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

Tomohito Suzuki

Tohoku University Knowledge Cast Co., Ltd.
Senior Consultant, Medical Device Development Support Division

D. in Pharmaceutical Sciences from Kyoritsu Pharmaceutical University (now Keio University). Formerly a medical device reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA). At PMDA, a member of the team in charge of the cardiovascular field and was in charge of approval review and consultation for many medical devices including new medical devices. Seconded from PMDA to the University of Tokyo Hospital as a Project Assistant Professor at the Translational Research Center, where supported the development of medical seeds in academia. Seconded from PMDA to Division of Medical Device Research of the Department of Industrial-Academic Collaboration of the Japan Agency for Medical Research and Development (AMED) as a manager in charge of overseeing projects with medical device-related budgets. He has been in his current position since 2020. Based on his experience in reviewing at PMDA and supporting R&D in academia and AMED, he supports efficient development of medical devices for many manufacturers including venture companies.

Yasuhisa Matsukawa

Kazuhiro Ikumi

MEDICOLAB Co., Ltd.

Board-certified neurologist, CEO at MEDICOLAB, Co., Ltd. My initial job was a medical doctor at a tertiary care emergency hospital. I have 14 years of clinical experience in Parkinson's disease, dementia and other neurodegenerative diseases. MEDICOLAB, Co., Ltd. receives PR and development support from Fujitsu, NVIDIA, Amazon, and Microsoft. I am involved in business development in the CNS area and support researchers for their idea and trial products or services for commercialization.

Masaho Ishino

After engaging in medical research for 25 years, I became a patent attorney (JAPAN). Over the next 20 years, I have supported medical researchers in creating intellectual property and planning research strategies, as well as engaged in contract practice and technology transfer of university IP. Intellectual property strategies for regenerative medicine and other new modalities require not only a high level of expertise in both cutting-edge medical research and intellectual property rights, but also comprehensive knowledge covering clinical development and regulations. Utilizing my experience of contributing to the development research and practical application of university-originated seeds as a representative of an institution responsible for the AMED's Project of Translational and Clinical Research Core Centers and an organizer of nationwide academia intellectual property networks, I aim to contribute to raising the potential of intellectual property of academia/venture.

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.