FDA Receives License to Entelos PhysioLab Modeler® Software
CDER to Use Entelos Software to Explore Mechanisms of Drug-Induced Liver Injury
San Mateo, CA, September 3rd, 2013 – Entelos, a provider of in silico modeling and simulation products and consulting services, today announced a licensing agreement with the US Food and Drug Administration (FDA) for use of the PhysioLab Modeler software in its drug safety research. The license provides FDA with access to a computer model of drug-induced liver injury (DILI) that was developed under a 5 year Research and Collaboration Agreement (CRADA) between Entelos and FDA’s Center for Drug Evaluation and Research (CDER). DILI is a potentially serious adverse event that can result from drug therapy.
The PhysioLab Modeler software is used to author models and edit Entelos PhysioLab® platforms. PhysioLab platforms are depictions of the body’s functional pathways paired with mathematical algorithms. The mathematical representation of normal and diseased biological systems makes it possible to simulate outcomes of specific interventions or treatments over any clinically relevant period of time using computer generated patients.
In contrast to the limitations of simulating a single generic virtual human, the PhysioLab platform can generate any number of virtual patients representing combinations of disease status, genetics, aging, lifestyle, or other factors. It is then possible to run a virtual clinical trial on a diverse patient population. Specialized PhysioLab platforms include Cardiovascular Disease, Metabolism, Rheumatoid Arthritis, Hypertension, Hypersensitivity, Dermis and Epidermis.
“Entelos recognizes the value of the regulatory aspect of pharmaceutical development in protecting the public’s health” said Shawn O’Connor, president and CEO of Entelos. “We believe our mechanistic platforms represent the next generation of tools that the FDA and other international regulators could use to reduce risk and predict success for new compounds undergoing review for safety and efficacy in diverse populations.”
The FDA’s Center for Drug Evaluation and Research (CDER) has expressed a keen interest in exploring the use of computer models as a way to better understand the risks of introducing new compounds into the nation’s arsenal of approved treatments and cures. A recently published CDER Science and Research Needs Report concluded that: “Given the high societal and economic cost of late stage drug failures because of efficacy or safety concerns, it is important to thoroughly assess the added value of predictive modeling to regulatory decision making during drug development.” It is currently standard practice for pharmaceutical companies and the FDA to estimate clinical trial doses using computer models. The use of mechanistic models may make it possible to evaluate why adverse events occur and to determine the potential basis for pharmacodynamic variability in patient response.
Dominic John, +1 925 640 8154