Our site uses cookies to improve the contents of the site and customize it according to individual use. Please confirm that you agree to our use of cookies by clicking Yes.

If you continue without explicit consent,
we will assume that you agree to our cookie policy.

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

厚生労働省

Knowledgeable experts support
the practical application of medicines,
medical devices,
and regenerative medicinal products.

2026年4月28日（火）～2026年5月6日（水）は、休業とさせていただきます。
この期間中にお受けしたお問い合せ・ご相談の申込みについては、休業明けに対応させていただきます。
何卒ご了承のほどお願いいたします。

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.

Click here for inquiries

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).

Akihiko Watanabe, Ph.D.

President, GlobalHumanScienceInnovation; Senior Consultant, Headland Strategy Group; Visiting Professor, Gifu Pharmaceutical University; BD Consultant, United Immunity; Executive Advisor, SOKK Japan

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Marketing
  • Business planning
  • Funding
  • Business operation systems

With R&D expertise atJapanese and global pharmaceutical companies as a backbone, he has been engaged in marketing, BD, management planning and fundraising, in addition to R&D. In the Editorial Committee of the Pharmaceutical Society of Japan, he organized roundtable discussions and special issues on practical application of academia seeds. He has been thinking about how Japanese bio-ventures can succeed. Over the past five years, he has worked at bio-venture companies as CBO or VP of BD and open innovation. He is also engaged in the making and analysing stratetgies of management, business, R&D, and marketing for pharmaceutical companies and bio-ventures on commission from a US consulting firm.

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.

Akiyo Inoko Hewett

Attorney, Smith, Gambrell & Russell, LLP

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Business planning
  • Funding
  • Business operation systems
  • Specialized support fields

Akiyo Inoko Hewett is a bilingual and double-licensed attorney based in Atlanta, Georgia, United States. She graduated from Tokyo University of Foreign Studies and earned her J.D. at Keio Law School. After passing the Japanese bar exam and completing her legal training in Kushiro, Hokkaido, Akiyo relocated to the United States. She earned an LL.M. from Emory University School of Law in Atlanta, Georgia. Currently, Akiyo serves as an attorney at Smith, Gambrell & Russell, LLP, where she provides legal services to Japanese companies doing business in the United States and supports clients across a broad range of corporate matters. Her practice areas include international and domestic commercial transactions, regulartory compliance, healthcare law, and immigration law.

Tamaki Nara

Lecturer, Medical Technology Innovation Center, Juntendo University
Director, Orbis Planning Co., Ltd.

Main specialty areas

  • medical devices

Specialized support fields

  • Regulatory compliance
  • Marketing
  • Business planning
  • Business operation systems

Master of Business Administration（MBA）. Field of expertise is innovation management. While working at a major precision equipment manufacturer, engaged in new business, product planning, and corporate planning. Mainly engaged in commercialization in the medical equipment and healthcare field (such as Medical IT), as well as the establishment and management of internal joint ventures. During this time, I became acutely aware of the great significance of building an appropriate collaborative development system between medical researchers and companies, and the necessity of a place for co-creation for both parties to work together. Since then, I have been involved in providing guidance on the implementation of research and development in the medical field and building plans for industry-academia collaboration, leveraging corporate technology and academia's knowledge at medical graduate schools and hospitals. Also have been supporting Start-ups mainly from academia.

Motohiro Kobayashi

University of Yamanashi Hospital, Clinical Trial Management Office, Associate Professor

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Business planning
  • Business operation systems

With over 30 years of practical experience in pharmaceutical companies, ranging from basic research to clinical development, licensing activities, and regulatory audits. Subsequently, I served as a technical expert in the Innovation Commercialization Support & Strategic Consultation Division of the Pharmaceuticals and Medical Devices Agency (PMDA), dealing with regulatory consultation services for academia and venture companies (especially for regenerative medicine products and pharmaceuticals). Currently, I am working in the clinical research support department of a university, supporting physician-led clinical trials and clinical research. I have experienced numerous pre-meetings and face-to-face advice with PMDA. I also have experience in application support for public research and development projects (such as Seeds C, etc.) by the Japan Agency for Medical Research and Development (AMED). In particular, I can provide detailed support for the development of regenerative medicine products (including quality and non-clinical).

About details of specialists

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.

See more about measures implemented by public institutions