ABSTRACT
The ability to apply clustered regularly interspaced short palindromic repeats technology to other than rodent models is potentially particularly beneficial for studying the translatability of nonclinical toxicity and accordingly, biomarkers of toxicity across species. This chapter focuses on the path to regulatory acceptance of novel biomarkers and highlights some of the current global public–private partnerships. Beyond novel technologies to measure biomarkers is the clinically translational advance to testing of nontraditional biofluids as substitute for or as more appropriate matrix than blood in evaluating biomarkers levels. The biomarkers flowing from the new fields of omics, system biology, and bioinformatics are likely the closest “next-generation” biomarkers. One strategy is to multiplex biomarkers, to collect a whole cadre of biomarkers simultaneously and then to create algorithms that cobble together subpopulations of biomarkers to capture the highest amount of risk information. Thus, the key interest of both assay and drug developers is to achieve regulatory qualification of safety biomarkers.
