Box 1 Role of biomarkers in clinical and research settings.

Diagnosis (clinical settings, subject selection for clinical trials).

Assess disease state, staging, and prognosis.

Assess and monitor the pharmacodynamic effects of candidate compounds.

Demonstrate target engagement.

Aid in dose selection/optimization.

Assess response to and efficacy of therapies.

Identify and mitigate toxicity and adverse effects.

Personalize interventions according to stage and patient characteristics (personalized medicine approach).