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 )

2026年8月8日（土）～2026年8月17日（月）は、休業とさせていただきます。
この期間中にお受けしたお問い合せ・ご相談の申込みについては、休業明けに対応させていただきます。
何卒ご了承のほどお願いいたします。

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).

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.

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.

Mineki Takechi

Cardio Intelligence Inc. Chief Development Officer
Director

Main specialty areas

medical devices

Specialized support fields

Business planning
Business operation systems
Etc

After working at Fujitsu Ltd. on the development of products and services such as image processing system and cloud information service for home healthcare, as well as research and development in information retrieval and AI, and new business development, I engaged in the construction of a pulmonary hypertension patient registry at the International University of Health and Welfare Mita Hospital. Since 2020, I have been serving as CDO at Cardio Intelligence Inc., responsible for the development of software medical devices for arrhythmia analysis and regulatory affairs. Since 2021, I have also been serving as COO, overseeing overall business planning and execution.

Kazuhiro Takekita

Osaka University Graduate School of Medicine, Department of Vascular Regeneration and Podiatry, Associate Professor

Main specialty areas

regenerative medicine products

Specialized support fields

Regulatory compliance
Specialized support fields

He was involved in launching a project of regenerative medicine by using autologous skeletal muscle-derived cell sheets in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University. Subsequently, he was involved in the evaluation of regenerative and biological devices at the Pharmaceuticals and Medical Devices Agency (PMDA). He performed several duties related to the Health Labour Sciences Research Grant, clinical study of human stem cells, and advanced medical care at the Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare. After that, he led the regenerative medical product evaluation unit as chief of the Office of Review for Regenerative Medical Product, PMDA. Also, he was involved in improving the legislation for regenerative medical products in the revision of the Pharmaceutical Affairs Law in 2014. From August 2017, he has been serving as a specially appointed lecturer in the Department of Cardiovascular Surgery, Graduate School of Medicine, Osaka University, where he promotes projects to develop various products derived from human-induced pluripotent stem cells.

Tomokazu Ichikawa

Director, TM Research and Investments Pte. Ltd.

Main specialty areas

medical devices

Specialized support fields

Regulatory compliance
Business planning
Funding

Leveraged cross-functional expertise in business strategy and legal to work on strategy development, M&A, and investments in the medical device sector. Practiced law at Nagashima, Ohno and Tsunematsu, handling M&A and other corporate matters. Worked for McKinsey & Company and Hoya Corporation. Completed several acquisitions and investments in the US and Europe in the medical device business. Experienced managing a healthcare service operator in India. Currently, helping AI Medical Service, an artificial intelligence software startup for endoscope and CUC, a healthcare service provision related company. Spent more than 10 years in Singapore and familiar with business in Southeast Asian countries. Graduated from Waseda University, London Business School's Masters in Finance, and Cambridge's MBA. Attorney at law admitted in Japan.

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