Conference Day One
Wednesday 23rd August 2023
8:05 am Chair’s Opening Remarks
OVERCOMING THE CLINICAL ROADBLOCK OF VALIDATING CNS BIOMARKERS TO DEMONSTRATE THERAPEUTIC EFFICACY & ACHIEVE REGULATORY APPROVAL
8:15 am Panel Discussion: What Are the Requirements for Validating CNS Biomarkers for Use as Surrogate Endpoints?
Synopsis
- Striving for consensus on what is considered a reliable and relevant biomarker of neurodegeneration or neuroinflammation
- Evaluating the ability of amyloid and NfL biomarkers to provide reliable measurements of therapeutic effects on disease neuropathology
- Defining fluid and imaging biomarker standards to be used in the clinic
8:45 am Regulatory Considerations for Fluid & Imaging Biomarkers of Neurodegeneration & Neuroinflammation
Synopsis
- Outline the different types of biomarkers using the BEST classification and their application in clinical trials
- Considerations for analytic and clinical validation of biomarkers
- Considerations for use of biomarkers as surrogate endpoints
9:15 am Developing Advanced & Reliable Biomarkers of CNS Pathology to Generate Clinically Validated Results
Synopsis
- Enhancing biological understanding of imaging and fluid-based biomarkers to accelerate their utility as pharmacodynamic biomarkers.
- Exploring the ability for fluid and imaging biomarkers to provide reliable and validated measurements of therapeutic outcome.
- Current understanding and examples for validation of multi-modal biomarkers and promising models for developing advanced biomarkers of neuroinflammation across CNS Disorders.
9:45 am SPEED NETWORKING & MORNING REFRESHMENTS
Synopsis
An optimal chance to network one-to-one with leading biomarker experts across numerous neurodegenerative and neuroinflammatory indications. Learn how your peers are leveraging innovative imaging and fluid biomarker techniques to accelerate neurological drug development.
10:45 am NULISA, a New Immunoassay Platform with Lowest Limits of Detection of Neurodegenerative Disease Fluid Biomarkers
Synopsis
- Introducing new immunoassay technology, NULISA™ – routine fluid biomarker detection to fg/mL levels for one to hundreds of biomarkers
- Demonstrate the superior performance in detection, precision and dynamic range of fully automated NULISA assays running on ARGO HT System compared to existing immunoassays and the ability to generate comprehensive profiles of neuroinflammation in biofluids
- Ultra-sensitive NULISA technology holds great promise to enable broad neuroinflammation profiling and earlier detection of critical neurodegenerative disease biomarkers to aid in the development of new therapeutics
EXPLORING ADVANCES IN TECHNOLOGIES AVAILABLE FOR NEUROIMAGING & IDENTIFYING OPPORTUNITIES FOR FURTHER DEVELOPMENT
11:15 am Reviewing the Current Landscape of Neuroimaging Markers for Research & Clinical Use in Dementia
Synopsis
- Discussing commonly used outcome measures from MRI and PET imaging
- Exploring the potentials of novel imaging biomarkers to be employed, such as diffusion weighted imaging and synaptic PET
11:45 am Evaluating Neuroimaging Markers of Inflammatory Progression in Neurodegenerative Diseases
Synopsis
- Evaluating targets for imaging of neuroinflammation
- Exploring the techniques available to image neuroinflammatory markers
- Direction of future research to enhance understanding of neuroinflammatory imaging biomarkers
12:15 pm LUNCH & NETWORKING BREAK
ENHANCING THE SPECIFICITY OF FLUID BIOMARKERS TO REFLECT CNS PATHOPHYSIOLOGY & MINIMIZE OFF-TARGET EFFECTS
1:15 pm A Holistic Overview on Current Development of Fluid-Based CNS Biomarkers
Synopsis
- Evaluating the use of novel fluid-based biomarkers of neurodegeneration
- Outlining the most recent advancements in fluid biomarker development across neurodegenerative and neuroinflammatory conditions
- Assessing the importance of fluid-based biomarkers, such as amyloid beta, tau and alpha synuclein
1:45 pm Translational Simoa Sensitivity Blood-Based Biomarkers for Neurological Drug Development & Clinical Trial Support
Synopsis
- New high-sensitivity blood-based assays for optimal detection of a wide range of neurodegeneration conditions
- Specific examples of clinical trial utility of Simoa biomarkers for NfL, N4PE, GFAP, and pTau 181 and pTau217
- The translational impact of blood-based biomarkers with Simoa sensitivity for Multiple Sclerosis, and Alzheimer's Disease detection and monitoring
2:15 pm Assessing Specificity Levels of CSF Biomarkers & How Correlation to the CNS Can Vary with Sample Origin
Synopsis
- Understanding how differences in homeostatic protein levels across ventricular and lumbar CSF samples influence biomarker specificity and interpretation
- Exploring location-induced variance in CSF biomarker panels and how this affects ability to determine CNS activity
- Identifying CSF biomarkers that demonstrate good correlation to CNS levels
2:45 pm Afternoon Break
3:15 pm Evaluating the Correlation Between Blood NfL & CSF NfL to Support Detection of Neurodegeneration
Synopsis
- Detection of Neurodegeneration
- Exploring underlying mechanisms to support strong correlation of NfL
- Determining the origin of blood NfL to ensure specific reflections to changes in the CNS
3:45 pm The Michael J Fox Foundation Translational Biomarker Portfolio & Research Resources Overview
Synopsis
- The Foundation’s biomarker portfolio has historically been largely focused on biochemical assays and spans a number of relevant pathways in Parkinson’s disease, including alpha-synuclein and neuroinflammation
- Challenges around inflammation-based biomarkers for Parkinson’s disease
- The Foundation offers a variety of resources to the research community in addition to funding opportunities: preclinical tools database, access to biospecimens and large datasets for additional analysis, venues for knowledge sharing
4:15 pm Exploring the Diversity of Fluid Biomarkers for Molecular Phenotyping
Synopsis
- Optimizing fluid biomarkers for molecular phenotyping in PD, AD and ALS
- Translating fluid biomarkers from preclinical to clinical to be harnessed for patient stratification
- Evaluating the use of one vs many biomarkers
4:45 pm Chair’s Closing Remarks
4:55 pm SCIENTIFIC POSTER SESSION
Synopsis
This is an informal session to help you connect with your peers in a relaxed atmosphere and continue forging new and beneficial relationships. With an audience of CNS enthusiasts eager to hear the latest cutting-edge advancements to innovate earlier, more sensitive, and objective biomarker measures, you will have the opportunity to display a poster presenting your own developments in the space. Additionally, you will have the chance to review other’s posters displaying novel approaches to integrate novel and advanced fluid and imaging biomarkers into neurological trials.