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2020年12月26日（土）～2021年1月4日（月）は、年末年始冬季休業とさせていただきます。
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2021.02.25【広報】JETRO_WEBセミナー【J&J Innovation社登壇！Partnering Workshopシリーズ 第三回】のご案内＜締め切り：3月11日（木）＞
NEWS
ジェトロでは、米国大手製薬企業と日本のスタートアップを含む企業、研究者を含む大学や研究機関各位とのコラボレーションを促進するため、全3回のPartnering Workshopシリーズを開催しています。
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 phones, e-mail, and meetings.
- ●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 and consultation requestsSpecialists Introduction
We will introduce registered specialists
(updated as necessary).
Miyuki Tanabe
Technical Expert
Main specialty areas
- medical devices
Specialized support fields
- Regulatory compliance
- Business planning
- Business operation systems
He is a licensed pharmacist (a master's degree in Medicinal Chemistry from Gifu Pharmaceutical University) He is specialized in pharmaceutical regulatory affairs about medical devices and in vitro diagnostics, QMS, and quality assurance. He was involved in research and development, clinical development, and quality assurance of medical devices and in vitro diagnostics as an employee of Asahi Kasei Pharma Corporation. After retirement, he provided consultations on the regulations for university academia or venture companies as a technical expert for the Innovation Practical Application Support and Strategy Consultation Section, Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA). From April 2018, he has been working as a freelance consultant in pharmaceutical regulatory affairs.
Miyuki Shimizu
Medical Lab Partners Corporation
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
- Specialized support fields
She graduated from the Graduate School of Natural Science, Chiba University. She holds the degrees of doctor of medicine and master of management in information technology. She worked on the development of medical devices and medicinal products in a wide range of fields related to blood, surgical operations, general-purpose medical devices, dialysis, and rehabilitation at Terumo Corporation. She also has experience in a series of project developments from planning a theme to commercializing at a medical practice, as well as experience in management. Since 2015, she has provided consulting services to more than 100 companies entering the medical industry as her current role. She is trying to provide consulting services with the viewpoint of the individual company in mind.
Katsuyuki Nakajima
Representative Director, Nakajima Associates Ltd.
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Marketing
- Business planning
- Business operation systems
He graduated with a master’s degree from the Graduate School of Science, Osaka University, and received a doctor of medicine in Nutrition Science from the School of Medicine, Osaka University. After contributing to Gunma Prefectural Institute of Public Health and Environmental Sciences, he was involved in the establishment of JIMRO Co., Ltd. After that, at the parent company, Otsuka Pharmaceutical Company, he was consistently involved in the diagnostic business and promoted research and development of new technology, science, and sales. Since 2005 when he started a consulting company, Nakajima Associates, he has worked to acquire FDA approval for new diagnostic technology developed mainly by Japanese diagnostic agent manufacturers, as well as instructing sales activities in Europe and the United States. He has served as many visiting professors in medical schools in Japan and the United States and used the network of personal connections built there to back up business that brings out new diagnostic agents and research reagents to the world.
Jun Utsumi
CEO, TIR Research Consulting, LLC. and Senior Advisor, Japanese Foundation for Cancer Research
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Regulatory compliance
- Marketing
- Business planning
- Business operation systems
- Specialized support fields
He graduated from the Graduate School of Veterinary Medicine, Hokkaido University. He has a Doctor of Science degree and an MBA; he is a professional engineer (biotechnology), PMRJ-certified regulatory science expert, and veterinarian (DVM). He was in charge of pharmaceutical research and clinical development at Toray Industries, Inc., and successfully developed a novel antipruritus drug (received the Pharmaceutical Society of Japan Award for Drug Research and Development and the Annual Okochi Memorial Technology Prize). After the business career, he engaged in services for collaboration between industry and academia at Hokkaido University and Kyoto University (professor). Then he consecutively held positions as an expert consultant on pharmaceutical affairs strategy in the Pharmaceuticals and Medical Devices Agency (PMDA) and a senior consultant for intellectual property at the Japan Agency for Medical Research and Development (AMED). Based on more than 30 years of experience in the areas of industry, government, and academia, he established a consulting company in 2018. He is providing commercialization strategies in which the essential three factors of medical R & D—technology (T), intellectual property (I) and pharmaceutical affairs (R)—are integrated. He wrote and published “A Guide to Integrated Strategy in Drug Discovery” (Nanzando Co., 2015).
Masanobu Naruto
Representative, Phronesystems (consulting)
Senior Research Fellow, Toray Corporate Business Research, Inc.
Main specialty areas
- medicines
- medical devices
- regenerative medicine products
Specialized support fields
- Marketing
- Business planning
- Funding
- Business operation systems
He has experienced and learned from many failures and successes through his career of research, planning, business development and business operation, which include co-development with domestic and global companies. In his experiences with startup companies, including opposite extremes of excellent bio-ventures and unsuccessful bio-ventures gave him practical wisdom of startup management. He was involved in the evaluation and review of about 90 startup companies at venture capital institutions. He graduated with a master's and doctoral degree in chemistry from Osaka University. He studied abroad at the Department of Molecular Biology, University of California, Berkeley, for two years. At Toray Industries, Inc., he contributed to R&D, business development and business operation of pharmaceuticals, serving as general manager(s) of several divisions including Regulatory Compliance Division, Pharmaceutical Research Laboratories, and Pharmaceuticals Division. After retiring from Toray, he has been working in the consulting business, and serving as Senior Research Fellow at Toray Corporate Business Research, Inc. and committee member at several public institutions for R&D. He has published 38 academic papers in English (total citation, 2090) and 37 opinion articles on research and development in Japanese journals.
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.
- The Ministry of Health, Labour and Welfare／
- Pharmaceuticals and Medical Devices Agency (PMDA)／
- Japan Agency for Medical Research and Development (AMED)／
- Cabinet Office／
- Ministry of Economy, Trade and Industry／
- Ministry of Internal Affairs and Communications／
- Small and Medium Enterprise Agency／
- Organization for Small & Medium Enterprises and Regional Innovation, Japan／
- Union of Kansai Governments／
- New Energy and Industrial Technology Development Organization (NEDO)／
- Life Science Innovation Network Japan, Inc. (LINK-J)／
- Japan Science and Technology Agency (JST)／
- Japan External Trade Organization (JETRO)／
- INCJ, Ltd.／
- Osaka Prefecture／
- Tokyo Metropolis／
- Kanagawa Prefecture／
- National Institutes of Biomedical Innovation, Health and Nutrition (NIBIOHN)
