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Entelos and FDA collaborate on liver drug injury computer prediction model

Entelos has entered into a cooperative R&D agreement with the FDAís Center for Drug Evaluation and Research (CDER) to

Entelos, a US-headquartered life sciences company which develops predictive computer models and virtual patients for drug discovery and development, has entered into a cooperative R&D agreement (CRADA) with the FDA's Center for Drug Evaluation and Research (CDER).

The two-year agreement charges Entelos to collaborate with the FDA to develop a computer model of drug-induced liver injury (DILI). The platform development plan has been designed by Entelos and the FDA with input from an expert scientific panel and a number of pharmaceutical companies.

The research goal is to use this platform to guide the development of clinical biomarkers and preclinical assays to identify patient types and drug combinations that increase the risk of developing liver injury.

DILI is the commonest cause of acute liver failure in the US, as well as the single greatest cause of regulatory action, including failure to approve, withdrawal from the market, restrictions on use and warnings to doctors and hospitals.

Deputy Commissioner of the FDA's CMO, Dr Janet Woodcock, said: "Early detection of potential drug safety problems is one of the objectives of the FDA's Critical Path Initiative, an effort seeking to modernise the drug development process. Under the Critical Path, the FDA is pursuing collaborations to find innovative ways to reduce the time it takes to bring new and therapeutically important medical products to the market."

James Karis, president and CEO of Entelos, said: "The DILI computer model will focus on defining healthy human liver function and creating a cohort of virtual patients to represent tolerator, adaptor and susceptible patient phenotypes and predict what combinations make patients susceptible to hepatic injury following exposure to a specific drug or drug class. Such information will help patients, physicians, the FDA, and pharmaceutical companies avoid costly clinical failures and withdrawal of life-saving drugs from the market."

7th August 2007

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