Dr. El Fiky is a Harvard-trained and educated clinical research expert. His experience include medical monitoring, pharmacovigilance, drug risk assessment/mitigation assessing safety and efficacy of novel drugs and biologics, including vaccines, cell and gene therapy. His experience include working as a Safety physician at the US Government (FDA), CRO industry (Emmes) and biopharmaceutical industry (Pfizer). At Pfizer, he was a Director/Safety Risk Lead (SRL) and a lead member of the safety surveillance and risk management team of the company’s COVID19 vaccine administered to hundreds of millions of individuals around the globe, as well as the company’s lead SRL for its RSV vaccine, at late stage clinical development. At Emmes, he was a member of the team that conducted medical monitoring for the early trials of the Ebola vaccine at the wake of the outbreak. The vaccine was later approved by the FDA in December 2019. While at the FDA (Jan 2010-Apr 2014), Dr. El Fiky worked as a clinical reviewer of immunomodulatory therapies at the FDA’s Center for Biologics’ Research and Review. He received his medical degree from Egypt’s University of Alexandria and Ph.D. in Experimental Pathology/Immunology from the University of California-Irvine. His clinical training specialized in infection control and laboratory medicine particularly molecular identification of virulence factors of endemic vector- and blood-borne pathogens. Dr. El Fiky’s PhD thesis and postdoctoral research revealed a novel signaling mechanism for type I interferon and investigated molecular signaling mechanism of cytokines in cancer, inflammation, and allergic pathogenesis. After completing his medical training and American Board of Medical Microbiology (ABMM)-approved fellowship, he continued postdoctoral training at the NIH’s National Cancer Institute, National Institute of Allergy and Infectious Diseases, and the FDA’s Office of Vaccine Research and Review. He completed his clinical trial training at Harvard Medical School. Dr. El Fiky co-authored peer-reviewed research publications including a review paper of the US hospital preparedness in the wake of the Ebola outbreak in 2015 and the re-structuring of the clinical research practice in Africa and the Middle East, in addition to two book chapters on clinical and regulatory pathway of stem cell-based therapy in the United States. Dr. El Fiky was awarded Harvard University’s clinical research scholarship, the FDA’s Commissioner Citation Award and the University of California’s William Holcomb Award for Excellence in Biomedical Research.