Yoji Sato National Institute of Health Sciences, Kanagawa, Japan

Dr Yoji Sato is Deputy Director General at the Japanese National Institute for Health Sciences (NIHS). As a graduate student at the University of Tokyo and a postdoctoral fellow at the University of Cincinnati, he conducted research in cardiovascular pharmacology and successfully established various transgenic mouse models to elucidate the mechanisms of cardiac excitation-contraction coupling and heart failure.

From 2014 to 2023, he served as Head of the Cell-Based Therapeutic Products Division at the NIHS, where he led a public-private partnership initiative (MEASURE Project) in Japan to validate a variety of test methods for evaluating the tumorigenicity of cell therapy products (CTPs) in collaboration with the Committee on Nonclinical Safety Evaluation of Pluripotent Stem Cell-Based Therapeutic Products of the Forum for Innovative Regenerative Medicine (FIRM-CoNCEPT). He also contributed to establishing Standards for Human Stem Cell Use in Research, which was published in June 2023, as a member of the Standards Initiative Steering Committee of the International Society for Stem Cell Research (ISSCR). In addition, he was a topic leader of the Expert/Implementation Working Group for ICH Q5A(R2). From April 2023 to March 2025, he served as Head of the Division of Drugs at the NIHS, responsible for quality assurance of small molecule drugs distributed in Japan, before being appointed Deputy Director of the NIHS in April 2025.

He continues to serve on the ISSCR’s Clinical Best Practices Task Force on Pluripotent Stem Cells-Derived Products. He is also the Chair of the Database Committee of the Japanese Society for Regenerative Medicine, which provides the National Regenerative Medicine Database (NRMD), a national patient registry system for clinical and post-marketing research on CTPs, and has been a member of the Pharmaceutical Affairs Council of the Japanese Ministry of Health, Labour, and Welfare.