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

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

After working at Fujitsu Ltd. on the development of products and services such as image processing system and cloud information service for home healthcare, as well as research and development in information retrieval and AI, and new business development, I engaged in the construction of a pulmonary hypertension patient registry at the International University of Health and Welfare Mita Hospital. Since 2020, I have been serving as CDO at Cardio Intelligence Inc., responsible for the development of software medical devices for arrhythmia analysis and regulatory affairs. Since 2021, I have also been serving as COO, overseeing overall business planning and execution.

Takato Noumi

Representative Director, FORESIGHT&LINX Cp., Ltd.

At his consulting company, he is currently providing practical support for constructing research strategies, business development, and licensing regarding to drug discovery to pharmaceutical companies and biotech venture companies in Japan and overseas. After completing his postgraduate course, he worked in basic research in molecular biology for 10 years followed by joining the Research Division of the headquarters of Novartis. Subsequently he served as the head of theTsukuba Research Laboratories of GlaxoSmithKline K.K. He had engaged in drug discovery research from a global point of view for 15 years. After that, he has been involved in searching for and evaluating drug discovery seeds and technologies and developing international businesses and licensing at Sanofi S.A. in France and his own consulting company for 10 years. He has a broad network of connections with pharmaceutical companies, biotech venture companies, academia, and venture capital firms in Japan and overseas.

Katsuhiro Fukunishi

Hirohumi Shido

I am a UI/UX design expert and specialize in driving product development. As a product manager at a medical startup, he was in charge of renewal and new planning for multiple SaMD products. My experience ranges from planning to obtaining regulatory approval, and I have won a Good Design Award for a healthcare product. These experiences have made me realize the importance of experience design and usability in SaMD products with a diverse mix of stakeholders.

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.