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The role of biomarkers in the future of drug development

Biomarkers are beginning to be used earlier in drug development, thus allowing the pharmacodynamic effects of targeted therapeutics to be explored before clinical signs and symptoms can be evaluated. This trend will continue and ultimately may enable pharmacodynamic biomarkers to be commonly used to determine therapeutic dosing based on these more accurate measures of human physiological responses. At the same time, biomarkers are also beginning to be used to determine which patients will be likely to respond to the therapeutic, thus avoiding administration to those who will not be likely to benefit. The strategy to achieve these aims and how this can lead to information that can be fed back into drug discovery is described in this perspective.