Joel Schwartz
Director, Scientific Digital Biomarkers Neuroscience Trc, R & Ed Bristol Myers Squibb
Seminars
This interactive workshop will explore how clinical trial endpoints can be designed to reflect what truly matters to people living with ALS. Participants will discuss strategies for integrating patient-reported outcomes, functional measures, digital biomarkers, and quality of-life metrics into trial design. The session will highlight collaborative approaches with patient advocacy groups, lessons from ongoing studies, and regulatory considerations for demonstrating clinical meaningfulness. Attendees will gain practical insights into creating endpoints that enhance trial relevance, patient engagement, and therapeutic impact.
Key Discussion Points
- Defining endpoints that capture functional, cognitive, and quality-of-life outcomes meaningful to patients
- Incorporating patient-reported outcomes, digital tools, and real-world data into trial design
- Regulatory perspectives on patient-centered endpoints and demonstrating clinical relevance
- Collaborative models to co-design endpoints with patients and advocacy groups