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

厚生労働省

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).

Miyuki Nagao

Globizz Japan Corporation Tokyo Office Director

Main specialty areas

  • medicines
  • medical devices
  • regenerative medicine products

Specialized support fields

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

After working at U.S. headquarters as an assistant for FDA registrations, FDA filings, and regulatory investigations for medical devices, pharmaceuticals, and food products, she moved to GLOBITS' Tokyo office to work as a project coordinator. While proposing and coordinating projects related to Japanese companies' entry into the U.S. market, she also provides support for attending and responding to FDA inspections in various fields, advises on FDA registration, conducts brief investigations, and teaches seminars.

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.

Masato Kishida

Main specialty areas

  • medicines

Specialized support fields

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

My global achivements are categorized in two main types as follows: 1. Succesfully cordinating and facilitating several business globalization projects of some orphan products for CNS disorders and inherited metabolic disorders as a project leader, and 2. Outstanding success in the legal entities' establishment of three key area, e.g., a global clinical development head office in EU, two clinical and RA offices in the US & Brazil and an ASEAN region business head office in Singapore. Global business expansion is composed of two main phase. First one is to elaborate specific business plan from global business policy to clinical development strategy to draw the master of global business big picture. Next one is to implement the fixed road map and steamlined action plans on the timeline basis under the frequent risk assessment and business environment analysis.

Kazuhiro Terashima

CaTe inc. CEO
Fujita Health University, Department of Cardiology, Assistant Professor

Main specialty areas

  • medical devices

Specialized support fields

  • Business planning
  • Funding
  • Business operation systems
  • Etc

Cardiologist, Fellow of Cardiovascular Intervention and Therapeutics, Registered Cardiac Rehabilitation Instructor, Certified Occupational Health Physician and Clinical Education Instructor. He graduated from Nagoya University School of Medicine in 2011. After working at the Japanese Red Cross Aichi Medical Center, Nagoya Daiichi Hospital, Sakakibara Memorial Hospital and other institutions, he joined Fujita Health University in 2023 as Assistant Professor of Cardiology and CCU Instructor. In 2020, he founded CaTe Inc. to research and develop programmed medical devices for cardiac rehabilitation, and to conduct clinical research and company-led clinical trials of such devices. He is currently the principal investigator for basic research on the Exercise Load Optimization function, a promising technology seed. In 2023 he closed Series A funding with JAFCO etc. as lead investor. While continuing his clinical work, he serves as CEO of the company and advises and supports other clinicians in the social implementation of clinical technology seeds.

Tomoko Maeda-Chubachi

TMC Clinical Development Consulting, Inc, President; The Institute of Drug Development Career Promotion, Founding Director; Japan Alliance of Medical School Startups, Director

Main specialty areas

  • medicines

Specialized support fields

  • Regulatory compliance
  • Business planning
  • Business operation systems
  • Etc

Dr. Maeda-Chubachi is an advisor and consultant for pharmaceutical and biotech companies and was the Chief Medical Officer at Pelthos Therapeutics (previously Novan), leading First-in-Human to launch preparation. Tomoko is known for her expertise in drug development with over 20 years industry experience. She has led clinical and medical affairs in large pharma as well as a small biotech. She led global drug development teams, resulting in 8 approvals in multiple regions, including Xalatan, Xeljanz, Taltz, Vtama, and Zelsuvmi. Tomoko has broad knowledge of drug development, of which process is highly regulated and need thorough risk assessment, management, and control. As a Chief Medical Officer, she worked closely with the CEO and board about the strategy and governance.

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