ABSTRACT
Personalized medicine holds the promise of tailoring diagnosis and treatment to an individual’s unique biology and, thus far, biomarkers—measured characteristics indicative of biological processes—are the best tools we have to deliver on this promise. The potential influence of biomarker applications is large, impacting activities from disease prognosis and diagnosis to treatment planning, drug development, and wellness monitoring. However, the biomarker development process is fraught with challenges and the road to fulfilling clinical utility has many barriers. Some of these impediments include obvious difficulties such as those encountered when defining clinical cohorts, whereas others are more nuanced, such as difficulties in evaluating the economic value of a biomarker test in terms of its impact on care and health care cost. In this section, we provide an overview of the biomarker discovery and development pipeline and share some of the practice-based lessons we have learned that could tear down some of these critical challenges and barriers. Such lessons include important discussions around the greater need for careful planning and test design well before initiation of the discovery process as well as for engagement with regulatory bodies and other stakeholders to ensure eventual translation into clinical use.
