The contract research organisation (CRO) announced last week the launch of its biomarker expert team, which consists of a panel of scientists who provide technical and scientific expertise for customers in the selection, development, validation and testing of biomarker assays. "Through our market research, we have identified a significant need that exists in drug development for high throughput biomarker development services," said Deborah Tanner, president of Covance Central Laboratory Services. "Our expert team offers experience in biomarker testing and validation, which combined with our high throughput capabilities will significantly increase the effectiveness and efficiency of our clients' drug development programmes." Biomarkers are components of bodily fluids or tissues that are indicative of the presence of disease, its progression or the response to therapeutic intervention. The discovery and molecular identification of biomarkers assist biotech and pharma companies in compound selection, dose optimisation, patient stratification, and efficacy and safety monitoring. "Effective use of biomarkers leads to faster decisions to continue or suspend a drug's development, saving pharmaceutical manufacturers money by reducing late stage failures while improving predictability of success," said Covance. As a result, drug makers are now using biomarkers for nearly every new drug candidate, and it is predicted that within the next ten years biomarkers will be a standard aspect of drug development for any novel candidate, according to Covance. What is more, the US Food and Drug Administration (FDA) has made biomarkers a key focus of its Critical Path initiative launched in 2004 - a scheme aimed at modernising and streamlining drug development. According to the FDA, biomarker development is one of the two most important areas for improving medical product development, along with streamlining clinical trials. Covance provides a range of biomarker assay development and validation services as well as biomarker testing services (both large and small scale) from early proof of concept to commercial laboratory testing. According to the CRO, in early drug development, biomarkers help identify viable drug targets by predicting early toxicological effects, while during late stage clinical trials, they help prove drug safety and effectiveness, guide trial design and support critical decision making.
