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, Bristol-Myers Squibb Company; Eli Lilly and Company; 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 audiovisual 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. SILVER PROGRAM PARTNERS Amgen Inc. Eli Lilly and Company SILVER PROGRAM PARTNER Bristol-Myers Squibb Company

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 08:30 Breakfast in R Yves Restaurant (Breakfast is included in the CMC Strategy Forum group sleeping room rate; other attendees / guests can pay individually for breakfast if they are not included in the group room rate) 07:30 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 Fred Jacobsen, Genentech, a Member of the Roche Group, USA 09:00 09:15 Management and Control of Raw Materials Annick Gervais, UCB Biopharma sprl, Belgium 09:15 09:30 Drug Device Combination Products Serge Mathonet, Sanofi Pasteur, France Medicines Adaptive Pathways to Patients (MAPPs) Initiative Workshop In the Forum Rooms E-J Session Chairs: Ronald Imhoff, Janssen Biologics BV and Karin Sewerin, MedImmune Limited (consultant) 09:30 09:45 Introduction to CMC Challenges and Opportunities for MAPPs / Accelerated Pathways Ronald Imhoff, Janssen Biologics BV, Netherlands 09:45 10:00 Use of Prior Knowledge: A Regulatory Agency Perspective Mats Welin, Medical Products Agency, Sweden 10:00 10:30 Networking Break in the Forum Foyer, Level 1

6 Monday, 9 May continued Use of Prior Knowledge Panel Presentations and Discussion In the Forum Rooms E-J Session Chairs: Ronald Imhoff, Janssen Biologics BV and Karin Sewerin, MedImmune Limited (consultant) 10:30 11:45 Panel Discussion Questions and Answers Ciro Cottini, Chiesi Pharmaceutici, Italy Earl Dye, Genentech, a Member of the Roche Group, USA Chana Fuchs, CDER, FDA, USA Alistair Kippen, IPSEN Biopharm Ltd., United Kingdom Mats Welin, Medical Products Agency, Sweden 10:30 10:55 Prior Knowledge in Drug Substance Process Validation Earl Dye, Genentech, a Member of the Roche Group, USA 10:55 11:20 Prior Knowledge in Establishing Control Strategy / Critical Quality Attributes Alistair Kippen, IPSEN Biopharm Ltd., United Kingdom 11:20 11:45 Drug Product Modeling in Scale-up and Transfer of Lyophilization Processes Ciro Cottini, Chiesi Pharmaceutici, Italy 11:45 12:00 Concluding Remarks Barbara Freischem, European Biopharmaceutical Enterprises (EBE), Belgium

7 Monday, 9 May continued CMC Strategy Forum Europe 2016 Scientific Program Summary 12:00 13:30 Buffet Lunch in Loft AD, Third Floor 13:00 17:00 Registration in the Forum Foyer, Level 1 13:30 13:45 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 13:45 14:00 TBD Pierre Demolis, ANSM-French Medicines Agency, France 14:00 14:15 TBD Pascal Venneugues, European Medicines Agency, United Kingdom 14:15 14:30 TBD Seán Barry, Health Products Regulatory Authority (HPRA), Ireland 14:30 14:45 TBD Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 14:45 15:00 Regulatory Update in Biopharmaceutical Products: FDA Perspective Sarah Kennett, CDER, FDA, USA 15:00 15:30 Networking Break in the Forum Foyer, Level 1 15:30 16:45 Panel Discussion Questions and Answers Seán Barry, Health Products Regulatory Authority (HPRA), Ireland Pierre Demolis, ANSM-French Medicines Agency, France 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

8 Monday, 9 May continued 16:45 17:00 Break 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. 17:00 17:05 Introduction 17:05 17:25 Continuous Process Verification: A Regulator s View Martijn van der Plas, College Medicines Evaluation Board (MEB), Netherlands 17:25 17:45 TBD Marcus Boyer, Bristol-Myers Squibb Company, USA 17:45 18:05 TBD Diane Wilkinson, Biogen Limited, United Kingdom 18:05 18:30 Panel Discussion Questions and Answers Marcus Boyer, Bristol-Myers Squibb Company, USA Niklas Ekman, Finnish Medicines Agency, Finland Martijn van der Plas, College Medicines Evaluation Board (MEB), Netherlands Diane Wilkinson, Biogen Limited, United Kingdom 18:30 Adjourn Day One Participants on their own

9 Tuesday, 10 May :30 08:45 Breakfast in R Yves Restaurant (Breakfast is included in the CMC Strategy Forum group sleeping room rate; other attendees / guests can pay individually for breakfast if they are not included in the group room rate) 08:00 17:00 Registration in the Forum Foyer, Level 1 08:45 09:00 Announcements by Jolanda Westerlaken, UCB Biopharma sprl 09:00 09:15 TBD - Introduction Anthony Ridgway, Health Canada, Canada 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 09:15 09:40 Will ICH Q12 Truly Go Beyond Q8/11? Opportunities and Challenges Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland 9:40 10:05 TBD Nanna Aaby Kruse, Danish Health and Medicines Authority, Denmark 10:05 10:30 TBD Christine Mitchell-Loegan, UCB Biopharma sprl, Belgium 10:30 10:55 TBD 11:00 11:30 Networking Break in the Forum Foyer, Level 1 11:30 12:45 Panel Discussion Questions and Answers Kowid Ho, F. Hoffmann-La Roche Ltd., Switzerland Nanna Aaby Kruse, Danish Health and Medicines Authority Christine Mitchell-Loegan, UCB Biopharma sprl, Belgium Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland TBD TBD 12:45 14:15 Buffet Lunch in Loft AD, Third Floor

10 Tuesday, 10 May continued 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 Anthony Ridgway, Health Canada 14:15 14:40 The Use of Comparability Protocols for Biologics: An Effective Tool to Managed Post-approval Changes Robin Levis, CBER, FDA, USA 14:40 15:05 Post-approval Safety Surveillance Studies to Support Biopharmaceutical Changes John Ayres, Eli Lilly and Company, USA 15:05 15:30 TBD Mats Welin, Medical Products Agency, Sweden 15:30 15:55 TBD 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 Mairead Duke, BioMarin Europe Ltd., United Kingdom Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Robin Levis, CBER, FDA, USA Mats Welin, Medical Products Agency, Sweden 17:45 Adjourn Day Two 18:30 23:00 Off-property Event

11 Wednesday, 1 May :30 08:45 Breakfast in R Yves Restaurant (Breakfast is included in the CMC Strategy Forum group sleeping room rate; other attendees / guests can pay individually for breakfast if they are not included in the group room rate) 08:30 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 Regulatory Challenges of Drug Device Combination Products in the EU Janine Jamieson, Medicines & Healthcare Products Regulatory Agency (MHRA), United Kingdom 09:30 09:55 Regulatory Challenges of Developing a Combination Product in a Globalised World An Industry Perspective Tim Chesworth, AstraZeneca, United Kingdom 09:55 10:20 TBD Dieter Schmalzing, Genentech, a Member of the Roche Group, USA 10:20 10:45 TBD Deborah Thomas, Sanofi, France Shayesteh Fürst Ladani - invited 10:45 11:15 Networking Break in the Forum Foyer, Level 1 11:15 12:30 Panel Discussion Questions and Answers Tim Chesworth, AstraZeneca, United Kingdom Janine Jamieson, Medicines & Healthcare Products Regulatory Agency (MHRA), United Kingdom Dieter Schmalzing, Genentech, a Member of the Roche Group, USA Deborah Thomas, Sanofi (invited) Shayesteh Fürst Ladani (invited) TBD 12:30 14:00 Buffet Lunch in Loft AD, Third Floor

12 Wednesday, 11 May continued Innovative Approaches: Tools and Technology Workshop Session Four in the Forum Rooms E-J Session Chairs: Emmanuelle Charton, EDQM, Council of Europe and Brendan Hughes, Bristol-Myers Squibb Company 14:00 14:05 Introduction 14:05 14:30 TBD Laurent Mallet, Sanofi Pasteur, France 14:30 14:55 TBD Jette Wypych, Amgen Inc., Thousand Oaks, CA USA 14:55 15:20 The Power of Data to Accelerate Development of Robust, Scalable Manufacturing Processes Susan Abu-Absi, Bristol-Myers Squibb Company, USA 15:20 15:45 TBD 15:45 16:15 Networking Break in the Forum Foyer, Level 1 16:15 17:30 Panel Discussion Questions and Answers Susan Abu-Absi, Bristol-Myers Squibb Company, USA Brigitte Brake, Federal Institute for Drugs and Medical Devices (BfArM), Germany Robin Levis, CBER, FDA, USA Laurent Mallet, Sanofi Pasteur, France Jette Wypych, Amgen Inc., USA TBD 17:30 17:45 Closing Remarks and Invitation to CMC Strategy Forum Europe 2017 Alistair Kippen, IPSEN Biopharm Ltd. 17:45 Adjournment

13 EBE Satellite Session