Getting Real About Biomarkers

Every week, academic scientists publish dozens of articles on biomarkers. Some results are strong enough to persuade drug companies to use certain biomarkers to guide development decisions. But only a handful of the ones that have been incorporated into marketing applications are accepted by regulators as evidence of efficacy or safety.

Moving biomarkers from academic journals to drug labels is a prerequisite for advancing personalized medicine and for enhancing the overall efficiency of drug development. However, identifying prospective markers has proven far simpler than getting them accepted by regulators...