title: From biomarker strategies to biomarker activities and back.
abstract: 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.
authors.affiliation: Translational Medicine Research Centre Singapore, Schering-Plough, 8 Biomedical Grove, Neuros #04-01, Singapore. alain.vangool@spcorp.com
authors.forename: Alain J
authors.initials: AJ
authors.lastname: van Gool
authors.forename: Brian
authors.initials: B
authors.lastname: Henry
authors.forename: Erik D
authors.initials: ED
authors.lastname: Sprengers
mesh_terms: D000818:Animals; D054316:Biomarkers, Pharmacological / Q000378:metabolism*; D055808:Drug Discovery / Q000379:methods*; D006801:Humans; D017146:Models, Organizational; D057170:Translational Research, Biomedical / Q000379:methods* / Q000639:trends
chemical_list: D054316:Biomarkers, Pharmacological