Victor (Xiaobin) Lu, Ph.D.
Senior Vice President, Head of Regulatory Affairs
Dr. Lu joined ICT in December 2018 and has over 18 years of experience in product development and regulatory affairs in the cellular and gene therapies space.
Prior to ICT, Dr. Lu worked for 10 years as a Product Reviewer at the U.S. FDA in the Gene Therapy Branch (GTB), Division of Cellular and Gene Therapies (DCGT), Office of Tissue and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER). His main role at the FDA was to review regulatory applications for cellular and gene therapy-based Investigational New Drug (IND) products and Biologics License Applications (BLAs), including for CAR-T cell based products. He served as Chair of the Review Committee for the first BLA approval of the first gene therapy-based CAR-T cell immunotherapy, Novartis’s Kymriah. Before that, he worked for seven years at VIRxSYS Corporation as Senior Director of Research & Development, where he led the product development program for the first lentiviral vector-based gene therapy investigational product in human clinical trials in the United States.
Dr. Lu completed postdoctoral training at the University of California, San Francisco (UCSF), holds a Ph.D. in Molecular Virology from State University of New York at Buffalo, and a BS in Biochemistry from Fudan University, Shanghai, China.