Explore the Agenda
8:00 am Check-In, Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
Operationalise Global Biomarker Strategies by Standardising Sample Collection, Logistics & Alternative Sampling Approaches to Generate High-Quality Clinical Trial Data
9:00 am Managing Multi-Site Biomarker Collection, Processing & Logistics – Ensuring Sample Integrity, Data Quality & Operational Success Across Global Trials
- Learn how to operationalise complex biomarker strategies across global clinical trials by standardising sample collection, processing and logistics to maintain sample integrity and generate reliable biomarker data
- Discover how to successfully implement advanced biomarker assays in real world trial settings through effective site training, streamlined workflows, regulatory compliant processes and high-quality sample management across diverse regions
- Explore strategies for balancing scientific objectives with operational feasibility through thoughtful protocol design, reduced burden on patients and sites and effective partnerships with central laboratories and biomarker service providers
10:00 am Speed Networking
A prime chance to make the most of in-person networking and forge new connections as new companies enter, and existing ones broaden their presence within fluid, imaging and digital biomarkers for CNS disorders. Designed to maximise your introduction to numerous new individuals and serve as a catalyst for ongoing discussions during the summit.
10:30 am Morning Break & Refreshments
Advance Disease-Specific Biomarker Discovery by Validating Novel Fluid Biomarkers That Improve Early Detection, Patient Stratification & Disease Monitoring
11:00 am Elevating Synaptic Biomarkers in Epilepsy: Unlocking the Potential of CSF & Plasma SV2A for Structural Disease Diagnosis
- Explore emerging evidence that SV2A, a marker of synaptic density and the target of levetiracetam, is elevated in CSF and plasma in patients with structural epilepsy, highlighting its potential as a novel fluid biomarker
- Learn how CSF and plasma SV2A measurements correlate with lesion status, temporal lobe pathology, seizure timing, and established markers of neuronal injury, providing new insights into disease activity and biomarker interpretation
- Understand the analytical validation of SV2A detection using ELISA and Western blot, the specificity of SV2A compared with other SV2 isoforms, and the opportunities and challenges of translating synaptic biomarkers into clinical practice for epilepsy diagnosis and monitoring
11:30 am Phospho-Ubiquitin: A Novel Biomarker for Neurodegenerative Diseases
- Explore the biological role of phospho-ubiquitin (pUb) as an early marker of mitochondrial dysfunction, generated through activation of the PINK1/ Parkin pathway and linked to mitophagy and mitochondrial quality control in neurodegenerative diseases, particularly Parkinson’s disease
- Learn how novel TUBE-based assay technologies overcome the limitations of conventional phospho-ubiquitin detection methods, enabling sensitive and selective measurement of pUb and phospho-polyubiquitin species as potential blood-based biomarkers
- Understand the potential clinical applications of pUb biomarkers for earlier disease detection, patient stratification, target engagement assessment in clinical trials, and monitoring therapeutic responses across Parkinson’s disease and other neurodegenerative disorders
12:00 pm Lunch & Networking
Implement Digital & EEG Biomarkers to Confirm Pharmacology, Stratify Patients & Generate Objective Endpoints for Neuropsychiatric Drug Development
1:30 pm Implementing EEG & Digital Biomarkers for Neuropsychiatric Indications – Navigating Pharmacology Confirmation, At-Home Monitoring & Technology Selection
- Discover how EEG biomarkers confirm GABAergic pharmacology translationally from rodents to healthy volunteers, providing dose navigation and PK-PD relationships in Phase 1 studies, while understanding the critical limitation of clinical translation
- Explore emerging at-home EEG technologies that enable remote data acquisition in psychiatric patient populations, addressing the operational challenges of implementing EEG in large Phase 2
- Comparing vendor selection criteria when evaluating digital biomarker technologies for neuropsychiatric trials and balancing selecting technologies that deliver reproducible, interpretable results that satisfy both scientific rigor and operational feasibility
2:00 pm Moving Beyond Symptom-Based Psychiatry: Using Digital Cognitive Biomarkers to Stratify Patients, Confirm Pharmacology & Advance Precision Medicine in Schizophrenia
- Discover how objective digital cognitive biomarkers can identify biologically distinct patient subgroups, reducing the heterogeneity that has historically contributed to schizophrenia trial failures and enabling precision medicine approaches in psychiatry
- Explore how multimodal biomarkers can be integrated across the clinical development pathway, from patient selection and experimental medicine through to objective efficacy endpoints, to generate stronger proof-of-mechanism and improve decision-making
- Learn from Monument Therapeutics’ translational development strategy for MT1988, including early regulatory engagement around digital biomarker validation and the challenges of moving novel digital endpoints towards broader clinical adoption
2:30 pm Afternoon Break
Reduce Reliance on Lumbar Puncture by Advancing Blood-Based & Minimally Invasive Biomarkers for Scalable CNS Clinical Trials
3:00 pm Roundtable Discussion: Considering Opportunity Cost, Patient Burden & Data Quality When Implementing Biomarkers – Making Strategic Trade-Offs That Maximise Value & Minimise Risk
Join this expert-led roundtable to examine the considerations of implementing multimodal biomarkers
Debate the cost-benefit reality of investment in multimodal biomarkers
Explore the practical implementation of novel biomarkers
Discuss strategic trade-offs in biomarker-driven trial design
1:30 pm Fireside Chat: New Efforts & Technologies to Avoid Invasive Lumbar Puncture – Comparing Blood- Based Biomarkers, Imaging Biomarkers, Olfactory Neurons, Extracellular Vesicles & Emerging Minimally Invasive Approaches
- Address the critical operational and patient burden challenges driving the urgent need for CSF alternatives: European sites increasingly unwilling to perform lumbar punctures, staff training requirements across multi-site trials, and the strategic limitations when you cannot run studies in Europe that force programmes to the US or abandon biomarker strategies entirely
- Compare the full spectrum of emerging technologies that eliminate lumbar puncture: ultrasensitive plasma biomarkers, achieving CSF-level correlations for trial pre-screening, olfactory bulb neurons providing direct CNS access, neuronalenriched extracellular vesicles and accessible peripheral nerve sampling that reflects brain pathology without invasive CNS procedures
- Debate practical implementation realities and validation status: which approaches show sufficient plasma-CSF correlation to confidently replace lumbar puncture in your specific indication, how exploratory technologies like EVs and olfactory sampling balance biological promise against current lack of standardisation and clinical validation
4:00 pm Scientific Poster Session
This is an informal session to help you connect with your peers in a relaxed atmosphere where you will continue forging new and beneficial relationships. With an audience of preclinical, translational, clinical and precision medicine experts eager to hear the latest advancements in fluid, imaging and digital biomarkers for CNS disorders, you will have the opportunity to display a poster presenting your own work and innovations. Don’t miss out on the chance to connect, learn, and present.