Simulations Plus, Inc. announced that its DILIsym Services (DSS) division has renewed licenses to its DILIsym® software platform, its flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI), for use by the U.S. Food and Drug Administration (FDA). The renewal ensures continued DILIsym software access to FDA employees across all FDA divisions at the FDA’s discretion through an unlimited licensing package.
DILIsym modeling supports key drug development decisions by predicting potential DILI risk of new drug candidates. The modeling also identifies the biochemical events that lead to DILI caused by a drug and can thereby predict certain subgroups of patients at increased risk for DILI from that drug. The information from DILIsym modeling serves to help guide go/no-go decisions on major drug development projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that DILI will not be an insurmountable obstacle to regulatory approval. For the past 10 years, the DILIsym Services division has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym software package. DILIsym is available to the pharmaceutical and chemical industries for direct use to predict and understand liabilities via membership in the DILI-sim Initiative consortium and/or commercial licenses. The DILIsym Services division also routinely uses DILIsym for comprehensive consulting services on safety-related issues.