Transporter Research for Global Outreach: Unleashing the Power of Everything, Everywhere, All at Once

Session Description

This session will highlight the scientific evidence of drug transporters in determining the tissue exposure to drugs in the body. Transporters play critical roles in determining drug exposure in both the systemic circulation and peripheral tissues. As a result, various factors, including age, disease, genetic polymorphisms, and drug-drug and endogenous compound-drug interactions, can influence the expression and activity of drug transporters, which consequently affecting pharmacokinetic and pharmacodynamic variability. It is essential for clinical pharmacologists involved in pre-clinical, clinical, and post-clinical drug development to understand how, when, and what considerations can be employed to predict these changes in drug transporter expression and activity. With the increasing role of clinical pharmacologists in quantitative biology and systems pharmacology, this session aims to educate attendees on new knowledge and understanding challenges in predicting drug concentrations in various tissues, specifically those that are difficult to access.

The overall goal of the session is to educate attendees on employing quantitative and mechanistic approaches to predict these changes, particularly in assessing drug exposure in challenging tissues, as well as in patients who are part of special populations or suffer from various disease states and during disease progression. Considering intrinsic and extrinsic differences among patient populations, researchers can improve study design and benefit-risk assessment, accelerating global access to drugs. Participants will learn about the technological advances in quantitative proteomics that will increase the confidence in the prospective prediction of IVIVE-linked PBPK modeling. They will learn how to integrate data generated from preclinical and clinical studies through PBPK/PKPD modeling to enable more accurate predictions of drug pharmacokinetic and pharmacodynamic variability in humans. By incorporating the influence of drug transporters and utilizing PBPK/PKPD modeling, researchers can improve drug efficacy and safety assessments. These efforts will ultimately benefit global patient populations by expediting access to safe and effective medications.

Learning Objectives

1. Understand at least one cutting-edge research tool and technology employed in the field of membrane transporter research.
2. Provide one example of how modeling and simulation are employed to study the function of transporters, and how the knowledge gained from these investigations can be effectively applied to address the needs of special populations or disease states.
3. Identify at least two scenarios where the expression and/or function of membrane transporters can potentially be modulated, as this is crucial for addressing global outreach challenges.

Session Schedule

9:30 AM - 9:32 AM MT
Introduction
Sook Wah Yee, PhD and Kathy Cheung, PharmD

9:32 AM - 9:50 AM MT
Accelerating Advancements in Translational Clinical Pharmacology through Integration of Transporter Research
Vikram Arya, PhD

9:50 AM - 10:08 AM MT
Predicting Fetal Drug Exposure throughout Human Pregnancy: Insights from Physiologically Based Pharmacokinetic Modeling and Simulation and in vitro studies
Jashvant D. Unadkat, PhD

10:08 AM - 10:26 AM MT
Harnessing the Power of IVIVE-Linked PBPK to Address Challenging Issues in Global Drug Development.
Sibylle Neuhoff, PhD

10:26 AM - 10:30 AM MT
Q&A and Closing Remarks