8:00 am Morning Refreshments

8:25 am Chair’s Opening Remarks

SHOWCASING THE CURRENT STATE OF PLAY OF NEUROLOGICAL DIGITAL MEASURES TO DRIVE CROSS-STAKEHOLDER VALIDATION & ADOPTION

8:30 am Exploring A Smartphone-Based Application for Quantitative Fine Motor Assessment

  • Bharat Koyani Associate Director - Digital Biomarker & Patient Innovation, Regeneron Pharmaceuticals Inc
  • Shawn Mishra Manager, Patient Innovation, Regeneron Pharmaceuticals Inc

Synopsis

  • Understanding the user experience of a mobile app for fine motor assessments
  • Outlining preliminary quantification and characterization of healthy controls’ motor performance
  • How sensitively can smartphone applications measure fine motor assessment?

9:00 am Can Digital Clinical Measures Accelerate Alzheimer’s Disease Drug Development? Key Considerations & Opportunities

Synopsis

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9:30 am Panel Discussion: What are the Current Unmet Needs in Tackling Neurological Diseases that Digital Biomarkers can Fill?

  • Bryan Cobb Medical Science Director, Genentech
  • Gul Erdemli Director - Global Program Regulatory, Novartis AG
  • Mark Gudesblatt Neurologist, South Shore Neurologic Associates/NYU & Innovative Precision Health

Synopsis

  • Improving the ability to both identify neurological diseases earlier in the disease process and monitor disease progression using novel digital biomarkers
  • In what types of neurological indications have digital measures seen the best success so far?
  • Outlining strategies for digital biomarker implementation into established clinical trial procedures

10:00 am Structured 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 FOR THE VALIDATION OF DIGITAL BIOMARKERS TO COMBAT POOR ANCHORS IN NEUROLOGICAL INDICATIONS

11:00 am Validating Neurological Digital Measures Using Real World Evidence & Remotely Collected Data

  • Ivan Clement Associate Director - Real-World Evidence & Innovative Evidence, Novartis AG

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 

11:30 am Leveraging Machine Learning & AI to Analyse Datasets & Identify Digital Biomarkers

Synopsis

  • Developing sophisticated analytical tools to analyze big datasets
  • Extracting more advanced features with deep machine learning and algorithm development for raw data
  • Should we move past machine learning? Illuminating the black box of machine learning to advance understanding of digital biomarkers

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12:00 pm Panel Discussion: Establishing Novel Anchors for Validating Digital Biomarkers in Neurological Indications

  • Xiangnan Dang Director - Engineering, Eli Lilly & Co.
  • Bhaskar Dutta Head of Digital Health Program Management, Alexion Pharmaceuticals

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, co-endpoints, or secondary endpoints

12:30 pm Lunch & Technology Slam

Synopsis

As you enjoy your lunch, you will also have the chance to be face-to-face with the field’s most innovative and exciting technology providers. Join our dedicated technology slam to identify your next technology provider and progress your digital biomarker development smoothly and efficiently

EXPLORING STRATEGIES TO VALIDATE DIGITAL MEASURES USING RWE & INCORPOARTE INTO EXISTING CLINICAL FRAMEWORKS

2:00 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?

2:30 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

3:00 pm Afternoon Break & Networking

4:00 pm Harnessing Real World Evidence from Remote Patient Assessments to Validate Digital Biomarkers for Neurological Conditions

  • Emrah Aras Digital Health Program Lead, Alexion Pharmaceuticals, Inc.

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

4:30 pm Understanding Strategies to Integrate Digital Tools with Enhanced Analytical Capabilities into Established Clinical Trials

  • Tairmae Kangarloo Associate Director, Digital Strategy, Takeda Pharmaceutical Co. Ltd.

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

5:00 pm Chair’s Closing Remarks

5:15 pm Scientific Poster Session

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 in the neurological field, to establish meaningful business relationships

6:00 pm End of Conference Day One