5th PQRI/FDA Conference on Advancing Product Quality

5th FDA/PQRI Conference on Advancing Product Quality: Advancing Quality & Technology of Future Pharmaceuticals

Unable to attend the Live Virtual 5th PQRI/FDA Conference?  PQRI is pleased to offer packages of recorded presentations, bundled together by session, for viewing ON DEMAND. 

Fee structure (per bundle):

• • Industry $100
  • FDA/Government $60   (USE DISCOUNT CODE:  GOVT2022)
  • Academic/Student $30  (USE DISCOUNT CODE:  ACADEMIA2022)
    
    • Discount Codes available for FDA/Gov’t and Academic/Student.  

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Bundle 1 Biopharmaceutics Track – Biopharmaceutical Considerations for Product Design and Development

• Welcome to Conference and Overview of PQRI – Ajit Narang, Ph.D., ORIC Pharmaceuticals, Conference Committee Co-Chair
• Introduction to the Conference – Lawrence X. Yu, Ph.D., Director, Office of New Drug Products, OPQ/CDER/FDA, Conference Committee Co-Chair
• Keynote Address: Advancing Pharmaceutical Product Quality – Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality/CDER/FDA
• Session 1: Patient-centric Dissolution and International Harmonization (Moderator: Filippos Kesisoglou, Ph.D., Distinguished Scientist, Merck and Co., Inc.)
  • How Do We Improve Predictions of Drug Concentration-Time Profiles? – Swati Nagar, Ph.D., Professor and Director of Graduate Studies, Temple University
  • The Link Between the Human Gastrointestinal Tract and Oral Drug Absorption: Theory and Case Examples – Bart Hens, Pharm.D., Ph.D., Biopharmaceutics Scientist and Drug Product Design Biomodeler, Pfizer, Sandwich, UK
  • Risk-based Approach to Establishing Patient-Centric Dissolution Specifications – Elsbeth Chikhale, Ph.D., Biopharmaceutics Team Leader Division of Biopharmaceutics ONDP/OPQ/CDER/FDA

Bundle 2 Biopharmaceutics Track – Biopharmaceutical Considerations for Product Design and Development

• Session 2: Biopharmaceutics for Complex Drug Products (Moderator: Wenlei Jiang, Ph.D., Senior Science Advisor, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), US FDA
  • Biopharmaceutics and Inhaled Drugs – Development of an iBCS – Jayne E. Hastedt, Ph.D., Managing Director, JDP Pharma Consulting LLC and PQRI iBCS Working Group
  • Modeling and Simulation of Long-Acting Injectable Psychiatric Products – Hao Zhu, Ph.D., Deputy Division Director, Division of Pharmacometrics OCP/OTS/CDER, US FDA
  • Biopharmaceutics of Complex Parenteral Drug Products – IVIVC and Development In Vitro Release Testing – Diane J. Burgess, Ph.D., Distinguished Professor, University of Connecticut
• HOT TOPIC: Biopharmaceutics for Nano-Drug Delivery (Moderator: Mehran Yazdanian, Ph.D., Vice President, R&D Operations, Teva Pharmaceuticals)
  • Overlooked Biopharmaceutics of Nanomedicines /NanoVaccines Impacts Clinical Dose/Efficacy/Safety – Duxin Sun, PhD., Charles Walgreen Jr. Professor of Pharmacy, Professor of Pharmaceutical Sciences, College of Pharmacy, The University of Michigan

Bundle 3: Development Track– New Horizons for Pharmaceutical Development

• Session 1: Accelerating Development: Fast Tracking Critical Treatments, Antibody Platforms, and Quality Standards for Emerging Modalities (Moderator: Doug Kiehl, Eli Lilly and Company)
  • Accelerated Development of Molnupiravir – Michael Lowinger, Ph.D., Director of Oral Formulation Sciences, Merck & Co., Inc.
  • Platform and Prior Knowledge in the Development of Neutralizing Monoclonal Antibodies: A Regulatory Perspective – Maria-Teresa Gutierrez-Lugo, Ph.D., Review Chief, Office of Biotechnology Products OPQ/CDER/FDA
  • Cell and Gene Therapy Consensus Standards – A Shared Path Forward – Catherine B. Zander, Ph.D., Scientific Program Manager, The Standards Coordinating Body
  • HOT TOPIC: Emergency Use Authorizations: COVID-19 Therapeutics – Andrew A. LeBoeuf, JD, MS, Associate Director for Policy (Acting), Office of New Drug Policy, OND/CDER/FDA
  • Q&A with above presenters

Bundle 4: Development Track– New Horizons for Pharmaceutical Development

• Session 2: Modeling and Simulations to Enable Rapid Decision Making (Moderator: Robert Meyer, Ph.D., Principal Scientist, Merck & Co., Inc.)
  • Navigating Potentials and Pitfalls in using Artificial Intelligence for Expedited Decision Making in Pharmaceutical Problems – Rob Smith, Ph.D., CEO and Founder, Prime Labs, Inc.
  • Data Visualization Approaches for Enabling Rapid, Heuristic Interpretation of Highly Complex Mixtures of Structurally and Compositionally Diverse Chemical Entities Associated with Pharmaceutically Relevant Materials – Doug Kiehl, Eli Lilly and Company
  • Role of eXtended Reality (XR) in Empowering Knowledge Workers of the Future – Suresh Nulu, MS, Director, Merck & Co., Inc.
  • Q&A with above presenters
• Roundtable: Drug-Device Combination Products (Moderator: Cheryl L.M. Stults, Ph.D., Principal, C&M Technical Consulting LLC)
  • Panelists:
    • Susan Neadle, MS, BS, FAAO Principal Consultant/Owner Combination Products Consulting Services, LLC
    • Karthik Balasubramanian, Ph.D., Director, Generic Combination Products and Semisolids R&D, Teva Pharmaceuticals
    • Prasad Peri, Ph.D., Senior Director, Teva Pharmaceuticals

Bundle 5: Product Quality Track– Innovation in Quality & Technology Beyond the Pandemic

• Session 1: Knowledge-aided Assessment and Structured Application (KASA) and Pharmaceutical Quality/CMC (PQ/CMC) Update (Moderator: Nina S. Cauchon, Ph.D., Director Regulatory Affairs, Amgen Inc.)
  • An Overview of FDA’s KASA System – Susan M. Rosencrance, Ph.D., Director, Office of Lifecycle Drug Products, OPQ/CDER, FDA
  • KASA for Biologics – Steven Kozlowski, M.D., Director, Office of Biotechnology Products, OPQ/CDER, FDA
  • FDA Pharmaceutical Quality Electronic Standards (aka PQ/CMC) – Geoffrey Wu, Ph.D., Deputy Office Director, Office of Lifecycle Drug Products, OPQ/CDER, FDA
  • Accumulus Synergy and Data Exchange: A CMC Application Using Structured Data and a Cloud-Based Eco-system – Michael Abernathy, MS, RAC, Data Exchange Product Owner, Accumulus Synergy
  • Cloud-based Assessment and M4Q(R2) Revision – Lawrence X. Yu, Ph.D., Director, Office of New Drug Products, OPQ/CDER, FDA
  • Q&A with above presenters

Bundle 6: Product Quality Track– Innovation in Quality & Technology Beyond the Pandemic

• HOT TOPIC: Remote Interactive Evaluations (RIEs) (Moderator: Cat Vicente, Johnson & Johnson)
  • Remote Interactive Evaluations
    • Lane Christensen, Ph.D., Branch Chief, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA
    • Stelios Tsinontides, Ph.D., Director, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA
• Session 2: Advanced Manufacturing Concepts Beyond Continuous Manufacturing (Moderators: Robert Meyer, Ph.D., Merck & Co., Inc. and Rajan Jog, Ph.D., FDA)
  • A Vision for Agile Manufacturing – Celeste Frankenfeld Lamm, Ph.D., Director, Merck & Co.
  • Pre-Fabricated Solutions for New Facilities – Peter Makowenskyj, MEng., Director of Design Consulting, G-CON
  • Decentralized Pharmaceutical Manufacturing: The Next Big Thing? – Christine M. V. Moore, Ph.D., Executive Director, Organon
  • Regulatory Perspective on Advanced Manufacturing – Sau (Larry) Lee, Ph.D., Deputy Director of Science, Office of Pharmaceutical Quality/ CDER, FDA
  • Q&A with above presenters

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Conference Overview

On December 1 – 3, 2021, FDA and PQRI hosted a virtual public Conference, the 5th FDA/PQRI Conference on Advancing Product Quality: Advancing Quality & Technology of Future Pharmaceuticals. This Conference brought together leaders from regulatory agencies, industry experts, and academia to discuss key, critical topics in drug product delivery. Input from attendees will aid in future FDA guidance development.  Each day focused on a different theme and included a Hot Topic discussion:

Day 1: Biopharmaceutics: Biopharmaceutical Considerations for Product Design and Development

• • • Development of robust pharmaceutical products requires comprehensive/orthogonal evaluation of the link between critical quality attributes (e.g., dissolution, release) and absorption properties along with the use of computational tools to predict in vivo performance.  The judicious use of physiological based pharmacokinetic modelling and simulation (PBPK) along with patient-centric approaches for drug product development is essential to the delivery of transformative therapies. Hot Topic:  Biopharmaceutics for mRNA and Nano-Drug Delivery.
      • Overview of Day 1 with Abstracts and bios  

Day 2: Development— New Horizons for Pharmaceutical Development

• • • The future direction of pharmaceutical development for small and large molecule drug products has been profoundly influenced by recent events and technological advances.  Prominent on the horizon are emerging modalities for novel therapeutics, and innovative approaches for applying knowledge and data to expedite meaningful decision-making.  This track will explore opportunities and challenges represented by these areas, superimposed on a landscape of rapidly evolving industry practice and regulatory expectations. Hot Topic: Experience with Emergency Use Authorizations and Accelerated Development
      • Overview of Day 2 with Abstracts and bios   

Day 3: Product Quality— Innovation in Quality & Technology Beyond the Pandemic

• • • In a post-pandemic world, developing agile and innovative solutions that adapt to the pace of change is critical for all aspects of the pharmaceutical product lifecycle including regulatory, manufacturing, and quality.  This Track will explore current developments in modernization of regulatory submissions, in advanced manufacturing, and in remote site evaluations which are each evolving in real-time to address these future challenges.  Hot Topic: Remote Interactive Evaluations (RIEs)
      • Overview of Day 3 with Abstracts and bios   

Conference Materials

The Final Program can be downloaded by clicking on the icon below. 

Thank you to our Sponsors!
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QUESTIONS

Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5607 or PQRISecretariat@pqri.org.