Senior Science Advisor
US Food and Drug Administration
Neali H. Lucas, Ph.D. is a regulatory scientist whose professional experience spans various environments including academia, industry, and government. In her current role, she serves as a Senior Science Advisor in the Office of the Chief Scientist for the US Food and Drug Administration. Her responsibilities include providing scientific and technical advice on various cross-cutting activities to advance FDA science and research. She also serves as the Chair for the FDA IRB to ensure compliance with regulations that assure the protections for human subjects participating in research conducted or supported by FDA.
She previously held various roles with the FDA’s Office of Regulatory Affairs, including management of staff conducting inspections for biological product manufacturing facilities and serving as technical lead/specialist in the bioresearch monitoring (BIMO) program, performing domestic and international inspections of entities relevant to clinical research. Prior to joining FDA in 2010 and commissioning as an officer in the United States Public Health Service Commissioned Corps, she worked for a global clinical research organization where she prepared integrated safety summaries, study protocols and briefing documents in support of FDA submissions for various therapeutic areas.
Dr. Lucas received her doctoral degree in Molecular and Cellular Pathology from the University of Michigan and completed postdoctoral training at the University of Michigan Comprehensive Cancer Center. Her research focused on molecular mechanisms of disease progression and cell signaling in ovarian and prostate cancer cells.
Disclosure(s): No financial relationships to disclose
Tuesday, March 26, 2024
8:30 AM – 5:30 PM MDT