CARsgen Therapeutics, a clinical-stage company developing Chimeric Antigen Receptor T cell therapies for cancer, has appointed Yong Fan, MD, as senior vice president, Global Regulatory Affairs. Dr. Fan will be responsible for CARsgen global regulatory strategy, leading the U.S. and China regulatory affairs team and working with clinical, medical and process development teams to advance CARsgen’s strategic objectives for immunotherapies.

Dr. Fan previously served as A2Z Reg Solutions senior consultant and owner, member of ISCT Legal and Regulatory Affairs North America Committee, and senior reviewer in the FDA Office of Tissues and Advanced Therapies (OTAT/Previous OCTGT), Center for Biologics Evaluation and Research (CBER), responsible for review, evaluation and inspection for cellular and gene therapies’ pre-IND, IND and BLA. Prior to the FDA, she served in several roles as staff scientist at the Cell Processing Section of National Institute of Health, Laboratory Supervisor of Cellular Activities in the Gene Transfer Core Facility at the Memorial Sloan-Kettering Cancer Center, Cell Processing Lab Supervisor for New York Presbyterian Hospital-University Hospital of Columbia and Weill Cornell.

“Dr. Fan’s insights and rich experiences of regulatory strategy consulting, FDA review and regulatory inspection, cell and gene therapy research & development, and related policy implementation is a precious asset as CARsgen is developing its global strategy,” said Dr. Zonghai Li, founder and chief executive officer of CARsgen. “In the near future, CARsgen aims to submit several INDs, BLAs to U.S. FDA, China NMPA and other regulatory agencies for our advanced CAR-T cell programs. We are delighted to have Dr. Fan joined, together with more and more global top talents to deliver our commitment to cancer patients.”