Sean Xiaochun Chen, Ph.D.
CSO
Dr. Chen is a senior pharmacology and toxicology expert with over 20 years of experience in new drug discovery and development research. He served as a senior non-clinical review expert at the US Food and Drug Administration (FDA), working for over 8 years in the FDA's Center for New Drug Evaluation (CDER/OND) and Center for Biological Products Evaluation (CBER/OTP). During this time, Dr. Chen was responsible for the oversight of clinical research and marketing applications for small molecules, macromolecules, cell therapy, gene therapy, live organisms, and combination products, and participated in the approval of hundreds of Investigational New Drug applications and more than ten NDA/BLA marketing applications. Dr. Chen has demonstrated outstanding leadership and innovation during his tenure at the FDA. He not only provides valuable advice and guidance to companies on experimental design, data interpretation and product development strategies, but also provides pioneering regulatory recommendations and solutions for highly complex innovative products where precedents and guidance are lacking. In addition, Dr. Chen serves on several FDA subcommittees, consults on internal reviews, and participates in the drafting and development of several industry guidelines.
Dr. Chen received his Ph.D. in biomedical engineering from Zhejiang University. After completing his postdoctoral research at the Johns Hopkins University School of Medicine, he served as an Assistant Professor at the Center for Stem Cell Biology and Regenerative Medicine, University of Maryland School of Medicine, focusing on the discovery and development of innovative drugs. His research team has discovered several novel anti-leukemia and anti-infective drug candidates, one of which is currently in non-clinical development for the treatment of leukemia.
