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).

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 graduating from a U.S. university, she began her career at Globizz Corp., the U.S. headquarters of Globizz Japan, where she was engaged in FDA registrations and regulatory research across the medical device, pharmaceutical, and food sectors. Through her involvement in a wide range of projects for international clients, she cultivated substantial, practice based expertise in FDA regulatory compliance. She subsequently joined Globizz Japan and currently serves as a Project Coordinator at the Tokyo office. In this capacity, she develops and proposes tailored support plans for companies seeking entry into the U.S. market, while overseeing comprehensive project coordination between U.S.-based consultants and clients. By working closely with a team of subject matter experts—including FDA consultants at the U.S. headquarters—she delivers highly precise and effective regulatory support. Drawing on her direct experience participating in FDA inspections, she also provides on site inspection assistance and collaborates with specialists to offer practical services, including interpretation support, Quality Management System (QMSR) development, Form 483 response preparation, and CAPA planning.

Hiroshi Morita

Aquaxis Law Office Special Counsel Patent Attorney (Qualified IP Litigator)
Pharmacist

Main specialty areas

medicines

Specialized support fields

Specialized support fields

Hiroshi Morita is a Japanese Patent Attorney and licensed pharmacist with broad knowledge of and experience in patent applications, trials and appeals, expert opinions, and litigation in the fields of pharmaceuticals, biotechnology, chemistry, pharmaceutical formulations, and biochemistry. Drawing on his extensive experience as Head of Intellectual Property at Astellas Pharma Inc., Mr. Morita has deep expertise in the life sciences sector, including securing product exclusivity through the strategic utilization of intellectual property rights and life-cycle management, worldwide patent filing and prosecution, patentability and freedom-to-operate evaluations for in-licensing and out-licensing transactions, formulation of IP strategies, domestic and international IP disputes, and liaison activities. Throughout his corporate career and thereafter, he has also been actively involved in supporting and advising startup and venture companies on intellectual property strategy, particularly through collaborative research projects and technology commercialization initiatives.

Motohiro Kobayashi

University of Yamanashi Hospital, Clinical Trial Management Office, Associate Professor

Main specialty areas

medicines
regenerative medicine products

Specialized support fields

Regulatory compliance
Business planning
Business operation systems

With over 30 years of practical experience in pharmaceutical companies, ranging from basic research to clinical development, licensing activities, and regulatory audits. Subsequently, I served as a technical expert in the Innovation Commercialization Support & Strategic Consultation Division of the Pharmaceuticals and Medical Devices Agency (PMDA), dealing with regulatory consultation services for academia and venture companies (especially for regenerative medicine products and pharmaceuticals). Currently, I am working in the clinical research support department of a university, supporting physician-led clinical trials and clinical research. I have experienced numerous pre-meetings and face-to-face advice with PMDA. I also have experience in application support for public research and development projects (such as Seeds C, etc.) by the Japan Agency for Medical Research and Development (AMED). In particular, I can provide detailed support for the development of regenerative medicine products (including quality and non-clinical).

Hiroaki Kato

Visiting Professor, The Graduate School of the Digital Hollywood University

Main specialty areas

medical devices

Specialized support fields

Regulatory compliance
Marketing
Business planning
Funding
Business operation systems

He is a former government official of the Ministry of Health, Labour and Welfare and is working as a doctor specialized in digital health, including telemedicine, AI, and IoT. As an ophthalmologist, he has experience in more than 1,500 surgical operations. He developed instruments for cataract operations and ophthalmic consultation services. He is a rare person who has experience in three areas—medical practice, medical systems, and business—which are required for medical care and the healthcare business, and he understands these areas, providing support for the development of new business covering the full range of medical care. He is also familiar with Japanese medical venture companies and works as a consultant, advisor, and director for large enterprises and venture companies. He wrote 41 books, including Medical Care 4.0 — Medical Care in the Fourth Industrial Revolution Era—.

Yuka Ichijo

Global Program and Regulatory Portfolio Management Consultant

Main specialty areas

medicines

Specialized support fields

Regulatory compliance
Etc

Global Program and Regulatory Portfolio Management: Expertise in driving the execution of clinical/regulatory goals across a company’s product portfolio in close collaboration with global cross-functional teams. Proven track record of facilitating development of regulatory strategies and overseeing timely execution to achieve global program milestones. Skilled leading strategic resource/timeline plannings for achieving goals with efficiency. Experience managing programs of multiple therapeutic areas including infectious disease, neuroscience, and immunotherapy including rare disease, in Japan, US and EU. Adept managing international & alliance programs and site monitoring of clinical trials. Key Areas of Expertise: Skills: Program Management, strategic leadership, operational efficiency, prioritization, critical thinking & problem-solving, team development & collaboration, decision making, empowerment, active listening Indications: infectious diseases (bacterial & viral), pain (post-operative, cancer, chronic), diabetic peripheral neuropathy, Alzheimer’s disease, AL Amyloidosis, hATTR Amyloidosis Phases: 1, 2, 3, post-marketing Regulatory interactions/submissions: CTN/NDA/ODA, PMDA/MHLW meetings (Japan), IND, NDA, sNDA, BLA & MAA preparations, Type A, B, C meetings with FDA including Pre-IND, Fast Track, Special Protocol Assessment, EOP, EOP2, pre-NDA (US), Scientific Advice (EMA)

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