NEW YORK (GenomeWeb News) — The US Food and Drug Administration will use Entelos’ computer modeling software to assess the safety and efficacy of a specific set of cardiovascular drugs, the company said today.
Under the agreement, FDA will use the company’s Cardiovascular PhysioLab, which is a large-scale computer simulation of cholesterol regulation, atherogenesis, and cardiovascular risk. The Foster City, Calif.-based firm would not disclose the compound class and drug set that will be evaluated.
Entelos said that the platform will generate a range of “virtual patients” that will be used to simulate multiple drug responses.
It can be used to predict the effects of drugs in patients and patient populations, evaluate novel drug targets, test combination therapies, identify and interpret biomarker patterns, and predict a drug’s long-term biological effects. The results of these studies will be compared to existing clinical trial data by FDA and by “multiple drug sponsors,” the company said.
"Although the modern controlled clinical trial is still the international gold standard for evaluating 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," FDA’s Director of the Center for Drug Evaluation and Research, Janet Woodcock, said in a statement.
"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,” Woodcock added.