Welcome to CMC Strategy Forum 2018

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 2018.

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 2018. 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, as well as Asian health authorities. The technical sessions will include discussions on new trends for quality control of biopharmaceutical products; new trends in manufacturing of biologics: technologies involved in continuous manufacturing and regulatory perspectives; and CMC development of regenerative medicines regulations and mandatory quality control of products, raw materials and cell substrates.

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.; Co., Ltd. F. Hoffmann-La Roche Ltd.; Kissei Pharmaceutical Co., Ltd.; Co., Ltd.; MedImmune, a Member of the AstraZeneca Group; Novo Nordisk A/S; 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: Ayako Enokida, PMDA-Pharmaceuticals and Medical Devices Agency Futaba , PMDA-Pharmaceuticals and Medical Devices Agency Yasushi Jotatsu, PMDA-Pharmaceuticals and Medical Devices Agency Yasuhiro Kishioka, PMDA-Pharmaceuticals and Medical Devices Agency Junichi Koga, Daiichi Sankyo Co., Ltd. Noriyuki Matsumoto, JPMA-Japan Pharmaceutical Manufacturers Association (Secretariat) Nao Nakamura, Sumitomo Dainippon Pharma Co., Ltd. Kei Nishimura, UCB Japan Co., Ltd. Hisako Ohnishi, JPMA-Japan Pharmaceutical Manufacturers Association (Secretariat) Yutaka Osawa, Pharma Kyoko Sakurai, PMDA-Pharmaceuticals and Medical Devices Agency 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-Pharmaceuticals and Medical Devices Agency, Japan Steven Kozlowski, CDER, FDA, USA Junichi Koga, Daiichi Sankyo Co., Ltd., Japan Rohin Mhatre, Biogen, USA Anthony Mire-Sluis, AstraZeneca, USA Wassim Nashabeh, Genentech, a Member of the Roche Group, 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 Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Mark Schenerman, CMC Biotech-MAS Consulting, USA Karin Sewerin, BioTech Development AB, Sweden Chikako Torigoe, CBER, FDA, USA

CASSS STAFF Noelle Atkins, Administrative Coordinator Karen A. Bertani, CMP, Director, Global Engagement and Knowledge Sharing, (CMC Forum Manager) Stephanie L. Flores, CAE, Executive Director Julia Fowle, Program Planning and Event Specialist Anna Lingel, CMP, Exhibitor Relations and Technology Specialist Renee Olson, Senior Program Manager Catherine Stewart, Finance Manager

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 2018.

STRATEGIC DIAMOND PROGRAM PARTNER F. Hoffmann – La Roche Ltd. Genentech, a Member of the Roche Group STRATEGIC PLATINUM PROGRAM PARTNER Biogen MedImmune, A member of the AstraZeneca Group STRATEGIC GOLD PROGRAM PARTNER Novo Nordisk A/S FORUM PROGRAM PARTNERS Chugai Pharmaceutical Co., Ltd. Daiichi Sankyo Co., Ltd. Kissei Pharmaceutical Co., Ltd. Kyowa Hakko 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 2018.

LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality MEDIA PARTNERS The Analytical Scientist BioProcessing Journal Genetic Engineering & Biotechnology News LC/GC The Pathologist

Technology Networks

CASSS Mobile App

Does the printed program look a little bit thinner this year? That’s because we’re going mobile. This year, we are pleased to once again offer the CASSS Mobile App for the CMC Strategy Forum Japan 2018!

Top Six Reasons You Need to Have the App: o Connect and network with fellow attendees, speakers, and exhibitors o View the schedule and create a personalized agenda o Download speaker abstracts and handouts o Take notes during the presentations and export later o Receive all the latest information on schedule changes or updates o Have all your questions answered during sessions through the activity feed

Log on and be a part of the CMC Japan Community!

STEP 1 OPTION 1: On your mobile phone, go to the App Store (Apple App Store, Google Play Store) and search "CASSS 365

OPTION 2: Use a QR code reader to scan the QR code on this page.

OPTION 3: To use the HTML version of the app on a laptop, go to the internet browser on your mobile phone, tablet, or computer and go to the link www.tripbuildermedia.com/apps/casss365

STEP 2 Follow store instructions to download the CASSS 365 mobile app.

STEP 3 Open the app. It will ask for your username and password. THIS IS THE SAME INFORMATION YOU USE TO REGISTER FOR A CASSS MEETING.

STEP 4 Go to Events and select "CMC Strategy Forum Japan" from the list. Enter your username and password again. This is the same username and password used in step three. You now have access to the entire schedule, session abstracts, speaker handouts and bios – as well as the ability to connect with your fellow attendees.

Need Help? Still not sure how to sign in and get the most out of the mobile app? Contact CASSS Technology Specialist Anna Lingel ([email protected]) or stop by the registration desk.

CMC Strategy Forum Japan 2018 Scientific Program Summary

Monday, 3 December 2018

06:30 – 08:45 Buffet Breakfast for all CMC registered guests of the 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 Oak Room

08:30 – 09:00 CASSS Welcome and Introductory Comments in the South Ballroom Wassim Nashabeh, F. Hoffmann-La Roche Ltd., USA

CMC Strategy Forum Japan 2018 Welcome and Introductory Comment