Model-Informed Drug Development (MIDD) – EMA’s Advancement

Modelling and simulation (M&S) plays a crucial role in drug development. It allows information from diverse sources – pre-clinical and in-vitro data, early and late-stage clinical trial data, biomarkers, and efficacy outcomes – to be included with a dataset. Modelling enables researchers to visualize complex scenarios and determine what will happen if a parameter is changed in a clinical trial. It can optimize clinical study design, enable unnecessary studies to be waived, and inform risk: benefits in “what if” scenarios with specific patient populations or drug-drug interactions (DDI).