8:30 am
Check-In & Coffee



9:00 am Workshop A: Navigating Regulatory Pathways for Digital Biomarkers: From Validation to Approval

  • Gul Erdemli Global Program Regulatory Director, Novartis AG


With rapid advancements in the sensitivity of digital health technologies, now it is more crucial then ever to understand the regulatory requirements for biomarker qualification. By agreeing clinically relevant measures to the patient’s disease and understanding the technologies and parameters available, we can relate this back to CNS dysfunction to present the best evidence case to health authorities.

Workshop highlights include:

  • Exploring standardization and validation of clinical biomarker measures to qualify decentralized trial requirements • Demonstrating incremental benefit over established technologies for a more thoughtful step-wise approach to ensure health authorities recognize outcomes as important
  • Investigating interagency collaboration, data sharing and harmonization efforts to streamline regulatory processes and establish consensus on standardization parameters
  • Delving into key geographical differences in regulation between the DHT regulations at the FDA and the IVDR at the EMA
  • Considering data quality and compliance implications with data handling security standards, such as GDPR, surrounding wearable technology for quality of life tracking and geotracking in psychiatric disorders
  • Adapting more aggressive approaches in trial design to ensure sufficient data



9:00 am Workshop B: Streamlining Digital Health Assessments: Enhancing Usability & Reducing Burden

  • Bryan Cobb Principal Medical Science Director, Eisai
  • Cyndi Grossman Head, Real-World Research Networks, Biogen (formerly)


As we develop more refined and technical digital health assessments, how can we ensure patients can use these tools in a way that actually improves their disease? With a patient-centric approach, this session aims to explore the practical applications of designing and implementing digital health technology that is clinically and functionally relevant to neurodegenerative patients, and avoid the pitfalls of producing invasive, cumbersome or irrelevant technology that won’t be applicable in a trial or real-world setting.

Join this session to:

  • Review population specific challenges of using digital biomarkers in Alzheimer’s patients with cognitive deficits, or older patient populations who might have difficulty with using complex technology without support e.g. home EEGs that require syncing and interface to phones and precise set up to be effective or complex artigraphy equipment for Alzheimer’s
  • Explore case studies of more fun, easy and quick assessments of cognitive decline that are easy to integrate into clinician assessment e.g. iPad video games to track cognitive decline for rapid clinical assessment of Alzheimer’s
  • Strategize on how we can best equip carers and patients on effective use of digital biomarkers to encourage patient compliance and ensure at-home recorded data is sufficiently precise to provide valuable insights on disease burden
  • Determine regulatory requirements for device usability for neurodegenerative disease
  • Establish relevance of measures at specific stages of disease

12:00 pm
Morning Break & Refreshments



1:00 pm Workshop C: Digitalizing Psychiatry: Objective & Precise Clinical Monitoring of Symptoms & Digital Therapeutics as an Intervention to Produce Patient Benefit


In an era of unprecedented technological advancement, the integration of digital tools in psychiatric care offers a promising avenue to revolutionize patient monitoring and treatment efficacy assessment. This workshop delves into the realm of digital psychiatry, focusing on how regular, objective clinical monitoring can provide invaluable insights into the symptoms and progress of patients with neuropsychiatric disorders such as Major Depressive Disorder (MDD) and Schizophrenia. Participants will explore the implementation of scalable digital health systems and minimally viable products tailored to the needs of psychiatric patients. Leverage digital platforms for evaluating therapeutic-induced effects on mood and symptoms, distinguishing genuine improvement from placebo responses, streamlining clinical procedures with digital monitoring, and ultimately enhancing patient support and satisfaction.

  • Leveraging digital platforms to determine therapeutic-induced effects on mood and symptoms • Achieving adequate digital assessments to delineate genuine improvement and separate out placebo responders
  • Streamlining clinical procedures with digital monitoring to maximize patient support and enhance patient experience
  • Evaluating the challenges of translating real-world insights from continuous objective measurements to determine patient benefit in neuropsychiatric disorders
  • Exploring clinical relevance of physical activity measures from wearable-based technology within a digital depression study for long-term patient retention and engagement patterns, in an app and digital study
  • Measuring emotional and mental measures using wearable technology, and using this data to further manage symptoms better and improve condition
  • Assessing postural dynamics and its association with higher illness burden in Bipolar Disorder



1:00 pm Workshop D: Harnessing Digital Cognitive Assessments in the Real World for MCI & Alzheimer’s Disease to Bridge the Gap to Early Diagnosis & Intervention

  • Wolfgang Liedtke Professor of Neurology, Anesthesiology and Neurobiology, Duke University, Professor of Dentistry, NYU Pain Research Center College of Dentistry
  • Mark Gudesblatt Head of Science Advisory Board, Innovative Precision Health, South Shore Neurologic Associates, NYU Langone


As we move into a landscape where disease modifying therapeutics are finally a reality for Alzheimer’s Disease, how can we ensure these patients can benefit from research and development? With just 8% of patients who have mild cognitive impairment receiving a diagnosis, more sensitive measures in the real world are crucial for ensuring patients are identified at an earlier stage where treatment will be effective. Digital health assessments that can more quantitatively, precisely and accurately measure cognition beyond the blunt tool of clinical outcome assessments are crucial in identifying earlier patient populations who will benefit from:

  • Evaluating computerized cognitive testing in the real world to save clinician time as an objective, examiner-independent and multidimensional tool
  • Harnessing disease diagnosis but also more subtle and sensitive measures to monitor progression and stage disease to understand the earlier time for cognitive impairment
  • Improving usability of cognitive assessments e.g. easy and fun iPad or mobile games to make integrating into clinical assessment easy and reduce patient burden
  • Ensuring diverse clinical trial populations to reflect the heterogeneity of a real-world population
  • Contextualizing variability to account for disease phenotype 

4:00 pm
End of Pre-Conference Workshop Day