U.S. FDA Renews DILIsym Software Licenses
DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical safety and efficacy, today announced that the U.S. Food and Drug Administration has renewed its multi-seat license for the company’s flagship quantitative systems toxicology (QST) modeling software, DILIsym®. The renewal provides DILIsym access to FDA employees across all FDA divisions.
DILIsym prospectively supports key management decisions by providing information about potential drug-induced liver injury (DILI) risk in upcoming experimental or clinical study designs, as well as mechanistic rationale for the underlying biochemical events that could cause liver toxicity. 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. DILIsym is the product of an ongoing public-private partnership (the DILI-sim Initiative) that involves scientists from the pharmaceutical industry and academia.
Dr. Paul Watkins, chair of the DILI-sim Scientific Advisory Board, said: “DILI remains a major problem for drug developers and regulators. DILIsym modeling software is helping to address this challenge. We’re excited to see the DILI-sim Initiative QST platform continue to be available to the FDA, especially as sponsor submissions with DILIsym results are ever increasing.”
Dr. Brett Howell, president of DILIsym Services, added: “The cost of developing new drugs continues to rise, and liver safety is an important component of this cost. If not adequately addressed during the drug development process, this issue can either force companies to run unrealistically large clinical trials to support safety or to abandon their molecule after expensive large trials and even drug approval in some cases. DILIsym is now helping companies address these concerns through the use of QST, and we are delighted to see that the FDA remains engaged in this process through the renewal of its license package for DILIsym.”
Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organizations imply endorsement by the United States Government.