FDA contract a fillip for Entelos

Related tags Clinical trial

In silico R&D specialist Entelos has entered into an agreement with the US Food and Drug Administration to use its PhysioLab to assess the safety and efficacy of cardiovascular drugs.

Entelos’ 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.

in silico​ R&D simulates experiments in a computer, rapidly testing what would likely take months or years to do in the laboratory or clinic.

Results will be compared to existing clinical trial data collected from multiple drug sponsors, and results will be available in a matter of days or weeks, compared with years required for most major clinical trials.

Entelos claims its in silico​ approach to R&D increases efficiency and productivity across the entire drug discovery and development pipeline, as well as post-marketing.

"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, ​" commented Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

The federal contract is a boost to Entelos, which has said it expects fourth-quarter revenues to be below expectations as some of its customers had delayed their drug development programmes

"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​,” said Woodcock.

Related topics Clinical Development

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