Dr Tang was most recently a Medical Officer and Clinical Reviewer in the General Medicine Branch of the Office of Tissue and Advanced Therapy, Center for Biologics Evaluation and Research, the United States Food and Drug Administration. As a Medical Officer, he was responsible for regulating submissions related to gene and cell therapies, polyclonal antibodies, selected vaccines and combination products. He specialized in the regulation of gene and immune therapies, stem cell therapies and orphan diseases. He has reviewed submissions covering all stages of clinical development from the pre-Pre IND (currently referred to as Interact) stage to Biologic License Applications. In addition to his review work, he also served on a FDA sponsored working group for renal replacement therapy (including xenotransplantation), coauthored a guidance document for genome editing (2018), and was involved in outreach activities with the biotech industry. Dr Tang was the recipient of the CBER Regulatory Scientist Achievement Award in 2017.
Prior to joining the FDA, Dr Tang was a veteran of the biotechnology industry with positions of increasing responsibility at Amgen, Vertex, Tularik, Isis, Amsterdam Molecular Therapeutics (currently UniQure) and Sangamo. He has successfully filed INDs and BLAs in the US and Clinical Trial Applications and Marketing Authorization Application in the European Union, respectively. He is experienced in clinical trial design, strategic planning, project management, and regulatory compliance.Dr Tang obtained his M.D. from the Albert Einstein College of Medicine in New York City and his M.S. degree in organic chemistry from Tufts University. He completed his Internal Medicine training at the Los Angeles County-University of Southern California Medical Center and subspecialty training in Nephrology at the University of California, San Diego Medical Center. He also completed a post-doctoral research fellowship in Immunology at the Scripps Research Institute, La Jolla, CA. on the pathogenesis of immune mediated kidney diseases and renal fibrosis.