Clinical Pharmacologist
US Food & Drug Administration
Dr. Xinning Yang is a Policy Lead in Guidance & Policy team (GPT) under the Office of Clinical Pharmacology (OCP), CDER of FDA. He received his Ph.D. in Pharmaceutical Science from University at Buffalo, mentored by Dr. Marilyn Morris. In the past, as a clinical pharmacology reviewer, he reviewed a number of IND/NDA submissions contributing to the benefit/risk assessment of neurology drug products. His current primary focus is guidance and policy development and implementation in various areas focusing drug-drug interactions and drug-food interactions related Clinical Pharmacology issues. He is the Chair of Transporter Focus Group of International Society of Studying Xenobiotics (ISSX), a committee member of the Regulatory Affairs of ISSX, Chair of the Membrane Transporter (MT) community of the American Society of Clinical Pharmacology and Therapeutics (ASCPT), a committee member of the PBPK community of ASCPT, and a member of International Transporter Consortium (ITC) committee. He is participating in the International Council Harmonization (ICH) M12 DDI guidance global harmonization working group and serves as the Deputy Topic Lead from FDA.