Theresa Crockett PhD

Director of Pharmacometrics at Merck

Friday, March 24, 2023

9:30 AM

102 Benedum Hall

Host: Jason Shoemaker

Abstract

Model-informed drug discovery and development is an essential tool in pharmacological research, with applications ranging from identifying appropriate drug targets, to optimizing dose and regimen, facilitating the design of clinical trials, and informing personalized medicine.  The benefits of MID3 approaches are recognized throughout industry and by regulatory authorities around the world, and most regulatory submissions leverage modeling and simulation.  MID3 encompasses many methods, including population PK/PKPD modeling, physiologically-based PK modeling, model-based meta-analyses, and mechanism-based quantitative systems pharmacology models.  This talk will discuss opportunities to inform decision-making in drug development through modeling and simulation.  First, population modeling concepts will be introduced.  A case study demonstrating their application to developing a real-world population pharmacokinetic model and its utility in enabling decisions on dose and regimen will be presented.  A second case study that demonstrates the use of quantitative systems pharmacology to understand the relationships between dose, exposure, and efficacy that could not be elucidated through observed clinical trial data alone, and incorporates concepts from population model approaches, will also be presented. 

Bio

Theresa has a PhD in Chemical Engineering from the University of California Santa Barbara, and 12 years of experience as a clinical pharmacologist and pharmacometrician in the pharmaceutical and biotechnology industries.  She has worked across all stages of development in a variety of therapeutic areas to develop small molecule drugs, large molecule drugs including monoclonal antibodies and recombinant protein replacement products, and bispecific T-cell engaging antibodies.  Her work has included translational modeling to support FIH dose selection, population PKPD modeling to support Phase 2 and Phase 3 dose selection, and quantitative systems pharmacology modeling to better understand mechanisms of response and non-response and to inform combination development for immune-oncology projects.  In her current role at Merck, she leads a group of pharmacometricians responsible for modeling and simulation activities across multiple therapeutic areas and all stages of drug development.