Welcome to the CMC Strategy Forum Europe 2016

Transcription

1 Welcome to the CMC Strategy Forum Europe 2016 The 10 th annual CMC Strategy Forum Europe, organized by CASSS, will explore a number of critical topics focused on improving the quality in development and manufacturing of biopharmaceutical products. A series of plenary sessions and workshops led by experts from global regulatory agencies, academia and industry seek to explore emerging aspects of CMC technology and regulation in areas where existing modalities and systems are undergoing change. Topics will include: Regulatory Update from Around the World; ICH Q12 Update: Established Conditions / Approved Matters; The Evolution of Post-approval Change Protocols in Biopharmaceutical Lifecycle Management; Innovative Approaches: Tools and Technology; Regulatory and Scientific Challenges of Combination Product Development and Leveraging Continuous Process Verification to Facilitate Faster Patient Access. The EBE session will present updates on the following concept papers: Antibody Drug Conjugates; Management and Control of Raw Materials; Drug Device Combination Products, as well as the workshop topic Medicines Adaptive Pathways to Patients Initiative. The CMC Strategy Forum is designed to maximize dialog between participants. Presentations are relatively short and focused and set the agenda for the panel discussions to engage all the participants who have experience and expertise to share. It should be important for you to attend this event as we come together to discuss important issues on how to ensure product safety and efficacy for the patients we serve. We would like to thank the speakers and panel members who are giving generously of their time and resources, and to you, for your attendance. We acknowledge the generosity of our program partners: AbbVie, Inc.; Amgen Inc.; Biogen, F. Hoffmann-La Roche Ltd.; MedImmune, A member of the AstraZeneca Group; Merck & Co., Inc.; Novo Nordisk A/S and Pfizer, Inc. We are grateful for the expert management from CASSS and the audio-visual expertise of Michael Johnston from JM Audio-Visual Productions. Their experience and guidance in the preparation of this Forum has been invaluable.

2 ACKNOWLEDGEMENTS CMC STRATEGY FORM EUROPE PROGRAM COMMITTEE Brigitte Brake, Federal Institute for Drugs and Medical Devices (BfArM), Germany Emmanuelle Charton, EDQM, Council of Europe, France Brian Corrigan, Pfizer Ireland Pharmaceuticals Limited, Ireland John Dougherty, Eli Lilly and Company, USA Niklas Ekman, Finnish Medicines Agency, Finland Chana Fuchs, CDER, FDA, USA Ralf Gleixner, Merck Serono, Switzerland Kowid Ho, F. Hoffmann-La Roche Ltd., Switzerland Brendan Hughes, Bristol-Myers Squibb Company, USA Ronald Imhoff, Janssen Biologics BV, Netherlands Alistair Kippen, IPSEN Biopharm Ltd., United Kingdom (Co-chair) Nanna Aaby Kruse, Danish Health and Medicines Authority, Denmark (Co-chair) Ingrid Markovic, CBER, FDA, USA Serge Mathonet, Sanofi Pasteur, France Jens Bjørn Nielsen, Novo Nordisk A/S, Denmark Ilona Reischl, AGES-Austrian Agency for Health and Food Safety, Austria Mark Schenerman, MedImmune, A member of the AstraZeneca Group, USA Martin Schiestl, Sandoz Biopharmaceuticals, Austria Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Karin Sewerin, BioTech Development AB, Sweden Lance Smallshaw, UCB Biopharma sprl, Belgium Jolanda Westerlaken, UCB Pharma sprl, Canada (Co-chair) Pierrette Zorzi, Consultant, France CMC STRATEGY FORUM GLOBAL STEERING COMMITTEE Siddharth Advant, KemWell Biopharma, USA Daniela Cerqueria, ANVISA-Brasilian National Health Surveillance Agency, Brasil John Dougherty, Eli Lilly and Company, USA Steven Kozlowski, CDER, FDA, USA Junichi Koga, Daiichi Sankyo Co., Ltd., Japan Rohin Mhatre, Biogen, USA Anthony Mire-Sluis, Amgen Inc., USA Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland (Chair) Ilona Reischl, AGES-Austrian Agency for Health and Food Safety, Austria Anthony Ridgway, Health Canada, Canada Nadine Ritter, Global Biotech Experts, LLC, USA Daisaku Sato, PMDA-Pharmaceutical and Medical Devices Agency, Japan Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Mark Schenerman, MedImmune, A member of the AstraZeneca Group, USA Karin Sewerin, BioTech Development AB, Sweden

3 The Scientific Organizing Committee gratefully acknowledges the program partners for their generous support of the CMC Strategy Forum Europe SUSTAINING DIAMOND PROGRAM PARTNER F. Hoffmann-La Roche Ltd. SUSTAINING PLATINUM PROGRAM PARTNERS AbbVie, Inc. Biogen MedImmune, A member of the AstraZeneca Group SUSTAINING GOLD PROGRAM PARTNERS Novo Nordisk A/S Pfizer, Inc. SUSTAINING SILVER PROGRAM PARTNER Merck & Co., Inc. BRONZE PROGRAM PARTNERS Bristol-Myers Squibb Company UCB Pharma srl FRIEND of CASSS PROGRAM PARTNER

4 The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of the CMC Strategy Forum Europe series. LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality MEDIA PARTNERS The Analytical Scientist BioProcessing Journal Chemical Communications Chemical Society / Chemical Society Reviews Genetic Engineering & Biotechnology News The Medicine Maker The Pathologist separationsnow.com Technology Networks

5 European Biopharmaceutical Enterprises (EBE) Satellite Session Monday, 9 May :30 12:00 Registration in the Forum Foyer, Level 1 08:30 08:45 Welcome and Introduction to the European Biopharmaceutical Enterprises (EBE) Ongoing Activities and Initiatives in the Forum Rooms E-J Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland Concept Paper 2016 Update: New Initiatives In the Forum Rooms E-J Session Chairs: Ronald Imhoff, Janssen Biologics BV and Karin Sewerin, MedImmune Limited (consultant) 08:45 09:00 Antibody Drug Conjugates Ursula 09:00 09:15 Management and Control of Raw Materials Lionel 09:15 09:30 Drug Device Combination Products Serge Mathonet, Sanofi Pasteur, France Medicines adaptive Pathways to Patients Initiative Workshop In the Forum Rooms E-J Session Chairs: Ronald Imhoff, Janssen Biologics BV and Karin Sewerin, MedImmune Limited (consultant) 09:30 10:00 CMC Challenges and Considerations Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland 10:00 10:30 Networking Break in the Forum Foyer, Level 1 10:30 10:45 Case Study 1: 10:45 11:00 Case Study 2:

6 Monday, 9 May continued 11:00 11:45 Panel Discussion Questions and Answers Presenter #1 Presenter #2 Chana Fuchs, CDER, FDA, USA Mats Welin, Medical Products Agency, Sweden 11:45 12:00 Concluding Remarks Piers Allin, European Biopharmaceutical Enterprises (EBE), Belgium

7 12:00 13:15 Buffet Lunch in Monday, 9 May continued CMC Strategy Forum Europe 2016 Scientific Program Summary 13:00 17:00 Registration in the Forum Foyer, Level 1 13:15 13:30 CASSS Welcome and Introductory Comments in the Forum Rooms E-J Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Introduction / Welcome to the 10 th European CMC Strategy Forum Jolanda Westerlaken, UCB Pharma sprl, Canada Regulatory Updates from Around the World Plenary Session in the Forum Rooms E-J Session Chairs: Nanna Aaby Kruse, Danish Health and Medicines Authority and Jolanda Westerlaken, UCB Pharma srl 13:30 13:50 Someone from the French RA 13:50 14:10 Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 14:10 14:30 Seán Barry, Health Products Regulatory Authority (HPRA), Ireland 14:30 14:50 Sarah Kennett, CDER, FDA, USA 15:00 16:15 Panel Discussion Questions and Answers Seán Barry, Health Products Regulatory Authority (HPRA), Ireland Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Sarah Kennett, CDER, FDA, USA Robin Levis, CBER, FDA, USA Anthony Ridgway, Health Canada, Canada Pascal Venneugues, European Medicines Agency, United Kingdom French RA 16:15 16:45 Networking Break in the Forum Foyer, Level 1

8 Monday, 9 May continued Leveraging Continuous Process Verification to Facilitate Faster Patient Access Update Session in the Forum Rooms E-J Session Chairs: Ralf Gleixner, Merck Serono and Jason Hampson, Amgen Inc. 16:45 17:00 17:00 17:15 17:15 17:30 17:30 18:30 Panel Discussion Questions and Answers 18:30 Adjourn Day One Participants on their own

9 Tuesday, 10 May :00 17:00 Registration in the Forum Foyer, Level 1 08:45 09:00 Announcements by Jolanda Westerlaken, UCB Biopharma sprl ICH Q12 Update: Established Conditions / Approved Matters Workshop Session One in the Forum Rooms E-J Session Chairs: Brian Corrigan, Pfizer Ireland Pharmaceuticals Limited and Ronald Imhoff, Janssen Biologics BV 09:00 09:05 Introduction 09:05 09:30 Nanna Aaby Kruse, Danish Health and Medicines Authority 09:30 09:55 09:55 10:20 10:20 10:45 10:45 11:15 Networking Break in the Forum Foyer, Level 1 11:15 12:30 Panel Discussion Questions and Answers Nanna Aaby Kruse, Danish Health and Medicines Authority 12:30 13:45 Buffet Lunch in The Evolution of Post-approval Change Protocols in Biopharmaceutical Lifecycle Management Workshop Session Two in the Forum Rooms E-J Session Chairs: John Dougherty, Eli Lilly and Company and Kowid Ho, F. Hoffmann-La Roche Ltd. 13:45 13:50 Introduction 13:50 14:15 Robin Levis, CBER, FDA, USA

10 Tuesday, 10 May continued 14:15 14:40 John Ayres, Eli Lilly and Company, USA 14:40 15:05 15:05 15:55 Anthony Ridgway, Health Canada, Canada 16:00 16:30 Networking Break in the Forum Foyer, Level 1 16:30 17:45 Panel Discussion Questions and Answers John Ayres, Eli Lilly and Company, USA Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Robin Levis, CBER, FDA, USA Anthony Ridgway, Health Canada, Canada Mats Welin, Medical Products Agency, Sweden 17:45 Adjourn Day Two 18:30 23:00 Off-property Event

11 Wednesday, 1 May :30 17:00 Registration in the Forum Foyer, Level 1 08:45 09:00 Announcements by Alistair Kippen, IPSEN Biopharm Ltd. Regulatory and Scientific Challenges of Combination Product Development Workshop Session Three in the Forum Rooms E-J Session Chairs: Chana Fuchs, CDER, FDA and Ilona Reischl, AGES-Austrian Agency for Health and Food Safety 09:00 09:05 Introduction 09:05 09:30 09:30 09:55 09:55 10:20 10:20 10:45 10:45 11:15 Networking Break in the Forum Foyer, Level 1 11:15 12:30 Panel Discussion Questions and Answers 12:30 13:45 Buffet Lunch in the Innovative Approaches: Tools and Technology Workshop Session Four in the Forum Rooms E-J Session Chairs: Emanuelle Charton, EDQM, Council of Europe and Brendan Hughes, Bristol-Myers Squibb Company 13:45 13:50 Introduction 13:50 14:15 Laurent Mallet, Sanofi Pasteur, France

12 14:15 14:40 Someone from Amgen 14:40 15:05 Wednesday, 11 May continued 15:05 15:30 15:30 16:00 Networking Break in the Forum Foyer, Level 1 16:00 17:15 Panel Discussion Questions and Answers Laurent Mallet, Sanofi Pasteur, France Someone from Amgen 17:15 17:30 Closing Remarks and Invitation to CMC Strategy Forum Europe 2017 Alistair Kippen, IPSEN Biopharm Ltd. 17:30 Adjournment

13 EBE Satellite Session