Dr. Vanitha Sekar is Division Director of the Division of Biomedical Informatics, Regulatory Tool Innovation & Biomarker Development (DBIRBD) at the Office of New Drugs, Office of Drug Evaluation Science (ODES) at the FDA, where she provides direction, oversight, and leadership to multidisciplinary scientific teams that play a crucial role in reviewing and consulting on biomarker development, drug development tools, standards for the review of safety databases and regulatory science activities. A licensed pharmacist and clinical pharmacologist by training, she brings over two decades of experience spanning both public and private sectors, including prior leadership roles in drug development, business strategy, and regulatory science.