Entelos Partners with FDA on Biosimulation Project

Entelos, a Foster City, CA, company that uses biosimulation — or “virtual patients” — to enhance drug development, has partnered with FDA to develop a computer model of drug-induced liver injury (DILI). The goal is to use the technology to develop clinical biomarkers and pre-clinical assays for identifying patient types and drug combinations that increase the risk of developing liver injury.

For FDA, the partnership was forged in the name of the agency’s Critical Path Initiative, an effort designed to accelerate the regulatory process for innovative and therapeutically necessary drugs, but one for which FDA has been criticized for slow implementation.

“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,” said FDA deputy commissioner Janet Woodcock, in a statement.

DILI is the most frequent cause of acute liver failure in the U.S. It’s also the single greatest cause of regulatory action, including failure to approve, withdrawal from the market, restrictions on use, and warnings to physicians. FDA is hoping Entelos’ technology will assist in facilitating or eliminating many of these actions.

“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,” said Woodcock.

Entelos uses in silico R&D to simulate experiments in virtual patients and drug targets, rapidly testing what would take months or years to do through traditional human or animal experiments. The company builds what it calls PhysioLab platforms for each disease or biological process it is working on. Entelos recently launched its Realab technology, a simulation tool to provide Internet access to these PhysioLab platforms.

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