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

Miyuki Shimizu

Medical Lab Partners Corporation

She graduated from the Graduate School of Natural Science, Chiba University. She holds the degrees of doctor of medicine and master of management information. She worked on the development of medical devices and pharmaceutical products in a wide range of fields related to transfusions, surgical operations, general-purpose medical devices, dialysis, and rehabilitation at Terumo Corporation. She also has experience in a series of project developments from planning a project to commercializing at a medical practice, as well as experience in management. Since 2015, she has provided consulting services to more than 350 companies entering the medical industry as her current role. She is trying to provide consulting services with the viewpoint of the individual company in mind.

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.

Hirokazu Yamaguchi

Satoshi Ogawa

TMI Associates Partner (Attorney)

Satoshi Ogawa, Ph.D., is a partner at TMI Associates specializing in life sciences and healthcare. After earning his Ph.D. in Life Sciences from Kyoto University, he joined TMI Associates as an attorney. Following a three-year secondment at a law firm in New Delhi, India, he has been based at TMI’s Kyoto Office since 2019. Dr. Ogawa advises both Japanese and international clients on cutting-edge technologies, including regenerative medicine, digital health, and AI-driven healthcare solutions. His work covers startup support, patent licensing, industry–academia collaboration, regulatory compliance, and intellectual property disputes. He works extensively with universities, startups, pharmaceutical and medical device companies, venture capital firms, and public institutions. He also serves as an advisor to BioCommunity Kansai (BiocK) and HVC KYOTO, and contributes to conflict-of-interest (COI) committees and institutional review boards (IRBs). Dr. Ogawa is passionate about advancing innovation and helping clients navigate complex legal and regulatory challenges in the life science ecosystem. His publications include “Startup Intellectual Property and Legal Guidebook – Key Points for Early-Stage Bio and Life Science Ventures” (METI-Kansai) and “Healthcare Business Legal Consultation Handbook” (Chuokeizai-sha).

Mirai Miyahara

President of i Access Consulting Inc.

Miyahara holds a Master's degree in Business Administration from the Graduate School of Economics at Tohoku University. She possesses 17 years of professional experience in Regulatory Affairs, QMS, business planning, and overseas marketing at a leading medical device company and Notified bodies in Japan. With a specific focus on multi-country regulatory compliance and extensive experience in overseas medical device markets, Miyahara has demonstrated proficiency in navigating the regulatory landscapes of diverse markets, including Japan, China, India, East Southern Asia, EU and the U.S. She has a proven track record of achieving success in supporting medical companies with regulatory compliance, facilitating international expansion, and establishing strategic partnerships with local entities. Miyahara is also an adviser for JETRO medical devices international expansion program.