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

Tadashi Sameshima

I have been engaged in product development and business operations of medical devices and regenerative medicine products for 37 years at Terumo Corporation. I have experienced the development of medical devices such as extracorporeal circulatory and blood transfusion devices, as well as the development to commercialization of cellular products. In addition, I am able to provide specific advice on various stages of development based on my participation in joint research with universities, collaboration among companies, discussions with government agencies, and activities of industry associations.

Motohiro Kobayashi

University of Yamanashi Hospital, Clinical Trial Management Office, Associate Professor

With over 30 years of practical experience in pharmaceutical companies, ranging from basic research to clinical development, licensing activities, and regulatory audits. Subsequently, I served as a technical expert in the Innovation Commercialization Support & Strategic Consultation Division of the Pharmaceuticals and Medical Devices Agency (PMDA), dealing with regulatory consultation services for academia and venture companies (especially for regenerative medicine products and pharmaceuticals). Currently, I am working in the clinical research support department of a university, supporting physician-led clinical trials and clinical research. I have experienced numerous pre-meetings and face-to-face advice with PMDA. I also have experience in application support for public research and development projects (such as Seeds C, etc.) by the Japan Agency for Medical Research and Development (AMED). In particular, I can provide detailed support for the development of regenerative medicine products (including quality and non-clinical).

Tomoyo Mori

Fast Track Initiative, Inc.　Capitalist

Tomoyo obtained her medical license and began her career by engaging in training and clinical practice in medically underserved areas. She then joined the Department of Cardiovascular Medicine at Tokyo Women's Medical University Hospital, where she treated patients with heart failure, heart transplants, and myocardial infarctions. At the university hospital, she also participated in clinical trials for medical device startups. In parallel with her clinical work, she was involved in domestic and international business development for medical device startups and led a team while participating in U.S.-based MedTech accelerators (MedTech Innovator, Fogarty Innovation). She holds an MBA from the University of Michigan's Ross School of Business and is a board-certified internist by the Japanese Medical Specialty Board as well as a certified occupational physician by the Japan Medical Association. Currently, she is part of Fast Track Initiative, where she focuses on investment, company creation, and business development for medical device startups.

Kazuhiro Kanmuri

Inter-Professional Inc.

He engaged in pharmaceutical research and development for more than 25 years. He has gained experience in Japan and in the US development organization of Daiichi Sankyo Co., Ltd., Pfizer Inc., and CRO/consulting organizations, and has been deeply involved in strategic/regulaotry planning of clinical developmentincluding overseas organizations. His specialized fields are extensive, which include company clinical trials and investigator-initiated clinical trials, organization management, strategy development, and clinical trial operation/implementation, safety and pharmacovigillance, and he is active in the academic area of regulatory science. Currently, he engages in the consulting business as an expert in clinical development/organization and human resources development through the corporation that he established by himself and specialized CRO. In addition to being the incumbent, he concurrently served as a visiting lecturer of an academia organization, and he belongs to DIA Japan, an industry association of the pharmaceutical industry, and served as the Vice Program Committee Chair of the DIA Japan annual convention in 2018.

Masakatsu Noguchi

SMILE CURVE, Inc.

Ph.D. in life sciences. Worked at consulting firm Dream Incubator, consulting in industry-academia collaboration, business support for tech startups (bio, semiconductor, environmental energy), new business development for large corporations, and overseeing government mega-projects. Previously employed at Abbott Japan and Singapore, managing product marketing for diagnostic tests, pharmaceuticals (women's health), and Asia-Pacific marketing for medical IT. As Business Development Director at Sanamedi, facilitated the commercialization of new medical devices, handled regulatory applications and market launches, and supported investments in and assistance to startups. Additionally served as an evaluator for AMED, and as a mentor for NEDO and university accelerator programs. Currently working independently, he serves as a specially appointed associate professor in the Hiroshima University and as an strategic advisor of MEJ.