9:00 From Design to Approval: Crafting Robust Clinical Trial Strategies to Accelerate Dry AMD & GA Therapeutic Development
Time: 9:10 am
day: Pre-Conf Workshop Day
Details:
While the first therapies for GA have recently received FDA approval, many promising candidates continue to stall in early or mid-stage trials due to challenges in trial execution, patient recruitment, and regulatory alignment. Given the unique demands of dry AMD and GA, particularly the slow disease progression and patient heterogeneity, developing a robust dry AMD and GA clinical strategy is not only essential for successful regulatory approval, but also critical for securing investment and sustaining momentum through development.
Join this workshop to:
- Examine how to adapt trial protocols to reflect differences in disease progression across global patient populations, including geographic and ethnic variation
- Uncover practical approaches to streamline patient recruitment and improve site-level trial execution through partnerships with specialist trial sites and reading centres
- Take a deep dive into study design considerations, data requirements and the expectations at each stage of development: from preclinical to approval
- Discuss the role of preclinical data in IND submissions and how to align translational findings with clinical development plans
- Uncover practical approaches to streamline patient recruitment and improve site-level trial execution through partnerships with specialist trial sites and reading centres
- Hear from leaders of late-stage trials on navigating FDA and EMA regulatory processes and aligning development plans with evolving agency expectations
