Vikram Arya is Associate Director for Therapeutic Review in the Division of Infectious Disease Pharmacology (DIDP) in the Office of Clinical Pharmacology (OCP), CDER, FDA. He is primarily responsible for providing technical and strategic leadership in the areas of regulatory science, policy implementation, and drug regulation to a multi-disciplinary group of scientific professionals. Prior to his current role, he was a Master Reviewer and Team Leader in OCP and extensively contributed to the review of clinical pharmacology aspects of regulatory submissions and benefit/risk assessment of antiviral drugs. Vikram has received the FDA Outstanding Service Award, FDA Leveraging and Collaboration Award, FDA Group Recognition Award, FDA Commissioner’s Special Citation, CDER Center Director's Special Citation, CDER Dr. Frances O. Kelsey Drug Safety Excellence Award, CDER Leadership Excellence Award, and numerous CDER Regulatory Science Excellence and Team Excellence Awards to recognize his contributions to a variety of regulatory science and policy setting initiatives. He is a Fellow of the Excellence in Government (EIG) Fellows Program. Vikram has presented at various national and international conferences and has extensively published in peer-reviewed journals. Vikram is Past-President of the American College of Clinical Pharmacology (ACCP), Honorary Regent of ACCP, and Associate Editor of the Journal of Clinical Pharmacology (JCP).