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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).

Kazuhiro Kanmuri

Inter-Professional Inc.

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Marketing
  • Business operation systems

He engaged in pharmaceutical research and development for more than 25 years. He has gained experience in Japan and in the US development organization of Daiichi Sankyo Co., Ltd., Pfizer Inc., and CRO/consulting organizations, and has been deeply involved in strategic/regulaotry planning of clinical developmentincluding overseas organizations. His specialized fields are extensive, which include company clinical trials and investigator-initiated clinical trials, organization management, strategy development, and clinical trial operation/implementation, safety and pharmacovigillance, and he is active in the academic area of regulatory science. Currently, he engages in the consulting business as an expert in clinical development/organization and human resources development through the corporation that he established by himself and specialized CRO. In addition to being the incumbent, he concurrently served as a visiting lecturer of an academia organization, and he belongs to DIA Japan, an industry association of the pharmaceutical industry, and served as the Vice Program Committee Chair of the DIA Japan annual convention in 2018.

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

Main specialty areas

  • medical devices

Specialized support fields

  • Business planning
  • Business operation systems
  • Etc

After working at Fujitsu Ltd. on the development of products and services such as image processing system and cloud information service for home healthcare, as well as research and development in information retrieval and AI, and new business development, I engaged in the construction of a pulmonary hypertension patient registry at the International University of Health and Welfare Mita Hospital. Since 2020, I have been serving as CDO at Cardio Intelligence Inc., responsible for the development of software medical devices for arrhythmia analysis and regulatory affairs. Since 2021, I have also been serving as COO, overseeing overall business planning and execution.

Akiko Yamamoto

Nissan Chemical Corporation
Environment, Safety and Quality Assurance Department
Quality Assurance Group
Senior Advisor (contract employee)

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.

Takato Noumi

Representative Director, FORESIGHT&LINX Cp., Ltd.

Main specialty areas

  • medicines

Specialized support fields

  • Business planning
  • Funding
  • Business operation systems

At his consulting company, he is currently providing practical support for constructing research strategies, business development, and licensing regarding to drug discovery to pharmaceutical companies and biotech venture companies in Japan and overseas. After completing his postgraduate course, he worked in basic research in molecular biology for 10 years followed by joining the Research Division of the headquarters of Novartis. Subsequently he served as the head of theTsukuba Research Laboratories of GlaxoSmithKline K.K. He had engaged in drug discovery research from a global point of view for 15 years. After that, he has been involved in searching for and evaluating drug discovery seeds and technologies and developing international businesses and licensing at Sanofi S.A. in France and his own consulting company for 10 years. He has a broad network of connections with pharmaceutical companies, biotech venture companies, academia, and venture capital firms in Japan and overseas.

Hikaru Saito

Saisei Ventures LLC Partner

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

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

As a partner of Saisei Ventures, a newly established global venture capital firm that invests in advanced biotech companies in cell and gene therapy, Dr. Saito is responsible for Japan operations including company creation, integrating Japanese science and technology with the Western ecosystem. Prior to joining Saisei, he started career as a research scientist at Astellas Pharma Inc. and then as a Senior Manager of Business Development and as a Senior Investment Manager at Astellas Venture Management, a CVC arm based in Silicon Valley, USA, where he was a lead role for deal process, due diligence and transactions for venture investments in RNA therapeutics, cell and gene therapy. He was providing business support to portfolio companies based on the expertise, experience, and global network. He also led the development of strategic partnerships with venture capital funds, accelerators, and institutional investors based in the U.S. and Europe. Prior to joining Astellas, he was a Visiting Fellow at the Institute of Medical Science, University of Tokyo, and a Research Fellow of the Japan Society for the Promotion of Science. He received his B.S. in Biotechnology and M.S. and Ph.D. in Biomolecular Molecularl Engineering from Tokyo Institute of Technology.

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