Simulations Plus Scores Big with Renewal of U.S. FDA Licenses for DILIsym Software

Simulations Plus, Inc. (Nasdaq: SLP) is thrilled to announce that its DILIsym® software platform has been granted another year of licensing by the U.S. FDA. This advanced quantitative systems toxicology (QST) software is used to predict and investigate drug-induced liver injury (DILI). With this renewal, FDA divisions across the country will have access to this invaluable software, allowing them to continue their vital work of ensuring the safety of consumers.

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, is thrilled with the FDA’s renewal of these licenses, recognizing the value of DILIsym software in predicting liver safety liabilities and defining the underlying mechanisms.

With the recent signing of the FDA Modernization Act 2.0, which encourages the FDA to limit animal use in drug development, the use of DILIsym software in drug development should be further encouraged. Dr. Watkins is enthusiastic about the public-private partnership guiding the further development of the DILIsym platform and its potential to benefit many stakeholders.

Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus, is thrilled to announce the FDA’s decision to renew their use of DILIsym and other Simulations Plus tools to enable reviews and enhance regulatory science.

With rising healthcare costs making drug development increasingly costly, the use of novel simulation technologies to streamline the process is now more important than ever. Through the FDA’s renewed commitment to these powerful tools, the mission of providing vital healthcare is bolstered.

DILIsym software provides key insights to support drug development decisions, helping to reduce the risk of costly clinical trial failures or regulatory roadblocks due to DILI. For over a decade, DILIsym Services, a division of Simulations Plus, has overseen the DILI-sim Initiative – a public-private partnership that has led to the development of the powerful DILIsym software package.

Through membership in the DILI-sim Initiative consortium and/or commercial licenses, pharmaceutical and chemical industries can access DILIsym to predict and understand liabilities. Additionally, DILIsym Services provides comprehensive consulting services on safety-related issues, utilizing DILIsym software.

About Simulations Plus

For over 25 years, Simulations Plus has been revolutionizing the biosimulation market with its cutting-edge software and consulting services. Our offerings span a range of AI/machine learning, physiologically-based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches, making us the go-to provider for major pharmaceutical, biotechnology, and regulatory agencies around the world. We are proud to support the drug discovery, development, research, and regulatory submissions processes and are committed to delivering innovative solutions for our clients.

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