Cancer has currently overtaken heart disease as the major cause of mortality in the United States. The Human Genome Project, advances in informatics, miniaturization of sample collection, and increased knowledge of cell signaling pathways has revolutionized the study of disease. Genomics, proteomics, and metabolomics are currently being used to develop molecular signatures for disease diagnosis, prognosis, and therapeutic efficacy. Tumor-associated antigens discovered by these methods are being used to develop passive (humoral) as well as active immunotherapy strategies to stimulate the immune system. Development and validation of biomarkers on a parallel track with therapeutics can speed development times by accurate screening of patient populations and substituting surrogate markers that correlate well with clinical outcomes.