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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).

Rou Irisawa

IRISAWA Consulting LLC

Main specialty areas

  • medicines
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Etc

Worked at Chugai Pharmaceutical Co., Ltd. for 27 years, primarily in antibody drug research and development, CMC regulatory affairs, and quality assurance, from preclinical trials stage to BLA stage. Involved in the BLA of Japan, US and EU approval for the CTD-Q of Actemra, Japan's original first antibody drug. And also involved in Japan BLA for several biologics Genentech original. Since 2017, involved in the development of many new modalities, including three SAKIGAKE designated cell products, and participated in 21 times PMDA consultations responsible for CMC regulatory and QA for cell products and gene therapy products. In 2023, became independent as a CMC regulatory consultant. Author of ""CMC Pharmaceutical Design - CMC Pharmaceutical Strategy in the Era of New Modality Pharmaceuticals"" (Yakuji Nipposha, 2022), and is the overall supervisor of the Japanese translation of A-CELL (CMC Development Guidance for CAR-T). Fellow at Tama University's Medical Care Solutions Research Institute, and a top performer in the regular course of Pharmaceutical Evaluation Science at the University of Tokyo Graduate School of Pharmaceutical Sciences in 2024. Certified in generative AI skills (November 2025).　Currently involved in various projects, including serving as CMC lecturer at seminars on how to proceed with the development of CMC for antibody drugs, cell products, gene therapy products, etc　for small company to semi-major company.

Tomohiko Goto

TAIYO Pharma Co.,Ltd CMC Solutions Dept. Manager

Main specialty areas

  • medicines

Specialized support fields

  • Etc

Having extensive experience and achievements in formulation development, new drug application processes, investigational drug formulation development, support for overseas clinical trials, plant construction and GMP acquisition through long years at a pharmaceutical company, and more recently, engaging in CMC activities for investigational drug development and clinical trial advancement at a medical bio-venture company within Shonan i-Park(Kanagawa,Japan), I hope to contribute as a part-time CMC supporter for MESIDO. I am passionate about supporting the swift delivery of unmet need pharmaceuticals developed by domestic and international medical pharmaceutical venture companies to patients. Among many support areas, if I can contribute my specialized and niche knowledge in the CMC field (particularly in formulation development) to address challenges in cutting-edge bio-venture research worldwide through the MEDISO project, and support quicker entry into clinical trials, it would be most gratifying.

Yumi Kawata ,MD, PhD

Hedgehog MedTech, Inc.

Main specialty areas

  • medical devices

Specialized support fields

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

She is Founder and CEO of Hedgehog MedTech, Inc, a start-up Digital Therapeutics (DTx) company. Previously, she was a manager with SoftBank Corp, where she evaluated new Healthcare & Life Science investment opportunities, managed relationships with strategic partners. Prior to SoftBank, she was a Government Relations specialist with Medley, Inc, where she built and maintained the relationships with Ministry of Health, Labour and Welfare and Academia. She launched researches and POCs, contributing to the spread of telemedicine in Japan. She also served as a technical officer for MHLW. she was involved in the management of researches on Rare and Intractable diseases and Infectious Diseases.

Kensuke Suzuki

Nagashima Ohno & Tsunematsu
Partner, 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

Kensuke Suzuki is a partner at Nagashima Ohno & Tsunematsu. He represents both domestic and international clients, with a special focus on cross-border transactions, with respect to pharmaceutical, medical and healthcare business, M&A and corporate transactions, fund formation and management, and financial regulations. With expert knowledge of the Japanese medical, pharmaceutical, medical device, and other various healthcare-related regulations, he advises on a wide variety of business activities in the broad healthcare sector, such as regulatory compliance, data protection, mergers and acquisitions, alliances, business startups, financing, licensing and other commercial transactions. He was admitted to the Japan Bar in 2000 and worked as visiting attorney at Kirkland & Ellis （Chicago） from 2006 to 2007. He served as a special adviser to the Ministry of Health, Labour and Welfare from 2014 to 2015. He is fluent in Japanese and English.

Yoshiki Kawabata

President, MedX Inc.

Main specialty areas

  • medical devices
  • regenerative medicine products

Specialized support fields

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

Advantage from over 35 years of multiple company & responsibility experience in medical device industry, helping foreign companies to enter into Japanese market. Key highlights in the past achievements are : with Johnson & Johnson Mdecial Company, worked with US R&D team to develop new product which reflecting Japanese patient and physicians needs - three years resided in Cincinnati, Ohio: HeartFlow Inc., which developed the first "program device" - FFRCT, enabling non-invasive detection of FFR, applied and received regulatory approval and reimbursement as a first product and company. : in Palette Lifesciences Japan, establishment of new subsidiary for start-up company which transferred the business from exclusive distributor. Started with minimum number of direct resources and having multiple partnerships with logistics, finance and regulatory affairs, revitalized the business and achieved a 149% growth over the last year of distributor.

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