Pharmacology and Toxicology

Biography

Biography: Mohamad Samer Mouksassi

Abstract

Nowadays it is rare to see any FDA submission package without a Pharmacokinetics/Pharmacodynamics modeling component where some clinical trials were designed based on simulation. The current workflow is that an expert modeler provide model outputs and simulation about scenarios that he thinks are important to emulate future trials and decisions. Then, the decision maker might then ask for new more relevant scenarios to the current situation. This decision process is iterative where one simulated scenario might warrant another question/scenario that need to be tested until we reach a satisfactory decision. As such this involves sveral cycles of back and forth. All this results in bottlenecks cycles where the decision maker is waiting for simualtion results and where simulation scientists are waiting for decision maker to give them more scenarios to test. Why is this ? The simulation workflow is so complicated that only the person who built the underlying models and simulation scenarios can get useful answers. However, recent technological advances has enabled simulation scientists to build specialized user interfaces that enable decision makers to be part of the design team and ask questions and get answers on the fly. Today this is possible using web based responsive user interface A successful simulation exercice involve a mathematical modeler (e.g.pharmacometrician), a clinical trial expert, a therapeutic area expert (or a clinician) a computational/web developer expert and the clinical development decision maker. An example of the development of such an app for Tuberculosis will be demoed.