Reinventing the Surrogate Landscape: Innovating Regulatory Acceptable Endpoints Most Meaningful to People Living with ALS
Time: 2:05 pm
day: Pre-Conference Day
Details:
The recent accelerated approval brings new waves of promise for transformative ALS drugs to be approved based on surrogate markers that correlate with ALSFRS-R. With increasing demand to define more acceptable endpoints for ALS, collaborate with industry sponsors and regulatory experts to:
- Evaluate the potential of novel surrogate biomarkers that extend beyond ALSFRS-R to monitor patients, enhancing dialogue with regulatory bodies about what these could be
- From mobility to respiratory function, explore the most meaningful endpoints to people living with ALS to help inform clinical trial design
- Debate the best primary, secondary and exploratory endpoints, and how to balance these based on different regulatory requirements
