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

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.

Hiroya Kuwahara

Department of Neurology and Neurological Science / Institute of Innovation Advancement
Tokyo Medical and Dental University

M.D. (graduated from Tokyo Medical and Dental University), and Ph.D. (completed doctral course at Graduate School, Tokyo Medical and Dental University). Specialist and Attending Neurologist of the Japanese Society of Neurology, and Fellow and Board Certified Member of the Japanese Society of Internal Medicine. He is engaged in 1) clinical practice, research, and education in neurology, 2) research and development of fudamental technologies for drug discovery (especialy nucleic acid drugs and drug delivery system), 3) promotion of clinical research and industry-academia collaboration, at Tokyo Medical and Dental University. He has a career of a Deputy Director at Research and Development Division, Health Policy Bureau, at the Ministry of Health, Labour, and Welfare from 2018 to 2019, and was involved in establishing a nationwide system for promoting clinical research and accelerating venture companies in the healthcare field. He provides consultations on the needs of clinical practice, on collaborative research and field provision in relation to project implementation, and on clinical research and development.

Teppei Konishi

Biomy Inc. CEO

He completed his graduate studies at the Graduate School of Engineering Science, Osaka University. At NTT DOCOMO, he specialized in big data analysis and AI-driven video analysis research, contributing to new business development. After leaving NTT DOCOMO, he served as CTO at an IT venture before founding Biomy Co., Ltd. There, he led the development of a personalized medical platform utilizing AI technology, collaborating with domestic and international pharmaceutical companies and research institutions. He also secured a Class II medical device manufacturing and sales license.

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.

Hirohumi Shido

I am a UI/UX design expert and specialize in driving product development. As a product manager at a medical startup, he was in charge of renewal and new planning for multiple SaMD products. My experience ranges from planning to obtaining regulatory approval, and I have won a Good Design Award for a healthcare product. These experiences have made me realize the importance of experience design and usability in SaMD products with a diverse mix of stakeholders.