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

Jun Utsumi

CEO, TIR Research Consulting LLC.

JU graduated from the Graduate School of Veterinary Medicine, Hokkaido University. He holds DVM, D.Sc., MBA and has licenses of Professional Engineer (biotechnology), Radiation Protection Supervisor and Certified Scientist of Medical AI. He was engaged in research and clinical development at Toray Industries, Inc. and succeeded in commercializing the world's first opioid kappa agonist (received Awards from the Pharmaceutical Society of Japan and Okochi Memorial Foundation). After the business career, he served as a professor in Hokkaido University and Kyoto University, as well as an expert in Pharmaceuticals and Medical Devices Agency (PMDA) and a senior consultant for intellectual property at the Japan Agency for Medical Research and Development (AMED). Over 30 years of experience led him to establish a consulting company in 2018, he is also involved in medical DX support and won the Japan Open Innovation Award in 2023. He is part-time lecturers at the graduate schools of the University of Tokyo, Kyoto University, Tokyo Medical and Dental University, and the University of Tsukuba. He published “A Guide to Integrated Strategy in Drug Discovery” (Nanzando Co., 2015).

Yumi Kawata ,MD, PhD

Hedgehog MedTech, Inc.

She is Founder and CEO of Hedgehog MedTech, Inc, a start-up Digital Therapeutics (DTx) company. Previously, she was a manager with SoftBank Corp, where she evaluated new Healthcare & Life Science investment opportunities, managed relationships with strategic partners. Prior to SoftBank, she was a Government Relations specialist with Medley, Inc, where she built and maintained the relationships with Ministry of Health, Labour and Welfare and Academia. She launched researches and POCs, contributing to the spread of telemedicine in Japan. She also served as a technical officer for MHLW. she was involved in the management of researches on Rare and Intractable diseases and Infectious Diseases.

Rou Irisawa

IRISAWA Consulting LLC

Worked at Chugai Pharmaceutical Co., Ltd. for 27 years, primarily in antibody drug research and development, CMC regulatory affairs, and quality assurance, from preclinical trials stage to BLA stage. Involved in the BLA of Japan, US and EU approval for the CTD-Q of Actemra, Japan's original first antibody drug. And also involved in Japan BLA for several biologics Genentech original. Since 2017, involved in the development of many new modalities, including three SAKIGAKE designated cell products, and participated in 21 times PMDA consultations responsible for CMC regulatory and QA for cell products and gene therapy products. In 2023, became independent as a CMC regulatory consultant. Author of ""CMC Pharmaceutical Design - CMC Pharmaceutical Strategy in the Era of New Modality Pharmaceuticals"" (Yakuji Nipposha, 2022), and is the overall supervisor of the Japanese translation of A-CELL (CMC Development Guidance for CAR-T). Fellow at Tama University's Medical Care Solutions Research Institute, and a top performer in the regular course of Pharmaceutical Evaluation Science at the University of Tokyo Graduate School of Pharmaceutical Sciences in 2024. Certified in generative AI skills (November 2025).　Currently involved in various projects, including serving as CMC lecturer at seminars on how to proceed with the development of CMC for antibody drugs, cell products, gene therapy products, etc　for small company to semi-major company.

Masato Kishida

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.

Motohiro Kobayashi

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

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).