医療系ベンチャー・トータルサポートオフィス：MEDISO ( Medical Innovation Support Office )

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.

●Support method：We provide support via online meeting or e-mail.
●Support source：Support is provided in cooperation with experts in R&D, consultants in pharmaceutical affairs, and experts from related organizations including the Ministry of Health, Labour and Welfare.
●Remarks：Consultation and support services are free of charge.

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).

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.

Motohiro Kobayashi

University of Yamanashi Hospital, Clinical Trial Management Office, Associate Professor

Main specialty areas

medicines
regenerative medicine products

Specialized support fields

Regulatory compliance
Business planning
Business operation systems

With over 30 years of practical experience in pharmaceutical companies, ranging from basic research to clinical development, licensing activities, and regulatory audits. Subsequently, I served as a technical expert in the Innovation Commercialization Support & Strategic Consultation Division of the Pharmaceuticals and Medical Devices Agency (PMDA), dealing with regulatory consultation services for academia and venture companies (especially for regenerative medicine products and pharmaceuticals). Currently, I am working in the clinical research support department of a university, supporting physician-led clinical trials and clinical research. I have experienced numerous pre-meetings and face-to-face advice with PMDA. I also have experience in application support for public research and development projects (such as Seeds C, etc.) by the Japan Agency for Medical Research and Development (AMED). In particular, I can provide detailed support for the development of regenerative medicine products (including quality and non-clinical).

Katsuya Hashizume

Beyond Next Venutes Inc.

Main specialty areas

medical devices

Specialized support fields

Marketing
Business planning
Funding

For over 10 years, he has been consistently involved in investing in academia startups. Joined BNV in 2020, focusing on investments in startups in the medical device and digital health sectors. Appointed as an Executive Officer in August 2021. Leads the investment department while also overseeing the community management of portfolio companies. Prior to BNV, he has served as the leader of industry-academic investment group at JAFCO and the chief promoter of JST START. While investing in startups, he has been involved in the company creation of several acedemia startups, including Microwave Chemical (IPO), Biomedical Solutions (M&A) and Bly Medical (M&A). Completed graduate studies at the Keio University Graduate School of Media and Governance.

Kenichi Yamahara

Professor at the Laboratory of Molecular and Cellular Therapy, Institute for Advanced Medical Sciences, Hyogo Medical University
Representative Director of CTEX Co., Ltd.

Main specialty areas

medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Marketing
Business planning
Business operation systems
Specialized support fields

From the time of a former position at the National Cerebral and Cardiovascular Center, he planned and implemented the formulation of the amnion-derived mesenchymal stem cells and investigator-initiated clinical trials for acute grafts versus host disease/Crohn's disease under the support by Health and Labour Sciences Research Grants/AMED. He often had PMDA consultations on the products of regenerative medicine and acquired knowledge of laws and regulations. Taking advantage of the experience, he founded a venture, Japan Biomedical Co., Ltd., which manufactures the domestic bovine serum NeoSERA® for the products of regenerative medicine by satisfying the standards for biological materials in January 2017. Furthermore, in order to aggressively develop investigator-initiated clinical trials of cell therapy making use of university hospital infrastructures, he founded a venture, CTEX Co., Ltd., from Hyogo Medical University in February 2018. Recently, he participated as a medical expert in the company developing the regenerative medical product and is a principal investigator for investigator-initiated clinical trials for the development of cell therapy in the medical device category (adopted by AMED). Currently, he is working on the practice of cell therapy development initiated at the university hospital while concurrently serving in the basic and clinical departments of Hyogo Medical University.

Tomoyo Mori

Fast Track Initiative, Inc.　Capitalist

Main specialty areas

medical devices

Specialized support fields

Marketing
Business planning
Funding
Business operation systems
Etc

Tomoyo obtained her medical license and began her career by engaging in training and clinical practice in medically underserved areas. She then joined the Department of Cardiovascular Medicine at Tokyo Women's Medical University Hospital, where she treated patients with heart failure, heart transplants, and myocardial infarctions. At the university hospital, she also participated in clinical trials for medical device startups. In parallel with her clinical work, she was involved in domestic and international business development for medical device startups and led a team while participating in U.S.-based MedTech accelerators (MedTech Innovator, Fogarty Innovation). She holds an MBA from the University of Michigan's Ross School of Business and is a board-certified internist by the Japanese Medical Specialty Board as well as a certified occupational physician by the Japan Medical Association. Currently, she is part of Fast Track Initiative, where she focuses on investment, company creation, and business development for medical device startups.

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