Donna Rivera, PharmD, MSc, FISPE, is a pharmacist and pharmacoepidemiologist with expertise in innovative and scientifically rigorous strategies for clinical evidence modernization—real-world data (RWD), real-world evidence (RWE), clinical trial design, artificial intelligence (AI)—from almost 15 years of experience in government, industry, and academia. She is the Executive Vice President of Clinical Evidence Modernization at Canal Row Advisors, focused on the use of RWD, RWE, and AI for drugs, biologics, and devices to support regulatory objectives.
At the FDA, Dr. Rivera was Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence (OCE) and led the Oncology Real-World Evidence Program, a collaborative effort among CDER, CBER, and CDRH to advance the appropriate use of real-world evidence in oncology product development to facilitate patient-centered regulatory decision-making. She directed initiatives to modernize evidence generation through regulatory review of all oncology submissions containing RWE, strategic management of a multimillion dollar regulatory science research portfolio, regulatory policy development, and leadership of partnerships and educational programs. Dr. Rivera contributed to the development of multiple FDA guidances related to RWD and RWE, clinical studies and pragmatic clinical trials, and the regulatory application of AI. She also formed the FDA Oncology AI Program, chairing the Oncology AI Council to guide the use of artificial intelligence applications in regulatory review, research, and policy.
In her prior role at the National Cancer Institute, she led a strategic RWD initiative to facilitate large-scale, longitudinal treatment data linkages with Surveillance, Epidemiology, and End Results (SEER) registry data through collaborative public-private partnerships, as well as other projects to advance data science and pharmacoepidemiology methods and outcomes. She has previous experience in clinical trial design from Stiefel, a GlaxoSmithKline company.
Dr. Rivera is a Fellow of the International Society for Pharmacoepidemiology and serves as an Affiliate Associate Professor at the University of Maryland School of Pharmacy. She has served on federal and international efforts focused on RWE, AI, COVID-19, the Cancer Moonshoot Initiative. She has authored over 90 peer-reviewed publications and presented at scientific conferences nationally and internationally. Dr. Rivera earned her Doctor of Pharmacy and Master of Science in Pharmaceutical Sciences, with a specialization in Pharmacoepidemiology, from the University of Florida College of Pharmacy. She completed an NCI Postdoctoral Fellowship in Pharmacoepidemiology and Pharmacogenomics.