Biomarkers as indicators of biological and pathogenic processes have been used for decades to diagnose patients and prescribe treatment. In the past 10 years, however, they’ve substantially changed drug development practices. The demand for analyzing biomarkers in drug development has increased dramatically with the advancement of precision medicine. In the drug development context, biomarkers that are indicative of mechanism of action, target engagement, and clinical outcomes have been employed to assess both the safety and efficacy of an intervention. More specifically, biomarkers have been used either to select patients for clinical trials, to make go/no-go decisions, to support registration and label claims, or to treat patients. 3696

Analyzing Biomarkers in Drug Development

Biomarkers as indicators of biological and pathogenic processes have been used for decades to diagnose patients and prescribe treatment. In the past 10 years, however, they’ve substantially changed drug development practices. The demand for analyzing biomarkers in drug development has increased dramatically with the advancement of precision medicine. In the drug development context, biomarkers that are indicative of mechanism of action, target engagement, and clinical outcomes have been employed to assess both the safety and efficacy of an intervention. More specifically, biomarkers have been used either to select patients for clinical trials, to make go/no-go decisions, to support registration and label claims, or to treat patients.