Brian Cicali | GLP-1 Receptor Agonists | MPRINT 2026 | Day 1

Distribution and Exposure of GLP-1 Receptor Agonists: Consideration of Fetal and Lactation Exposure via Quantitative Clinical Pharmacology Methods Presented by Brian Cicali, PhD, MS Assistant Professor University of Florida College of Pharmacy Recorded 4/13/2026 at the 2026 MPRINT Annual Meeting. In this presentation, Dr. Brian Cicali gives an overview of GLP-1 receptor agonists and discusses key questions around fetal and lactation exposure in pregnancy and breastfeeding. The talk reviews the current clinical concern, the limitations of existing human and animal data, and the reasons mechanistic modeling is needed to better inform risk and benefit in special populations. Dr. Cicali describes the pharmacology of GLP-1 receptor agonists, their pharmacokinetic and pharmacodynamic properties, and the current modeling approaches being used to estimate exposure in pregnancy and lactation. The presentation also highlights major evidence gaps, the need for better verification data, and the role of quantitative clinical pharmacology in supporting safer decision-making. About MPRINT: The Indiana CTSI Pharmacometric Modeling and Simulation Program and Maternal Pediatric Precision in Therapeutics Hub (MPRINT Hub) supports collaboration, education, and research in pharmacometrics, model-informed drug development, translational science, and clinical pharmacology. Conference details: Event: 2026 MPRINT Annual Meeting Day: 1 Date: April 13, 2026 Location: Hine Hall, Indianapolis, IN Chapters: 00:00 Introduction and talk overview 01:32 GLP-1 background and clinical questions 03:00 Receptor biology and tissue distribution 05:56 Pharmacokinetics and current agents 07:38 Pharmacodynamics and adverse effects 09:28 Fetal exposure and pregnancy guidance 11:53 Breast milk exposure 14:37 Existing modeling approaches 16:47 Knowledge gaps and study needs 20:02 Modeling framework for fetal exposure 22:30 Modeling framework for breast milk exposure 24:16 Challenges and opportunities 26:37 Audience Q&A Accessibility: Captions/subtitles are available for this video. Disclaimer: The views and opinions expressed in this presentation are those of the speaker and do not necessarily reflect those of Indiana University, Purdue University, the Indiana CTSI, or affiliated organizations.