Explore the Agenda
8:00 am Check-In, Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
8:59 am Translate Emerging Biomarkers into Clinical Development by Advancing α-Synuclein & Toxic Oligomer Assays for Earlier Diagnosis & Precision Patient Selection
9:00 am Expanding α-Synuclein Seed Amplification Assays Beyond Parkinson’s Disease: Advancing Biomarker Development in MSA & Rare Synucleinopathies
- Explore how α-synuclein seed amplification assays are enabling earlier, pathology-driven patient identification
- Examine the opportunities and challenges of applying emerging biomarker technologies in rare neurodegenerative diseases, where limited patient populations require innovative validation approaches
- Discuss how lessons learned from Parkinson’s disease biomarker development can accelerate clinical trial design, patient stratification, and therapeutic development in MSA and related disorders
9:30 am Exploring How Toxic Oligomer Biomarkers Can Improve Early Detection & Monitoring in Alzheimer’s & Parkinson’s Disease
- Explore how AltPep’s toxic oligomer assays perform alongside established biomarkers such as pTau217 and what each biomarker reveals about disease initiation, progression and pathology
- Examine the commonalities and distinctions between Alzheimer’s and Parkinson’s disease, discussing how disease-specific toxic oligomer biomarkers can differentiate AD, PD and mixed pathology while providing insights into shared mechanisms of protein misfolding and aggregation
- Explore the role of biomarkers in next-generation clinical trials, including how measuring disease-driving toxic oligomers can support earlier patient identification, improve stratification strategies and potentially serve as a tool for monitoring therapeutic response alongside AltPep’s therapeutic programme
10:00 am Morning Break & Refreshments
Bridge Biomarker Discovery & Clinical Development Through Assay Harmonisation, Analytical Validation & Multimodal Translation
10:30 am Roundtable Discussion: Advancing Ultrasensitive Assays from Research-Grade to Clinical-Grade – Analytical Validation, Quality Control & Standardisation Strategies
Join expert-led roundtables to discuss advancing ultrasensitive assays through to clinic
Discover the validation steps to transform exploratory ultrasensitive assays into regulatory-acceptable clinical tools
Debate how inconsistent assay thresholds and readouts are preventing reliable comparison of biomarker data across studies
Learn quality control strategies that
ensure reproducibility across batches,
sites and time
11:30 am Translating Multimodal Biomarker Strategies from Preclinical Models to Early Clinical Development in ALS
- Building a multimodal biomarker strategy across early development: integrating blood-based transcriptomics, CSF markers, pharmacodynamic readouts, and disease-relevant endpoints in a Phase I ALS programme
- Leveraging public datasets to de-risk biomarker selection by mining gene expression and proteomic data to identify translatable signatures, aligning preclinical model readouts with human datasets, and validating candidates through access to patient-derived samples
- Designing biomarkers for small, early-phase cohorts through selecting and prioritising analytes, developing bespoke assays, and ensuring translational relevance ahead of patient readouts
NEW DATA
12:00 pm Lunch & Networking
Build Regulator-Ready Multimodal Endpoints by Integrating Imaging, Digital & Fluid Biomarkers Across CNS Clinical Trials
1:30 pm Digital Biomarkers: Shaping the Future of Rare Diseases
- Discuss the strategic value and transformative impact of digital biomarkers in rare disease development
- Tackle the key challenges and mitigations to deployment and validation of digital endpoints in CNS studies
- Enable adoption through fit‑for‑purpose evidence strategies
2:00 pm Fusing Imaging & Digital Biomarkers: Building Regulator-Ready Multimodal Endpoints for Alzheimer’s, ALS & Rare CNS Trials
- Moving beyond single-modality endpoints by integrating structural and functional neuroimaging (MRI, PET) with remote digital biomarkers (EEG, actigraphy, speech and cognitive sensors) to better capture neurodegenerative disease biology and treatment response
- Building a regulator-facing multimodal endpoint framework through practical harmonisation of imaging and digital biomarker platforms, with cross-validation against fluid biomarkers such as p tau217 and NfL to strengthen biological plausibility and regulatory confidence
- Applying lessons from Phase IIb/III Alzheimer’s programmes, EMA CHMP/ SAG-Neurology engagement, and ALS and rare disease trials to improve patient stratification, reduce screen failures, and create actionable endpoint strategies across AD, ALS, PD, and rare CNS indications
2:30 pm Afternoon Break
3:00 pm Translating Biomarkers from Blood & Peripheral Tissues into Multimodal CNS Assessment
- How a rare genetically driven amyloid disease, Hereditary Cystatin C Amyloid Angiopathy (HCCAA), can inform Alzheimer’s treatment by evaluating alternative biomarkers, including skin biopsies, reduced glutathione levels, and blood-based measurements of amyloid oligomerization
- How combining tissue-based, skin and blood-based biomarkers, and redox signals in HCCAA can help establish biological concordance and strengthen interpretation of systemic markers of amyloid pathology. And how these biomarkers can inform and functionally characterize diverse contributors of disease progression, such as impaired perivascular clearance mechanisms and extracellular matrix (ECM) remodelling. These measurements are extremely relevant to HCCAA with implications for Cerebral Amyloid Angiopathies (CAAs), as well as Alzheimer’s disease
- How these findings are being translated into Alzheimer’s biomarker studies, where blood-based assays are combined with advanced brain imaging to assess their relevance to broader pathology underpinned by amyloid aggregation