Model alliance

An FDA pilot program on model-informed drug development could generate the information FDA needs to fulfill a commitment under PDUFA VI and answer a big industry ask: more clarity on the agency’s standards for accepting the models.

Model-informed drug development (MIDD) can streamline R&D by replacing some experimental data collection with simulation, and can generate information when considerations like scarcity, safety or ethics make clinical data collection difficult or inappropriate. Some companies already use modeling to support internal decisions -- such as which compounds or combinations to take into the clinic, or which indications or populations to study -- based on predictions of dose-response, biodistribution, drug-drug interactions, efficacy or safety...