The US FDA released two draft guidance documents in October to replace the 2012 draft guidance. The two documents entitled “clinical drug interaction studies” and “in vitro metabolism- and transporter-mediated DDI studies” provide drug hunters the guidance to evaluate investigational drugs for potential clinical DDIs and drug labeling. In the “clinical drug interaction studies”, the timing of clinical DDI trials, the design and conduct of the DDI studies, the reporting and interpreting of such study results and labeling recommendations are provided. On the other hand, the “in vitro metabolism-and transporter-mediated DDI studies” discusses the in vitro approaches to evaluation the potential DDIs that involved metabolizing enzymes and/or transporters, and how in vitro outcomes can help inform clinical DDI studies. The presentation will discuss the changes of the new guidances and their impact on in vitro studies and data interpretation for transporter DDI assessment.
Yurong Lai, Ph.D.
Director of Drug Metabolism , Gilead Sciences
Dr. Lai is the director of Drug Metabolism at Gilead Sciences. His current role in Gilead is to manage DM-drug disposition labs, to implement in vitro/in vivo preclinical/clinical strategies for compound advancement to regulatory filing. Dr Lai holds an Adjunct Faculty position in the Department of Pharmacy of the University of Rhode Island. He received his M.D from Fujian Medical University in China and his Ph.D. (Toxicology) from Sapporo Medical University in Japan in 1998. From 1998 to 2001, he was a research fellow of Japanese Society for Promotion (JSPS) in Department of Physiopathology, Graduate School of Medicine of Hokkaido University, followed by a position as Research Associate in Department of Pharmaceutics, University of Washington. In 2004, he Joined pharmacokinetics, dynamics and metabolism (PDM), PGRD St. Louis, Pfizer Inc and then moved to Groton in 2010. He has been serving as a PDM representative (PI), postdoc supervisor and lab head for drug transporter research. In 2013, he joined BMS. He has been the research fellow and had a significant role in translational researches in transporter associated ADME-PK-Tox. In 2017, he moved to Gilead Science. He is a patent inventor and the author of a book, book chapters and over 130 original publications in the peer-reviewed journals. He is the associate editor/editorial board member of top ranking DMPK journals including DMD, BDD, JPS and Frontier Pharmacology etc.