Contract research organisations (CRO) have been bolstering their biomarker capabilities to help clients decide at an early stage which therapeutic candidates to continue developing. Demand for this insight has increased as a result of cost cutting and need to reduce Phase II attrition.
“We believe that the current regulatory requirements for biomarkers in drug development and diagnostics coupled with the need for fast, flexible and cost effective workflows have meant that specialist services will be increasingly required”, said Christopher Pearce, CEO of Proteome.
Parexel is using Proteome Sciences’ PS Biomarker Services to meet this demand. The system provides mass spectrometric and pharmacokinetic assays for protein and peptide compounds.
Proteome has an ISO 9001:2008 facility in Frankfurt, Germany which is “designed to provide expert protein biomarker discovery and validation and for the development of rapid mass spectrometric-based assays”, Pearce added.
This provides Parexel with the capacity and expertise needed to select the relevant biomarkers for their developmental programmes. Results from the biomarker work will then be interpreted to determine the biological activity and safety profile of a therapeutic candidate.
Early phase offering
The alliance strengthens Parexel’s early phase offering, which includes a broad portfolio of biomarkers and non-routine laboratory analysis. Using this infrastructure Parexel can offer biomarkers in a range of therapeutic fields, including oncology, neurology and cardiology.
Furthermore, the CRO offers cellular and soluble biomarker analysis. This is supported by bioanalytical services for quantitative and qualitative drug, metabolite and biomarker analysis in a variety of matrices.