Division Director
U.S. Food and Drug Administration
Nicole Gormley, MD, is the Division Director for the Division of Hematologic Malignancies II at the U.S. Food and Drug Administration and serves as the Acting Associate Director for Oncology Endpoint Development in the Oncology Center of Excellence. The Division of Hematologic Malignancies II oversees the drug development of products for the treatment of multiple myeloma, lymphomas, and chronic lymphocytic leukemia. In her role as the Acting Associate Director of Oncology Endpoint Development, Dr. Gormley provides direction, coordination and oversight for scientific and policy efforts related to early endpoint development in oncology.
Dr. Gormley joined the FDA in 2011 and previously served as a clinical reviewer and the Multiple Myeloma Clinical Team Lead. While in these roles, Dr. Gormley actively engaged with the multiple myeloma community on the development of novel endpoints, including minimal residual disease, and methods to address racial disparities. Dr. Gormley completed fellowship training in hematology and critical care at the National Institutes of Health and served as the Deputy Clinical Director at the National Heart, Lung and Blood Institute prior to joining the Food and Drug Administration.
Regulatory Perspective on MRD in hematological malignancies
Thursday, September 28, 2023
8:30 AM – 8:45 AM EEST