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.
In 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.

Yoshinori Shinoki
Pharma Initiative Support LLC
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
He graduated from the Department of Biopharmaceutical Sciences, Kyoto Pharmaceutical University, and is a licensed pharmacist. At Sawai Pharmaceutical Co., Ltd., and Eli Lilly Japan K.K., after taking charge of clinical development, business planning, etc., he acquired experience in planning and implementing various clinical development plans as a project leader for newly developed items in the project management department. In addition, he led NHI price negotiation strategy, post-marketing clinical startegy, and market planning. After that, he built up clinical development department at Global CRO. he also led the planning of the clinical development for Japan for small and biological products, as well as negotiating with regulatory authorities. Recently, in addition to medicines, he also led the development of clinical development strategies of medical devices and the products of regenerative medicine (gene therapy products and cell/tissue processed products).

Hirohumi Shido
Main specialty areas
- medical devices
Specialized support fields
- Etc
I am a UI/UX design expert and specialize in driving product development. As a product manager at a medical startup, he was in charge of renewal and new planning for multiple SaMD products. My experience ranges from planning to obtaining regulatory approval, and I have won a Good Design Award for a healthcare product. These experiences have made me realize the importance of experience design and usability in SaMD products with a diverse mix of stakeholders.

Masaho Ishino
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Business operation systems
- Specialized support fields
- Etc
After engaging in medical research for 25 years, I became a patent attorney (JAPAN). Over the next 20 years, I have supported medical researchers in creating intellectual property and planning research strategies, as well as engaged in contract practice and technology transfer of university IP. Intellectual property strategies for regenerative medicine and other new modalities require not only a high level of expertise in both cutting-edge medical research and intellectual property rights, but also comprehensive knowledge covering clinical development and regulations. Utilizing my experience of contributing to the development research and practical application of university-originated seeds as a representative of an institution responsible for the AMED's Project of Translational and Clinical Research Core Centers and an organizer of nationwide academia intellectual property networks, I aim to contribute to raising the potential of intellectual property of academia/venture.

Hiroyuki Hasegawa
Director of Life Science, Mitsubishi UFJ Capital Co., Ltd.
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Funding
- Business operation systems
He graduated with a master’s degree from the Faculty of Pharmaceutical Sciences, Hokkaido University. In 1994, he joined Daiichi Seiyaku Company (current Daiichi Sankyo Company, Limited) and was in charge of the areas of infectious diseases and cancers in the Department of Post-marketing Surveillance. In 2004, he joined UFJ Capital Co., Ltd. (current Mitsubishi UFJ Capital Co., Ltd.), where he served as an analyst and capitalist. From 2013, he made an attempt to use open innovation for the Development of Emerging Technologies (OiDE) Fund for the purpose of nurturing outcomes from academia-launched research to become the fundamental technology for drug discovery in collaboration with Daiichi Sankyo Company Limited(liquidated in 2023).Since the first fund in 2017, we have been promoting investment activities using a total of 50 billion yen, including the "Mitsubishi UFJ Life Science Fund No. 4" (20 billion yen).Currently, he holds the position of outside director at Kamuipharma, GAIA Biomedicine, and Luxonus Co. Ltd., as well as serving as a fellow for collaboration between industry and academia at Kyoto University Medical Science and Business Liaison Organization.

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