The Hamner-University of North Carolina Institute for Drug Safety Sciences is spearheading a multi-stakeholder partnership aimed at predicting drug-induced liver injury
The goals of the DILI-sim Initiative are to improve patient safety, reduce the need for animal testing, and reduce the costs and time necessary to develop new drugs.
Drug-induced liver injury (DILI) remains the single major adverse drug event that terminates drug development programs and results in regulatory actions leading to failed or stalled drug approvals, market withdrawals, usage restrictions, and warnings to physicians. There is an industrywide need for predictive tools which will incorporate safety earlier in the drug development process. These new tools will predict and quantify the risk of DILI in preclinical species and humans, thus reducing development timelines and enabling real-time decision-making.
The DILI-sim Initiative is a pre-competitive partnership between The Hamner and a diverse set of stakeholders to develop a computational model that will predict whether new drug candidates will cause drug-induced liver injury (DILI) in patients. The goals of the Initiative are to improve patient safety, reduce the need for animal testing, and reduce the costs and time necessary to develop new drugs. It is the intent of the DILI-sim Initiative to make the model, in the form of DILIsym® software, broadly available so that it may be used by the pharmaceutical industry, the U.S. Food and Drug Administration (FDA), and other entities in academia, government and industry.
The Institute for Drug Safety Sciences has secured significant funding from major pharmaceutical partners, and is in active discussions with several others. Committed partners thus far include: AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Gilead, Janssen Research and Development, Merck, Mitsubishi Tanabe Pharma, Otsuka, Pfizer, and Takeda. The FDA is also actively participating in the development of DILIsym® and preparing to begin early evaluations of the model's capabilities.
The vision for the DILI-sim Initiative over the next three years is for DILIsym® software to build upon its foundation as a key resource in the pharmaceutical industry’s preclinical toolbox by further optimizing and enhancing DILIsym® for the prediction of less frequent human DILI that may only become evident in late stage clinical development or post-marketing.
Please visit www.dilisym.com to learn even more about The DILI-sim Initiative and DILIsym® software.
DILIsym® featured on UNC-TV
Slide Presentation and Flyer
CLICK HERE to view a slide presentation on DILI-sim.
The presentation features:
•DILI-sim Initiative overview
•DILIsym® software overview
•Insights from modeling with DILIsym® software
Additionally, click on the image on the right to view our 2-page marketing flyer on The DILI-sim Initiative.
DILIsym® and MITOsym® are registered trademarks of
The Hamner Institutes for Health Sciences for computer modeling software and for consulting services.