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FDA collaborates with Elsevier on drug-induced liver injury (DILI) tool

Posted on December 3rd, 2019 by in Pharma R&D

A leading cause of attrition of compounds in drug development, drug-induced liver injury (DILI) is also one of the top causes of drug withdrawals, restrictions and project terminations. DILI results when reactive metabolites – formed when certain orally administered drugs are metabolized in the liver – end up binding to cellular proteins and damaging liver cells.

While there is not yet a reliable in vitro, animal or computational model that can effectively predict DILI, we are hoping that a promising new partnership between Elsevier and the National Center for Toxicological Research (NCTR) at the FDA could eventually help lead to one. The two entered into a Collaborative Research and Development Agreement (CRADA), and have been working together since October 8, 2019.

As the press release notes, “NCTR and Elsevier began collaborating on a project to conduct research for the development of a predictive drug-induced liver injury (DILI) algorithm by integrating the rule-of-two model and preclinical data from the literature and the summary basis of FDA and European Medicines Agency (EMA) approval documents collected in Elsevier’s PharmaPendium database.”

With its status as a leading cause of liver failure, DILI poses a significant danger to patients. It also presents major problems for pharmaceutical companies that can lose billions of dollars in development costs and future earnings when DILI leads to late-stage failures. The development of a predictive model would enable pharma businesses and regulators to make more informed decisions earlier, optimize R&D efficiency, reduce costs and, most critically, improve patient safety.

It is a tribute to the high quality of PharmaPendium’s safety data that the FDA, the world’s most authoritative regulatory body, has signed on to this collaborative agreement. It also points to Elsevier’s growing reputation as a trusted predictive analytics company that is relied upon in the industry for its unique expertise.

Read the full press release here.

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