Welcome to CMC Strategy Forum Japan 2015

Transcription

1 Welcome to CMC Strategy Forum 2015 On behalf of the CASSS Board of Directors and the CMC Strategy Forum Global Steering Committee, we would like to extend to you a warm welcome to the second meeting of the CMC Strategy Forum We are very pleased that with the strong support from the Pharmaceuticals and Medical Devices Agency (PMDA ), as well as the Pharmaceutical Manufacturers Association (JPMA), and with the continued organization by CASSS and the support from the United States Food and Drug Administration, that we are continuing with the CMC Strategy Forum The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for and Asia and will feature an opening regulatory session that will include presentations from PMDA, FDA, EMA, Health Canada, as well as Asian health authorities. The technical sessions will include discussions on the development of biosimilars, an overview of ICH Q12, specifically established conditions and post-approval change management protocols. The success of the CMC Strategy Forum will depend on your active participation in discussing and raising issues pertaining to the development of biologics. We encourage you to participate wholeheartedly in the panel discussions that have been designed to stimulate exchange of ideas and information. We would like to thank the speakers and the panel members who are giving generously of their time and resources and to you for your attendance. We would also like to acknowledge the generosity of our program partners for the continued support of the Forum series.

2 ACKNOWLEDGEMENTS JAPAN SCIENTIFIC ORGANIZING COMMITTEE: Ayako Enokida, Pharmaceuticals and Medical Devices Agency (PMDA) Futaba Honda, Pharmaceuticals and Medical Devices Agency (PMDA) Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA) Junichi Koga, Daiichi Sankyo Co., Ltd. In Eui Lee, Chugai Pharmaceutical Co., Ltd. Noriyuki Matsumoto, Pharmaceutical Manufacturers Association (JPMA) (Secretariat) Yuuki Miyatake, Teijin Pharma Ltd. Kei Nishimura, UCB Co., Ltd. Hisako Ohnishi, Pharmaceutical Manufacturers Association (JPMA) (Secretariat) Daisaku Sato, Pharmaceuticals and Medical Devices Agency (PMDA) Yasushi Shikata, Eisai Co., Ltd. Kazuhisa Uchida, Kyowa Hakko Kirin Co., Ltd. Masatoshi Yamada, Nippon Kayaku Co., Ltd. Reiko Yanagihara, Pharmaceuticals and Medical Devices Agency (PMDA) CMC STRATEGY FORUM GLOBAL STEERING COMMITTEE Siddharth Advant, KemWell Biopharma, USA John Dougherty, Eli Lilly and Company, USA Steven Kozlowski, CDER, FDA, USA Junichi Koga, Daiichi Sankyo Co., Ltd., Rohin Mhatre, Biogen, USA Anthony Mire-Sluis, Amgen Inc., USA Marcelo Moreira, ANVISA-Brasilian National Health Surveillance Agency, Brasil Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland (Chair) Ilona Reischl, AGES-Austrian Medicines and Medical Devices Agency, Austria Anthony Ridgway, Health Canada, Canada Nadine Ritter, Global Biotech Experts, LLC, USA Daisaku Sato, PMDA-Pharmaceutical and Medical Devices Agency, 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 pharmaceutical and biotechnology industry for their generous support of the CMC Strategy Forum SUSTAINING DIAMOND PROGRAM PARTNER F. Hoffmann La Roche Ltd. SUSTAINING PLATINUM PROGRAM PARTNER AbbVie, Inc. MedImmune, A member of the AstraZeneca Group FORUM PROGRAM PARTNERS

4 LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality MEDIA PARTNERS The Analytical Scientist BioProcessing Journal Genetic Engineering & Biotechnology News The Medicine Maker The Pathologist separationsnow.com Technology Networks Limited

5 CMC Strategy Forum 2015 Scientific Program Summary Monday, 9 November :30 08:45 Buffet Breakfast for all CMC registered guests of the Tokyo Marriott Hotel in the Dining Grill (Lobby Level) 07:00 09:15 Coffee Service in the South Ballroom Foyer 07:15 17:00 Registration in the South Ballroom Foyer 08:45 09:15 CASSS Welcome and Introductory Comments in the South Ballroom Wassim Nashabeh, Genentech, a Member of the Roche Group CMC Strategy Forum 2015 Welcome and Introductory Comments in the South Ballroom Tetsuo Nagano, Pharmaceuticals and Medical Devices Agency (PMDA), Recent Trends in the Regulation of Biopharmaceutical Products Plenary Session in the South Ballroom Session Chairs: Futaba Honda, Pharmaceuticals and Medical Devices Agency (PMDA) and Anthony Ridgway, Health Canada 09:15 09:45 PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals Daisaku Sato, Pharmaceuticals and Medical Devices Agency (PMDA), 09:45 10:15 FDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals Susan Kirshner, CDER, FDA, USA 10:15 10:45 TBD TBD 10:45 11:15 AM Break in the South Ballroom Foyer 11:15 11:45 Indonesian and ASEAN Perspectives: Recent Trends in the Regulation of Biopharmaceuticals Roy Sparringa, National Agency of Drug and Food Control (NADFC), Indonesia 11:45 12:15 Thailand Perspectives: Recent Trends in the Regulation of Biopharmaceuticals Piyanan Boonprasirt, Bureau of Drug Control, Thai FDA, Thailand

6 Monday, 9 November continued 12:15 13:00 Korean and APEC Perspectives: Recent Trends in the Regulation of Biopharmaceuticals Jeewon Joung, Ministry of Food and Drug Safety (MFDS), Korea NOTE: Jeewon Joung will join the session via teleconference. The time allotted for this presentation also includes 15 minutes for questions and answers. 13:00 14:15 Buffet Lunch in the Iris/Camellia Room 14:15 15:30 Panel Discussion Questions and Answers Piyanan Boonprasirt, Bureau of Drug Control, Thai FDA, Thailand Susan Kirshner, CDER, FDA, USA Daisaku Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Roy Sparringa, National Agency of Drug and Food Control (NADFC), Indonesia 15:30 16:00 PM Break in the South Ballroom Foyer Development of Biosimilars: Technical Aspects Workshop Session in the South Ballroom Session Chairs: Teruyo Arato, Hokkaido University and Kazuhisa Uchida, Kyowa Hakko Kirin Co., Ltd. 16:00 16:10 Introduction 16:10 16:35 Development of Infliximab Biosimilar in Masatoshi Yamada, Nippon Kayaku Co., Ltd., 16:35 17:00 TBD Niklas Ekman, Finnish Medicines Agency, Finland (invited) 17:00 17:25 TBD Jennifer Liu, Amgen Inc., USA 17:30 18:30 Panel Discussion - Questions and Answers Piyanan Boonprasirt, Bureau of Drug Control, Thai FDA, Thailand Niklas Ekman, Finnish Medicines Agency, Finland (invited) Susan Kirshner, CDER, FDA Jennifer Liu, Amgen Inc., USA Kenji Sawanobori, Pharmaceuticals and Medical Devices Agency (PMDA), Masatoshi Yamada, Nippon Kayaku Co., Ltd., 18:30 20:00 Networking Reception in the Iris/Camellia Room 20:00 Adjourn Day One

7 Tuesday, 10 November :30 08:45 Buffet Breakfast for all CMC registered guests of the Tokyo Marriott Hotel in the Dining Grill (Lobby Level) 07:30 09:15 Coffee Service in the South Ballroom Foyer 08:00 17:00 Registration in the South Ballroom Foyer ICH Q12 Overview: Established Conditions / Approved Matters Workshop Session in the South Ballroom Session Chairs: Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA) and Wassim Nashabeh, F. Hoffmann-La Roche Ltd. 09:00 09:10 Introduction 09:10 09:35 ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), 09:35 10:00 New Drug Application (Biologics) in : CTD Submission Related to CMC Part Takao Kojima, Takeda Pharmaceutical Co., Ltd., 10:00 10:25 J-Module 1 Preparation (CMC): Model Document for Manufacturing Process Description Kei Nishimura, UCB Co., Ltd., 10:25 10:50 Application Form in Reiko Yanagihara, Pharmaceuticals and Medical Devices Agency (PMDA), 10:50 11:15 AM Break in the South Ballroom Foyer 11:15 12:15 Panel Discussion - Questions and Answers Susan Kirshner, CDER, FDA, USA Takao Kojima, Takeda Pharmaceutical Co., Ltd., Kei Nishimura, UCB Co., Ltd., Anthony Ridgway, Health Canada, Canada Reiko Yanagihara, Pharmaceuticals and Medical Devices Agency (PMDA), 12:15 13:30 Buffet Lunch in the Camellia and Garden View Rooms

8 Tuesday, 10 November continued ICH Q12 Overview: Post-approval Change Management Protocol (PACMP) Workshop Session in the South Ballroom Session Chairs: Junichi Koga, Daiichi Sankyo Co., Ltd. and Helena Madden, Biogen 13:30 13:40 Introduction 13:40 14:05 Regulatory Perspective on Comparability Protocols in Biologics: A Tool to Effectively Manage Post-approval Changes Ingrid Markovic, CBER, FDA, USA 14:05 14:30 Post-approval Change Management Protocols - Current Status and Next Steps on the Way towards a Global Tool Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland 14:30 14:55 Industry Perspective: Current Status of Global Change Control Management Tetsuya Kawakami, Chugai Pharmaceutical Co., Ltd., 15:00 15:30 PM Break in the South Ballroom Foyer 15:30 16:30 Panel Discussion Questions and Answers Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland Tetsuya Kawakami, Chugai Pharmaceutical Co., Ltd., Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Ingrid Markovic, CBER, FDA, USA TBD 16:30 17:00 Recap of Program Summary Slide Presentation Nadine Ritter, Global Biotech Experts, LLC 17:00 17:15 Closing Remarks Wassim Nashabeh, F. Hoffmann-La Roche Ltd. 17:15 Adjournment