A Pathologist's View of Drug and Biomarker Development

Biomarkers need to be non- or minimally invasive and should be able to follow disease progression. The search for biomarkers has often been fueled by hype. If biomarkers were to alleviate the cost and/or speed to approval of drug development, then the search for biomarkers has not been very successful. The chapter provides suggestions for improving drug and biomarker development. If drug and biomarker development need to be better aligned with molecular biology, then morphologic assessment of tissues also needs to become more rigorous. It needs to be remembered that tying histopathology to advance drug or biomarker development will require more than a making diagnosis and validation of its associated prognosis. Anatomic pathology needs to evolve from a primarily descriptive and diagnostic discipline to one that is far more quantitative and analytical. This "multiplexing" of disciplines and technologies offers the potential of taking drug and biomarker development to a new and more successful plane.