2Nd FDA/PQRI Conference on Advancing Product Quality

2nd FDA/PQRI Conference on Advancing Product Quality 5-7 October 2015 Comprehensive List of Presentations and Speakers

October 5 Plenary Session 8:30 – 10:15 AM Moderators: Margaret Szymczak, J&J and Lawrence Yu, FDA Speakers: Janet Woodcock, FDA Michael Thien, Merck Bernhardt Trout, Massachusetts Institute of Technology

EMERGING REGULATORY INITIATIVES October 5 Biopharmaceutics – BCS Biowaivers 10:30 AM – 12:15 Moderators: Vinod Shah, PQRI and Mehul Mehta, FDA PM Speakers:  BCS Guidance and Biowaivers- BCS Monographs - Vinod Shah, PQRI Bertil Abrahamsson, AstraZeneca Yu Chung Tsang, Apotex  Implementation of BCS Guidance, Analysis of BCS Submissions to FDA and Guidance Update - Mehul Mehta, FDA October 5 Pharmaceutical Product Lifecycle Management – Q12 1:15 – 5:00 PM Moderators: Moheb Nasr, GlaxoSmithKline and Robert Iser, FDA Speakers:  Introduction to Product Lifecycle Management - Robert Iser, FDA Mark Rosolowsky, Bristol-Myers Squibb  ICH-Q12: Opportunities for the Generic Drug Industry - Keith Webber, Perrigo  Lifecycle Management: Future Vision / ICH Q12 - Moheb Nasr, GlaxoSmithKline  Change Management - Liam Feely, AbbVie Ingrid Markovic, FDA Mahesh Ramanadham, FDA October 6 Dissolution Testing and Specification for BCS I and III Drugs in Immediate Release 8:30 – 10:15 AM Products Moderators: Richard Lostritto, FDA and Gregory Amidon, University of Michigan Speakers:  The Future of In Vivo Predictive Dissolution Methods - Gregory Amidon, University of Michigan Rik Lostritto, FDA Lucinda Buhse, FDA October 6 Dissolution Testing and Specification for Extended Release Products 10:30 AM – 12:15 Moderators: Paul Seo, FDA and Jim Polli, University of Maryland PM Speakers:  Designing Quality into ER Products: Technology Selection - Alfred Berchielli, Pfizer  Use of Pharmacoscintgraphy in ER Formulation Understanding - David Sperry, Eli Lilly & Company  Mitigating Patient Risks Using Dissolution Testing in Manufacturing ER Products - Yihong Qiu, AbbVie 2nd FDA/PQRI Conference on Advancing Product Quality Page 2

EMERGING REGULATORY INITIATIVES October 6 Quality Metrics 1:15 – 3:00 PM Moderators: Tara Gooen Bizjak, FDA and Louis Yu, Perrigo Speakers: Tara Gooen Bizjak, FDA Paul Weninger, Perrigo Mairead Goetz, Novartis Diane Hagerty, Genentech October 6 Botanical Drug Development and Quality Standards 3:15 – 5:00 PM Moderators: Sau Larry Lee, FDA and Steven Hoag, University of Maryland Speakers: Sau Larry Lee, FDA  Aspects of the Discovery and Development of Plant-Derived Drugs - Douglas Kinghorn, The Ohio State University Haibin Qu, Zhejiang University Vikas Moolchandani, Amway Inc. October 6 How to Interact and Communicate with FDA on Quality Issues 5:00 – 6:30 PM Moderator: Giuseppe Randazzo, FDA Speakers: Robert Gaines, FDA  How to Interact and Communicate with FDA on Quality Issues - Tanya Clayton, FDA

REGULATORY SUBMISSION, ASSESSMENT AND INSPECTION October 5 Breakthrough Therapy – CMC Challenges 10:30 AM – 12:15 Moderators: Ganapathy Mohan, Merck and Margaret Caulk, FDA PM Speakers: . Breakthrough Therapy – CMC Challenges - Ganapathy Mohan, Merck John Groskoph, Pfizer Inc. . Review Considerations for Break-Through-Designated Products - Olen Stephens, FDA October 5 Pre-Approval and Surveillance Inspection 1:15 – 5:00 PM Moderators: Mary Oates, Pfizer and Rebeca Rodriguez, FDA Speakers: Ambarish Singh, BMS . An Industry View of Surveillance Inspections - Mary Oates, Pfizer Nancy Rolli, FDA Christine Moore, FDA October 6 Risk-based Regulatory Assessment 8:30 – 10:15 AM Moderators: G.K. Raju, Light Pharma and Ramesh Sood, FDA Speakers: Roger Nosal, Pfizer 2nd FDA/PQRI Conference on Advancing Product Quality Page 3

REGULATORY SUBMISSION, ASSESSMENT AND INSPECTION October 6 How Quality Risk Management can Enable a More Effective Pharmaceutical Quality 10:30 AM – 12:15 System Resulting in Improved Product Quality PM Moderators: Dave Doleski, FDA and Martin VanTrieste, Amgen Speakers: Fionnuala Walsh, Eli Lilly Mark Swatling, AstraZeneca Tom Cosgrove, FDA

October 6 FDA Integrated Quality Assessment: Common Deficiencies/Information Request 1:15 – 5:00 PM Moderators: Ashley Boam, FDA and Tony Tong, Teva Speakers: Mike Saleh, Pfizer Siva Vaithiyalingam, Teva Sarah Pope Miksinski, FDA Susan Rosencrance, FDA . Challenges Integrating Regulatory Filings and Pre-Approval Inspection with the Expectations of Current Regulatory Guidance - Tony Mire-Sluis, Amgen

PRODUCT AND PROCESS DEVELOPMENT October 5 Current Challenges in the Characterization of Complex Drug Formulations Containing 10:30 AM – 12:15 Nanomaterials PM Moderators: Katherine Tyner, FDA and Henry Havel, Nanomedicines Alliance Speakers: . Quality Considerations and Regulatory Perspectives for Drug Products Containing Nanomaterials - Katherine Tyner, FDA . Industrial Perspective on Nanomedicine Characterization Strategies - Don Parsons, BIND Therapeutics, Inc. . Nanoparticle Size Analysis: A Survey and Review -Marc Wolfgang, Cerulean

October 5 Biosimilar Product Assessment – How Similar is Similar? 1:15 – 5:00 PM Moderators: Anna Schwendeman, University of Michigan and Emanuela Lacana, FDA Speakers: . Implementing the Biologics Price Competition and Innovation Act of 2009 and Quality Considerations for the Development of Biosimilar Products - Marjorie Shapiro, FDA Anna Schwendeman, University of Michigan Corinna Sonderegger, Sandoz . Challenges with Establishing a Control Strategy for Biosimilars - Barbara Rellahan, Amgen . The Making of Advanced Biosimilars: Enabling Advanced Biosimilars through Technical Development and Manufacturing - Orlando Jaquez, Biogen 2nd FDA/PQRI Conference on Advancing Product Quality Page 4

PRODUCT AND PROCESS DEVELOPMENT October 6 Palatability and Swallowability-Benefits of Transdisciplinary Learning 8:30 – 10:15 AM Moderators: Arzu Selen, FDA and Rob Ju, AbbVie Speakers: . The Role of Tribology in Oral Processing -Stefan Baier, PepsiCo . In-Vitro Taste Sensors: Methods, Uses and Opportunities - Julie Lorenz, Zoetis

October 6 Alternatives for Content Uniformity Acceptance Criteria and Stratified Sampling 10:30 AM – 12:15 Moderators: PM Geoffrey Wu, FDA and Lisa Tan, GPhA Speakers: Jon Clark, USP James Drennen, Duquesne University Alex Viehmman, FDA

October 6 The Science of Tech Transfer/Scale-up 1:15 – 5:00 PM Moderators: Grace McNally, FDA and Ilgaz Akseli, Boehringer-Ingelheim Speakers: . Implementing Fundamental Pharmaceutical Science and Materials/Engineer Expertise in Scale-Up - Ecevit Bilgili, New Jersey Institute of Technology Stephen Conway, Merck Alberto Cuitino, Rutgers University . Mitigating Product Risk in Manufacturing or During Formulation Development and Identify Opportunities to Maximize Efficiency -Ilgaz Akseli, Boehringer Ingelheim San Kiang, Independent Consultant

MANUFACTURING, RISK MANAGEMENT AND QUALITY ASSURANCE October 5 How to Prevent, Detect, and Respond to Data Integrity Events 10:30 AM – 12:15 Moderators: Paula Katz, FDA and Joseph Famulare, Genentech PM Speakers: Paula Katz, FDA . Building Business Processes that Optimize Accurate and Reliable Data - Monica Cahilly, Green Mountain Quality Assurance . Benefits of Combining Quality Risk Management (Q9) with Pharmaceutical Quality System - Joseph Famulare, Genentech 2nd FDA/PQRI Conference on Advancing Product Quality Page 5

MANUFACTURING, RISK MANAGEMENT AND QUALITY ASSURANCE October 5 Continuous Manufacturing 1:15 – 5:00 PM Moderators: Thomas O’Connor, FDA and Diane Zezza, Novartis Speakers: . Scientific Considerations for the Assessment of Continuous Manufacturing Processes - Thomas O’Connor, FDA Yanxi Tan Cain, Novartis . cGMP and Regulatory Considerations for Continuous Manufacturing Processes - Patric Klotzbuecher, FDA Hayden Thomas, Vertex . Quality and Regulatory Considerations for Continuous API: A Case Study - Douglas Mans, GlaxoSmithKline October 6 How to Monitor, Control, and Improve Product Quality using Process Capability 8:30 AM – 12:15 Moderators: Barbara Allen, Eli Lilly & Company and Larisa Wu, FDA PM Speakers: . Pharmaceutical Product Quality, Quality by Design, cGMP, and Quality Metrics - Lawrence Yu, FDA Daniel Peng, FDA . Quality as Foundation for OPEX - Thomas Friendli, University of St. Gallen . The Journey From Good to Great: Process Monitoring Leads to Improving Product Quality- Martin VanTrieste, Amgen Bryan Winship, Mylan . Process Capability and Relationship to Quality Management - Barbara Allen, Eli Lilly & Company

October 6 How to Identify Critical Quality Attributes and Critical Process Parameters 1:15 – 5:00 PM Moderators: Scott Furness, FDA and Bruce Johnson, Perrigo Speakers: . Generic Pharma Perspective on the Identification of Critical Quality Attributes and Critical Process Parameters- Bruce Johnson, Perrigo . FDA Perspective on Identification of CQAs, CMAs and CPPs in A/NDAs - Jennifer Maguire, FDA Daniel Peng, FDA . Generic Pharma Perspective on the Identification of Critical Quality Attributes and Critical Process Parameters - Bruce Johnson, Perrigo . A Structured Statistical Approach to Aid the Assessment of Process Parameter Criticality- Ke Wang, Pfizer . Identification of CPPs based on CQAs and Mechanistic Process & Product Understanding: A Case Study - Ajit Narang, BMS

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