Entelos signs "virtual patient" deal with FDA

US life sciences company Entelos has entered into an agreement with the Food and Drug Administration to use its Cardiovascular PhysioLab to assess the safety and efficacy of a drug belonging to a specific class.

The platform is a comprehensive, large-scale computer simulation of cholesterol regulation, atherogenesis and cardiovascular risk. A broad range of "virtual patients" will be generated using the Entelos' technology and used for simulations to test the cardiovascular safety and efficacy of multiple drugs. Results will be compared to existing clinical trial data collected from multiple drug sponsors.

"Although the modern controlled clinical trial is still the international gold standard for evaluating the safety and efficacy of new therapies, rare and serious adverse events may only appear after a drug has been administered to a large heterogeneous population, long after it has been approved," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Having information that may be predictive of likely adverse events or that can help to explain the biological mechanisms leading to adverse events in certain patient types could be extremely valuable. This project will thus test the predictive value of using a dynamic, mechanistic computer model of cardiovascular disease processes and a large virtual patient population for detecting rare adverse events," she added.