María José (Pepa) López Barragán is a former U.S. FDA regulator with 15 years of combined experience in Regulatory Affairs (CMC) and multiple aspects of drug development and research. While at the FDA, Pepa participated in the approval of 15 original and biosimilar biologic license applications and led multiple Pre-license and For-cause surveillance inspections of pharmaceutical manufacturers for compliance to cGMPs in 8 countries.
Prior to joining the FDA, Pepa held a Principal Scientist position at GlaxoSmithKline where she contributed to the discovery of new antimalarial drugs and, a Senior Analyst position at GeneDx where she contributed to the clinical diagnosis of patients with rare genetic disorders.
Pepa received her PhD in Biochemistry and Molecular Biology from Universidad Complutense de Madrid (Spain) and completed a 5-year post-doctoral research program at the U.S. National Institute of Allergy and Infectious Diseases. Pepa has authored 20 peer-reviewed scientific publications and one biotechnology patent and she is recipient of several awards, including two FDA Special Recognition Honor awards and a FEMS (Federation of European Microbiological Societies) award. Besides her professional experience, Pepa volunteers at ECUSA (a 501(c)(3) non-profit organization of Spanish professionals of Science and Technology in the U.S.) in which she completed a 2-year term as Vice-President of the Washington DC chapter.
Pepa is fluent in English, Spanish and Portuguese and she is a U.S.-Spain dual national.