Challenges in Predicting PK for Transporter Substrates

Challenges in Predicting PK for Transporter Substrates

Includes a Live Web Event on 07/09/2024 at 11:00 AM (EDT)

This webinar is organized by ISSX M&S and transporter FG jointly. It will cover from in vitro to the human PK prediction for transporter substrates with focus on the current challenge and possible solutions related to:

1) Critical In vitro methods /parameters needed for a reliable PBPK model predictions, data quality, gaps and how to overcome the limitations of in vitro system; 

2) Key model structure and population parameters (including special populations) for transporter substrates - gaps in addressing multiple transporter involvement and interplay with enzymes; 

3) Status of model validation for index substrates, applications in regulatory interaction and filing -challenges and future direction.

The webinar will include sufficient time for Q&A with invited field expert as panelists.

Xiaomin Liang

Xiaomin Liang, Ph.D., is a Senior Scientist II in the Department of Drug Metabolism at Gilead Sciences Inc. She obtained her B.S. degree in molecular toxicology from the University of California, Berkeley in 2011, and her Ph.D. degree in pharmaceutical sciences with a focus on membrane transporters, transporter-mediated drug disposition, and pharmacokinetics (PK) from the University of California, San Francisco in 2016. Following a brief fellowship at the Office of Clinical Pharmacology at the FDA, she joined Gilead in 2017. Her primary research interests are in the applications of transporter biology, in vitro methodologies, and mechanism-based PK/PBPK modeling to understand the ADME of compounds and translate preclinical data to predict human PK.

Ying-Hong Wang

Dr. Ying-Hong Wang is a senior reviewer in the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences (OTS)/CDER. Prior to joining the FDA, she worked for 14 years at Merck, where she was responsible for preclinical and clinical development of numerous compounds in multiple therapeutic areas. She chaired the Quantitative Prediction of Drug Interaction Working Group and developed the internal guidelines for DDI prediction. Her modeling work on predicting and characterizing enzyme and transporter-mediated DDI and hepatic impairment contributed to the NDA approvals of grazoprevir/elbasvir and letermovir. Dr. Wang earned her Ph.D. from the Oregon Health Science University and completed her Clinical Pharmacology Fellowship training at the Indiana University-Purdue University Indianapolis. Her current research focuses on applications of PBPK modeling in CYP induction, transporter-mediated DDI, and hepatic impairment.

Kunal Taskar

Kunal Taskar, Ph.D., is currently working as Director, Global Head of PBPK Modelling at GSK. Kunal completed his doctorate more than a decade ago and postdoctoral research at Texas Tech University Health Sciences department, USA, in Quentin Smith’s lab with research focused on Neuropharmacokinetics and role of transporters in drug delivery across the blood-brain barrier (BBB).

Kunal’s experience and research focus include: PBPK modeling of small/large molecules and new modalities for PK and dose predictions, drug-drug interaction predictions and mechanistic understanding of the clinically occurring drug–drug interactions; and application of PBPK modeling in special populations including pediatrics, pregnancy, and organ impairment. His expertise also includes transporter mediated drug delivery and intracellular drug concentrations, especially the role of uptake and efflux transporters in drug pharmacokinetics-pharmacodynamics in disease and toxicology; novel transporters and role in drug disposition and use of endogenous probes and modeling for drug mediated transporter modulations.

Kunal is a member of American Society of Clinical Pharmacology and Therapeutics (ASCPT), International Society for the Study of Xenobiotics (ISSX) and the International Brain Barriers Society. Kunal is a member of several IQ consortiums including MIDD Pilot Program WG, Transporters, Induction PBPK and Pediatric PBPK. He is the founder member and Chair of the ASCPT QP PBPK Community. He received the 2014 AAPS Pharmaceutical Research Meritorious Manuscript Award for a manuscript that was published in the same journal in 2012. He has actively published and given invited talks and conducted workshops at international conferences.

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Challenges in Predicting PK for Transporter Substrates
07/09/2024 at 11:00 AM (EDT)  |  105 minutes
07/09/2024 at 11:00 AM (EDT)  |  105 minutes This webinar is organized by ISSX M&S and transporter FG jointly. It will cover from in vitro to the human PK prediction for transporter substrates with focus on the current challenge and possible solutions related to: 1) Critical In vitro methods /parameters needed for a reliable PBPK model predictions, data quality, gaps and how to overcome the limitations of in vitro system; 2) Key model structure and population parameters (including special populations) for transporter substrates - gaps in addressing multiple transporter involvement and interplay with enzymes; 3) Status of model validation for index substrates, applications in regulatory interaction and filing -challenges and future direction. The webinar will include sufficient time for Q&A with invited field expert as panelists.
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