A comprehensive portal site for Medical Innovation Support Office (MEDISO).Medical Innovation Support Office

Kenichi Yamahara

Professor at the Laboratory of Molecular and Cellular Therapy, Institute for Advanced Medical Sciences, Hyogo Medical University
Representative Director of CTEX Co., Ltd.

From the time of a former position at the National Cerebral and Cardiovascular Center, he planned and implemented the formulation of the amnion-derived mesenchymal stem cells and investigator-initiated clinical trials for acute grafts versus host disease/Crohn's disease under the support by Health and Labour Sciences Research Grants/AMED. He often had PMDA consultations on the products of regenerative medicine and acquired knowledge of laws and regulations. Taking advantage of the experience, he founded a venture, Japan Biomedical Co., Ltd., which manufactures the domestic bovine serum NeoSERA® for the products of regenerative medicine by satisfying the standards for biological materials in January 2017. Furthermore, in order to aggressively develop investigator-initiated clinical trials of cell therapy making use of university hospital infrastructures, he founded a venture, CTEX Co., Ltd., from Hyogo Medical University in February 2018. Recently, he participated as a medical expert in the company developing the regenerative medical product and is a principal investigator for investigator-initiated clinical trials for the development of cell therapy in the medical device category (adopted by AMED). Currently, he is working on the practice of cell therapy development initiated at the university hospital while concurrently serving in the basic and clinical departments of Hyogo Medical University.

Chia-Feng Lu

Shareholder(Senior Partner), Greenberg Traurig, LLP

Chia-Feng Lu represents life sciences companies and industry associations in strategic regulatory and legislative worldwide to guide and develop new legislation and policy, to frame effective approaches to working with the various agencies on compliance and investigation issues. He has intensive experience in provision of the guidance to companies introducing novel technology products, such as AI, block chain, 3D-printing, cancer immunotherapy, digital health, cell / gene therapy, precision medicine-related products and services, RNAi drug, as well as SMART device. In his past experience, he has already assisted companies in translating the scientific ideas from Nobel Laureates into the successful commercial launch of at least two products. In addition, he advises investment banks, private equity firms, and venture capital groups on their evaluations of the technologies, deal structures, and the resulting business impacts, as well as regulatory uncertainty with respect to novel technology and compliance. He specializes in various issues in connection with biotech investors or life sciences companies’ research & development strategy, portfolio management, corporate strategy planning, partnerships, licensing, project finance, auction, investment, and M&A. He has also served as an adjunct faculty member of a number of leading academic institutions in the U.S. and Japan, and an advisor to numerous government agencies.

Satoshi Morimoto

Morimoto Phrma Partrnering, Representative

Representative of Morimoto Pharma Partnering. Master of Science in Applied Biochemistry, Graduate School of Waseda University. I stared my carrier at the former The Green Cross Corporation (now Mitsubishi Tanabe Pharma Corporation), experienced in pharmaceutical R&D, product strategy planning, and business development. During that time, I was dispatched as the liaison to Germany for four years. My last position was Director of Business Development. Then, I joined to CMIC Holdings, where I led the business development of rare disease drugs as Director of Business Development and Head of IPD Company. From 2016, I spent six years at the Mitsubishi Chemical Group's Life Science Institute(LSII) as head of the Regenerative Medicine Division, where I was involved in the early stages of cell product development, initiating clinical trials, and leading the construction and operation of cell processing facilities.　After retiring from LSII in 2021, I started own business as a consultant. I would like to provide practical advice based on my experience in the development and commercialization of rare disease drugs and regenerative medicine products. In addition, I would like to provide practical advice on business development from the perspective of having been introduced to various projects from venture companies over 30 years.

Hiroyuki Kajiyama

Graduated from Kyoto University Faculty of Pharmaceutical Sciences. Worked at Tanabe Mitsubishi Pharma Corporation in pharmaceutical research and development, primarily handling clinical development tasks. Since 2016, employed at the Pharmaceuticals and Medical Devices Agency (PMDA), Review Management Department, as a Technical Expert in Regulatory Science Strategy Consultation. Engaged primarily in providing consultation services on pharmaceuticals, medical devices, regenerative medicine products, focusing on academia and venture companies.

Makoto Shigematsu

Representative Director, Kai Fostering Partners Inc.

He worked on a new project research and development, trial manufacture, mass production, and commercializing of glass delay line element for VTR at Asahi Glass Co., Ltd. He moved to CSKVC by making use of his relevant experience. As a venture capitalist, he engaged mainly in establishing, financing, fostering, and managing venture companies. He practiced monetizing of novel technologies, timely financing, establishing organization and management, sharing an exit strategy as a milestone, active use of intellectual property rights (open and close), and business talks and negotiations (not bargaining) hated by engineers. He has providing support for company’s growth fostered by competition and cooperation, while being employed by traditional companies for 20 years and by venture companies for 20 years with an understanding exactly the opposite of the corporate culture of both.