Clinical biomarkers in drug discovery and development.
Biomarkers enable the characterization of patient populations and quantitation of the extent to which new drugs reach intended targets, alter proposed pathophysiological mechanisms and achieve clinical outcomes. In genomics, the biomarker challenge is to identify unique molecular signatures in complex biological mixtures that can be unambiguously correlated to biological events in order to validate novel drug targets and predict drug response. Biomarkers can stratify patient populations or quantify drug benefit in primary prevention or disease-modification studies in poorly served areas such as neurodegeneration and cancer. Clinically useful biomarkers are required to inform regulatory and therapeutic decision making regarding candidate drugs and their indications in order to help bring new medicines to the right patients faster than they are today.
Frank
Richard
R
Pharmacia, Peapack, New Jersey 07977, USA. Richard.Frank@verizon.net
Hargreaves
Richard
R
D000544:Alzheimer Disease / Q000188:drug therapy; D015415:Biomarkers; D002097:C-Reactive Protein / Q000032:analysis; D015195:Drug Design; D020869:Gene Expression Profiling; D006331:Heart Diseases / Q000188:drug therapy; D006801:Humans; D008279:Magnetic Resonance Imaging; D009369:Neoplasms / Q000188:drug therapy; D010597:Pharmacogenetics; D040901:Proteomics; D014055:Tomography, Emission-Computed
D015415:Biomarkers; D002097:C-Reactive Protein