Emerging roles and mechanisms of intestinal excretion in drug clearance

Chen Chen is a postdoctoral fellow in the Department of Drug Metabolism and Pharmacokinetics at Genentech, Inc. He earned his Ph.D. from the Tri-Institutional Chemical Biology program, a joint offering from Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center, and The Rockefeller University. His research focuses on the mechanistic understanding of drug clearance pathways, as well as nanoparticle drug assembly and tumor-targeted delivery.

Murali Subramanian is a director of research in DMPK at Gilead Sciences where he is a project leader and DMPK representative for multiple programs in discovery and development across several therapeutic areas. Prior to this, he worked in Janssen Pharmaceutica and Biocon Bristol Myers Squibb Research Center. He obtained his PhD in Chemical and Biological Engineering from Iowa State University and was a postdoctoral and research fellow under Professor Timothy S Tracy and Professor Rory Remmel at the University of Minnesota. His interests lie in the mechanistic understanding and translation of DMPK and ADME principles.

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 on drug metabolism, pharmacokinetics, and drug-drug interactions related Clinical Pharmacology issues. He is active in research and led or co-led multiple research projects funded internally. He served as the Chair of Transporter Scientific Interest Group of OCP from 2014 to 2015. He has received a number of individual and team awards from CDER which recognized his contribution to regulatory science and research. He is the Co-Chair of Transporter Focus Group of ISSX and a member of International Transporter Consortium (ITC) committee. He is participating in the International Council Harmonization (ICH) M12 DDI guidance working group. He has been an invited speaker for multiple conferences and workshops and organized symposia at several meetings.