The role and impact of quantitative discovery pathology.

The decision to advance an early-stage compound into formal preclinical testing depends on confidence in mechanism, efficacy and toxicity profiles. A substantial percentage of this confidence comes from histopathology interpretation, as the local tissue environment contains strong signals of both efficacy and toxicity. Accessing this tissue information is made difficult by biological variability across organs and tissues, an insufficient pool of pathology experts working in discovery, and the high subjectivity and individual isolation of microscope-based observations. This article describes how whole-slide imaging and quantitative analysis by trained pathologists are improving early-stage decision-making.