DILIsym Services, Inc., a Simulations Plus company (NASDAQ: SLP) and a leading provider of simulation and modeling software for pharmaceutical safety, today announced that the U.S. Food and Drug Administration has secured an annual government license for its flagship QSP (quantitative systems pharmacology) modeling software, DILIsym®.
DILIsym is the product of an ongoing public-private partnership (the DILI-sim Initiative – www.DILIsym.com) that involves scientists from the pharmaceutical industry, academia and the FDA. The software incorporates properties determined in the laboratory for new drug candidates to predict whether they will be safe for the liver in patients. The use of modeling and simulation tools like DILIsym is being promoted by FDA Commissioner Dr. Scott Gottlieb to improve the efficiency of drug development (https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/).
Dr. Paul Watkins, chair of the DILI-sim Scientific Advisory Board, said: “Since the inception of the DILI-sim Initiative to drive the development of DILIsym, our stated goal has always been widespread evaluation and use of the DILIsym software. We are excited to see this mission moving forward through this licensing arrangement with the FDA.”
Dr. Brett Howell, President of DILIsym Services, added: “The number of pharmaceutical and biotech companies now benefitting from DILIsym in the first part of 2018 has nearly doubled over all of 2016. Investigations have included analyses comparing lead and backup compounds, comparing the company’s compound with a competitor, combination therapy analysis, safety prediction for a new dose for opening a new IND, biomarker safety analysis for review board and regulatory presentations, hepatocyte loss simulations, and mechanistic analysis of compounds based on safety concerns, among others. The information from such studies serves to guide go/no-go decisions on major projects, potentially avoiding the disastrous financial effects of failed clinical trials or better, providing assurances that drug-induced liver injury will not be an insurmountable obstacle to establishing the safety of a new compound or dose. Getting more FDA reviewers trained on and using the platform will be very helpful as they evaluate the liver safety of new drugs.”