Donna Rivera

Donna Rivera

Donna R. Rivera, PharmD., MSc., is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real World Data (RWD) and RWE for regulatory purposes, as well as management of the RWD research portfolio strategy and development of regulatory policy to support the OCE mission. As a pharmacist and pharmacoepidemiologist, Dr. Rivera has interests in the use of RWD to advance health equity, observational study designs and methodological approaches, and appropriate uses of RWD for drug development to increase access of effective therapies to patients. She is a Scientific Executive Committee member for the COVID-19 and Cancer Consortium (CCC19) and leads Project Post COVIDity, a collaborative RWD effort to assess longitudinal sequalae, outcomes, safety, vaccination, and immunity. She has published > 40 peer reviewed publications and presented at > 45 scientific conferences nationally and internationally.

In her previous role at the National Cancer Institute (NCI), she led a strategic RWD initiative to facilitate large scale, longitudinal treatment data linkages with SEER through collaborative public private partnerships. She also has previous experience in clinical trials from Stiefel, a GlaxoSmithKline company. Dr. Rivera earned her Doctor of Pharmacy and Master of Science in Pharmaceutical Sciences with a concentration in Pharmaceutical Outcomes and Policy from the University of Florida College of Pharmacy. She completed a postdoctoral fellowship in Pharmacoepidemiology and Pharmacogenomics at the NCI in the Epidemiology and Genomics Research Program.

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