Figure 1.

Drug discovery and development in the postgenomic era. Top: one rendition of the modern drug pipeline, indicating typical activities conducted during Exploration, Discovery, Preclinical Studies and Clinical Trials. Bottom: “Omic” sciences, which are typically invoked during Exploration, serve the added purpose of enabling a biomarker pipeline to parallel the drug development pipeline. The upper biomarker pipeline illustrates the typical process for biomarkers of disease progression or predictors of efficacy. The bottom biomarker pipeline illustrates that the Discovery stage for surrogate endpoint biomarkers begins much later, typically in parallel with preclinical studies.