Faced with remarkably low approval rates and frequent late phase failures, oncology drug developers need new ways to accelerate and streamline what is often an inefficient, expensive process. One answer is biomarkers, which can confirm a drug’s mechanism of action and help guide patient selection to reduce both risk and cost.

In the first of a two-part series, Quintiles experts in strategic drug development Eric Groves, Jason Hill and Christopher Ung recommend using biomarkers in anticancer therapy research and creation, exploring the critical role these indicators can play in every stage of the process, from preclinical efforts to post-marketing. They explain common reasons for drug failure, discuss the timing of biomarker utilization and demonstrate why biomarker research should be at the center – not the periphery – of development programs.