It's a confident move by the Contract Research Organisation (CRO), who are eager to supply those services to serve the majority of drug companies who engage in drug toxicity and drug response clinical studies. The new QPS department, located at its Newark facility, has assembled instrumentations, platforms, and processes required to conduct studies supporting client drug discovery and development strategies. It offers pharmacogenomic (PGx) services into drug development, including automated RNA and DNA isolation, genotyping and genetic mutation analysis, gene expression profiling analysis, quantitative determination of CpG methylation, viral load determination, and custom assays. "This new service will provide our pharmaceutical and biotech customers with data to help assess drug characteristics necessary for patient stratification, treatment decision making, and therapy evaluation in drug development," said Ben Chien, President and CEO of QPS. According to pharmaceutical industry data, it takes an average of 10-15 years and over $800m (€632m) dollars to discover, develop, and receive regulatory approval for a new chemical entity (NCE).
Any delays in regulatory approval of a novel treatment for an unmet medical need translate into delayed therapeutic benefits for patients and decreased financial benefits for drug companies. Delays most often occur during pre-clinical or clinical development due to lack of an effective plan for pre-clinical and clinical evaluations of the drug candidates. "Our mission is to provide PGx technologies to help drug sponsors develop therapeutics with better efficacy and safety profiles," says Dr. Ling Sing Chen, executive director of Molecular Biology at QPS. "This in turn will shorten drug development timelines and reduce development costs."
QPS launches the service at two major meetings this week - the American Association of Pharmaceutical Scientists' National Biotechnology Conference in Boston and the annual meeting of the Drug Information Association in Philadelphia, US.