The Centre for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) and Prous Science have begun a joint study on the use of the BioEpisteme technology, developed by Prous Science for the prediction of drug-related toxicity and adverse effects in humans.

The study, which will be performed over 12 months, seeks to establish the utility and feasibility of using 3D molecular conformations for the rational study of the synthesis of active principles obtained from theories that relate quantitative variations in biological activity to structural changes (QSAR, Quantitative Structure Activity Relationships). The objective is to determine the potency of BioEpisteme at predicting drug-induced carcinogenicity. The determination of carcinogenicity is crucial from the regulatory point of view because of the cost and time required to collect experimental data. For example, a standard 2-year carcinogenicity study in rodents has an estimated cost of around 2 million dollars. Therefore, the successful application of BioEpisteme technology to the prediction of drug-induced carcinogenicity could lead to significant cost savings in drug development, and may also reduce the time required to introduce new pharmacological drugs into the market.

Prous Science, headquartered in Barcelona and with subsidiaries in Philadelphia, Tokyo and Buenos Aires, has been providing information and communication services on drug R&D and clinical medicine since 1958. The firm’s information tools, known for their accuracy and high quality content, have become industry standards. Prous Science maintains its competitive position through collaboration with more than 500 leading international authorities in the biomedical, clinical and IT fields. Over the years, its products have developed from print journals to sophisticated electronic products that incorporate the latest IT advances. More recently, Prous Science began a series of research projects in the fields of drug discovery and audio/video information retrieval techniques.

The Centre for Drug Evaluation and Research (CDER) of the FDA promotes and protects the heath of Americans by ensuring that all prescription and over-the-counter drugs sold in the United States are safe and effective. The CDER evaluates all new drugs before their release into the market, and serves as a consumer watchdog for the more than 10,000 drugs currently available to be sure they continue to meet the highest standards. Furthermore, the centre routinely monitors drug advertisements to ensure that they are truthful. The CDER also plays a critical role in providing health professionals and consumers information on appropriate and safe use of drugs.