title: The biomarker is not the end.
abstract: As drug discovery and translational scientists think about using stratification with biomarkers to improve the chances of getting medicines to patients, several areas of expertise need to be considered. These include analytical validation, clinical validation, regulatory affairs and intellectual property. Getting the right input from the right expert at the right time can make or break an effort to bring a biomarker-based companion diagnostic successfully into clinical practice.
authors: Novartis Pharma AG, CHBS, WSJ-760CH, 4002 Basel, Switzerland. michael_james.nohaile@novartis.com
authors: Michael
authors: M
authors: Nohaile
mesh_terms: D000818:Animals; D015415:Biomarkers; D017277:Drug Approval; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends; D033161:Government Regulation; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods / Q000639:trends; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends; D057170:Translational Research, Biomedical / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends
chemical_list: D015415:Biomarkers