Biomarker use in translational medicine is predicated upon preclinical qualification and validation – 2 distinct steps in the biomarker development process. Prior to issue in 2009 (EMA) and 2010 (FDA, PMDA) of the renal-specific DRAFT qualification guidelines, there was no clear direction by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) of how companies should qualify new biomarkers for disease progression or clinical trial endpoints. The trend in biomarker use is multivariant analysis, the tracking of subtle changes in multiple biomarkers simultaneously, often utilizing various tissue types. While the new guidance addresses biomarker qualification, analytical validation of new biomarkers remains undefined. This review updates the reader of the status of both qualification and validation of translational biomarkers.
Source: Drug Discovery & Development
Predictive Safety Testing Consortium: special issue of Nature Biotechnology (renal biomarkers) (http://www.c-path.org/PSTCPublications.cfm)
EMA: Qualification of novel methodologies for drug development guidance to applicants.