3rd FDA/PQRI Conference on Advancing Product Quality
Use this color guide as a reference:
Track #1 Drug Classification, Release, and Modeling for Setting Clinically Relevant Specifications
Track #2 Achieving Drug Product Quality: Novel Approaches and Applications
Track #3 Enhancing Product Quality through Continuous Manufacturing
| Day 1 – Wednesday, March 22, 2017 | |||
| 7:30 – 8:15 AM REGISTRATION | |||
| 8:15 – 10:00 AM Plenary Session
Opening (15 minutes) 8:15 – 8:30 AM Office of Pharmaceutical Quality Progress Update – Michael Kopcha, FDA (8:30 -9:00 AM) ICH Q12 : A Unique Opportunity to Realize 21st Century Quality Vision– Moheb Nasr, GlaxoSmithKline (9:00 – 9:30 AM) Clinical Relevance: Connections, Collaboration, and Context – Sarah Pope Miksinski, FDA (9:30-10:00 AM) |
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| 10:00 -10:30 AM Coffee Break | |||
| Track #1:
Drug Classification, Release, and Modeling for Setting Clinically Relevant Specifications |
Track #2:
Achieving Drug Product Quality: Novel Approaches and Applications |
Track #3:
Enhancing Product Quality through Continuous Manufacturing |
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| 10:30 AM – 12:15 PM | Session 1. Biowaivers and Harmonization Guidelines for Class 1 and 3 Drugs
Moderator: Mehran Yazdanian, Teva Where are We on the Latest Draft Guidance on BA/BE Waivers for Class 1 and Class 3 Drugs Mehul Mehta, FDA Barbara Davit, Merck The BCS and Biowaivers – A Global Overview Raimar Löbenberg, University of Alberta Q&A Discussion |
Session 1. Oligonucleotide Therapeutics: Quality, Standards, and Regulation
Moderator: Larisa Wu, FDA and Mohan Sapru, FDA Challenges and Approaches Used in Current Process Development of Oligonucleotide Therapeutic APIs Joe Guiles, Agilent A High-Throughput Process for the Solid-Phase Purification of Synthetic DNA Sequences Serge Beaucage, FDA CMC Regulatory Considerations for Oligonucleotide Drug Products: FDA Perspective Mohan Sapru, FDA Panel Discussion
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Session 1: Where Are We Now
Moderator: Steve Tyler, AbbVie Perspectives on Continuous Manufacturing: Where Are We Now, Where Are We Going Christine Moore, Merck Continuous Manufacturing as an Emerging Technology Celia Cruz, FDA Continuous Manufacturing: An Industry View Diane Zezza, Novartis Panel Discussion |
| 12:15 –1:15 PM Lunch | |||
| 1:15 – 3:00 PM | Session 2: Dissolution Challenges for BCS Class 2/4 Drugs
Moderator: Allen Templeton, Merck & Co., Inc. BCS Class 2 Immediate Release (IR)Dissolution in Two-Phase Media Rik Lostritto, FDA Establishing Clinically Meaningful Drug Product Specifications: A Possibility without IVIVC? Sandra Suarez-Sharp, FDA Development of Dissolution Methods for Class 2/4 Drugs – A USP Perspective Erika Stippler, USP Q&A Discussion |
Session 2: PQRI PODP Working Group Recommendations on Extractables and Leachables
Moderator: Diane Paskiet, West General Recommendations on PODP Extractables & Leachables Diane Paskiet, West Parenteral Drug Products Best Practices Dennis Jenke, Triad Scientific Solutions, LLC Ophthalmic Drug Products Best Practices Christopher Houston, iuvo Bioscience Q&A and Panel Discussion |
Session 2: API Focus
Moderator: Robert Meyer, Merck & Co., Inc. Development and Implementation of Continuous Manufacturing Processes for API Paul Collins, Eli Lilly and Company Scientific Considerations for Continuous API Manufacturing Thomas O’Connor, FDA Aaron Côté, Merck & Co., Inc. Panel Discussion |
| 3:00 – 3:30 PM Coffee Break | |||
| 3:30 – 5:15 PM | Session 3. In-Vivo Predictive Dissolution Methods and Modeling
Moderator: Greg Amidon, University of Michigan Building an Enhanced Analytical Toolbox for In-Vivo Predictive Dissolution Justin Pennington, Merck& Co., Inc. Development of Biorelevant Dissolution Methods Nikoletta Fotaki, University of Bath Dissolution Coupled with Oral Absorption Modeling to Predict Clinically Relevant Performance David Sperry, Eli Lilly and Company Panel Discussion |
Session 3. Extractables and Leachables: the Future
Moderator: Reggie Saraceno, Boehringer Ingelheim Michael Hodgson, Baxter John Iannone, AMRI Dealing with Extractables and Leachables from a Regulatory Perspective Timothy Robison, FDA Panel Discussion |
3. Drug Product Focus
Moderator: Sharmista Chatterjee, FDA Overview of the session : 5 min (3:30 – 3:35 PM) Considerations for CM Implementation for a New Molecule (3:35 – 4:00 PM) Eleni Dokou, Vertex Considerations for CM Implementation for a Legacy Product (4:00 – 4:40 PM) Eric Sanchez and Gilfredo Navarro, Janssen Excipient Considerations for CM Implementation (4:40 – 5:05 PM) Dave Schoneker, Colorcon Scientific and Regulatory Considerations for Continuous Manufacturing Implementation for Drug Product (5:05 – 5:30 PM) Arwa El Hagrasy, FDA |
| 5:30 – 7:00 PM Reception | |||
| Day 2 – Thursday, March 23, 2017 | |||
| 8:00- 8:30 AM Continental Breakfast | |||
| 8:30 – 10:00 AM Plenary Session
PQRI Strategic Plan, Vision and Future Plans – Stephen Tyler (AbbVie) PQRI Steering Committee Chair 8:30 – 9:00 AM Opportunities for Standardization In Continuous Manufacturing– Robert Femia, USP 9:00 – 9:30 AM Future of Pharmaceutical Quality and the Path to Get There – Lawrence Yu, FDA 9:30 – 10:00 AM |
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| 10:00 AM – 10:30 AM Coffee Break – | |||
| Track #1
Drug Classification, Release, and Modeling for Setting Clinically Relevant Specifications |
Track #2
Achieving Drug Product Quality: Novel Approaches and Applications |
Track #3
Enhancing Product Quality through Continuous Manufacturing |
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| 10:30 – 12:15 PM | Session 4. Drug Release from Non-Oral Routes
Moderator: Wenlei Jiang, FDA An In Vitro Approach to Model Specific Events Occurring at Injection Sites Randy Mrsny, University of Bath Drug Release from Liposomes: Role of Mechanism-Based Models Bradley Anderson, University of Kentucky Setting Size Specifications for PRINT® Particles Douglas Mar, Liquidia Technologies, Inc. Panel Discussion |
Session 4. Elemental Impurities
Moderator: Tony DeStefano, PQRI Implementing ICH Q3D and USP 232/233 for Drug Products – Challenges and Opportunities Nancy Lewen, Bristol-Myers Squibb PQRI/USP Workshop on Implementation Status and Progress Report on Collaborative Studies Donna Seibert, Perrigo A Reviewer’s Perspective on the Monitoring of Elemental Impurities Danae Christodoulou , FDA Q&A Panel Discussion |
Session 4. Strategies to Support Continuous Manufacturing
Moderator: Linda Evans O’Connor, Lachman Consultants cGMP and Regulatory Considerations of Continuous Manufacturing Processes LCDR Patric C. Klotzbuecher, FDA Integrated Product-Process Design to Minimize Expense, Time, and Material Fernando Muzzio, Rutgers University Ahmad Almaya, Eli Lilly and Company Q&A Panel Discussion
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| 12:15 – 1:15 PM Lunch | |||
| 1:15 – 3:00 PM | Session 5. Modeling for Oral and Non-Oral Routes
Moderator: Filippos Kesisoglou, Merck& Co., Inc. Modeling Long Acting Injectable Administrations Roberto Gomeni, PharmacoMetrica Modeling Deposition in the Respiratory Tract: What Can We Learn That Impactors Don’t Tell Us ? Maureen Donovan, University of Iowa David Good, Bristol-Myers Squibb Panel Discussion |
Session 5. Drug/Device combination products: Quality
Moderator: Nina Cauchon, Amgen & Laura O’Brien, Boehringer Ingelheim Introduction of Session 5 and 6 (5 minutes) Regulatory Perspectives on CQAs, CPPs, and Risk Analyses for Combination Products Doug Mead, Janssen Clint Judd, Amgen Ensuring the Quality of Some Drug-Device Combination Products – FDA Perspective Ramesh Raghavachari, FDA |
Session 5: Challenges to Implementing Continuous Manufacturing
Moderators: Larry Lee, FDA & Ganapathy Mohan, Merck Regulatory Challenges to Implementing Continuous Manufacturing Roger Nosal, Pfizer Enabling Continuous Manufacturing: An FDA Perspective Rapti Madurawe, FDA Continuous Manufacturing: Challenges and Opportunities – EMA Perspective Dolores Hernán Pérez de la Ossa, EMA PMDA’s Perspectives on Continuous Manufacturing Yoshihiro Matsuda, PMDA Panel Discussion |
| 3:00 – 3:30 PM Coffee Break | |||
| 3:30 – 5:15 PM | Session 6. Topical Classification System
Moderator: Kailas Thakker, Tergus Pharma The Science of Topical Drug Classification System Vinod Shah, PQRI Physiochemical Characterization of Acyclovir Topical Semisolid Dosage Forms Towards TCS Validation Flavian Radulescu, University of Medicine and Pharmacy Carol Davila In Vitro Characterization of Topical Semisolid Dosage Forms Sam Raney, FDA Panel Discussion |
Session 6. Drug/Device Combination Products: Bioequivalence
Moderator: Bing Li, FDA and Andrew Leboeuf, FDA Bing Li, FDA Understanding BE Requirements for Combination Products – A Focus on Auto Injectors Andrea Redd, Fresenius-Kabi User Interface Considerations for Drug-Device Combination Products Submitted in an ANDA Irene Chan, FDA Joint Panel Discussion (Session 5 and 6)
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Session 6. Where Are We Heading in Continuous Manufacturing?
Moderator: Rich Levy, PDA Introduction (5 minutes) Rich Levy, PDA How are you getting ready? Future Vision FDA CDER Perspective – Larry Lee, FDA Timescales for Change – A Look at Innovation in the Pharmaceutical Industry Bob Meyer, Merck Navigating the Challenges of Integrated Continuous Bioprocessing Charles Cooney, Massachusetts Institute of Technology Panel Discussion – Above speakers, plus: Yoshihiro Matsuda, PMDA LCDR Patric C. Klotzbuecher, FDA
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| Day 3 – Friday, March 24, 2017 |
| 7:30 – 8:00 AM Continental Breakfast |
| 8:00 – 10:15 AM Topic Summaries (45 minutes per track)
8:00 – 8:45 AM Track #1 Summary 8:45 – 9:30 AM Track #2 Summary 9:30 – 10:15 AM Track #3 Summary |
| 10:15 – 10:45 AM Coffee Break |
| 10:45 AM – 12:00 PM Global Harmonization? Conversation with FDA, EMA, PMDA and Industry Leaders
Moderator: Louis Yu, Valeant Panelists: Ashley Boam, FDA Dolores Hernán, EMA Robert Iser, FDA Yoshihiro Matsuda, PMDA Christine Moore, Merck & Co., Inc. Keith Webber, Perrigo |
| 12:00 PM Closing Remarks |