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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).

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.

Shinichi Watanabe

WNW IP ATTORNEYS

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Specialized support fields

Shinichi Watanabe began his career as a patent attorney in 2003, and with the valuable experience gained at global patent law firms. His practice primarily deals with filing and prosecution of domestic and international patent applications in the pharmaceutical and biotechnology fields. Backed up by a wealth of practical experience and technical expertise, he is actively engaged in IP counselling and advises start-up pharmaceutical and biotech companies on patent filing strategies. Recently, he is interested in AI and machine learning, and now also working on support in the interdisciplinary area between life science, IT and AI.

Tetsuo Miura

Specially Appointed Researcher, Center for Clinical Sciences, National Center for Global Health and Medicine

Main specialty areas

  • medicines
  • medical devices

Specialized support fields

  • Marketing
  • Business planning
  • Business operation systems
  • Etc

I worked as a product and business development manager primarily in the fields of diagnostic equipment-reagent systems and medical devices at major foreign pharmaceutical and domestic medical device companies, and also participated in global product development teams at the US and French headquarters. I have medical science knowledge in the fields of infectious diseases, immunology, cardiovascular diseases, metabolism, reproductive medicine, and laboratory medicine, as well as information on the medical field. After mandatory retirement, I served as a senior researcher at the National Center for Global Health and Medicine, responsible for developing and implementing international collaborative clinical research and clinical trials for pharmaceuticals and medical devices with clinical trial networks in Southeast Asian countries. Currently, as part of an industrial-medical collaboration project, I also provide guidance and support to companies in product development with an eye toward exit strategies such as obtaining pharmaceutical or WHO PQ approval, and being included in guidelines in cooperation with related medical sectors and societies.

Yoshimi Naruo

Orizuru Therapeuics, Inc. Associate Director, IP&Legal Ph.D., Patent attorney

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Specialized support fields

Education: Ph.D. in Bioinformatics/Systems Biology, Tokyo Medical and Dental University. Conducted research in systems biology at RIKEN for 3 years (student internship). Experience: 5 years of experience in drug regulatory affairs at an originator pharmaceutical company, followed by 2 years as an in-house IP specialist handling invalidation and infringement matters at a generic pharmaceutical company. Patent prosecution primarily in the fields of pharmaceuticals, biotechnology, and food at an IP law firm. Fulfilling a long-held aspiration to join a startup, she took on the role of Vice President of Legal IP & Strategy at Splink, Inc., where she contributed to winning the Grand Prix at the 3rd IP BASE AWARD hosted by the Japan Patent Office and the 2022 WIPO Global Awards hosted by the World Intellectual Property Organization (WIPO). Currently, she is responsible for intellectual property and legal affairs at Orizuru Therapeutics, Inc., a company aiming to commercialize regenerative medicine derived from iPS cells. She leads the formulation of IP strategies and the development of an IP portfolio. Her strength lies in creating IP strategies with a focus on pharmaceutical regulatory affairs, and she strives to provide practical advice in the face of limited resources and uncertainties surrounding technology and commercialization.

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