Speakers

Dr. Gutierrez-Lugo is a Supervisory Pharmaceutical Scientist in the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). In this role, she oversees the product quality review of biotechnology products — including biosimilars — across the full product lifecycle. Prior to joining the FDA in 2008, Dr. Gutierrez-Lugo completed postdoctoral research at the National Institutes of Health (NIH) and the University of Arizona, where her work focused on the identification and characterization of biologically active small molecules and recombinant proteins. She earned her Ph.D. in Chemical Sciences (Pharmacy) from the National Autonomous University of Mexico.