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

Hiroki Yamada

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

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.

Hikaru Saito

Saisei Ventures LLC Partner

As a partner of Saisei Ventures, a newly established global venture capital firm that invests in advanced biotech companies in cell and gene therapy, Dr. Saito is responsible for Japan operations including company creation, integrating Japanese science and technology with the Western ecosystem. Prior to joining Saisei, he started career as a research scientist at Astellas Pharma Inc. and then as a Senior Manager of Business Development and as a Senior Investment Manager at Astellas Venture Management, a CVC arm based in Silicon Valley, USA, where he was a lead role for deal process, due diligence and transactions for venture investments in RNA therapeutics, cell and gene therapy. He was providing business support to portfolio companies based on the expertise, experience, and global network. He also led the development of strategic partnerships with venture capital funds, accelerators, and institutional investors based in the U.S. and Europe. Prior to joining Astellas, he was a Visiting Fellow at the Institute of Medical Science, University of Tokyo, and a Research Fellow of the Japan Society for the Promotion of Science. He received his B.S. in Biotechnology and M.S. and Ph.D. in Biomolecular Molecularl Engineering from Tokyo Institute of Technology.

Hitoshi Fujimaki

TMI Associates Attorney-at-law (admitted in Japan and New York)

Joined TMI Associates in 2016. Completed an LL.M. in National and Global Health Law at Georgetown University Law Center in 2023, earning the Food & Drug Law Certificate. Admitted to the New York State Bar in 2024. The practice focuses on pharmaceutical, medical device, and healthcare regulatory matters in both Japan and the United States, with extensive experience supporting R&D and commercial operations of Japanese companies domestically and abroad. Work includes licensing and collaboration agreements with overseas partners, joint research and development arrangements, CRO agreements, GCP compliance during clinical trials, promotional review, regulatory assessments (including medical-device classification), authority inspections, and broad advisories on pharmaceutical and medical-device regulations. Also advises on U.S. healthcare compliance issues, including the Anti-Kickback Statute, the Sunshine Act, and related federal and state requirements. Author of Introduction to U.S. FDA Drug and Medical Device Law and Regulation (Shojihomu, September 2024).

Tetsuomi Takano

t2T Healthcare Inc. CEO／Drug R&D Expert Editor-in-Chief

Tetsuomi Takano possesses over 33 years of clinical development experience spanning multiple therapeutic areas. He has accumulated extensive expertise in development strategy, project management, clinical development, regulatory intelligence, and regulatory affairs across Asian countries and regions including Japan and China. He previously held key positions in the clinical development departments at Astellas Pharma, overseeing processes from IND applications for first-in-human studies to NDA approvals in Asian countries and regions. A graduate of Tokyo University of Science's Faculty of Pharmaceutical Sciences and a RPh, his career began in 1986 at Astellas, where he worked for 31 years till 2017. After working as Senior Strategy Director, Strategy & Planning at Covance (currently Fortrea) from 2017 to 2023, he founded t2T Healthcare Inc. in October 2023. The company is dedicated to providing clients with efficient and distinctive strategic solutions to facilitate operational implementation, clinical development, and IND/NDA programs across the Asia-Pacific region. Additionally, he serves as a member of the PMDA China Expert Committee since 2020 and co-founded the web journal “Drug R&D Expert” in 2021, where he holds the positions of Editor-in-Chief and primary author.