Leonard van den Berg
Professor of Neurology, Neurologist & Chairman of TRICALS UMC Utrecht
Seminars
Wednesday 3rd June 2026
Panel Discussion: Given Recent Failures, How Can We Tailor ALS Clinical Trials to Successfully Meet Regulatory Expectations
2:10 pm
- Leveraging innovative trial designs, such as adaptive, Bayesian, and platform models (e.g., MAGNET), alongside advanced outcome measures including PROs and digital endpoints to enhance trial success
- Defining clear, patient-relevant endpoints and integrating biomarkers to more effectively demonstrate clinical efficacy
- Navigating and aligning divergent regulatory expectations across agencies (e.g., FDA, EMA) to optimise trial design and approval pathways
- Identifying and mitigating late-stage risks by addressing common Phase 3 failure points and strengthening earlier-stage trial design, including adaptive Phase 2b approaches
Wednesday 3rd June 2026
Driving Innovation and Consistency in ALS Trials: Collaborative Models, New Outcomes, and Smarter Study Design
12:00 pm
- Elevating trial quality through harmonized SOP‑based training across 60 European sites.
- Advancing TRICALS outcome measures and prediction models to include broader patient populations.
- Strengthening industry–academic collaboration to streamline innovation without duplicating efforts.
- Key insights from annual pharma masterclasses on emerging challenges in ALS trial design.
