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

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.

Shin-ichi Kamachi

CRO-K Co.,Ltd

Completed doctoral course at Kyushu University Graduate School of Pharmaceutical Sciences. After joining Chugai Pharmaceutical Co., Ltd. Research Institute in 1977, he worked consistently on pharmaceutical research and development. He has experience in approving one small molecule drug and four biopharmaceuticals. He also has the experience of being the first Japanese company to recommend approval for a central review of EMA. He took early retirement in 2004 and mainly assists with biopharmaceutical CMC and non-clinical testing. After establishing the Japanese branch of an American biopharmaceutical consulting company (Biologic Consulting Group, BCG), he currently serves as a senior consultant for CLOCK Co., Ltd., providing support and advice on the development of biopharmaceuticals.

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).

Shin Koike

Smith, Gambrell & Russell, LLP
Attorney at Law

Shin Koike is an attorney with Smith, Gambrell & Russell, LLP. After being admitted to practice law in Japan in 2016, he joined Nagashima Ohno & Tsunematsu, where he advised pharmaceutical and healthcare companies on a broad range of regulatory and transactional matters. From 2021 to 2023, Mr. Koike was seconded to the Minister's Secretariat of Japan's Ministry of Health, Labour and Welfare, where he was involved in the development and implementation of a number of significant government policies. From 2024 to 2025, he pursued an LL.M. degree at Stanford Law School. During his studies, he also served as a Student Fellow at The Center for Law and the Biosciences, engaging in research on legal and policy issues at the intersection of law, medicine, and biotechnology. Since 2025, Mr. Koike has been with Smith, Gambrell & Russell, LLP as a Visiting Attorney, advising clients on U.S. regulatory and legal matters. Mr. Koike's publications include The Legal 500: 1st Edition Life Sciences Country Comparative Guide –Japan (co-author, Legalease Ltd., 2024), among others.

Tomoko Maeda-Chubachi

TMC Clinical Development Consulting, Inc, President; The Institute of Drug Development Career Promotion, Founding Director; Japan Alliance of Medical School Startups, Director

Dr. Maeda-Chubachi is an advisor and consultant for pharmaceutical and biotech companies and was the Chief Medical Officer at Pelthos Therapeutics (previously Novan), leading First-in-Human to launch preparation. Tomoko is known for her expertise in drug development with over 20 years industry experience. She has led clinical and medical affairs in large pharma as well as a small biotech. She led global drug development teams, resulting in 8 approvals in multiple regions, including Xalatan, Xeljanz, Taltz, Vtama, and Zelsuvmi.　Tomoko has broad knowledge of drug development, of which process is highly regulated and need thorough risk assessment, management, and control. As a Chief Medical Officer, she worked closely with the CEO and board about the strategy and governance.