DAY 1 WEDNESDAY, MARCH 22, 2017

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1 Timing and speakers subject to change DRAFT November 1, 2016 Track #1 Track #2 Track #3 Use this color guide as a reference: DRUG CLASSIFICATION, RELEASE, AND ACHIEVING DRUG PRODUCT QUALITY: NOVEL ENHANCING PRODUCT QUALITY THROUGH DAY 1 WEDNESDAY, MARCH 22, :30 8:15 AM REGISTRATION 8:15 10:00 AM Plenary Session OPENING (15 minutes) 8:15 8:30 AM FDA S CURRENT THINKING ON (FDA) (8:30-9:00 AM) invited UPDATE ON ICH Q12 Moheb Nasr (GSK) (9:00 9:30 AM) CLINICALLY RELEVANT Sarah Pope Miksinski (FDA) (9:30-10:00 AM) 10:00-10:30 AM Coffee Break TRACK #1: DRUG CLASSIFICATION, RELEASE, AND TRACK #2: ACHIEVING DRUG PRODUCT QUALITY: NOVEL TRACK #3: ENHANCING PRODUCT QUALITY THROUGH 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and Harmonization Guidelines for Class 1 and 3 Drugs Moderator: Mehran Yazdanian (Teva) Where are we on the latest draft Guidance on BA/BE waivers for Class 1 and Class 3 Drugs o Mehul Mehta (FDA Biowaiver, Case Studies o Barb Davit (Merck) Biowavers A Global Overview o Raimar Loebenberg (U of Alberta, Canada) Session 1. Clinically Relevant Specifications for Complex Drug Substance Moderator: Larissa Wu (FDA) Biosimilarity Presentation 2 Presentation 3 Session 1: Where Are We Now Moderator: Steve Tyler (AbbVie) FDA Perspective o tbc Industry Perspective o [Merck speaker] -INVITED Academic or Industry o [Novartis speaker] INVITED 12:15 1:15 PM Lunch

2 1:15 3:00 PM TRACK #1: DRUG CLASSIFICATION, RELEASE, AND Session 2. Dissolution Challenges for BCS Class 2 and 4 Drugs Moderator: Allen Templeton (Merck) Current challenges for dissolution testing and in vivo prediction o Rik Lostritto (FDA) INVITED IVIVC/R development and clinically relevant specifications o Sandra Suarez-Sharp (FDA) INVITED Development of relevant USP dissolution methods o Erika Stippler (USP) 3:00 3:30 PM Coffee Break TRACK #2: ACHIEVING DRUG PRODUCT QUALITY: NOVEL Session2: PQRI PODP Working Group Recommendations on Extractables and Leachables Moderator: Diane Paskiet (West) PODP chemistry recommendations o Dennis Jenke (Baxter) PODP toxicology recommendations o Douglas Ball (Pfizer) Regulatory perspectives o FDA Speaker INVITED Panel Discussion o Unmet needs issues that PODP could not address fully o Ophthalmics perspectives o Add other discussion points TRACK #3: ENHANCING PRODUCT QUALITY THROUGH Session 2: API Focus Moderator: David Nadig (Vertex) Case Study Case Study Industry Experience

3 3:30 5:15 PM Session 3. In-Vivo Predictive Dissolution Methods and Modeling Moderator: Greg Amidon (U Michigan) In vivo predictive dissolution o Justin Pennington (Merck) INVITED Biorelevant experimental method development o Nikoletta Fotaki (University of Bath) INVITED Dissolution coupled with oral absorption modeling for regulatory/specifications o David Sperry (Lilly) INVITED Session 3. Extractables and Leachables: the Future Moderator: Reggie Saraceno, Boehringer Ingelheim Biologics with focus on cell therapies or transdermals o [tbc] Novel delivery systems/future delivery systems; implantable medical devices landscape, current challenges/issues o John Iannone, Amri Regulatory perspectives and needs o Dan Mellon (FDA) INVITED 3. Drug Product Focus Moderator: Sharmista Chatterjee (FDA) Overview of the session : 5 min Considerations for CM implementation for a new molecule : 20 min + 5 min Q&A : o speaker TBD Vertex INVITED Considerations for CM implementation for a legacy product : 20 min + 5 min Q&A : o speaker TBD Janssen INVITED Excipient considerations for CM implementation: 20 min + 5 min Q&A : o Dave Schoneker, Colorcon Regulatory considerations for CM implementation, includes both submission and inspection considerations: 20 min + 5 min Q&A : o Arwa El-Hagrasy (FDA) INVITED 5:30 7:00 PM Reception

4 8:00-8:30 AM Continental Breakfast 8:30 10:00 AM Plenary Session Timing and speakers subject to change DRAFT November 1, 2016 DAY 2 THURSDAY, MARCH 23, 2017 FDA/OPQ Update (30 minutes) 8:30 9:00 AM FDA INVITED Why is PQRI important to FDA; how is FDA leveraging PQRI; what are FDA s expectations for PQRI going forward? What are key FDA initiatives for 2017 and how can PQRI help. Lawrence Yu, FDA (30 minutes) 9:00 9:30 AM PQRI Strategic Plan; vision and plans going forward; PQRI resources - Steve Tyler (AbbVie) PQRI Steering Committee Chair (30 minutes) 9:30 10:00 AM 10:00 AM 10:30 AM Coffee Break TRACK #1 DRUG CLASSIFICATION, RELEASE, AND TRACK #2 ACHIEVING DRUG PRODUCT QUALITY: NOVEL TRACK #3 ENHANCING PRODUCT QUALITY THROUGH 10:30 12:15 PM Session 4. Drug Release from Non-Oral Routes Moderator: Wenlei Jiang (FDA) Subcutaneous, Intramuscular o Randy Mrsny (University of Bath) Liposomes o Bradley Anderson (U of Kentucky) Nanoparticles o To be determined 12:15 1:15 PM Lunch Session 4. Elemental Impurities Moderator: Tony DeStefano, PQRI Implementing ICH Q3D and USP 232/233 for Drug Products Challenges and Opportunities" o Nancy Lewen ( Bristol-Myers Squib) Summary of the November 2016 PQRO/USP Elemental Impurities Workshop and Phase 2 Inter-lab Study Update o Donna Seibert (Perrigo) A Reviewer's Perspective on the Monitoring of Elemental Impurities o FDA Invited 4. Strategies to Support Continuous Manufacturing Moderator: Linda Evans O Connor (Lachman Consultants) ORA FDA speaker Invited Rutgers IQ Consortium o Douglas Hausner or Fernando Muzzio CMAC speaker Invited

5 1:15 3:00 PM TRACK #1 DRUG CLASSIFICATION, RELEASE, AND Session 5. Modeling for Oral and Non-Oral Routes Moderator: Filippos Kesisoglou (Merck) Modeling long acting injectable administrations o Roberto Gomeni (PharmacoMetrica) Nasal/inhalation modeling o Maureen Donovan (U of Iowa) Model Based Approaches to Target Special Populations with Rational Formulation and Clinical Design Strategies o David Good (BMS) 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 o Vinod Shah (PQRI) Physiochemical characterization of acyclovir topical semisolid dosage forms towards TCS validation o Flavian Radulescu (University of Medicine and Pharmacy Carol Davila Bucharest) BE Standards for Topical drug products o Sam Raney ( FDA) Invited TRACK #2 ACHIEVING DRUG PRODUCT QUALITY: NOVEL Session 5. Drug/Device combination products: Quality Moderator: Nina Cauchon (Amgen) Laura O Brien ( BI) Introduction of Session 5 and 6 (5 minutes) Stability Protocols and Design speaker to be confirmed Regulatory Perspectives on CQAs, CPPs, and Risk Analyses for Combination Products. o Doug Mead, Janssen Examples from real-world data case study examples o Ramesh Raghavachari, FDA Session 6. Drug/Device Combination Products: Bioequivalence Moderator: Bing Li, FDA Bioequivalence on Nasal and Inhalation Products o Bing Li, FDA Challenging in Developing Combination Products from BE perspective [Industry speaker, TBD] Comparative Device Task Analysis and Human Factor Study o Irene Chan, FDA Joint Panel Discussion (Session 5 and 6) Add discussion points TRACK #3 ENHANCING PRODUCT QUALITY THROUGH Session 5: Barriers for Continuous Manufacturing Moderators: Larry Lee (FDA) & Ganapathy Mohan (Merck) An industry speaker that can speak to potential barriers (case study industry perspective) Regulatory Perspective ( An FDA speaker) Regulators from EMA and/or PMDA o Dolores Hernán (EMA) invited o Yoshihiro Matsuda (PMDA) - Panel Discussion Session 6. Where Are We Heading in Continuous Manufacturing? Moderator: Rich Levy (PDA) Introduction (5 minutes) Rich Levy What are the challenges faced. How are you getting ready? Global acceptance from other regulatory bodies (MHRA?) Inspection Readiness (PICs) proposed speakers: CDER and CBER speakers INVITED Global regulator: Health Products Regulatory Authority INVITED MIT speaker INVITED

6 DAY 3 FRIDAY, MARCH 24, :30 8:00 AM Continental Breakfast 8:00 10:15 AM Topic Summaries (45 minutes per theme) 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 Roundtable with FDA Leaders 12:00 PM Closing Remarks