Application of commercial research-grade biomarker assays in drug development: is it time to create ‘pharmaceutical-grade’ kits?

“In pharmaceutical/biotechnology companies, the demand for increased innovation and efficiency has never been greater, but, at the same time, there is a profound need to reduce the overall cost associated with the development of new therapeutics.” Today, the application of biomarkers is routinely included as an integral component in pharmaceutical/biotechnology R&D strategies to improve the success rate and cost–effectiveness of rational drug development [1–3]. This notion is illustrated nicely by a PubMed search in which biomarkers and drug development were used in combination as search terms to gauge the growth in publication rate between 1990 and 2010. This topical search...