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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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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).

Tsutomu Hoshiba

Kievit Scientific LLC President

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Marketing
  • Business planning
  • Etc

For over 30 years, I've established and managed Japanese life science companies in the US and Europe. In 2021, I founded Kievit Scientific in Philadelphia, utilizing my Western-acquired experience, up-to-date information, and network. I assist Japanese companies in the pharmaceutical, medical device, and chemical sectors in their international expansion, from strategic planning to product development and market entry. Harnessing my understanding of different cultures and wide-ranging scientific knowledge, I provide solutions to challenges faced by Japanese academia and startups in their global ventures, with the aim of supporting as many Japanese companies as possible to succeed overseas. Furthermore, through these endeavors, I promote the widespread adoption of innovative medical technologies, striving to realize a society where the benefits are extended to many.

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.

Yutaka Kono

Guest professor
Drug Discovery Science Division,Institute for Open and Transdisciplinary Research Initiatives, Osaka University

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Business planning
  • Funding
  • Business operation systems
  • Etc

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.

Shunji Okamoto

Smith, Gambrell & Russell, LLP
Attorney at Law

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

After being admitted to the practice of law in Japan in 2010, he focused on corporate and commercial law matters at a law firm. In 2020, he relocated to the United States to pursue an LL.M. degree at Cornell Law School. Since then, he has been advising Japanese companies on a broad range of cross-border legal matters, with a particular emphasis on supporting their expansion into the U.S. market. Licensed in both Japan and New York, he regularly counsels Japanese startups and emerging companies on U.S. market entry, corporate governance, business formation, venture capital and other financing transactions, immigration and visa matters, FDA and other regulatory compliance issues, and the drafting and negotiation of commercial agreements, including business alliance, distribution, and licensing agreements. In addition to his legal practice, he has served as outside counsel to a multinational medical device manufacturer and as an outside director of healthcare-related startup companies in Japan. These experiences enable him to provide practical, business-oriented advice that extends beyond legal analysis to encompass regulatory strategy, corporate governance, and broader business objectives. By combining legal expertise with an understanding of operational realities, he helps clients navigate complex cross-border challenges and achieve their strategic goals in both Japan and the United States.

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