Agenda for
the 1st Asia Partnership Conference of Regenerative Medicine

Date and time

Wednesday, April 11, 2018

12:30 ~ 18:00 (Conference), 18:30 ~ (Reception) (JST)
(Closed, FIRM Member Only)


Nihonbashi Life Science Building,

2-3-11, Nihonbashi Honcho, Chuo-ku, Tokyo 103-0023, Japan, http://www.nihonbashi-lifescience.jp/en/

Conference; 2nd Floor Conference Room
Reception; 10th Floor


FIRM (Forum for Innovative Regenerative Medicine)


MC: Dr. Fusako Nishigaki (Vice Chair, Steering Committee of FIRM)

12:30-12:40 Opening Remarks Mr. Yuzo Toda (Chairman of FIRM)
12:40-12:50 Introduction of APACRM Dr. Fusako Nishigaki (Vice Chair, Steering Committee of FIRM)
12:50-14:05 Keynote lecture: Three speakers from Academia and Regulatory authority scheduled Chair: Dr. Yoshikazu Morishita (Chair, Public Affairs Committee of FIRM)
12:50-13:15 Manufacturing Technologies for Allogeneic Stem Cell Therapies. Dr. Steve Oh (Bioprocessing Technology Institute, A*STAR)
13:15-13:40 Development of Regenerative Therapy for Advanced Heart Failure Dr. Yoshiki Sawa (Director, The Japanese Society for Regenerative Medicine)
13:40-14:05 Regenerative Medicine Product Regulations in Japan
-Enhancing the development of Advanced Therapy-
Dr. Kiyohito Nakai (Ministry of Health, Labour and Welfare)
14:05-14:25 <Break>
14:25-16:25 Presentation from Industrial association Chair: Mr. Hajime Miyamoto (Vice Chair, Steering Committee of FIRM)
14:25-14:45 Status-sharing presentation by each participant on market and regulatory environment surrounding Regenerative Medicine and Cell/Gene therapy Mr. Ning Wu, CMBA (China)
14:45-15:05 Dr. Oscar K. Lee, BPIPO (Taiwan)
15:05-15:25 Dr. Bryan Choi, GSRAC & CARM (Korea)
15:25-15:45 Mr. Balu Narasimhan Manohar, ABLE (India)
15:45-16:05 Mr. Wong Kum Cheun, SAPI (Singapore)
16:05-16:25 Mr. Masanobu Kimura, FIRM (Japan)
16:25-16:45 <Break>
16:45-17:45 Round table Chair: Mr. Kunihiko Suzuki (Vice Chair of FIRM)
Round table by all participants toward a cooperative framework for regulation harmonization over the region Speakers: Industrial Association
Mr. Ning Wu, CMBA (China)
Mr. Ching-Lung Hu, BPIPO (Taiwan)
Dr. Bryan Choi, GSRAC & CARM (Korea)
Mr. Balu Narasimhan Manohar, ABLE (India)
Mr. Wong Kum Cheun, SAPI (Singapore)
Mr. Masanobu Kimura, FIRM (Japan)
Speakers: Regulatory Authority
Dr. Jeewon Joung, Korea FDA (Korea)
Dr. V. G. Somani, CDSCO (India)
Dr. Hsin Jung Lee, CDE (Taiwan)
Dr. Yoshiaki Maruyama, PMDA (Japan)
17:45-17:55 Summary Mr. Kunihiko Suzuki (Vice Chair of FIRM)
17:55-18:00 Closing Remarks Dr. Nobuyuki Osakabe (Vice Chair of FIRM)
18:30-20:00 <Reception>

CMBA (China Medical Biotech Association), CARM (The Council for Advanced Regenerative Medicine), ABLE (Association of Biotechnology Led Enterprises), SAPI (Singapore Association of Pharmaceutical Industries), BPIPO (Biotechnology & Pharmaceutical Industries Promotion Office, Ministry of Economic Affairs), CDSCO (Central Drugs Standard Control Organization), CDE (Center for Drug Evaluation)