How To Leverage Modeling And Simulation In The Candidate Development Stage To Help Ensure Clinical Success

By Alison Wilby, Director, Modeling and Simulation, Quotient Sciences

All drug developers wish they had a crystal ball that could predict the future outcome of their molecules. Having the ability to know whether you have a clinical or commercial success before investing the time and money required would be a game changer. Unfortunately, magic and mystics do not have the proven and peer-reviewed data needed to make clinical decisions. Fortunately, modeling and simulation (M&S) provides another way to predict the clinical performance of a molecule, based on a much more robust and holistic approach.

M&S is a proven scientific approach used to inform key drug development decisions, and it can be employed throughout the development lifecycle of a drug. Specifically, physiologically based pharmacokinetic (PBPK) modeling integrates knowledge of a drug’s characteristics (measured or in-silico properties) with physiological information, allowing for maximum leverage from data already obtained. Drug developers can use this approach early in the candidate development stage to help guide their formulation strategy and ensure that their program is well prepared for entering the clinical phase.