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

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.

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.

Jun Yamadera

Eyes, JAPAN co. ltd.

Jun Yamadera founded Eyes, JAPAN co. ltd. in 1995, the first IT startup from the University of Aizu, Fukushima. In the past 20 years, he has been working on various cutting edge projects such as exporting Fukushima rice via web in 1995, making world’s first virtual pottery system, making CG of historical archives of national treasure of Japanese castles, temples, traditional dances and medical motions using motion capture. He is a pioneer in Augmented Reality wearable technologies, Medical x IT and has been organizing world’s first medical security hackathon since 2012. His team won the the championship in Developers Challenge 2013 Health 2.0 in Silicon Valley. He is the Health 2.0 Fukushima Chapter Leader and a TEDxKobe 2015 Speaker. He started a project called “FUKUSHIMA Wheel” in the aftermath of the terrible disaster caused by the earthquake and nuclear accident in Fukushima, JAPAN in March 11, 2011. More than 24 years experience in Cutting Edge Technologies such as AI, Blockchain and Cyber Security. He is also advisor of Safecast and LivingAnywhere.

Hiroki Yamada

Medii, Inc. CEO, M.D.,Ph.D.

Tomokatsu Hongo

Keio Innovation Initiative, Inc
Corporate Officer

Ph.D. in Biological Chemistry from Nagoya University. At Summit Pharmaceuticals International Corporation, I was engaged in VC fund management, investment and sales support for bio-ventures, and domestic sales agency business for overseas bio-ventures. In 2016, I joined Keio Innovation Initiative (KII) as an investment manager in the medical and health field. I have been investing in drug discovery, regenerative medicine, and medical device ventures by leveraging his business experience in the pharmaceutical industry and career as a researcher, and providing a wide range of hands-on support, not only in terms of funding, but also in business development.