Entelos entered into a two-year CRADA with FDA’s Center for Drug Evaluation and Research to develop a computer model of drug-induced liver injury (DILI).
“Early detection of potential drug safety problems is one of the objectives of the FDA's Critical Path Initiative, an effort seeking to modernize the drug development process,” comments deputy commissioner Janet Woodcock, M.D., FDA's CMO. “The FDA has identified modeling and simulation and quantitative disease models as one of the important new methods to help bring a systems-level, mechanistic understanding of human biology that can lead to trial designs and early prediction of efficacy and safety.”
Entelos and the agency designed the platform development plan with input from an expert scientific panel and a number of pharmaceutical companies. The 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.
“This 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,” states James Karis, president and CEO of Entelos.