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 long-range goal of the DILI-sim Initiative will be to produce a mathematical model capable of predicting the hepatotox response across a wide range of patient types and to use simulations to propose candidate biomarker combinations and/or mechanistic links to hepatocellular DILI.
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 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: Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Gilead, Janssen Research and Development, LLC, Merck, Mitsubishi Tanabe Pharma, Pfizer, and Sanofi. The FDA is also actively participating in the development of DILIsym® and preparing to begin early evaluations of the model's capabilities.
The ultimate deliverable for DILI-sim is a model, in the form of DILIsym® software, used by the pharmaceutical industry and the FDA to evaluate the plausibility of DILI across multiple pathways when liver signals appear during various phases of the drug development process.
Please visit www.dilisym.com to learn even more about The DILI-sim Initiative and DILIsym® software.
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.