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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).

Masashi Matsunaga

Biospire Japan Ltd. / Biospire UK Ltd.
CEO

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Marketing
  • Business planning
  • Funding
  • Business operation systems

As an experienced global business development strategist, Dr Masashi Matsunaga provides business soft-landing, clinical and regulatory support to the UK and European market. He also enables to support IP management, marketing and pitch-deck brush-up in the MEDISO support package. He is based at Harwell Science & Innovation Campus, a core UK innovation hub located near Oxford.

Tomohisa Hayasaki

GVA LPC Attorney-at-Law / Partner
The Leader of The Team ""Medical / Healthcare / Cosmetic Industry""

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Marketing
  • Funding
  • Specialized support fields
  • Etc

After registering as a lawyer, I have been handling disputes such as corporate and labor disputes, as well as providing legal support for the designing lawful business models of new businesses and for funding. In addition, I have been providing legal support for businesses in the field of medical and beauty based on my knowledge of laws relating to medicals including the Japanese Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and the Japanese Medical Care Act. In particular, I have been providing extensive support for numerous businesses operating in new field such as Software as Medical Device (SaMD) and Non-Software as a Medical Device (Non-SaMD), telemedicine/home call medical services, and also for companies utilizing medical information by employing new technologies such as AI. I am also addressing legal issues faced by companies using advance technologies. Furthermore, I have expertise in the latest marketing trend and offer advice on marketing strategies based on the Japanese Act against Unjustifiable Premiums and Misleading Representations, advertising regulations in Japan such as medical advertising regulations, and medical and pharmaceutical devices regulations.

Moto Dohi

cdmo.jp Representative

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Business planning
  • Business operation systems
  • Etc

Moto Dohi studied biology and regenerative medicine in the United States before joining Pfizer, where he worked in formulation development, manufacturing process development, and new product launches. He subsequently spent approximately ten years in Switzerland, one of the world’s major pharmaceutical and life science hubs, working across pharmaceutical and CDMO organizations. His experience includes the development of an oncology drug-delivery product, technology transfer, clinical supply, and the resolution of manufacturing and quality challenges. He later earned an MBA from IMD Business School in Switzerland and expanded his responsibilities into finance, corporate transformation, and international business management within the pharmaceutical industry. Today, he leads cdmo.jp as its Representative and CDMO Navigator, connecting pharmaceutical companies and biotech startups with CDMOs in Japan and overseas. His main areas of support include CMC and manufacturing strategy, CDMO selection, technology transfer, GMP and quality, business development and licensing, and international expansion. Drawing on experience across both technical and management functions, as well as Japan and overseas markets, he supports entrepreneurs and researchers in developing practical pathways from promising science to development, manufacturing, and ultimately patient access. He also serves as a reservist in Japan’s Self-Defense Forces.

Masaho Ishino

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Business operation systems
  • Specialized support fields
  • Etc

After engaging in medical research for 25 years, I became a patent attorney (JAPAN). Over the next 20 years, I have supported medical researchers in creating intellectual property and planning research strategies, as well as engaged in contract practice and technology transfer of university IP. Intellectual property strategies for regenerative medicine and other new modalities require not only a high level of expertise in both cutting-edge medical research and intellectual property rights, but also comprehensive knowledge covering clinical development and regulations. Utilizing my experience of contributing to the development research and practical application of university-originated seeds as a representative of an institution responsible for the AMED's Project of Translational and Clinical Research Core Centers and an organizer of nationwide academia intellectual property networks, I aim to contribute to raising the potential of intellectual property of academia/venture.

Yoshinori Shinoki

Pharma Initiative Support LLC

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

He graduated from the Department of Biopharmaceutical Sciences, Kyoto Pharmaceutical University, and is a licensed pharmacist. At Sawai Pharmaceutical Co., Ltd., and Eli Lilly Japan K.K., after taking charge of clinical development, business planning, etc., he acquired experience in planning and implementing various clinical development plans as a project leader for newly developed items in the project management department. In addition, he led NHI price negotiation strategy, post-marketing clinical startegy, and market planning. After that, he built up clinical development department at Global CRO. he also led the planning of the clinical development for Japan for small and biological products, as well as negotiating with regulatory authorities. Recently, in addition to medicines, he also led the development of clinical development strategies of medical devices and the products of regenerative medicine (gene therapy products and cell/tissue processed products).

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