November 18, 2021
10 am (EST)
3 pm (GMP)
Summary of the presentation:
Current regulatory guidances use in vitro transporter inhibition data to determine if clinical DDI trials are necessary. In order to reduce the number of false negatives, the approaches are conservative, which result in an increased number of clinical DDI trials. The endogenous transporter DDI biomarkers are increasingly used to resolve the limitations in using in vitro data to trigger clinical DDI trials. Since coproporphyrin-I and III were discovered as endogenous biomarkers for OATP1B inhibition, the specificity, sensitivity and analytical perspectives of the biomarkers have been well-characterized. Additionally, several endogenous metabolites are recently identified to potentially serve as DDI markers for renal transporters. The current presentation will review the emerging transporter DDI biomarkers and propose how these endogenous biomarkers can be used to assess the DDI liability for investigational drugs.
Dr. Lai is currently Sr. director of Drug Metabolism at Gilead Sciences. He is Fellow of American Association of Pharmaceutical Scientists and Adjunct Faculty in the Department of Pharmacy of the University of Rhode Island. His current role in Gilead is to manage and implement in vitro/in vivo preclinical and clinical strategies for compound advancement to regulatory filing. He received his M.D from Fujian Medical University in China and his Ph.D. (Toxicology) from Sapporo Medical University in Japan in 1998. Prior to joining Gilead, Dr. Lai led research programs at Pfizer and BMS in transporter research and ADME-PK-Tox. He is the associate editor/editorial board member of top ranking DMPK journals including DMD, BDD, JPS and Frontier Pharmacology etc. He is a patent inventor and the author of a book, book chapters and over 160 original publications.
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