Kathryn Williams
Chief Regulatory Officer Neurizon
Seminars
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
Tuesday 3rd February 2026
Panel Discussion: Deciphering the Landscape of Emerging Neurodegenerative Fluid Markers Beyond p-tau & α-Synuclein
9:00 am
- GBA, LRRK2, and TREM2: Where do these emerging targets stand in terms of measurable, scalable biomarkers?
- What should define a ‘clinically useful’ biomarker when translatability remains uncertain?
- How do we ensure fluid biomarkers reflect causal disease biology rather than downstream noise?
