Associate Director for Therapeutic Review (ADTR)

Vikram Arya served as Associate Director for Therapeutic Review (ADTR) in the Division of Infectious Disease Pharmacology (DIDP) in the Office of Clinical Pharmacology (OCP), CDER, FDA. He was 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 ADTR 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. He received the FDA Outstanding Service Award, FDA Leveraging and Collaboration Award, FDA Group Recognition Award, CDER Leadership Excellence Award and several CDER Regulatory Science Excellence and Team Excellence Awards to recognize his contributions to a variety of regulatory science and policy setting initiatives. Vikram has presented at various national and international conferences and extensively published in peer reviewed journals. He is a Past President, Fellow and Honorary Regent of the American College of Clinical Pharmacology (ACCP), currently serves as Councilor to the President of ACCP and as an Associate Editor of the Journal of Clinical Pharmacology (JCP).