The Hamner Institutes for Health Sciences has announced the formation of the DILI-sim Initiative, 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, Food and Drug Administration, and other entities in academia, government and industry.
Current members of the Initiative include Amgen, AstraZeneca, Eli Lilly and Company, GlaxoSmithKline, Janssen Research & Development, LLC, Merck, Novartis Pharmaceuticals, Pfizer, and Sanofi. It is anticipated that additional members will join, as the Initiative continues to grow and meet its objectives. The FDA is also involved, providing support for one of the modelers on the project.
The Initiative will provide a forum for sharing knowledge and experiences related to DILI across the partner organizations. Top experts from the stakeholders will help to identify relevant data to be incorporated into the computational model, and to recommend reasonable standards for developing, using, and accessing DILIsym software. In the process of producing DILIsym software, the Initiative will advance fundamental understanding of the mechanisms that cause DILI. This knowledge should aid the development of safer new drugs in the future, and help identify improved tests to monitor patient safety in clinical trials and in clinical practice.
Date: June 17, 2012
Source: The Hamner Institutes for Health Sciences