Scientific missteps in target selection, mechanism validation, and translational predictability often set trials up for failure before they begin. This session will examine the biological assumptions that contributed to past setbacks and how we an improve early-stage decision-making.

• Target Selection & Validation: Were we confident in the mechanism of action before advancing to the clinic? Did preclinical models confirm target engagement and therapeutic relevance?
• Translational Gaps & Dosing Challenges: Did preclinical studies establish that effective doses were achievable in humans? Were PK/PD models predictive of clinical exposure and response?
• Fibrotic Pathways & Patient Variability: How did inter-patient heterogeneity impact response? Did we overlook key immune or regenerative mechanisms that may have influenced outcomes?