8:00 am Morning Refreshments
8:25 am Chair’s Opening Remarks
GALVANIZING COGNITION & SLEEP FOR MORE LONGITUDINAL ASSESSMENT OF PATIENT IMPROVEMENT
8:30 am Precision Neuroscience Requires Precision Measures: Unveiling Neural Computation through Digital Measures
Synopsis
- Developing Precision Medicines requires more than building evidence of therapeutic efficacy. It requires building evidence for a new disease definition and its measurement strategy
- Gamified apps can measure aspects of an individual’s neural computation not otherwise externally accessible
- These digital measures form a critical component of a broader precision measure strategy enabling clinical development in neurodegenerative and neuropsychiatric diseases
9:00 am Digital Health Innovation & Real-World Evidence in Neuro: Opportunities & Challenges
Synopsis
- Overview of the landscape assessing real world evidence & opportunities presented by the digital innovation and use of real world evidence
- Review of frameworks and process for the development of novel measurements and endpoints that meaningfully address patient's needs
- Discussion of interplay of factors that present challenges to patient-centricity
9:30 am Measuring Vital Signs Digitally & Remotely for Pediatric Populations
Synopsis
- Evaluating the analytic validity and usability of digitally measured vital signs actigraphy where remotely measured endpoints would make a tangible difference to pediatric populations
- Understanding design needs for wearable devices from pediatric patients to encompass differences in size, usability and approach
- Accounting for variability in readings across different pediatric populations and age ranges to provide a more comprehensive picture of disease state
- Contextualizing the wider use of pediatric digital health tools and how they can contribute to decentralized clinical trials
10:00 am Developing AI Frameworks for Dementia Trials on Standard Clinical Data
Synopsis
- Describing the current workflow of Dementia trials, their pain points and opportunities
- Overviewing data routinely collected in a clinical setting, the multimodal nature of it and potential ways it can be used for trials
- Developing of novel AI framework that use routinely collected clinical data to assist dementia trials
10:30 am Morning Break & Networking
COMBINING A BATTERY OF APPOACHES FOR EPILEPSY & ALS FOR MORE HOLISTIC & LONGITUDINAL MONITORING OF DISEASE BURDEN
11:00 am Taking a Pragmatic Approach on the Art of the Possible for Seizure Forecasting
Synopsis
- Lessons learned from the seizure-gauge initiative
- Incorporating the patient voice in this decision-making while using a patient centered benefit/risk framework to assess value of a wearable
11:30 am Lessons Learned from a Study to Evaluate the Performance of Digital Measures in ALS
Synopsis
- Applying a battery of digitally collected outcome measures in an observational cohort of ALS patients exploring
- Exploring measures multiple aspects of function in ALS to traditional clinical outcome measures
- Evaluating lessons learned for future studies
12:00 pm Lunch & Networking
ASSESSING COMMERCIAL VIABILITY & SCALABILITY OF DIGITAL BIOMARKERS IN THE CNS LANDSCAPE
1:00 pm Enhancing the Commercial Scalability of Digital Biomarkers for Neurological Indications
Synopsis
- Exploring the reimbursement landscape for payers and market access to digital biomarkers in a real world setting through the TCET pathway
- Discussing challenges and opportunities in deploying digital biomarkers at scale, addressing issues related to data privacy, regulatory compliance, and technological infrastructure
- Examining case studies and best practices for implementing scalable digital biomarker solutions in clinical trials and real-world clinical settings to advance CNS research and patient care
- Evaluating real world evidence as the role for health outcome studies in the post-launch phase
1:30 pm Panel Discussion: Strategizing on How we can Build & Develop a Network of Internal & External Capabilities to Process Complex Data from Digital Biomarkers to Determine Patient Centric Challenges
Synopsis
- Sharing different approaches to building out internal capabilities of digital technology expertise
- Identifying the right partners to work with for external outsourcing capabilities
- Exploring parallel growth cycles for digital health and how they have established as a team
- Discussion of teams to implement adoption within organization of novel digital endpoints
2:00 pm Establishing the Need for a Software Infrastructure Stack when Moving Trials into the Market
Synopsis
- Delving into the need of digital biomarkers to anticipate a different infrastructure stack
- Innovating solutions to safeguard patient data privacy and security throughout the digital data collection process, including encryption protocols, secure data storage, and compliance with data protection regulations
- Overcoming obstacles in validating digital measures for CNS indications, including establishing reliability, reproducibility, and clinical relevance, while navigating evolving regulatory guidelines and technological advancements
2:30 pm Afternoon Break & Networking
PATIENT PERSPECTIVES ON CLINICAL RELEVANCE OF DIGITAL BIOMARKERS TO NEUROLOGICAL DISEASE BURDEN
3:30 pm Patient Perspectives: How Relevant Are Digital Biomarkers to CNS Conditions?
Synopsis
- Exploring real life accounts of the day-to-day challenges in using digital biomarkers to shed light on challenges surrounding usability of devices for varied CNS indications
- Sharing perspectives on clinical relevance of devices to their disease burden
- Ensuring recruitment of diverse populations to ensure drug development considers underserved populations
- Leveraging patients as advocates for change in driving research and policy initiatives
4:15 pm Chair’s Closing Remarks
4:20 pm End of Conference
