FDA Renewal Ensures Access for DILIsym Evaluation of Drug Candidate Submissions

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that the U.S. Food and Drug Administration (FDA) has renewed its licenses to the DILIsym^® software platform, the DILIsym Services division’s flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI). The one-year renewal provides continued DILIsym software access to FDA employees across all FDA divisions at their discretion through an unlimited licensing package.

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, remarked: “DILIsym has been developed over 12 years with input from the pharmaceutical industry and regulators, and the FDA continues to maintain access to the platform. I am aware of many cases of its past and current use for high-profile liver safety projects that are pivotal for the success of large and small pharma companies alike. Interestingly, while there is no formal FDA approval pathway for the use of software like DILIsym in drug development, regulators continue to utilize the software when relevant to the research. By virtue of their continued renewals, the FDA clearly finds DILIsym useful in assessing the liver safety of new drug candidates as they review such cases from sponsors.”

Dr. Scott Q. Siler, Chief Scientific Officer of the DILIsym Services division, added: “We are excited that the FDA has continued access to DILIsym with this license renewal. This will enable them to understand in depth the methods used to develop and utilize DILIsym as well as the resultant simulation results as they need to review simulation results submitted to them.”

DILIsym software results support crucial 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 12 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.

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About Simulations Plus

Serving clients worldwide for 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.

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