8:25 am Chair’s Opening Remarks

  • Amir Lahav Head of Digital R&D, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma Holdings America

Delineating Evolving Regulatory Pathways to Device Validation as Sensitive Predictors of Efficacy & Disease Progression

8:30 am Panel Discussion: Navigating Regulatory Discussions to Move the Needle on Validating Novel Digital Biomarkers

  • Michael Ropacki Chief Medical Officer, CNS Clinical & Product Development, Oryzon Genomics
  • Sachin Shah Global Medical Partner, Digital Health & Devices, GSK
  • Vikas Jaitely Head, Digital Health & Devices, Merck
  • Bernard Hamelin Former Vice President, Head of Evidence Generation, Sanofi
  • Thomas Switzer Head, Digital Health, Early Clinical Development, Genentech

Synopsis

  • Approaching conversations with regulators: when to start dialogue, what is expected, and best practice for continued contact strategy
  • What is an approvable endpoint? Aligning on expectations in developing valid digital biomarkers
  • Moving beyond retrospective regulations: developing a framework for validating novel technologies

9:00 am Leveraging Remote Patient Monitoring & Real-World Evidence to Validate a Digital Marker of Disease Progression & Efficacy

  • Sachin Shah Global Medical Partner, Digital Health & Devices, GSK

Synopsis

  • Developing a robust clinical evidence framework to move beyond digital devices as exploratory markers
  • Elucidating pathways to clinical validation of digital products and applying learnings from other disease areas to neurological disorders
  • Assessing opportunities for industry collaboration to capture real world evidence and progress validation efforts

9:30 am Technical Validation of Real-World Monitoring of Gait for Remote Assessment of Mobility

Synopsis

  • Technical challenges in quantifying digital mobility outcomes with wearable devices in real world conditions
  • Establishing technical validity and patient acceptability of digital mobility biomarkers
  • Understanding validity and reliability of algorithms for the quantification of digital biomarkers using real-world data and translating to clinical validation

10:00 am In Person Structured Networking

Synopsis

This session is the ideal opportunity to take advantage of face-to-face networking time, and understand who is also prioritising and overcoming challenges in developing digital biomarkers.

10:30 am Morning Break & Networking

Sensors, Smartphones, Speech & Beyond: Investigating Device Development to Monitor Patients & Assess Disease State

11:00 am Home is the New Digital Clinic: Remote Monitoring of Neurological Diseases using AI-driven Technology

  • Amir Lahav Head of Digital R&D, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma Holdings America

Synopsis

  • Emerging trends in remote monitoring technology for measuring health in everyday life
  • Translating vast streams of real-world digital data into clinical insights
  • Using predictive analytics and passive digital monitoring for identifying at-risk patients

11:30 am Can Digital Clinical Measures Accelerate Alzheimer’s Disease Drug Development? Key Considerations & Opportunities

Synopsis

  • Addressing an unmet need in Alzheimer’s disease clinical trials using digital clinical measures
  • Translating meaningful aspects of health in Alzheimer’s disease to measurable digital clinical outcome measures
  • Promising candidate digital clinical measures and considerations to facilitate their acceptance in Alzheimer’s disease drug development

12:00 pm Harnessing Wearable Technologies as Digital Biomarkers to Assess Mobility & Function in Neurological Disorders

  • Lauren Li Global Head of Digital Health, Ipsen

Synopsis

  • Building an integrated digital solution to evaluate evolving symptoms
  • Combining digital assessments with patient services and physician support
  • Forging industry partnerships and evaluating wearable technologies for
    commercialization

12:30 pm Lunch & Networking

1:30 pm Panel Discussion: Purpose Driven Hardware or Commercial Devices? Identifying the Right Tool to Monitor Disease Progression & Efficacy

  • James Berry Chief, Division of ALS & Motor Neuron Diseases, Massachusetts General Hospital
  • Mihaly Hajos Chief Scientific Officer, Cognito Therapeutics
  • Bryan Hansen Director, Data Science & Digital Health Neuroscience, Janssen
  • Adam Vogel Professor of Speech Science, The University of Melbourne

Synopsis

  • From smartphones to wearable sensors: establishing appropriate tools as a biomarker
  •  Considering sensitivity of device to aid assessment of disease progression
  • Selecting a biomarker that promotes patient engagement to avoid missing data

2:00 pm Evaluating Speech-Based Digital Biomarkers to Detect Cognitive Impairment

Synopsis

  • Analysing automated speech assessments as sensitive tools to detect early signs of cognitive impairment
  • Monitoring progression over time with speech-based biomarkers to reduce clinical visits and assess language abilities and cognitive status
  • Assessing the quality of speech recordings and analysing the effects of hardware and recording conditions on the integrity of the recordings

2:30 pm Navigating Speech as a Sensitive Marker of Neuropsychiatric & Neurodegenerative Conditions

  • Adam Vogel Professor of Speech Science, The University of Melbourne

Synopsis

  • Examining principles behind speech analysis to assess disease progression in Huntington’s, dementia, and Parkinson’s
  • Characterizing pre-symptomatic cases of genetically inherited disorders with digital markers sensitive to disease manifestation
  • Investigating application of speech tests in clinical trials and understanding where it has been used successfully

3:00 pm Afternoon Break & Networking

Transforming Approaches to Gathering & Evaulating Data From Digital Biomarkers

3:30 pm Integrating Multiple Types of Digital Data & Patient Reported Outcomes to Predict or Monitor Disease Progression

  • James Berry Chief, Division of ALS & Motor Neuron Diseases, Massachusetts General Hospital

Synopsis

  • Identifying an effective biomarker panel with multiple markers and driving patient compliance and adherence
  • Correlating digital biomarker panels with the ground truth to establish accurate disease assessment
  • Examining challenges in diagnosing cognitive disorders in the context of overlapping motor clinical manifestations

4:00 pm Fireside Chat

4:30 pm Leveraging Machine Learning & AI to Analyse Datasets & Identify Reflective Digital Biomarkers

Synopsis

  • Developing sophisticated analytical tools to analyse big datasets
  • Extracting more advanced features with deep machine learning and algorithm development for raw data
  • Should we move past machine learning

5:00 pm Chair’s Closing Remarks

  • Amir Lahav Head of Digital R&D, Digital Healthcare Innovation, Mitsubishi Tanabe Pharma Holdings America