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

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.

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.

Minori Kosuge

Senior Manager, Regulatory Affairs and Quality Assurance
Rokken, Inc.

- Experience of working for 15 years at a Japanese medical device company: Technical writing, regulatory affairs (US 510k submissions, translation for QSR inspection), R&D of patient monitor and its related programs. - Experience of working at Japanese SaMD startup companies: experience of negotiation with PMDA and consultation for regulatory affairs/quality assurance.
- Currently working as a regulatory affairs/quality assurance consultant and an in-house regulatory affairs/quality assurance specialist.
Support available for class II active medical devices and SaMD, for Japan and US.

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.

Masaomi Tajimi

MedCon Tajimi, Represent
Kobe University, Visiting Professor

Masaomi Tajimi, D.V.M., Ph.D., is the founder of Medcon Tajimi and a Visiting Professor at Kobe University School of Medicine. He holds a Ph.D. degree and Veterinarian licence from a national university and has over 30 years of experience spanning drug discovery research, clinical development, regulatory affairs, and commercialization strategy. After building his foundation in drug discovery at two major global mega pharmaceutical companies, he served as Head of Clinical Development at a domestic drug discovery startup, overseeing programs across Japan, EU, and the US. He then spent many years as a Medical Expert in oncology at a global mega pharmaceutical company, contributing to numerous Phase I and Phase III studies and leading regulatory submissions and regulatory authority interactions. Drawing on his background in drug discovery, he brings a Translational Research perspective — bridging nonclinical and clinical data — combined with hands-on expertise in clinical development strategy and execution. At MEDISO, he provides practical, rapid-turnaround advice on clinical, regulatory, research, and market access challenges, and supports clients through PMDA consultations and beyond.