Hilary Marston, M.D., M.P.H., Chief Medical Officer, FDA, serves as the primary clinical advisor to the Commissioner and oversees the Office of Clinical Policy and Programs. She leads cross-cutting initiatives that support the FDA’s centers in making effective, safe, and innovative medical products available for patients. Dr. Marston previously served as the Senior Advisor for Global COVID-19 Response on the White House COVID-19 Response Team. Other prior roles include Director for Medical Biopreparedness and Response at the U.S. National Security Council and Medical Officer and Policy Advisor for Pandemic Preparedness at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. Dr. Marston also served in positions with McKinsey & Company and the Bill & Melinda Gates Foundation.Dr. Marston trained in Internal Medicine and Global Health Equity at Brigham & Women's Hospital. She completed her M.P.H. at the Harvard T.H. Chan School of Public Health.
- Courtney McFall, UCSF
- Ben Rubin, UCSF
Patient-centric data – Real-World Evidence (RWE) and Real-World Data (RWD) - is becoming instrumental in the drug development process and for health care decisions in general. This data is not only informative for the process from discovery to new indications, clinical trial design, and drug development, it also can be of value to monitor post-marketing drug safety and for decision support in clinical practice. As the data becomes a decision driver, science companies and medical organizations are increasingly focused on leveraging RWD and RWE to not only better understand the patient populations using their drugs and the respective outcomes, but also to accelerate clinical decision support. This session will focus on the various aspects of integrating RWE and RWD to support drug development and clinical decision support.