Yasuhiro Kishioka, PhD

Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved in various international activities including ICMRA (collaborative assessment pilot under PQKMS), ICH (Q12 and M4Q(R2)), WHO (biosimilar activity), APEC (biotheraputics activity), and IPRP (Biosimilar WG). He also served as ICH Technical Coordinator (2019-2020) and MHLW/PMDA international liaison official at EMA (2020-2022). He obtained a Ph.D. from Hokkaido University in Meat Science with emphasis in Molecular Biology.