patient-Focused Quality Standards via Modeling and Simulation for Oral Products Moderator: *Sandra Suarez Sharp, FDA* PBPK-based and Traditional IVIVC as Complementary Tools to Quality by Design in the Biopharmaceutics Space *David Good, Bristol-Myers Squibb* Application of Physiologically Based Biopharmaceutics Modeling in Support of Drug Product Quality *Yang Zhao, FDA* Mechanistic Absorption Modeling and Clinically Relevant Specifications for Enabling Formulation Technologies *Christophe Tistaert, Janssen Research & Development* Panel Discussion (above speakers)	Session 5: New Visualization and Analysis Techniques in Drug Development Moderator: *Bob Meyer, Merck & Co., Inc.* What do Petroleomics, Jet Fuel and Pharmaceuticals Have In Common? Visualization and Characterization of Complex Mixtures of Extractables/Leachables and Other Pharmaceutically Relevant Compounds using High Resolution 2-D and 3-D Mass Mapping *Douglas Kiehl, Eli Lilly and Company* Advanced Analytical Techniques for Characterizing Amorphous Solid Dispersions *Eric Munson, Purdue University* Beyond the Big Crunch of Excel: The Big Bang of Digital Visualizations *Marcus Adams, Merck & Co., Inc.* Panel Discussion (above speakers)	SESSION 5: Challenges with Drug Device Combination Products Post Approval Moderator: *Susan Neadle, Johnson & Johnson* The Role of Human Factors Engineering in Combination Product Post Approval Changes *Quynh Nguyen, FDA* Types and Handling of Product Complaints for Combination Products *John Towns, Eli Lilly and Company* Challenges Based on Differences in Global Regulatory Filing Requirements *Doug Mead, Janssen* Panel Discussion (above speakers)
3:00 – 3:30 PM Coffee Break
3:30 PM – 5:15 PM	Session 6: Oral Biopharmaceutics: Challenges, Opportunities, and Advancements Moderator: *Andreas Abend, Merck & Co., Inc.* Advancing the Dissolution Toolbox in Drug Development: Novel Bio-predictive Dissolution Methodologies for Oral Products *Greg Amidon, University of Michigan* Use of 3D-printed Tablets as a Biopharmaceutics Investigation Tool *Adam Procopio, Merck & Co., Inc.* Advancing Biopharmaceutics Knowledge and Toolkit to Improve the Quality of Pediatrics Medicine *Gilbert Burckart, FDA* Panel Discussion (above speakers)	Session 6: Emerging Technologies for Improving Patient Adherence Moderator: *Dave Schoneker, Colorcon* Emerging Technologies for Improving Patient Adherence: an FDA Viewpoint *Douglas Throckmorton, FDA* The Expanding Universe of Patient Adherence Solutions: Long-acting Implantables, Micro-Chip, Smart Packaging, Apps, and Social Robotics *Stephanie Barrett, Merck & Co., Inc.* New Formulation Technologies for Patient Adherence: Solid Oral Dosage Forms *Ali Rajabi-Siahboomi, Colorcon* Panel Discussion (above speakers)	SESSION 6: CMC Innovation in the 21st Century – Global Regulatory Perspectives Moderator: *Nina Cauchon, Amgen* A European Perspective on Global CMC Innovation *Sven Stegemann, Graz University of Technology* Pharmaceuticals and Medical Devices Agency (PMDA) Perspective *Yoshihiro Matsuda, PMDA* Innovation and Regulatory Landscape: Emerging Technologies Program *Celia Cruz, FDA* Panel Discussion (above speakers)

Day 3 – Thursday, April 11, 2019

7:30 – 8:00 AM Continental Breakfast

8:00 – 9:30 AM Track Summaries from Day 2

8:00 – 8:30 AM Track #1 Summary

8:30 – 9:00 AM Track #2 Summary

9:00 – 9:30 AM Track #3 Summary

9:30 – 10:00 AM Coffee Break

10:00 – 11:30 AM Introducing FDA’S New Initiative: KASA (Knowledge-aided Assessment and Structured Application)

A creative regulatory approach for modernizing the quality assessment and enhancing submission format

Moderator: Lawrence Yu
Presenters: Susan Rosencrance, Andre Raw, Derek Smith, and Mary Ann Slack
Panelists: Susan Rosencrance, Sharmista Chatterjee, Mahesh Ramanadham, Paul Seo, Ramesh Sood, Geoffrey Wu, Larisa Wu

11:30 AM – 12:00 PM Poster Award Announcement and Presentations

12:30 PM Closing Remarks