A comprehensive portal site for Medical Innovation Support Office (MEDISO).
Knowledgeable experts support
the practical application of medicines,
medical devices,
and regenerative medicinal products.
What is MEDISO
MEDISO provides support for business ventures, academia,
and individuals intending to put into practical use medicines,
medical devices, and regenerative medicinal products.
Click here for further details.
About the Medical Innovation Support Office
The medical innovation support office matches medical venture companies and academic institutions facing challenges in the practical application of medical products and devices for specialists* who provide detailed consultation and support for solving problems at each stage from research and development to practical use, as well as insurance coverage at clinical sites, while looking ahead to the overall comprehensive advances and dissemination into the global market.
* Specialists in each field provide support for the response to laws and regulations, marketing, business planning, fund rasing, management strategy, intellectual property management, and international development, etc.
This website is operated by Mitsubishi Research Institute, Inc., as a trustee under instructions from the Economic Affairs Division, Health Policy Bureau, and Ministry of Health, Labour and Welfare as a part of the total support for the medical ventures program sponsored by the Ministry of Health, Labour and Welfare.
Support targets
Ventures, academic institutions, and individuals aiming to put into practical use the medicines, medical devices, regenerative medicinal products, and novel drug-discovery technologies or medical materials subject to the Pharmaceuticals and Medical Devices Law.
Details of support
MEDISO provides support for the practical application of medicines, medical devices, regenerative medicinal products, and other products subject to the Pharmaceuticals and Medical Devices Law.
That support includes business planning, financing, advice on laws and regulations, and other assistance as required.
- ●Support method：We provide support via online meeting or e-mail.
- ●Support source：Support is provided in cooperation with experts in R&D, consultants in pharmaceutical affairs, and experts from related organizations including the Ministry of Health, Labour and Welfare.
- ●Remarks：Consultation and support services are free of charge.
Click here for inquiriesIn case the link does not work, please contact us at the email address below
mediso@ml.mri.co.jp
Specialists Introduction
We will introduce registered specialists
(updated as necessary).
Rou Irisawa
IRISAWA Consulting LLC
Main specialty areas
- medicines
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Etc
Worked at Chugai Pharmaceutical Co., Ltd. for 27 years, primarily in antibody drug research and development, CMC regulatory affairs, and quality assurance, from preclinical trials stage to BLA stage. Involved in the BLA of Japan, US and EU approval for the CTD-Q of Actemra, Japan's original first antibody drug. And also involved in Japan BLA for several biologics Genentech original. Since 2017, involved in the development of many new modalities, including three SAKIGAKE designated cell products, and participated in 21 times PMDA consultations responsible for CMC regulatory and QA for cell products and gene therapy products. In 2023, became independent as a CMC regulatory consultant. Author of ""CMC Pharmaceutical Design - CMC Pharmaceutical Strategy in the Era of New Modality Pharmaceuticals"" (Yakuji Nipposha, 2022), and is the overall supervisor of the Japanese translation of A-CELL (CMC Development Guidance for CAR-T). Fellow at Tama University's Medical Care Solutions Research Institute, and a top performer in the regular course of Pharmaceutical Evaluation Science at the University of Tokyo Graduate School of Pharmaceutical Sciences in 2024. Certified in generative AI skills (November 2025). Currently involved in various projects, including serving as CMC lecturer at seminars on how to proceed with the development of CMC for antibody drugs, cell products, gene therapy products, etc for small company to semi-major company.
Kazushi Kamitani
JPRO INCUBATION OFFICE, FOUNDER
Main specialty areas
- medicines
- medical devices
Specialized support fields
- Marketing
- Business planning
- Funding
- Business operation systems
- Specialized support fields
- Etc
He worked for domestic & international life science firms in the areas of product development, marketing, PR&IR, international business, and business development.
After serving the US subsidiary of a Japanese firm as a board director & CFO and the European startup as CEO, he established the incubation office.
He supports oversea startups to explore Japan market from business & administration side, providing info, advisory and functional services.
International MBA, Certified Specialist of Intellectual Property Management, Financial Planner, IT Coordinator
Kazuhiro Takekita
Osaka University Graduate School of Medicine, Department of Vascular Regeneration and Podiatry, Associate Professor
Main specialty areas
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Specialized support fields
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.
Yuki Yamakage
Representative Director, Takashi Shimada Office Co., Ltd.
Managing Partner, BD Consulting Ltd.
Main specialty areas
- medical devices
- regenerative medicine products
Specialized support fields
- Marketing
- Business planning
- Etc
I have experience working for a global medical device company in insurance strategy development and insurance applications for products in a wide range of medical specialties and disease areas, as well as market access work (relevant academic societies, patient groups, government agencies and industry associations). I have now set up my own private practice and provide support to medical device and pharmaceutical companies and new entrants in terms of healthcare and care systems and insurance strategies. I have experience in the insurance application category (C1/C2 applications) for innovative medical devices. I also have a lot of experience in training employees and conducting seminars, most recently on SaMD insurance applications. My motto is to provide consulting services that address the concerns of my clients after explaining information on insurance applications for medical devices in a way that is easy to understand for beginners.
Atsushi Usami
The University of Tokyo Edge Capital Partners Co., Ltd. (UTEC)
Partner and Board Director
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Marketing
- Business planning
- Funding
- Business operation systems
- Specialized support fields
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.
Introduction of measures implemented by public institutions
We will describe the measures from public institutions for pharmaceutical companies,
medical device companies, companies manufacturing regenerative medicinal products, and venture companies.
- The Ministry of Health, Labour and Welfare／
- Pharmaceuticals and Medical Devices Agency (PMDA)／
- Japan Agency for Medical Research and Development (AMED)／
- Cabinet Office／
- Ministry of Economy, Trade and Industry／
- Ministry of Internal Affairs and Communications／
- Small and Medium Enterprise Agency／
- Organization for Small & Medium Enterprises and Regional Innovation, Japan／
- Union of Kansai Governments／
- New Energy and Industrial Technology Development Organization (NEDO)／
- Life Science Innovation Network Japan, Inc. (LINK-J)／
- Japan Science and Technology Agency (JST)／
- Japan External Trade Organization (JETRO)／
- INCJ, Ltd.／
- Osaka Prefecture／
- Tokyo Metropolis／
- Kanagawa Prefecture／
- National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN)
