Symposium 13: Clinical Pharmacology Challenges in Obesity & Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis: Mechanisms & Therapeutics

Tuesday, September 12, 2023

1:30 PM - 3:00 PM PT

Location:Grand Ballroom E-H

CE: 1.5

Co-Chair & Faculty(s)

Kim Brouwer, PharmD, PhD

WR Kenan Jr Distinguished Professor, Associate Dean, Research & Graduate Education
Univ of North Carolina at Chapel Hill
Catherijne Knibbe, PharmD, PhD

Professor, Pharmacology
Leiden Univ

Manal Abdelmalek, MD, MPH

Professor of Medicine, Director, Hepatobiliary Disease Interest Group, Div. of Gastroenterology & Hepatology
Mayo Clinic
Insook Kim, PhD

Team Lead, Clinical Pharmacology
US Food & Drug Administration
Yurong Lai, PhD

Executive Director, Drug Metabolism
Gilead Sciences Inc

The target audience for this Symposium includes PharmD, MD, and PhD scientists interested in obesity.

Following the completion of this activity, the learner will be able to:

Discuss the mechanistic basis and practical consequences of the influence of obesity and Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis (NAFLD/NASH) on drug disposition;
Articulate relevant disease aspects of NALFD/NASH for diagnosis and treatment for clinical practice and clinical trials;
Demonstrate how physiologically-based pharmacokinetic modeling can support clinical trials in obesity and NAFLD/NASH;
Discuss regulatory issues in drug development for obesity and NAFLD/NASH.

The Obesity Epidemic: Consequences for Dosing in Adults & Children
Co-Chair & Faculty: Catherijne J. Knibbe, PharmD, PhD – Leiden Univ
Pathophysiologic Changes, Staging, Diagnosis & Trial Endpoints for NAFLD/NASH
Faculty: Manal Abdelmalek, MD, MPH – Mayo Clinic
Mechanistic Understanding of Physiological Changes in NASH that Impact Drug Disposition
Co-Chair & Faculty: Kim LR Brouwer, PharmD, PhD – Univ of North Carolina at Chapel Hill
Challenges & Current Regulatory Issues in Drug Development for Obesity & NAFLD/NASH
Faculty: Insook Kim, PhD – US Food & Drug Administration
Use of Physiologically-based Pharmacokinetic Modeling to Advance Clinical Trials in Obesity & NAFLD/NASH
Faculty: Yurong Lai, PhD – Gilead Sciences Inc
Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation