Session 7 – Cell & Gene Therapies
Date: 26 July (Friday) 9:00 – 12:00 Venue: 3F, Bldg. A, CTBC Financial Park, Ballroom A
Masayuki Nomura, Ph.D.
Member, Steering Committee
Forum for Innovative Regenerative Medicine
Dr. Masayuki Nomura is General Manager, Business Development & Licensing Dept., Healthcare R&D Center of Asahi Kasei Corporation. The Asahi Kasei Group operates business in the three sectors of Material, Homes, and Health Care. One of focusing area is the regenerative medicine for the fields of orthopedics. He has more than 30-year experience in professional research and development of cellular immunology and biotechnology. He also worked as a venture partner with Mitsui & Co. Venture Partners, Inc. in US from 2006 to 2007. He holds a Ph.D. degree in biophysics from Nagoya University. He has been member of steering committee and international affairs committee of Forum for Innovative Regenerative Medicine (FIRM) since 2018. Session Speech Title & Synopsis: Manufacture and Regulations in Regenerative Medicine
Following introduction of Forum for Innovative Regenerative Medicine (FIRM) activity, we will update the situation of regenerative medicine in Japan. There are 7 approved regenerative medical products, more than 50 sites of licensed CPCs, and more than 5 sites of accredited foreign CPCs including Taiwan-based. Regenerative medical products are controlled by two laws in Japan: The Act on the Safety of Regenerative Medicine (ASRM) and the Act on Pharmaceuticals and Medical Devices (PMD Act). ASRM applies to all medical technologies using processed cells whose safety and efficacy have not yet been established. PMD Act applies to production and marketing of regenerative and cellular therapeutic products by firms. Outsourcing of cell culturing and processing carried out under the responsibility of physicians based on ASRM is exempt from the application of PMD Act. If physician commissions cell processing to a Cell Processing Center (CPC) outside hospital, license or accreditation by Ministry of Health, Labour and Welfare (MHLW) is required. License/accreditation is subject to PMDA’s site inspection and compatible to business license/accreditation of PMD Act. Both types of CPCs need to be compliant with the Good Gene, Cellular, and Tissue-based Products Manufacturing Practices (GCTP). Most of the regenerative medicine CMOs focus on PMD Act route to market, but a few also provide services for those looking to enter the market under ASRM route. We also would like to comment about several regulatory matters which the manufacturer faces.