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

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.

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).

Yutaka Kono

Guest professor
Drug Discovery Science Division,Institute for Open and Transdisciplinary Research Initiatives, Osaka University

Yoshiki Kawabata

President, MedX Inc.

Advantage from over 35 years of multiple company & responsibility experience in medical device industry, helping foreign companies to enter into Japanese market. Key highlights in the past achievements are : with Johnson & Johnson Mdecial Company, worked with US R&D team to develop new product which reflecting Japanese patient and physicians needs - three years resided in Cincinnati, Ohio: HeartFlow Inc., which developed the first "program device" - FFRCT, enabling non-invasive detection of FFR, applied and received regulatory approval and reimbursement as a first product and company. : in Palette Lifesciences Japan, establishment of new subsidiary for start-up company which transferred the business from exclusive distributor. Started with minimum number of direct resources and having multiple partnerships with logistics, finance and regulatory affairs, revitalized the business and achieved a 149% growth over the last year of distributor.

Shin-ichi Kamachi

CRO-K Co.,Ltd

Completed doctoral course at Kyushu University Graduate School of Pharmaceutical Sciences. After joining Chugai Pharmaceutical Co., Ltd. Research Institute in 1977, he worked consistently on pharmaceutical research and development. He has experience in approving one small molecule drug and four biopharmaceuticals. He also has the experience of being the first Japanese company to recommend approval for a central review of EMA. He took early retirement in 2004 and mainly assists with biopharmaceutical CMC and non-clinical testing. After establishing the Japanese branch of an American biopharmaceutical consulting company (Biologic Consulting Group, BCG), he currently serves as a senior consultant for CLOCK Co., Ltd., providing support and advice on the development of biopharmaceuticals.