Given the high social and economic costs associated with late stage drug failures, FDA has been assessing the added value of computer modeling in regulatory decision making as a way of predicting drug safety and efficacy during drug development. A major effort in the Center for Drug Evaluation and Research is the development and use computer simulations to predict drug toxicity and to understand the mechanisms responsible for unexpected adverse events. Liver toxicity remains an area in which safety concerns continue to lead to drug failures across all phases of the drug development process. CDER is working with the DILI-sim team to develop models that could be used in the evaluation of the liver safety of new drug products. Their work with the DILI-sim team is being directed to the development of predictive models for other organ toxicities as well.
Currently, the FDA is participating in an early evaluation of the model's capabilities. A recent commentary published by employees of the FDA on the DILIsym® software praises early examples of DILIsym® use and comments on the prospect of future predictions.