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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.

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.

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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).

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).

Kenji Harada

Director & Chief Venture Capitalist, Medical Incubator Japan K.K

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

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

He graduated with a Ph.D. in Pharmacology from the Faculty of Pharmaceutical Sciences, the University of Tokyo, and is an immunologist by training. He is also a licensed pharmacist and a licensed first-class radiation supervisor. After obtaining his doctorate, he performed a wide range of tasks from basic research to preclinical research as a team leader at Toray Basic Research Laboratories (currently Pharmaceutical Research Laboratories), during which he was developing anti-inflammatory and central nervous system drugs. Subsequently, he was involved in planning and promoting collaborative research with universities and making assessments of platform technologies and drug candidates of American and European biotech startup companies from the technological and intellectual aspects. Furthermore, he conducted GMP inspections in pharmaceutical products and medical device areas multiple times. After starting his career as a venture capitalist, he consistently invested in the biotech sector in the U.S. and Japan. He served as a board member in some of the investees of the U.S. and Japan. Since August 2020, He has expanded his investments into European countries at his current company. He is also engaged in several Japanese governmental projects supporting Japanese startups and research projects.

Akiko Yamamoto

Nissan Chemical Corporation
Risk Management ＆Compliance Office
Risk Management Department

Main specialty areas

  • medicines

Specialized support fields

  • Regulatory compliance
  • Business operation systems
  • Etc

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.

Nobutaka Tani

Chair Person, Nonprofit Organization Japan Organoid Repository
Independent Consultant (New Business in Life Sciences)

Main specialty areas

  • medical devices
  • regenerative medicine products

Specialized support fields

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

He graduated with a master’s degree from the Department of Synthetic Chemistry, Graduate School of Engineering, University of Tokyo. He led the research and development and the launching new project for medical devices, including blood purification system and brain and heart catheters, at Kaneka Corporation. After that, he was involved in RD of the whole life science, including biopharmaceuticals, as the head of the Life Science RD Center, while investing in medical venture companies such as DDS and establishing joint ventures. He then moved to JSR Corporation and established JSR Life Sciences. He led the launch of the life science project for M&A as the first president since JSR Life Sciences was established. As a part of open innovation, he established a CVC and invested in or acquired venture companies in Japan and overseas, while successively holding the positions of president of the invested companies.

Masatoshi Tachibana

BPM Consulting Office Representative

Main specialty areas

  • medicines
  • medical devices

Specialized support fields

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

He worked in the medical device division of a precision equipment company for over 25 years, working in a series of tasks spanning the product life cycle, including marketing (domestic and overseas market research, business development), product planning, legal and regulatory compliance, quality management system construction. He has experience managing numerous projects, including those outside the company also. His policy in conducting business is to maximize the performance of the organization by promoting overall optimization, making decisions based on a bird's-eye view, and building good relationships with all of stakeholders. Based on these knowledge and policies, He provides fact-based and risk-based support to ventures and small and medium-sized enterprises aiming for practical application in the medical field.

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