Washington D.C., USA: Prous Institute for Biomedical Research will be jointly presenting a scientific poster with the US FDA Center for Drug Evaluation and Research (CDER) at the Annual Meeting of the Society of Toxicology in Washington D.C.. The poster is titled: “Computational Modeling for QT Prolongation: A Drug Cardiovascular Safety Endpoint of Paramount Importance”. The poster will present one of the new modeling efforts with BioEpisteme® v.4.1, a quantitative structure-activity relationship (QSAR) software program that creates customized drug prediction models against fundamental research endpoints. BioEpisteme® was made available to FDA/CDER/OPS via an agency approved Research Collaboration Agreement with Prous Institute. The poster will form part of the SOT poster session: “Bioinformatic Profiling and Computational Pathway Prediction” which will take place on March 7, 2011 from 9:30 am to 12:30 pm in the Exhibit Hall (Convention Center), Abstract Number: 146, Poster Board number: 235.
Abstract:
“Due of the potentially catastrophic nature of unanticipated “off-target” drug-related cardiovascular effects, adequate assessment of cardiac safety is of paramount importance. Torsades de pointes (TdP), which is a potentially lethal cardiac arrhythmia, has been linked with a number of drugs after they were approved and made available for purchase. Early prediction would have allowed for a more thorough assessment of clinical trial data, potentially halted the clinical trials or terminated the drug's development. QT interval prolongation is a precursor to TdP, and therefore its early detection would allow for better clinical development of potential drug products. The measurement of QTc interval effects has been adopted into the FDA’s and international health authority guidelines as a method of assessing the pro-arrhythmic potential of new drugs. In recognizing this public health concern and the goal of developing better predictive methods, Prous Institute has deployed a computational modeling approach based on new, high quality, human clinical trial data. This data will support the development of innovative qualitative and quantitative structure-activity models that can make predictions based on chemical structure. This present effort is innovative, where human clinical trial data will be used to construct predictive computational toxicology models to help screen drugs, and will serve as a support tool for risk assessment of new drugs.”
To learn more about of BioEpisteme® prediction software, please visit www.prousresearch.com