The pharmaceutical industry must find ways to improve the unacceptably high attrition rate during drug development. Clearly, pharma has moved away from treat-and-see testing of new drugs in patients, with a strong current focus on generating translational biomarkers early in the research process to enable more predictive evaluation of drug action in clinical trials. Underlying such a translational medicine approach is the intensive search for and use of high-quality biomarkers indicative of successful drug target engagement, pharmacological effects, efficacy or safety. This review outlines our rational question-based drug development strategy in which biomarker data drive decisions on which drug candidates to progress to clinical testing.
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| http://dx.doi.org/10.1016/j.drudis.2009.11.004 | DOI Listing |
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