Panel Discussion: Translating Preclinical Combination Data into Clinical Development Strategy
- Strategies for testing new investigational agents on top of standard-of-care drugs (Nintedanib, Pirfenidone, Nerandomilast), including selecting appropriate patient populations, managing heterogeneity, and adapting inclusion/exclusion criteria to balance scientific rigor with feasibility
- Evaluating potential pharmacodynamic and pharmacokinetic interactions, predicting additive, synergistic, or antagonistic effects, and translating mechanistic insights from preclinical models into clinical trial design to ensure patient safety while maximizing therapeutic benefit
- Leveraging biomarkers, imaging readouts, and exploratory endpoints to validate mechanism-of-action, identify early signals of efficacy, and design trials that are both regulatory-compliant and clinically meaningful, while learning from existing trials and real-world experience