Discovery, development, and validation of biomarkers for use in early development to aid decision making are critical activities for translational medicine scientists. In the past, pharmaceutical companies attempted to create a competitive advantage for themselves by using biomarkers to reduce costs and improve productivity. Although these activities often must remain proprietary, biomarkers for some uses require external acceptance, and sponsors can benefit from sharing development costs. For these reasons, companies have recently come to the realization that much of this work can be done in the precompetitive space. This is especially true in the area of safety biomarkers and outcome biomarkers, where external acceptance of validity is critical to their value.

In this section, we describe the basic concepts involved in the process of biomarker validation within the proprietary space of early drug development and then provide three examples of organizational structures in which precompetitive partnerships for biomarker development projects can be created and executed.