Imaging offers a direct window into disease progression, but its role in predicting treatment response and improving trial design remains uncertain. While AI-driven imaging shows promise, regulatory acceptance and standardization are key challenges. This panel will explore how imaging can enhance clinical trials and accelerate drug development.

Key Discussion Points:

• What role can imaging play as a surrogate or co-primary endpoint? How close are we to standardized, validated imaging biomarkers, and what can be learned from oncology or neurology?
• How should the field approach integration of patient-reported outcomes and real-world evidence to reflect lived patient experience?
• What are the key regulatory considerations in validating novel endpoints, whether AI-derived, biomarker-based, or functional? How can stakeholders proactively align on evidentiary standards?
• How can trial sponsors, academic experts, and regulators collaborate to build a more flexible, data-driven framework for endpoint selection in future studies?