Deputy Director, Division of Clinical Outcome Assessment
FDA / CDER
Dr. Selena Daniels serves as the Deputy Division Director in the Division of Clinical Outcome Assessment at the FDA. She provides direction, oversight, and leadership to a team of expert analysts who provide consultation and advice on clinical outcome assessment (COA) endpoint development and validation, including considerations for clinical trial design, conduct, analysis, interpretation, and reporting for regulatory determinations of medical product benefit.
Prior to joining the FDA in 2015, Dr. Daniels worked in the Health Economic and Outcomes Research (HEOR) group at Allergan, Inc (now Abbvie), where she developed and executed HEOR strategies, as well as developed and implemented innovative COA strategies and endpoints for clinical trials. Dr. Daniels received her Doctor of Philosophy degree in Education at Nova Southeastern University and Doctor of Pharmacy degree at Loma Linda University.
Quantifying Patient Burden in Protocol Design to Reduce Complexity and Drive Patient-Centricity
Wednesday, September 18, 2024
2:15 PM – 3:15 PM PDT
Thursday, September 19, 2024
3:15 PM – 4:15 PM PDT