ABSTRACT

Precision medicine is defined as a clinical intervention, using designated therapies based upon a person’s or populations’ unique genetic or molecular makeup, providing the right treatment, to the right patient, at the right time. This process must be data driven, streamlined through clinical development design, and include characterization of biomarker profiles informing clinical outcomes. Regarding precision medicine, the right time to treat the right patient is established by patient physiology and disease presentation. Toward this, the inherent biology and molecular/physiological presentation of the disease must be defined through either genomic analysis determining relative development risk or characterization of the disease’s phenomic signature. Phenomic analysis refers to systematic measurement and subsequent analysis of quantitative traits relying upon comprehensive multi-omic profiling. This includes clinical, behavioral, and dietary data overlaid by proteomic analysis and subsequent posttranslational modifications of proteins within biofluids/cells compared with lipidomic and metabolomic signatures defining a patient’s systemic physiological state at a given time. Aligning an individual’s or population’s disease progression with molecular signatures requires dynamic multiannual sampling of biofluids to track changes within the individual as well as the disease population.