Simulations Plus to Collaborate with FDA to Develop Predictive Toxicity Models

Simulations Plus, Inc., a leading provider of software for pharmaceutical discovery and development, announced that the U.S. Food and Drug Administration (FDA) and Simulations Plus have signed a five-year research collaboration agreement (RCA) to work together to develop Quantitative Structure-Activity Relationship (QSAR) toxicity models for FDA regulatory and research applications.

Under the agreement, the FDA will provide non-proprietary toxicology data for a variety of toxicological endpoints: including, carcinogenicity, developmental toxicity, genetic toxicity, and reproductive toxicity. Simulations Plus and FDA scientists will use Simulations Plus’ ADMET Predictor/Modeler™ software to build and validate the predictive QSAR models, and these models will be incorporated into ADMET Predictor. These models will provide decision support information on the safety of substances in both pre- and post-market evaluations by the FDA’s CFSAN. This agreement allows Simulations Plus to commercialize the QSAR models that are developed under this collaboration. The results of the collaboration will be published through various scientific publications and presentations. Simulations Plus will provide the FDA’s CFSAN with two copies of each of its software programs to use in the Center’s research.

Walt Woltosz, chairman and chief executive officer of Simulations Plus, said, “This is an exciting collaboration and we appreciate the FDA’s consideration of Simulations Plus for this important work. Our best-in-class property prediction program, ADMET Predictor, will be enhanced further with the availability of the toxicity models we’ll develop under this collaboration and will provide the FDA with new tools to assist in their evaluation of food additives and contaminants to enhance public safety.”