VP of Modeling and Simulation Services Applied BioMath Concord, Massachusetts
The application of modeling in the early stages of drug discovery to understand doses required to be effective can help determine feasibility of drugging a target, prioritize between targets, or define optimal drug properties for a target product profile (TPP). However, applying modeling in early discovery can be challenging due to the lack of pharmacokinetic (PK) and pharmacodynamic (PD) data at this stage. Early Feasibility Assessment (EFA) is the application of mechanistic PKPD models, built from first principles, and parameterized by data that is readily available early in drug discovery to make effective dose predictions. This presentation demonstrates the ability of EFA to make accurate predictions of clinical effective doses for nine approved biotherapeutics and outlines the potential of extending this approach to novel therapeutics to impact early drug discovery decisions.
Learning Objectives:
Upon completion, participants will learn what is Early Feasibility Assessment (EFA).
Upon completion, participants will be able to understand how to use EFA to predict clinical effective dose for biotherapeutics when there is no PK and PD data available yet.
Upon completion, participants will learn examples on how early feasibility assessment is used to accurately predict clinical effective dose for a variety of biotherapeutics.
.jpg "Fei Hua, PhD photo")