Targeted Protein Biomarkers in Drug Development

The evaluation of protein expression and modification as a function of disease state and drug response is critical for the identification of new therapeutic targets and biomarkers in drug development. Protein biomarkers offer great potential for streamlining preclinical trials by aiding in rapid go/no go decision making, and can reduce clinical trial costs through effective patient enrichment, narrowing the patient population while reducing the likelihood for late-stage failures. This approach is also strengthened through the use of outcome and surrogate biomarkers. Biomarker-enabled efficiencies gained in the drug development process also translate to longer periods of commercialization exclusivity. Furthermore, biomarkers discovered during the development of targeted therapeutics are will lead to the development of companion diagnostics, resulting in theranostic products for personalized medicine.