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

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.

Katsuhiro Fukunishi

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).

Kenji Harada

Director & Chief Venture Capitalist, Medical Incubator Japan K.K

He graduated with a Ph.D. in Pharmacology from the Faculty of Pharmaceutical Sciences, the University of Tokyo, and is an immunologist by training. He is also a licensed pharmacist and a licensed first-class radiation supervisor. After obtaining his doctorate, he performed a wide range of tasks from basic research to preclinical research as a team leader at Toray Basic Research Laboratories (currently Pharmaceutical Research Laboratories), during which he was developing anti-inflammatory and central nervous system drugs. Subsequently, he was involved in planning and promoting collaborative research with universities and making assessments of platform technologies and drug candidates of American and European biotech startup companies from the technological and intellectual aspects. Furthermore, he conducted GMP inspections in pharmaceutical products and medical device areas multiple times. After starting his career as a venture capitalist, he consistently invested in the biotech sector in the U.S. and Japan. He served as a board member in some of the investees of the U.S. and Japan. Since August 2020, He has expanded his investments into European countries at his current company. He is also engaged in several Japanese governmental projects supporting Japanese startups and research projects.

Hirokazu Yamaguchi