JAPAN 2020
7-8 December 2020 Virtual Program Agenda
Organized by
Welcome to CMC Strategy Forum Japan 2020
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 eighth meeting of the CMC Strategy Forum Japan 2020.
We are very pleased that with the strong support from the Pharmaceuticals and Medical Devices Agency (PMDA Japan), as well as the Japan 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 Japan 2020. Due to the current situation with COVID-19 (also known as coronavirus) outbreak, this forum will now take place virtually. Each session will still include live speaker presentations and panel discussions. This means that you will have the opportunity to login and view each session, ask questions of the speakers and panel members, as well as interact with other attendees.
Workshop session one “Recent Trends in the Regulation of Biopharmaceutical Products” will be held on Monday, 7 December 2020 starting at 9:00 am Japan Standard Time (JST). Topics that will be discussed are: how communications being handled between the Sponsor and each Health Authority during COVID- 19; what are the options for accelerated CMC development of prophylaxis / treatment of COVID-19; and what are the regulatory opportunities and challenges when new modalities are utilized.
Workshop session two “Implementation of ICH Q12 – Where Are We in Japan and Globally? will be held on Tuesday, 8 December 2020 starting at 9:00 am Japan Standard Time (JST). Topics that will be discussed include: a case study of the Japan PACMP pilot program for a biotech product will be introduced, as well as the PACMP mock-up document prepared by the Japan Agency for Medical Research and Development (AMED) PACMP working group.
The success of the CMC Strategy Forum Japan will depend on your active participation in discussing and raising issues pertaining to the development of biologics. We encourage you to participate whole- heartedly 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: Biogen; Chugai Pharmaceutical Co., Ltd.; F. Hoffmann-La Roche Ltd.; Kyowa Kirin Co., Ltd.; Merck Research Laboratories; Nippon Kayaku Co., Ltd.; Sumitomo Dainippon Pharma Co., Ltd. and Takeda Pharmaceutical Company Limited. We are grateful for the expert management from CASSS and the audio-visual expertise of Michael Johnstone from MJ Audio-Visual Productions. Their experience and guidance in the preparation of this Forum has been invaluable.
ACKNOWLEDGEMENTS
JAPAN SCIENTIFIC ORGANIZING COMMITTEE: Hirotomo Akabane, Meiji Seika Pharma Co., Ltd. Futaba Honda, PMDA-Pharmaceuticals and Medical Devices Agency Norifuni Itoh, JPMA-Japan Pharmaceutical Manufacturers Association (Secretariat) Junichi Koga, Daiichi Sankyo Co., Ltd. Yoshinori Kubodera, Chugai Pharmaceutical Co., Ltd. Nao Nakamura, Sumitomo Dainippon Pharma Co., Ltd. Ryoko Naruse, PMDA-Pharmaceuticals and Medical Devices Agency Hisako Ohnishi, JPMA-Japan Pharmaceutical Manufacturers Association (Secretariat) Shinichi Okudaira, PMDA-Pharmaceuticals and Medical Devices Agency Kyoko Sakurai, PMDA-Pharmaceuticals and Medical Devices Agency Makoto Shinozaki, Sanofi K.K. Kazuhisa Uchida, Kyowa Kirin Co., Ltd. Masatoshi Yamada, Nippon Kayaku Co., Ltd.
CMC STRATEGY FORUM GLOBAL STEERING COMMITTEE Daniela Cerqueira, ANVISA-Brasilian National Health Surveillance Agency, Brasil Yasuhiro Kishioka, PMDA-Pharmaceuticals and Medical Devices Agency, Japan Junichi Koga, Daiichi Sankyo Co., Ltd., Japan Steven Kozlowski, CDER, FDA, USA Rohin Mhatre, Biogen, USA Wassim Nashabeh, F. Hoffmann-La Roche Ltd., USA (Chair) Ilona Reischl, BASG-Federal Office for Safety in Health Care, Austria Anthony Ridgway, Health Canada, Canada Nadine Ritter, Global Biotech Experts, LLC, USA Chikako Torigoe, CBER, FDA, USA
CASSS STAFF Karen A. Bertani, CMP, Director, Global Engagement and Knowledge Sharing, (CMC Forum Manager) Rose Bueno, Administrative and Accounting Specialist Alissa Doyle, Program Planning Coordinator Stephanie L. Flores, CAE, Executive Director Julie Harris, CMP, Program Manager Isolde Honoré, Member Relations and Website Coordinator Randi Jacobs, Program and Event Technology Manager Renee Olson, Senior Program and Marketing Manager Anne Ornelas, DES, Senior Operations Manager Carolyn Slade, Program Manager Catherine Federle Stewart, CPA, Director of Finance
AUDIO VISUAL Michael Johnstone, MJ Audio Visual Productions The Scientific Organizing Committee gratefully acknowledges the pharmaceutical and biotechnology industry for their generous support of the CMC Strategy Forum Japan 2020.
STRATEGIC DIAMOND PROGRAM PARTNER F. Hoffmann – La Roche Ltd.
STRATEGIC PLATINUM PROGRAM PARTNERS Biogen Merck Research Laboratories
FORUM PROGRAM PARTNERS Chugai Pharmaceutical Co., Ltd. Kyowa Kirin Co., Ltd. Nippon Kayaku Co., Ltd. Sumitomo Dainippon Pharma Co., Ltd. Takeda Pharmaceutical Company Limited
The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of the CMC Strategy Forum Japan 2020.
LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality
CMC Strategy Forum Japan 2020 Scientific Program Summary
Monday, 7 December 2020
NOTE: All times are Japan Standard Time (JST)
08:45 – 09:00 Sign-on to Virtual Platform
09:00 – 09:15 CASSS Welcome and Introductory Comments Wassim Nashabeh, F. Hoffmann-La Roche Ltd., USA
09:15 – 09:30 CMC Strategy Forum Japan 2020 Welcome and Introductory Comments Hiroyuki Arai, PMDA-Pharmaceuticals and Medical Devices Agency, Japan
Recent Trends in the Regulation of Biopharmaceutical Products Workshop Session One Session Chairs: Shinichi Okudaira, PMDA-Pharmaceuticals and Medical Devices Agency and Maria Cecilia Tami, Genentech, a Member of the Roche Group
09:30 – 09:35 Introduction
09:35 – 10:05 PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals Futaba Honda, PMDA-Pharmaceuticals and Medical Devices Agency, Japan
10:05 – 10:35 Communications, Regulatory Flexibilities and Quality Challenges for Biologics in the COVID-19 Pandemic: An EMA Perspective Ragini Shivji, European Medicines Agency (EMA), Netherlands
10:35 – 11:05 Regulatory Challenges: Expediting CMC Development While Ensuring Product Quality Robin Levis, CBER, FDA USA
11:05 – 11:35 Regulatory Approaches to CMC Development During COVID-19: Challenges and Opportunities Marjorie Shapiro, CDER, FDA USA
11:35 – 11:45 Break
Monday, 7 December continued
11:45 – 12:50 Panel Discussion – Questions and Answers Yasuhiro Araki, PMDA-Pharmaceuticals and Medical Devices Agency, Japan Futaba Honda, PMDA-Pharmaceuticals and Medical Devices Agency, Japan Robin Levis, CBER, FDA USA Marjorie Shapiro, CDER, FDA USA Ragini Shivji, European Medicines Agency (EMA), Netherlands Fumihiko Takeshita, Daiichi Sankyo Co., Ltd.
12:50 Adjourn Day One
Tuesday, 8 December 2020
NOTE: All times are Japan Standard Time (JST)
08:45 – 09:00 Sign-on to Virtual Platform
Implementation of ICH Q12 – Where Are We in Japan and Globally? Workshop Session Two Session Chairs: Markus Goese, F. Hoffmann-La Roche Ltd. and Akiko Ishi-Watabe, NIHS-National Institute of Health Sciences
09:00 – 09:05 Introduction
09:05 – 09:30 Reflections on the US FDA Established Conditions Pilot Program Joel Welch, CDER, FDA USA
09:30 – 09:55 Case Study: Industry Experience from PACMP Pilot Program in Japan Yoshinori Kubodera, Chugai Pharmaceutical Co., Ltd., Japan
09:55 – 10:20 Introduction of Post-approval Change Management Protocol (PACMP) Mock-up in Japan – Preparation by the AMED PACMP Working Group Keiko Funato, GlaxoSmithKline K.K., Japan
10:20 – 10:35 Update of Q12 Implementation in Japan Satomi Yagi, PMDA-Pharmaceuticals and Medical Devices Agency, Japan
10:35 – 10:45 Break
10:45 – 11:50 Panel Discussion - Questions and Answers Keiko Funato, GlaxoSmithKline K.K., Japan Yoshinori Kubodera, Chugai Pharmaceutical Co., Ltd., Japan Jean-Louis Robert, ICH Q12 EC-EU Topic Lead Joel Welch, CDER, FDA USA Satomi Yagi, PMDA-Pharmaceuticals and Medical Devices Agency, Japan
11:50 – 12:00 Closing Remarks Wassim Nashabeh, F. Hoffmann-La Roche Ltd., USA
12:00 Adjournment