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

Osamu Tabuchi

JMDC Inc. Quality Assurance Office manager

I am a dedicated professional with extensive experience in safety management and post-marketing surveillance (PMS) in the pharmaceutical industry. After joining SANWA KAGAKU KENKYUSHO CO., LTD., I focused on risk management for diabetes medications and treatments for dialysis complications. My work included PMS literature development and cardiovascular event evaluations, contributing significantly to drug development.
At CureApp, Inc, a company specializing in software as medical devices, I served as the Safety Management Officer. I successfully established the safety management system and operational processes for Japan's first therapeutic app. My involvement in risk management for various therapeutic applications, including those for hypertension, allowed me to engage deeply with the core aspects of product development.
Currently, I am the Head of Quality Assurance at JMDC, Inc, where I oversee GxP compliance and reliability assurance. I am actively involved in building a new PMS framework that combines e-source data with additional collected data, as well as managing certification acquisition and maintenance.

Takayuki Hirose

Patent attorney, Hirose International Patent Firm

He graduated with a master’s degree from the Graduate School, University of Tokyo. Patent attorney. After working in the intellectual property department in a major company, he was involved in lawsuit-, adviser- and application-relating services at a lawyer's office, followed by establishing his own international patent attorney's office in 2017. He offers intellectual property strategies in cooperation with companies as an adviser for multiple companies, including the Japanese Organization for Medical Device Development, Inc., (JOMDD) and Shin Nippon Biomedical Laboratories, Ltd. Furthermore, he applies for patent rights and trademarks in a wide variety of areas. He is involved in intellectual property-related services that include medical devices and pharmaceutical products. When he applies for a patent in foreign countries, he offers application strategies by placing the most importance on client’s profit, for example, to give advice to receive a subsidy or to select a foreign agent at a reasonable price depending on the company’s size.

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.

Atsushi Usami

The University of Tokyo Edge Capital Partners Co., Ltd. (UTEC)
Partner and Board Director

He holds a Ph.D. in pharmaceutical sciences from the University of Tokyo and is a licensed pharmacist. Prior to joining UTEC in October 2013, he worked as a consultant at Mitsubishi Research Institute. Currently serving as a Partner and Board Director, he oversees venture investments and provides management support primarily in the life sciences sector for seed and early-stage startups. He has played a key role in investments in companies such as OriCiro Genomics, Inc. (acquired by Moderna, Inc.) and Repertoire Genesis, Inc. (acquired by Eurofins Scientific SE). In recognition of his contributions, he was awarded the Encouragement Award for Venture Capitalists at the 23rd Japan Venture Awards in 2023.

Yasuhisa Matsukawa