Welcome to the CMC Strategy Forum Europe 2010: Challenges Facing Biopharmaceutical Development in the Next Decade

Transcription

1 Welcome to the CMC Strategy Forum Europe 2010: Challenges Facing Biopharmaceutical Development in the Next Decade The fourth annual CMC Strategy Forum Europe, organized by CASSS, An International Separation Science Society, offers a unique blend of topics that characterize the challenges facing the biotechnology industry in the next decade. A series of plenary sessions and workshops will enable attendees to participate in discussions that will help shape future directions in biopharmaceutical development. Topical plenary presentations and interactive workshops involving experts from global regulatory agencies, academia, and industry will include: Immunogenicity assessment of monoclonal antibodies for in vivo clinical use Managing biopharmaceutical drug product formulation changes Quality documentation for biologic IMPs in clinical trials Assessing comparability after changes to primary packaging and devices for biopharmaceutical products CMC challenges facing vaccine development Evolving approaches to Quality by Design Professionals from the following functional areas are encouraged to actively engage in these important discussions: Process / Product Development Molecular and Cell Biology Quality Assurance / Quality Control Analytical Development Regulatory Affairs Manufacturing Sciences Immunology Clinical Pharmacology Forum Co-Chairs: Ilona Reischl, AGESPharmMed, Austria Karin Sewerin, BioPharmaLinx AB, Sweden Scientific Organizing Committee: Brigitte Brake, BfArM, Federal Institute for Drugs and Medical Devices, Germany John Dougherty, Eli Lilly and Company, USA (PAC Liaison) Kowid Ho, AFSSAPS, France Brendan Hughes, Pfizer Global Manufacturing, Ireland Christopher Joneckis, CBER, FDA, USA Anneke Koole, Schering-Plough Corporation, The Netherlands Inger Mollerup, Novo Nordisk A/S, Denmark Gene Murano, BioScope Associates, USA Wassim Nashabeh, Genentech, A Member of the Roche Group, USA (PAC Liaison) Ilona Reischl, AGES PharmMed, Austria Martin Schiestl, Sandoz GmbH, Austria Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Karin Sewerin, BioPharmaLynx AB, Sweden Lance Smallshaw, Eli Lilly and Company Ltd., United Kingdom Keith Webber, CDER, FDA, USA Mats Welin, Medical Products Agency, Sweden Hannelore Willkommen, RBS-Consulting, Germany

2 The Scientific Organizing Committee gratefully acknowledges the program partners for their generous support of the CMC Strategy Forum Europe GOLD PROGRAM PARTNERS Biogen Idec Inc. Eli Lilly and Company F. Hoffmann-La Roche AG (Ltd.) Genentech, A Member of the Roche Group MedImmune Novartis Pharma AG SILVER PROGRAM PARTNER Pfizer, Inc. FRIEND OF CASSS PROGRAM PARTNER Novo Nordisk A/S MEDIA PARTNERS BioPharm BioProcess International

3 CMC Strategy Forum Europe 2010 Scientific Program Summary Tuesday, 25 May :00 18:00 Registration in the Grosses Foyer 12:00 13:00 Hosted Lunch in the Grosses Foyer 13:00 13:15 Introduction / Welcome to the 4 th European CMC Strategy Forum Wassim Nashabeh, Genentech, A Member of the Roche Group, USA European Regulatory and IMPD Update Plenary Session in Reitschule Session Chairs: Ilona Reischl, AGES PharmMed and Karin Sewerin, BioPharmaLinx AB 13:15 13:40 Welcome and Brief Overview of Clinical Trials in Austria Marcus Müllner, Austrian Medicines and Medical Devices Agency, Austria 13:40 14:05 Overview of Perceived Regulatory Challenges Over the Next 5-10 Years John Purves, European Medicines Agency, United Kingdom 14:05 14:30 Guidelines on the Quality Requirements for Biological Investigational Medicinal Products Challenges and Progress: An Update Brigitte Brake, BfArM, Federal Institute for Drugs and Medical Devices, Germany 14:30 15:00 Panel Discussion Questions and Answers 15:00 15:30 PM Break in the Grosses Foyer Evolution of Process Understanding and Control for Vaccine Manufacturing Workshop Session One in Reitschule Session Chair: Brendan Hughes, Pfizer Global Manufacturing 15:30 15:50 An Introduction to Vaccines and Their Quality Control Methods Roland Dobbelaer, Independent Vaccine Expert, Belgium 15:50 16:10 Recent Developments in the Field of Vaccines Mats Welin, Medical Products Agency, Sweden 16:10 16:30 Merging of Process and Analytical Control Strategies for Complex Vaccines Paul Rohlfing, Pfizer Global Manufacturing, USA 16:30 16:50 Vaccines Based on Recombinant Proteins and Adjuvant Systems: GSK's Malaria Vaccine Candidate as a Case Study Marie-Chantal Uwamwezi, GlaxoSmithKline Biologicals, Belgium

4 16:50 17:00 Mini Break Tuesday, 25 May continued Open Forum Panel Discussion: Workshop Session One: Evolution of Process Understanding and Control for Vaccine Manufacturing In Reitschule Session Chairs: Brendan Hughes, Pfizer Global Manufacturing and Martin Schiestl, Sandoz GmbH 17:00 18:15 Panel Discussion Questions and Answers Roland Dobbelaer, Belgium Philip Krause, CBER, FDA, USA Paul Rohlfing, Pfizer Global Manufacturing, USA Marie-Chantal Uwamwezi, GlaxoSmithKline Biologicals, Belgium Mats Welin, Medical Products Agency, Sweden 18:15 19:30 Welcome Reception in the Renaissance Garden Club (weather permitting) Back-up: Grosses Foyer

5 Wednesday, 26 May :30 09:00 Buffet Breakfast in the Restaurant Borromäus 06:30 11:00 Buffet Breakfast in the Restaurant Borromäus (for accompanying guests) 08:30 17:00 Registration in the Grosses Foyer 09:00 09:15 Announcements by Ilona Reischl, AGES PharmMed, Austria Immunogenicity for Therapeutic Proteins: Key CMC Considerations Plenary Session in Reitschule Session Chairs: Inger Mollerup, Novo Nordisk A/S OK and Wassim Nashabeh, Genentech, A Member of the Roche Group 09:15 09:40 European Guidance for the Assessment of Unwanted Immunogenicity of Biologicals: An Update Robin Thorpe, National Institute for Biological Standards and Control, United Kingdom 09:40 10:05 Post-translational Modifications of Therapeutic Proteins: An Immunologic Perspective Amy Rosenberg, CDER, FDA, USA 10:05 10:30 Immunogenicity of Monoclonal Antibodies An Industry Perspective Anna-Maija Autere, Roche Products Limited, United Kingdom 10:30 11:00 AM Break in the Grosses Foyer 11:00 12:00 Panel Discussion Questions and Answers 12:00 13:30 Hosted Lunch in the Restaurant Borromäus Drug Product Formulation Changes Workshop Session Two in Reitschule Session Chairs: Thomas Schreitmüller, F. Hoffmann-La Roche Ltd. and Pierrette Zorzi, AFSSAPS 13:30 14:00 Scope and Limits of Preclinical Safety- and/or PK/PD Studies in the Context of DP-Formulation Changes Bernd Müller-Beckmann, Roche Diagnostics GmbH, Germany 14:00 14:30 Case Studies for Comparability Following Formulation Changes Early in Development Kimberly May, Merck & Co., Inc., USA 14:30 15:00 Challenges Assuring Comparability for Formulation Changes: A Lifecycle Approach Jason Hampson, Amgen Ltd., United Kingdom

6 Wednesday, 26 May continued 15:00 15:30 PM Break in the Grosses Foyer Open Forum Panel Discussion: Workshop Session Two: Drug Product Formulation Changes In Reitschule Session Chairs: Thomas Schreitmüller, F. Hoffmann-La Roche Ltd. and Pierrette Zorzi, AFSSAPS 15:30 17:00 Panel Discussion Questions and Answers Barry Cherney, CDER, FDA, USA Jason Hampson, Amgen Ltd., United Kingdom Kimberly May, Merck & Co., Inc., USA Bruce Meiklejohn, Eli Lilly and Company, USA Bernd Müller-Beckmann, Roche Diagnostics GmbH, Germany 18:00 22:00 Networking Reception at Heuriger Zum Martin Sepp Transportation will be provided

7 Thursday, 27 May :30 08:45 Buffet Breakfast in the Restaurant Borromäus 06:30 11:00 Buffet Breakfast in the Restaurant Borromäus (for accompanying guests) 08:30 17:00 Registration in the Grosses Foyer 08:45 09:00 Announcements by Karin Sewerin, BioPharmaLynx AB, Sweden Drug Product Primary Packaging / Device Changes Workshop Session Three in Reitschule Session Chairs: Cornelia Lipperheide, BfArM, Federal Institute for Drugs and Medical Devices and Stacey Ma, Genentech, A Member of the Roche Group 09:00 09:25 TBA 09:25 09:50 Biologicals and Primary Container Compatibility A View From a Regulator Martijn van der Plas, Centre for Biological Medicines and Medical Technology, RIVM, The Netherlands 09:50 10:15 Primary Packaging Change: Switch From a Lyophilisate in Vial to a Lyophilisate in Double Chamber Cartridge Christoph Stark, Novartis Pharma AG, Switzerland 10:15 10:40 Devices for Delivery and Dosing of Drug Products - Safety and Performance Kirsten Nielsen Tallerup, Novo Nordisk A/S, Denmark 10:45 11:15 AM Break in the Grosses Foyer Open Forum Panel Discussion: Workshop Session Three: Drug Product Primary Packaging / Device Changes In Reitschule Session Chairs: Cornelia Lipperheide, BfArM, Federal Institute for Drugs and Medical Devices and Stacey Ma, Genentech, A Member of the Roche Group 11:15 12:30 Panel Discussion Questions and Answers Dov Pluznik, CDER, FDA, USA Anna Karin Rehnström, Medical Products Agency, Sweden Christoph Starck, Novartis Pharma AG, Switzerland Kirsten Nielsen Tallerup, Novo Nordisk A/S. Denmark Martijn van der Plas, RIVM, The Netherlands 12:30 14:00 Hosted Lunch in the Restaurant Borromäus

8 Thursday, 27 May continued Quality by Design: Challenges in Establishing and Maintaining a Design Space Plenary Session in Reitschule Session Chairs: John Dougherty, Eli Lilly and Company and Peter Richardson, European Medicines Agency 14:00 14:25 Implementation of Quality by Design for Biotechnology Products: The Design Space Steven Kozlowski, CDER, FDA, USA 14:25 14:50 Design Space for Biologics: An EU Perspective Kowid Ho, AFSSAPS, France 14:50 15:15 Upstream Process Development Using a QbD Approach: Proposal for Design Space Victor Vinci, Eli Lilly and Company, USA 15:15 15:45 PM Break in the Grosses Foyer 15:45 16:10 EFPIA Mock S.2 (Biotech): QbD-associated Data in a CTD Dossier and Lifecycle Implications Stefanie Pluschkell, Pfizer, Inc., USA Open Forum Panel Discussion: Plenary Session: Quality by Design: Challenges in Establishing and Maintaining a Design Space In Reitschule Session Chairs: John Dougherty, Eli Lilly and Company and Peter Richardson, European Medicines Agency OK 16:15 17:00 Panel Discussion Questions and Answers Jason Hampson, Amgen Ltd., United Kingdom Kowid Ho, AFSSAPS, France Steven Kozlowski, CDER, FDA, USA Stefanie Pluschkell, Pfizer, Inc., USA Victor Vinci, Eli Lilly and Company, USA 17:00 17:30 Session Discussion Recap Evolution of Process Understanding and Control for Vaccine Manufacturing Drug Product Formulation Changes Drug Product Primary Packaging / Device Changes Quality by Design: Challenges in Establishing and Maintaining a Design Space 17:30 17:45 Closing Remarks and Invitation to CMC Strategy Forum Europe 2011 John Dougherty, Eli Lilly and Company, USA March 2011, Ritz-Carlton Hotel Arts, Barcelona, Spain 17:45 Adjournment