Leila Lackey is the Program Lead for Decision Support at FDA’s Center for Drug Evaluation and Research, Decision Support and Analysis Staff (DSAS). This group provides benefit-risk and decision analysis expertise for regulatory and policy decisions at the Center and led development of the Draft Guidance for Industry on Benefit-Risk Assessment for Human Drugs and Biologics. She has a Master of Health Science from Johns Hopkins in Environmental Health Sciences and a doctorate from UCLA in Environmental Science and Engineering and currently serves on the ASA/DIA Benefit-Risk Assessment Planning Taskforce as well as the Bayesian Scientific Working Group Benefit-Risk Subteam.