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

Yasuhisa Matsukawa

Kazuhiro Takekita

Osaka University Graduate School of Medicine, Department of Vascular Regeneration and Podiatry, Associate Professor

He was involved in launching a project of regenerative medicine by using autologous skeletal muscle-derived cell sheets in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University. Subsequently, he was involved in the evaluation of regenerative and biological devices at the Pharmaceuticals and Medical Devices Agency (PMDA). He performed several duties related to the Health Labour Sciences Research Grant, clinical study of human stem cells, and advanced medical care at the Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare. After that, he led the regenerative medical product evaluation unit as chief of the Office of Review for Regenerative Medical Product, PMDA. Also, he was involved in improving the legislation for regenerative medical products in the revision of the Pharmaceutical Affairs Law in 2014. From August 2017, he has been serving as a specially appointed lecturer in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University, where he promotes projects to develop various products derived from human-induced pluripotent stem cells.

Kensuke Suzuki

Nagashima Ohno & Tsunematsu
Partner, Attorney-at-law

Kensuke Suzuki is a partner at Nagashima Ohno & Tsunematsu. He represents both domestic and international clients, with a special focus on cross-border transactions, with respect to pharmaceutical, medical and healthcare business, M&A and corporate transactions, fund formation and management, and financial regulations. With expert knowledge of the Japanese medical, pharmaceutical, medical device, and other various healthcare-related regulations, he advises on a wide variety of business activities in the broad healthcare sector, such as regulatory compliance, data protection, mergers and acquisitions, alliances, business startups, financing, licensing and other commercial transactions. He was admitted to the Japan Bar in 2000 and worked as visiting attorney at Kirkland & Ellis （Chicago） from 2006 to 2007. He served as a special adviser to the Ministry of Health, Labour and Welfare from 2014 to 2015. He is fluent in Japanese and English.

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.

Masashi Matsunaga

Biospire Japan Ltd. / Biospire UK Ltd.
CEO

As an experienced global business development strategist, Dr Masashi Matsunaga provides business soft-landing, clinical and regulatory support to the UK and European market. He also enables to support IP management, marketing and pitch-deck brush-up in the MEDISO support package. He is based at Harwell Science & Innovation Campus, a core UK innovation hub located near Oxford.