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

Kazuhiro Terashima

CaTe inc. CEO
Fujita Health University, Department of Cardiology, Assistant Professor

Cardiologist, Fellow of Cardiovascular Intervention and Therapeutics, Registered Cardiac Rehabilitation Instructor, Certified Occupational Health Physician and Clinical Education Instructor. He graduated from Nagoya University School of Medicine in 2011. After working at the Japanese Red Cross Aichi Medical Center, Nagoya Daiichi Hospital, Sakakibara Memorial Hospital and other institutions, he joined Fujita Health University in 2023 as Assistant Professor of Cardiology and CCU Instructor. In 2020, he founded CaTe Inc. to research and develop programmed medical devices for cardiac rehabilitation, and to conduct clinical research and company-led clinical trials of such devices. He is currently the principal investigator for basic research on the Exercise Load Optimization function, a promising technology seed. In 2023 he closed Series A funding with JAFCO etc. as lead investor. While continuing his clinical work, he serves as CEO of the company and advises and supports other clinicians in the social implementation of clinical technology seeds.

Daisuke Sugiyama

Hiroshima University, Translational Research Center, Professor

He obtained his PhD thesis at University of Tokyo. After working at several hospitals as a clinician, he has engaged in medical reserach at University Paris 6 (French Government Scholar), Dartmouth College (JSPS research fellow), Kyushu University and Hiroshima University. Based on the experiences working at ARO research core hospital and starting up bio-venture company, he supports and conducts both translational and clinical researches.

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.

Yasuo Sasaki

He graduated with a doctoral degree in science from the Department of Chemistry, Graduate School of Science, Hokkaido University. He was involved in the research and development of pharmaceutical products as an employee of Asahi Kasei Pharma Corporation. He was mainly in charge of preclinical studies and regulatory affairs. From 2013, he provided support for research and development by academia, drug discovery venture companies, and small and medium enterprises centering on the eastern part of Shizuoka Prefecture. Since 2018, he has been providing support services as a freelance advisor or coordinator in the life science field.

Rou Irisawa

IRISAWA Consulting LLC

Worked at Chugai Pharmaceutical Co., Ltd. for 27 years, primarily in antibody drug research and development, CMC regulatory affairs, and quality assurance, from preclinical trials stage to BLA stage. Involved in the BLA of Japan, US and EU approval for the CTD-Q of Actemra, Japan's original first antibody drug. And also involved in Japan BLA for several biologics Genentech original. Since 2017, involved in the development of many new modalities, including three SAKIGAKE designated cell products, and participated in 21 times PMDA consultations responsible for CMC regulatory and QA for cell products and gene therapy products. In 2023, became independent as a CMC regulatory consultant. Author of ""CMC Pharmaceutical Design - CMC Pharmaceutical Strategy in the Era of New Modality Pharmaceuticals"" (Yakuji Nipposha, 2022), and is the overall supervisor of the Japanese translation of A-CELL (CMC Development Guidance for CAR-T). Fellow at Tama University's Medical Care Solutions Research Institute, and a top performer in the regular course of Pharmaceutical Evaluation Science at the University of Tokyo Graduate School of Pharmaceutical Sciences in 2024. Certified in generative AI skills (November 2025).　Currently involved in various projects, including serving as CMC lecturer at seminars on how to proceed with the development of CMC for antibody drugs, cell products, gene therapy products, etc　for small company to semi-major company.