Senior Advisor
Real World Evidence Analytics, Office of Medical Policy, CDER, US FDA
Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US FDA. Her responsibilities related to real-world evidence (RWE) include serving as lead for a portfolio of externally conducted RWE demonstration projects, evaluating real-world evidence protocols, participating in internal Agency processes, interacting with external stakeholders, and contributing to guidance development. She is a pharmacoepidemiologist and a pharmacist with over 15 years of experience working in regulatory, government, and academic sectors in UK and the US, including 10 years at the FDA. Dr. Bradley has a PhD in Pharmacoepidemiology and a Masters in Pharmacy degree from Queen’s University Belfast as well as an MPH degree from London School of Hygiene and Tropical Medicine.