9:00 P-tau217: Clinical Promise, Regulatory Hurdles & the Path to Surrogate Endpoint Status
Time: 9:00 am
day: Pre-Conference Workshop Day
Details:
Highlighted by the recent approval of the first in vivo blood test for Alzheimer’s Disease, advancements in new technologies to measure p-tau217 are at an all-time-high. Join this session for an inside look on how p-tau217 is setting the gold standard in AD diagnostics, exploring its scientific evolution, clinical impact, and regulatory breakthrough, offering a model for future biomarker development.
In this session:
- Explore the progression of phosphorylated Tau from cerebrospinal fluid (CSF) assays to more scalable and accessible blood-based tests
- Discuss the role of p-tau217 in enriching clinical trial populations and enabling more accurate disease staging and monitoring
- Examine current limitations, including questions around specificity, diagnostic breadth, and standardization
- Assess regulatory interest in p-tau217 as a potential surrogate endpoint and what is needed to achieve that designation
- Review lessons from recent clinical trials and biomarker validation efforts
- Identify ongoing research gaps and collaborative opportunities to accelerate adoption and approval
