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MEDISOA comprehensive portal site for Medical Innovation Support Office (MEDISO).Medical Innovation Support Office

厚生労働省

2024年8月9日(金)~2024年8月18日(日)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.

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.

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.

Daisuke Sugiyama

Hiroshima University, Translational Research Center, Professor

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

  • Regulatory compliance
  • Funding
  • Business operation systems
  • Specialized support fields
  • Etc

He obtained his PhD thesis at University of Tokyo. After working at several hospitals as a clinician, he has engaged in medical reserach at University Paris 6 (French Government Scholar), Dartmouth College (JSPS research fellow), Kyushu University and Hiroshima University. Based on the experiences working at ARO research core hospital and starting up bio-venture company, he supports and conducts both translational and clinical researches.

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.

Takeshi komatani

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

Takeshi S Komatani is currently principal litigation certified patent attorney in the field of chemical/pharma and bio/life sciences at a patent law firm, and has a number of counsels, including in academia, start-ups and big pharma internationally. Takeshi received his PhD from the University of Tokyo, Japan, received his LLB and LLM (global legal practice) from Keio University, and is currently a visiting professor at Kobe University, teaching IP strategy in entrepreneurship and Doshisha University (Kyoto). He has completed CEIPI Summer School on IP (University of Strasbourg), France. He is also qualified as a pharmacist with a certificate of Kampo and natural medicines specialist qualification. He was a researcher at F Hoffmann-La Roche in Basle, Switzerland. He has completed the EU-recognised PharmaTrain course at Osaka University, and is qualified as a board-certified member of the Japanese Association of Pharmaceutical Medicine. He is a member of the AIPPI and vice chair of TRIPS SC and a member of IP-GRTK SC and Pharma SC, and a member of the editorial board of the Pharmaceutical Patent Analyst (UK). He is also a member of JPAA, APAA, IPAJ, PSA, JPA, CSAIP and AAAS. He has lectured in academia, including at Japanese and German universities and WIPO Academy, and contributed to a number of articles.

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