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

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).

Saaya Hirai

Globizz Japan Corporation　Osaka Office Director

After studying abroad in New Zealand during junior high school, she became interested in doing business with foreign countries, and after graduating from high school, she entered a university in Taiwan in English and Mandarin Chinese. At university, she majored in international business administration. During her studies, she experienced corporate internships in the U.S. and Taiwan, gaining insight into the business world from her student days. Currently, as a project controller at headquarters, she is in charge of overall project management and strategic planning for companies entering the U.S. market as a project coordinator.

Hitoshi Takuma

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.

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.