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

厚生労働省

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サポーターの紹介
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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).

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.

Hiroya Kuwahara

Department of Neurology and Neurological Science / Institute of Innovation Advancement
Tokyo Medical and Dental University

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Marketing
  • Business operation systems

M.D. (graduated from Tokyo Medical and Dental University), and Ph.D. (completed doctral course at Graduate School, Tokyo Medical and Dental University). Specialist and Attending Neurologist of the Japanese Society of Neurology, and Fellow and Board Certified Member of the Japanese Society of Internal Medicine. He is engaged in 1) clinical practice, research, and education in neurology, 2) research and development of fudamental technologies for drug discovery (especialy nucleic acid drugs and drug delivery system), 3) promotion of clinical research and industry-academia collaboration, at Tokyo Medical and Dental University. He has a career of a Deputy Director at Research and Development Division, Health Policy Bureau, at the Ministry of Health, Labour, and Welfare from 2018 to 2019, and was involved in establishing a nationwide system for promoting clinical research and accelerating venture companies in the healthcare field. He provides consultations on the needs of clinical practice, on collaborative research and field provision in relation to project implementation, and on clinical research and development.

Nao Yoshizawa

GRiT Partners　Law offices/Willsame.co.ltd/Cabinet office advisor for National bioecnomy strategy/Keio university Medical school

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

After leaving the law firm Nishimura Asahi, [the individual] established the law firm GRiT Partners and assumed the role of managing partner. They also serve as the representative of Willsame Corporation and hold qualifications as a lawyer, patent attorney, CFE (Certified Fraud Examiner), Applied Information Technology Engineer, Information Processing Security Support Engineer, and IT Strategist. They have served as a committee member for the formulation of standards in electronic commerce and related information transactions at the Ministry of Economy, Trade and Industry, as an expert in the Cabinet Office's bioecnomy strategy, and as an advisor to Biock. They have been involved in the establishment of the Japan Chapter of Aging2.0 in Silicon Valley and served as a mentor for Alchemist Accelerator. A graduate of the law faculty at Hitotsubashi University, they completed intellectual property and machine learning programs at Stanford University, as well as multiple AI programs at MIT. They serve as a program committee member for the Graduate School of Pharmaceutical Sciences at the University of Tokyo and the Medical Innovation Human Resources Development Course at Tokyo Medical and Dental University. With a deep understanding of international perspectives on digital health, they provide advisory support for startups and pharmaceutical companies' DX (Digital Transformation) programs. They founded the Life Science Incubation Council and focus on launching projects and connecting them with ecosystems both domestically and internationally.

Kazushi Kamitani

JPRO INCUBATION OFFICE, FOUNDER

Main specialty areas

  • medicines
  • medical devices

Specialized support fields

  • Marketing
  • Business planning
  • Funding
  • Business operation systems
  • Specialized support fields
  • Etc

He worked for domestic & international life science firms in the areas of product development, marketing, PR&IR, international business, and business development. After serving the US subsidiary of a Japanese firm as a board director & CFO and the European startup as CEO, he established the incubation office. He supports oversea startups to explore Japan market from business & administration side, providing info, advisory and functional services.
International MBA, Certified Specialist of Intellectual Property Management, Financial Planner, IT Coordinator

Miyuki Nagao

Globizz Japan Corporation　Tokyo Office Director

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

After graduating from a U.S. university, she began her career at Globizz Corp., the U.S. headquarters of Globizz Japan, where she was engaged in FDA registrations and regulatory research across the medical device, pharmaceutical, and food sectors. Through her involvement in a wide range of projects for international clients, she cultivated substantial, practice based expertise in FDA regulatory compliance. She subsequently joined Globizz Japan and currently serves as a Project Coordinator at the Tokyo office. In this capacity, she develops and proposes tailored support plans for companies seeking entry into the U.S. market, while overseeing comprehensive project coordination between U.S.-based consultants and clients. By working closely with a team of subject matter experts—including FDA consultants at the U.S. headquarters—she delivers highly precise and effective regulatory support. Drawing on her direct experience participating in FDA inspections, she also provides on site inspection assistance and collaborates with specialists to offer practical services, including interpretation support, Quality Management System (QMSR) development, Form 483 response preparation, and CAPA planning.

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