Kathryn Williams
Chief Regulatory Officer Neurizon
Seminars
Tuesday 3rd February 2026
The Use of TauPET & Blood GFAP in Clinical Trials & Practice to Enable Earlier Change Detection & Smaller Alzheimer’s Trials
10:30 am
- Leveraging biomarker stratification and early change detection through integrated analysis of cognitive and functional scores to reduce trial duration and enhance patient engagement.
- How close are Tau PET and blood GFAP being accepted as primary end‑points to enable smaller sample sizes once validated?
Wednesday 4th February 2026
Roundtable Discussion: Is Biomarker‑Only “Preclinical Alzheimer’s” a Disease Stage or a Risk Flag
2:30 pm
- Comparing FDA/Alzheimer’s Association staging versus the International Working Group’s “risk‑only” view, unifying language for target‑discovery teams so translational models match the biology regulators will ultimately judge
- Exploring how the ongoing pre‑symptomatic Donanemab and Lecanemab studies will read out time‑to‑symptoms data, supplying hard evidence on early intervention that can recalibrate animal‑model endpoints and biomarker cut‑offs before the next IND
- Weighing the risk‑benefit of treating asymptomatic, amyloid‑positive individuals given ARIA and payer concerns, clarifying safety and economics thresholds that determine which pre‑clinical candidates advance and at what dose
