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.

Akiko Yamamoto

Nissan Chemical Corporation
Risk Management ＆Compliance Office
Risk Management Department

Graduated from the Department of Pharmacy at Kyoritsu Collage of Pharmacy (currently Keio University) and received a Ph.D. from Gifu Pharmaceutical University. Engaged in work related to each process of pharmaceutical life cycle (research and development, sales promotion, licensing/alliance, quality assurance and Good Vigilance Practice(GVP)) at Nissan Chemical Corporation. Especially, as the corporate quality assurance department leader, managed the company's pharmaceutical quality system, and maintained and improved appropriate quality assurance systems for API manufacturing sites, manufacturing contractors, and contract testing facilities. Specifically, provided support during FDA inspections and global pharma quality audits, and advised on improvements and response policies for issues raised. Also has experience in implementing regulations and change processes when adding starting material, intermediate and API manufacturing sites, and testing facilities. In addition, has reviewed documents such as license and quality assurance-related contract contents, change applications and master files to be submitted to authorities.

Satoshi Fukushima

Globis Capital Partners & Co.

He graduated from the Faculty of Economics, University of Tokyo. He was involved in investment activities in reformed fields of existing industries, including digital health, at Globis Capital Partners & Co. (GCP). He served as an outside director of several companies, including Medley, Inc., Kakehashi Inc., and Yoriso. Co. Ltd., and provided support to their management personnel mainly in strategy formulation, development of the organization, and finance. In addition to investigation activities, he provided support for fund structuring and open innovations provided by large companies in healthcare fields.

Before joining GCP, he was serving as an M&A advisor mainly in the technology, media, and telecommunication fields and worked on financing at the general headquarters of German Securities Finance Corporation.

Takeshi komatani

Takeshi S Komatani is currently principal litigation certified patent attorney in the field of chemical/pharma and bio/life sciences at a patent law firm, and has a number of counsels, including in academia, start-ups and big pharma internationally. Takeshi received his PhD from the University of Tokyo, Japan, received his LLB and LLM (global legal practice) from Keio University, and is currently a visiting professor at Kobe University, teaching IP strategy in entrepreneurship and Doshisha University (Kyoto). He has completed CEIPI Summer School on IP (University of Strasbourg), France. He is also qualified as a pharmacist with a certificate of Kampo and natural medicines specialist qualification. He was a researcher at F Hoffmann-La Roche in Basle, Switzerland. He has completed the EU-recognised PharmaTrain course at Osaka University, and is qualified as a board-certified member of the Japanese Association of Pharmaceutical Medicine. He is a member of the AIPPI and vice chair of TRIPS SC and a member of IP-GRTK SC and Pharma SC, and a member of the editorial board of the Pharmaceutical Patent Analyst (UK). He is also a member of JPAA, APAA, IPAJ, PSA, JPA, CSAIP and AAAS. He has lectured in academia, including at Japanese and German universities and WIPO Academy, and contributed to a number of articles.

Hiroya Kuwahara

Department of Neurology and Neurological Science / Institute of Innovation Advancement
Tokyo Medical and Dental University

M.D. (graduated from Tokyo Medical and Dental University), and Ph.D. (completed doctral course at Graduate School, Tokyo Medical and Dental University). Specialist and Attending Neurologist of the Japanese Society of Neurology, and Fellow and Board Certified Member of the Japanese Society of Internal Medicine. He is engaged in 1) clinical practice, research, and education in neurology, 2) research and development of fudamental technologies for drug discovery (especialy nucleic acid drugs and drug delivery system), 3) promotion of clinical research and industry-academia collaboration, at Tokyo Medical and Dental University. He has a career of a Deputy Director at Research and Development Division, Health Policy Bureau, at the Ministry of Health, Labour, and Welfare from 2018 to 2019, and was involved in establishing a nationwide system for promoting clinical research and accelerating venture companies in the healthcare field. He provides consultations on the needs of clinical practice, on collaborative research and field provision in relation to project implementation, and on clinical research and development.