Pre-Conference Workshop Day

Tuesday, October 7

8:00 Check-In & Coffee

WORKSHOP A

9:00 P-tau217: Clinical Promise, Regulatory Hurdles & the Path to Surrogate Endpoint Status

Synopsis

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 

12:00 Lunch Break & Networking

WORKSHOP B

1:00 Alpha-Synuclein Biomarkers: Overcoming Biological Complexity to Transform Parkinson’s & Synucleinopathy Research

  • Holly Soares Global Head Neuroscience and Rare Disease Biomarkers pRED NRD, VP, Roche

Synopsis

Exploring the evolving role of alpha-synuclein in Parkinson’s and related disorders, focusing on both its promise and its limitations. Delve into the challenges of using alpha-synuclein for patient stratification and monitoring in clinical trials, review cutting-edge blood-based and seed amplification assay technologies that aim to reduce reliance on imaging, and unpack the complex biology of protein aggregates.

In this session:

  • Examine the role of alpha-synuclein in Parkinson’s and related synucleinopathies, and explore the key challenges limiting its use in clinical trial stratification and disease monitoring
  • Evaluate emerging seed amplification assays and blood-based detection methods aiming to reduce reliance on invasive CSF collection or expensive imaging techniques for diagnosis and staging
  • Discuss the biological complexity of protein aggregates and whether understanding their behaviour can provide insight beyond mere disease correlation – single particle proteomics 

4:00 End of Pre-Conference Workshop Day