Welcome to CMC Strategy Forum Japan 2017

Transcription

1 Welcome to CMC Strategy Forum Japan 2017 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 Japan 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 The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Japan 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 challenges in global development of drug-device combination products, use of prior knowledge to support CMC development in conventional and expedited settings and an ICH Q12 update. 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 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 strategic program partners for the continued support of the Forum series: XXXXXXX. 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.

2 ACKNOWLEDGEMENTS JAPAN SCIENTIFIC ORGANIZING COMMITTEE: Kazuhiko Chikazawa, Pharmaceuticals and Medical Devices Agency (PMDA) 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. Noriyuki Matsumoto, Japan Pharmaceutical Manufacturers Association (JPMA) (Secretariat) Nao Nakamura, Sumitomo Dainippon Pharma Co., Ltd. Kei Nishimura, UCB Japan Co., Ltd. Hisako Ohnishi, Japan Pharmaceutical Manufacturers Association (JPMA) (Secretariat) Yutaka Osawa, Asahi Kasei Pharma Kyoko Sakurai, Pharmaceuticals and Medical Devices Agency (PMDA) Kazuhisa Uchida, Kyowa Hakko Kirin Co., Ltd. Masatoshi Yamada, Nippon Kayaku Co., Ltd. Takeshi Yoshino, Chugai Pharmaceutical Co., Ltd. CMC STRATEGY FORUM GLOBAL STEERING COMMITTEE Siddharth Advant, Celgene Corporation, USA Daniela Cerqueira, ANVISA-Brasilian National Health Surveillance Agency, Brasil Yasuhiro Kishioka, PMDA-Pharmaceutical and Medical Devices Agency, Japan Steven Kozlowski, CDER, FDA, USA Junichi Koga, Daiichi Sankyo Co., Ltd., Japan Rohin Mhatre, Biogen, USA Ingrid Markovic, CBER, FDA, USA Anthony Mire-Sluis, AstraZeneca, USA 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 Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Mark Schenerman, 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 Japan STRATEGIC DIAMOND PROGRAM PARTNER F. Hoffmann La Roche Ltd. STRATEGIC PLATINUM PROGRAM PARTNER AbbVie, Inc. Biogen MedImmune, A member of the AstraZeneca Group FORUM PROGRAM PARTNERS

4 The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of the CMC Strategy Forum Japan LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality MEDIA PARTNERS The Analytical Scientist BioProcessing Journal Genetic Engineering & Biotechnology News LC/GC Asia Pacific The Pathologist separationsnow.com Technology Networks

5 CMC Strategy Forum Japan 2017 Scientific Program Summary Monday, 4 December :30 08:45 Buffet Breakfast for all CMC registered guests of the Tokyo Marriott Hotel in the Dining Grill (Lobby Level) 07:30 09:30 Coffee Service in the South Ballroom Foyer 07:30 17:00 Registration in the South Ballroom Foyer 08:30 09:00 CASSS Welcome and Introductory Comments in the South Ballroom Wassim Nashabeh, F. Hoffmann La Roche Ltd., Switzerland CMC Strategy Forum Japan 2017 Welcome and Introductory Comments in the South Ballroom Takao Yamori, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Recent Trends in the Regulation of Biopharmaceutical Products Plenary Session in the South Ballroom Session Chairs: Ineui Lee, Kobe University and Anthony Ridgway, Health Canada 09:00 09:30 PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals Futaba Honda, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 09:30 10:00 Korean Perspective: Recent Trends in the Regulation of Biopharmaceuticals Il Ung Oh, Ministry of Food and Drug Safety (MFDS), Republic of Korea 10:00 10:30 The China Regulatory Framework: Recent Trends in the Regulation of Biopharmaceuticals Kaikun Wei, Center for Drug Evaluation (CDE), P.R. China (invited) 10:30 11:00 AM Break in the South Ballroom Foyer 11:00 11:30 Vietnam Perspective: Recent Trends in the Regulation of Biopharmaceuticals Truong Quoc Cuong, Drug Administration of Vietnam, Vietnam (invited) 11:30 12:00 EU Update on Regulatory Developments Niklas Ekman, Finnish Medicines Agency, Finland

6 Monday, 4 December continued 12:00 12:30 US FDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals TBD, CDER, FDA, USA 12:30 13:45 Buffet Lunch in the 13:45 15:00 Panel Discussion Questions and Answers 15:00 15:30 PM Break in the South Ballroom Foyer ICH Q12 Update Workshop Session in the South Ballroom Session Chairs: Niklas Ekman, Finnish Medicines Agency and Toshiyuki Suzawa, Kyowa Hakko Kirin Co., Ltd. 15:30 15:35 Introduction TBD 15:35 16:00 TBD Frank Montgomery, AstraZeneca, United Kingdom 16:00 16:25 How Will ICH Q12 Fly in Japan? Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 16:30 17:30 Panel Discussion - Questions and Answers Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Frank Montgomery, AstraZeneca, United Kingdom Mats Welin, Medical Products Agency (MPA), Sweden Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Anthony Ridgway, Health Canada, Canada Yamin Wang, Center for Drug Evaluation (CDE), China (invited)

7 Monday, 4 December continued 17:30 19:00 Networking Reception in the Iris/Camellia Room 19:00 Adjourn Day One

8 Tuesday, 5 December :30 08:45 Buffet Breakfast for all CMC registered guests of the Tokyo Marriott Hotel in the Dining Grill (Lobby Level) 07:30 09:30 Coffee Service in the South Ballroom Foyer 08:00 17:00 Registration in the South Ballroom Foyer Challenges in Global Development of Drug Device Combination Products Workshop Session in the South Ballroom Session Chairs: Junichi Koga, Daiichi Sankyo Co., Ltd. and TBD 09:00 09:25 Update on Regulation of Drug Device Combination Products Europe and Beyond Janine Jamieson, IPQ Publications-EU Editor, Sweden 09:25 09:50 Challenges and Opportunities in the Development of Integrated Drug Device Combination Products An Industry Perspective Ulla Grauschopf, F. Hoffmann-La Roche Ltd., Switzerland 09:50 10:15 TBD Seiji Ueno, Chugai Pharmaceutical Ltd., Japan 10:15 10:45 AM Break in the South Ballroom Foyer 10:45 12:00 Panel Discussion - Questions and Answers Ayako Enokida, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Ulla Grauschopf, F. Hoffmann-La Roche Ltd., Switzerland Janine Jamieson, IPQ Publications-EU Editor, Sweden Seiji Ueno, Chugai Pharmaceutical Ltd., Japan TBD TBD 12:00 13:15 Buffet Lunch in the Camellia and Garden View Rooms

9 Tuesday, 5 December continued Use of Prior Knowledge to Support CMC Development in Conventional and Expedited Settings Workshop Session in the South Ballroom Session Chairs: Akiko Ishii-Watabe, National Institute of Health Sciences (NIHS) and TBD 13:15 13:30 Introduction Yutaka Osawa, Asahi Kasei Pharma, Japan 13:30 13:55 Making Use of Prior Knowledge in Regulatory Files An Assessor s View Mats Welin, Medical Products Agency (MPA), Sweden 13:55 14:20 Making Use of Prior Knowledge in Regulatory Files An Industry Perspective Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland 14:20 14:45 Development and Implementation of a Binding Assay to Assess the Potency of Synagis (palivizumab) Mark Schenerman, CMC Biotech-MAS Consulting, USA 14:45 15:15 Prior Knowledge in Attribute Based Control Strategies Michael Abernathy and Jette Wypych, Amgen Inc., USA 15:15 15:45 PM Break in the South Ballroom Foyer 15:45 17:00 Panel Discussion Questions and Answers Michael Abernathy, Amgen Inc., USA Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland Mark Schenerman, CMC Biotech-MAS Consulting, USA Mats Welin, Medical Products Agency (MPA), Sweden Jette Wypych, Amgen Inc., USA 17:00 17:30 Recap of Program Summary Slide Presentation Nadine Ritter, Global Biotech Experts, LLC, USA 17:30 17:45 Closing Remarks Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland 17:45 Adjournment

10 Welcome and Introductory Comments Wassim Nashabeh F. Hoffmann La Roche Ltd., Switzerland AND Futaba Honda Pharmaceuticals and Medical Devices Agency (PMDA), Japan NOTES:

11 Recent Trends in the Regulation of Biopharmaceutical Products Session Chairs: TBD, Pharmaceuticals and Medical Devices Agency (PMDA) and Anthony Ridgway, Health Canada NOTES:

12 Presenter s Abstracts PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals Pharmaceuticals and Medical Devices Agency (PMDA), Japan NOTES:

13 Recent Trends in the Regulation of Biopharmaceutical Products Plenary Session Panel Discussion Questions and Answers The following questions will guide the panel discussion: NOTES:

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15 ICH Q12 Update Session Chairs: TBD and Toshiyuki Suzawa, Kyowa Hakko Kirin Co., Ltd. NOTES:

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20 Panel Discussion Questions and Answers Yasuhiro Kishioka Frank Montgomery, AstraZeneca, United Kingdom ICH Q12 Update Workshop Session The following questions will guide the panel discussion: NOTES:

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22 Challenges in Global Development of Drug Device Combination Products Session Chairs: NOTES:

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28 Challenges in Global Development of Drug Device Combination Products Workshop Session Panel Discussion Questions and Answers Janine Jamieson, IPQ Publications EU Editor, Sweden The following questions will guide the panel discussion: NOTES:

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30 Use of Prior Knowledge to Support CMC Development in Conventional and Expedited Settings Session Chairs: Ishii Watabe, National Institute of Health Sciences (NIHS) and TBD NOTES:

31 Presenter s Abstracts Established Conditions for the Specification and Analytical Procedure PMDA Perspective Mats Welin Medical Products Agency (MPA), Sweden NOTES:

32 An Industry Perspective on Established Conditions in the Analytical Control System Markus Goese F. Hoffmann-La Roche Ltd., Switzerland NOTES:

33 TBD Mark Schenerman CMC Biotech-MAS Consulting, USA NOTES:

34 TBD Jette Wypych Amgen Inc., USA NOTES:

35 Use of Prior Knowledge to Support CMC Development in Conventional and Expedited Settings Workshop Session Panel Discussion Questions and Answers Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland Mark Schenerman, CMC Biotech-MAS Consulting, USA Mats Welin, Medical Products Agency (MPA), Sweden Jette Wypych, Amgen Inc., USA The following questions will guide the panel discussion: NOTES:

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