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).

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.

Kazufumi Nakamura

Mitsui & Co. Global Investment, Inc.　Investment Director

Main specialty areas

medicines
regenerative medicine products

Specialized support fields

Business planning
Funding
Business operation systems
Etc

Kazufumi Nakamura is an Investment Director focused on the investment in biotech in US and China. By leveraging his experiences and networks in Pharma, Biotech and Academia, he connects companies to those experts to expand business and gain scientific insight to help the companies succeed with their important missions.
Kazufumi has over 20 years of healthcare and life sciences experience, spanning business development, investment, entrepreneurship and R&D. Prior to joining MGI, he co-founded a biotech to accelerate innovations through academic institutions in Japan. Previously, he engaged in business development and conducted scientific evaluation, and license-in and license-out of pharmaceutical products at Santen Pharmaceuticals. In addition, he was responsible for creating relationships with the leading academic institutions and innovators, gaining Santen early access to innovation. Prior to Santen, he held a number of clinical development roles at Janssen Pharmaceuticals, including the development of Alzheimer’s disease and Rheumatoid arthritis programs.

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.

Nobutaka Tani

Chair Person, Nonprofit Organization Japan Organoid Repository
Independent Consultant (New Business in Life Sciences)

Main specialty areas

medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Business planning
Business operation systems
Specialized support fields

He graduated with a master’s degree from the Department of Synthetic Chemistry, Graduate School of Engineering, University of Tokyo. He led the research and development and the launching new project for medical devices, including blood purification system and brain and heart catheters, at Kaneka Corporation. After that, he was involved in RD of the whole life science, including biopharmaceuticals, as the head of the Life Science RD Center, while investing in medical venture companies such as DDS and establishing joint ventures. He then moved to JSR Corporation and established JSR Life Sciences. He led the launch of the life science project for M&A as the first president since JSR Life Sciences was established. As a part of open innovation, he established a CVC and invested in or acquired venture companies in Japan and overseas, while successively holding the positions of president of the invested companies.

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.

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