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).

Kunishige Masui

Managing Partner

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Funding
Specialized support fields

Graduated from Kyoto University Faculty of Law, University of Tokyo Law School, and University of California, Irvine LLM. 2014 - 2021 at Nagashima Ohno & Tsunematsu; 2020 - 2021 at Smith, Gambrell & Russell, LLP （US law firm）. Established Masui & Partners in December 2021. Mr. Kunishige Masui assisted numerous startups, from angel rounds to companies nearing IPO, and has also assisted in the launch of many new businesses, including cross-border localization. He is well versed in the legal and financing issues that arise for startups and new business development, and provides support as a mentor for JETRO, Healthcare Innovation Hub, Kawasaki-NEDO Innovation Center （K-NIC）, Venture Café Tokyo, and IDEC. In addition to providing easy-to-understand explanations of foreign legal systems in comparison to those in Japan, he also specializes in removing obstacles to business growth by not only providing answers to "points that clients have actually consulted with" but also by digging into "points that need attention that clients are not yet aware of.”

Masakatsu Noguchi

SMILE CURVE, Inc.

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Marketing
Business planning
Business operation systems

Ph.D. in life sciences. Worked at consulting firm Dream Incubator, consulting in industry-academia collaboration, business support for tech startups (bio, semiconductor, environmental energy), new business development for large corporations, and overseeing government mega-projects. Previously employed at Abbott Japan and Singapore, managing product marketing for diagnostic tests, pharmaceuticals (women's health), and Asia-Pacific marketing for medical IT. As Business Development Director at Sanamedi, facilitated the commercialization of new medical devices, handled regulatory applications and market launches, and supported investments in and assistance to startups. Additionally served as an evaluator for AMED, and as a mentor for NEDO and university accelerator programs. Currently working independently, he serves as a specially appointed associate professor in the Hiroshima University and as an strategic advisor of MEJ.

Taku Seriu

Seriu Medical Consulting Ltd. CEO
APCER Life Sciences. Senior Advisor to the Board
The Institute of Drug Development Career Promotion. Representative Director

Main specialty areas

medicines
regenerative medicine products

Specialized support fields

Regulatory compliance
Business planning
Business operation systems
Etc

A physician and Doctor of Medical Science, he began his career as an internist before leading clinical leukemia research at the Universities of Ulm and Heidelberg in Germany. After returning to Japan, he took on leadership roles including Head of Clinical Development at Nihon Schering, Executive Officer at Bristol-Myers Squibb, and Executive Vice President and Board Member at Otsuka Pharmaceutical, where he oversaw drug development, medical affairs, regulatory affairs, pharmacovigilance, and quality assurance.
He has led the development, approval, and post-marketing activities of more than 50 therapeutics and diagnostics across oncology, neuroscience, cardiovascular and renal diseases, infectious diseases, and rare diseases, contributing to global launches and appropriate-use initiatives.
He currently serves as President of Seriu Medical Consulting and Senior Advisor at APCER Life Sciences, supporting R&D strategy, safety and risk management, organizational development, and new business planning. He also advises startups on development strategy, TPP creation, and fundraising pitch preparation, and has a strong track record in post-acquisition organizational integration, aligning cultures, talent, and processes. He teaches pharmaceutical medicine at several universities and is an editor and contributing author of Introduction to Pharmaceutical Medicine, the first textbook of its kind published in Japan. He continues to practice clinical medicine and remains committed to supporting those driving pharmaceutical innovation in Japan, guided by the principle: “Learn Together, Grow Together.”

Chia-Feng Lu

Shareholder(Senior Partner), Greenberg Traurig, LLP

Main specialty areas

medicines
medical devices
regenerative medicine products

Specialized support fields

Regulatory compliance
Business planning
Funding
Business operation systems
Specialized support fields

Chia-Feng Lu represents life sciences companies and industry associations in strategic regulatory and legislative worldwide to guide and develop new legislation and policy, to frame effective approaches to working with the various agencies on compliance and investigation issues. He has intensive experience in provision of the guidance to companies introducing novel technology products, such as AI, block chain, 3D-printing, cancer immunotherapy, digital health, cell / gene therapy, precision medicine-related products and services, RNAi drug, as well as SMART device. In his past experience, he has already assisted companies in translating the scientific ideas from Nobel Laureates into the successful commercial launch of at least two products. In addition, he advises investment banks, private equity firms, and venture capital groups on their evaluations of the technologies, deal structures, and the resulting business impacts, as well as regulatory uncertainty with respect to novel technology and compliance. He specializes in various issues in connection with biotech investors or life sciences companies’ research & development strategy, portfolio management, corporate strategy planning, partnerships, licensing, project finance, auction, investment, and M&A. He has also served as an adjunct faculty member of a number of leading academic institutions in the U.S. and Japan, and an advisor to numerous government agencies.

Tsutomu Uchiyama Ph.,D.

Founder, Uchiyama IP Strategies

Main specialty areas

medicines
regenerative medicine products

Specialized support fields

Specialized support fields

Patent attorney/Ph.D.
After working as a researcher in molecular biology for Daiichi Pharmaceutical Co., Ltd. (current Daiichi-Sankyo), he passed the examination for patent attorneys in 1996. He worked in the intellectual property departments of three companies as an in-house patent attorney, practitioner, manager and global IP head (Eisai)—Takeda Pharmaceutical Company Limited, SoftBank Investment, and Eisai Co., Ltd.—for a total of 20 years, where he was involved in patent practice and patent strategies, as well as patent portfolio management including patent filing, patent clearance and intellectual property due diligence.
In April 2017, he founded Uchiyama IP Strategies. Currently, utilizing his experience, he mainly assists venture companies, small and medium-sized enterprises, and academia in patent strategy and contractual matters in drug discovery, regenerative medicine, and biotechnology research.

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