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

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.

Takayuki Hirose

Patent attorney, Hirose International Patent Firm

He graduated with a master’s degree from the Graduate School, University of Tokyo. Patent attorney. After working in the intellectual property department in a major company, he was involved in lawsuit-, adviser- and application-relating services at a lawyer's office, followed by establishing his own international patent attorney's office in 2017. He offers intellectual property strategies in cooperation with companies as an adviser for multiple companies, including the Japanese Organization for Medical Device Development, Inc., (JOMDD) and Shin Nippon Biomedical Laboratories, Ltd. Furthermore, he applies for patent rights and trademarks in a wide variety of areas. He is involved in intellectual property-related services that include medical devices and pharmaceutical products. When he applies for a patent in foreign countries, he offers application strategies by placing the most importance on client’s profit, for example, to give advice to receive a subsidy or to select a foreign agent at a reasonable price depending on the company’s size.

Yutaka Kono

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

Yoshinori Shinoki

Pharma Initiative Support LLC

He graduated from the Department of Biopharmaceutical Sciences, Kyoto Pharmaceutical University, and is a licensed pharmacist. At Sawai Pharmaceutical Co., Ltd., and Eli Lilly Japan K.K., after taking charge of clinical development, business planning, etc., he acquired experience in planning and implementing various clinical development plans as a project leader for newly developed items in the project management department. In addition, he led NHI price negotiation strategy, post-marketing clinical startegy, and market planning. After that, he built up clinical development department at Global CRO. he also led the planning of the clinical development for Japan for small and biological products, as well as negotiating with regulatory authorities. Recently, in addition to medicines, he also led the development of clinical development strategies of medical devices and the products of regenerative medicine (gene therapy products and cell/tissue processed products).