Explore the Agenda
8:00 am Check-In, Coffee & Light Breakfast
Workshop A
9:00 am Mastering α-Synuclein Biomarkers Across Fluid & Imaging Modalities to Accelerate Parkinson’s Disease Drug Development
Gain comprehensive expertise in the most transformative biomarker class for synucleinopathies. This intensive workshop delivers practical knowledge on seed amplification assays, novel PET tracers, and plasma-based detection methods, enabling you to design robust biomarker strategies that de-risk your PD, MSA, and Lewy body dementia programmes. Learn standardisation protocols, compare vendor platforms, and understand regulatory pathways to confidently implement α-synuclein biomarkers from Phase 1 through registration trials.
Key Questions to be Answered:
- How do you establish standardisation protocols for α-synuclein seed amplification assays with different labs and vendors yielding different results, and what harmonisation strategies ensure reproducible outcomes across multiple sites?
- What are the key differences between α-synuclein detection methods, seed amplification assays in CSF and skin biopsies versus novel PET tracers versus plasma-based assays and when should you prioritise each modality based on your trial design, patient population, and mechanism of action?
- How do you validate that α-synuclein biomarkers accurately reflect brain pathology and disease progression, and what evidence is required to use them as eligibility criteria, pharmacodynamic endpoints, or surrogate markers in regulatory submissions?
- How do you integrate α-synuclein fluid biomarkers with PET imaging to create multimodal strategies that provide convergent evidence of target engagement and disease modification, and what are the operational challenges of combining these modalities?
- What are the current limitations of α-synuclein biomarkers, peripheral contamination in blood, lack of correlation with clinical outcomes, unclear relationship to disease subtypes and how do leading programmes address these challenges to build regulatory-grade validation packages?
12:00 pm Lunch Break
Workshop B
1:00 pm Overcoming Assay Harmonisation & Validation Challenges to Ensure Cross-Trial Comparability & Regulatory Acceptance
Eliminate the variability and comparability issues that undermine biomarker confidence across studies. This hands-on workshop equips you with frameworks for selecting validated assays, establishing harmonisation protocols across multiple vendors and platforms, and building regulatory-grade validation packages. Walk away with actionable strategies to reduce interlab variability, leverage IVD-approved assays, and create biomarker data sets that withstand regulatory scrutiny and enable meaningful historical data comparisons.
Workshop Highlights Include:
- Dissection of a failed biomarker programmes, examining the root causes, financial impact, and specific corrective actions that could have prevented the failure, providing cautionary lessons you can apply immediately
- Interactive group discussion on navigating the regulatory landscape in Europe versus US, understanding when validated assays are mandatory versus when research-use-only assays are acceptable, and strategies for transitioning from exploratory to regulatory-grade biomarkers
- Approaches to managing the competitive multi-vendor assay landscape, where differing platforms complicate standardisation, including the use of round-robin studies, shared reference materials, and harmonisation consortia
- Quality control strategies to ensure reproducibility across batches, sites, and time when deploying ultrasensitive biomarkers in multi-site global trials, including the establishment of internal standards and calibration procedures to maintain assay performance throughout a clinical programme