8:00 am Morning Refreshments
8:25 am Chair’s Opening Remarks
SHOWCASING THE CURRENT STATE OF PLAY OF NEUROLOGICAL DIGITAL MEASURES TO TACKLE ASSESSMENT OF CLINICAL BENEFIT
8:30 am Digital Biomarkers in Neurology: Value, Regulatory & Validation Guidelines, & Current Digital Measures
Synopsis
- Limitations of established diagnosis in neurology and value of digital biomarkers
- Regulatory and validation guidelines for digital biomarkers
- Current state of neurological digital measures (examples on Parkinson's and other neurological indications)
9:00 am Understanding Strategies to Integrate Digital Tools with Enhanced Analytical Capabilities into Established Clinical Trials
Synopsis
- Forward planning: having a secure understanding of scientific rational and measurements required ahead of involvement in clinical trials
- Conducting bridging studies to optimize integrating digital measures
- Benefit not burden: showcasing the positives of including digital biomarkers in existing clinical trial frameworks
9:30 am Panel Discussion: Improving Digital Endpoints with Wearable Technology to Enhance Clinical Research & Care in Neurological Conditions
10:00 am Speed Networking
Synopsis
This session is a great opportunity to introduce yourself to digital biomarker experts across leading neurological biopharma. This session is the ideal opportunity to get face-to-face time with many of the brightest minds capturing the main challenges and changes in digital biomarker development, specifically in the neurological field, to establish meaningful business relationships
10:30 am Morning Break & Networking
LAYING OUT THE PATH TO SELECT DIGITAL MEASURES IN NEUROLOGICAL INDICATIONS WITH POOR ANCHORS
11:00 am Digital Biomarkers using Augmented Reality in Alzheimer’s Disease
Synopsis
Digital biomarkers hold tremendous potential in the early detection, monitoring, and management of Alzheimer's disease. This fireside chat will bring together experts in the field to discuss the latest advancements, opportunities, and challenges associated with using digital biomarkers, focusing on Altoida's innovative approach using augmented reality and machine learning. The panelists will explore the following topics:
Synopsis
- How can digital neurological biomarkers can assess cognition in clinical trials
- Use of digital biomarkers for early detection and diagnosis of Alzheimer's disease
- Current applications of Altoida’s technology to support the advancement and adoption of digital biomarkers in Alzheimer's disease clinical trials
- Digital biomarkers on Quality of Life measures
- Challenges and opportunities for use of digital biomarkers in Alzheimer’s clinical trials
11:30 am Validating Neurological Digital Measures Using Real World Evidence & Remotely Collected Data
Synopsis
- Constructing an evidence-based framework to validate digital biomarkers
- Outlining what constitutes a digital endpoint to maximise the approvability of validated digital measures
- Outlining the tools to translate big data into effective clinical measures for biomarker validation
12:00 pm How to Choose Technology & Data Measurements for Developing Ideal Digital Biomarkers
Synopsis
- Outlining the pathway for selecting disease-specific digital measurements
- Characterizing data requirements for developing digital biomarkers via machine learning algorithms
- Can we transfer prior knowledge to advance digital biomarker development?
12:30 pm Lunch & Networking
EXPLORING STRATEGIES TO VALIDATE DIGITAL MEASURES USING CLINICAL DATA & REAL WORLD EVIDENCE TO INCORPORATE INTO EXISTING CLINICAL FRAMEWORKS
1:30 pm Validating Digital Measures in Neurological Conditions: Lessons Learned from Technology-based Assessments of Upper Limb Disability
Synopsis
- Introducing a systematic framework to validate digital measures
- Presenting an exemplary use-case based on digital measures describing upper limb sensorimotor impairments
- Discussion of potential pitfalls and lesson learned from ongoing development and validation
2:00 pm A Novel Technology platform Enabling Digital Measurements of CNS Diseases & Greater Patient Participation Through Fully Remote Capabilities Applied in ALS
Synopsis
- How to build a large-scale patient participation with diversity, equity, and inclusion and obtain quality longitudinal datasets
- Innovative framework with decentralized and remote monitoring that improves patient engagement
- Outlining technology platform results applied in ALS
2:30 pm Cognivue: The Next Generation of Digital Cognitive Assessment
Synopsis
- Outlining the current state of the market for digital cognitive assessments
- Detailing Cognivue’s technology platform to digitally measure cognition across neurological indications
- Looking forward – what is the future of digital cognitive assessments?
2:40 pm Panel Discussion: Establishing Novel Anchors for Validating Digital Biomarkers in Neurological Indications
Synopsis
- How can digital biomarkers be validated in neurological indications with poor anchors?
- What are the regulatory requirements for digital biomarker validation?
- Debating the potential of digital biomarkers as primary endpoints, secondary endpoints, and exploratory endpoints
3:10 pm Afternoon Break & Networking
3:40 pm Exploring Combined Oculometrics as a Digital Biomarker for CNS disorders
Synopsis
- Understanding the existing scientific evidence supporting oculometrics in CNS disorders
- Impact of combining multiple oculometrics on predictive power in clinical staging and monitoring
- Forward look: how in-clinic or remote assessment of oculometrics can improve screening, diagnosis, monitoring, and treatment choice
4:10 pm Harnessing Real World Evidence from Remote Patient Assessments to Validate Digital Biomarkers for Neurological Conditions
Synopsis
- Building an evidence-based framework to validate digital biomarkers
- Defining the digital endpoint and biomarkers to meet the expectations of patients, caregivers and HCPs
- Use of digital biomarkers to bridge the evidence generation gaps