Paul Ford

Many failed trials reveal weaknesses in preclinical rigor and translational assumptions, including inadequate target engagement studies, incomplete biomarker strategies, or insufficiently powered phase 2 trials. Preclinical Strategy & Target Confidence: Did we truly establish a direct link between the target and IPF pathogenesis? Were preclinical efficacy signals robust, or were they driven by artificial conditions?

• Dosing, PK/PD & Translation to Humans: Was there a clear therapeutic window? Were effective concentrations realistically achievable in patients, or did preclinical studies rely on unrealistic drug levels?
• Early-Stage Trial Design & Biomarkers: How can we optimize early clinical studies to ensure meaningful phase 2 readouts? Are small, underpowered trials leading to misleading efficacy signals that don’t hold up in phase 3?