Associate Director for Therapeutic Review (ADTR)
US Food and Drug Administration
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.
He is the recipient of 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. He is a fellow of the Excellence in Government (EIG) Fellows Program.
Vikram is Co-Chair of OCP Food Effect Guidance revision working group, Chair of OCP Transporter Scientific Interest Group (SIG) and served as Chair of CDER’s Regulatory Science and Review Enhancement (RSR) Program. He is a member of the FDA Internal Expert Working Group on the Drug-Drug Interaction Studies Subgroup to Support ICH M12 and Fed Bioequivalence Subgroup to Support ICH M13, has contributed to the development of numerous guidances and represents OCP on the CDER Integrated Assessment of Marketing Applications (IAMA) initiative.
Vikram has presented at various national and international conferences and has extensively published in peer reviewed journals. He currently serves as the Immediate Past President of the American College of Clinical Pharmacology (ACCP), is a fellow of ACCP, and an Editorial Board member of the Journal of Clinical Pharmacology (JCP).
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Wednesday, March 16, 2022
4:15 PM – 5:15 PM ET
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