Fibroinflammatory diseases, characterized by chronic inflammation and dysregulated tissue remodeling, represent a major unmet medical need across multiple organ systems. Advances in translational medicine have driven a paradigm shift toward biomarker-driven drug development. This presentation will highlight strategies for integrating biomarkers throughout the discovery and development continuum—from target identification and validation to patient stratification, pharmacodynamic assessment, and proof-of-mechanism in both early and late clinical stages. Through case examples, I will demonstrate how a well-crafted biomarker strategy can accelerate decision-making, de-risk development, and enable precision medicine approaches. Finally, I will discuss how successful biomarker implementation can transform the therapeutic landscape for fibroinflammatory diseases, leading to a more predictive, efficient, and patient-centered model of drug development.