Shaw Chen, M.D., Ph.D.

Executive Vice President, Regulatory Affairs

Dr. Chen spent more than 26 years with the U.S. Food and Drug Administration in new drug development as a primary/supervisory medical staff, holding the role of Deputy Director, Office of Drug Evaluation, Center for Drug Evaluation and Research. His achievements included management of new drug review divisions, drafting and implementing FDA guidance for new class drug products and establishing modern drug review agency, as well as educating and training regulatory scientists in the Asian Pacific region. Dr. Chen received his M.D. from the University of Miami and his Ph.D. in Biophysics from Johns Hopkins University. He completed post-graduate training at Johns Hopkins, Yale University, the University of Minnesota, and the U.S. National Institutes of Health. Dr. Chen has authored numerous basic science and clinical papers, as well as drug regulatory guidance publications.