8:00 am Morning Refreshments

8:25 am Chair’s Opening Remarks

  • Lauren Li Global Head, Commercial Digital Innovation, Ipsen

MAKING IT A REALITY: SHOWCASING DIGITAL MEASURES FOR INTERVENTION ACROSS NEURODEGENERATION

8:30 am Advancing a Medical Device Technology to Slow Cognitive Decline and Modify Disease Progression in Alzheimer’s Disease

  • Ralph Kern Chief Medical Officer, Cognito Therapeutics Inc.

Synopsis

  • Leveraging an innovative medical device technology to target participantfunction, cognition, and brain structure in Alzheimer’s Disease
  • Launching our pivotal HOPE study in participants with mild-moderateAlzheimer’s Disease to demonstrate safety and efficacy

9:00 am The Need for Novel Endpoints: A Case for Using Multimedia, Audio & Video to Capture Novel Digital Endpoints

Synopsis

  • Outlining the need for novel digital endpoints in neurological clinical trials
  • Exploring the collection of audio and video evidence during clinical trials
  • Using generated evidence to provide quantitative and qualitative data to evaluate the efficacy of novel treatments for patients

9:30 am Quantifying Digital Measures to Validate Digital Biomarkers for Parkinson’s Disorders

Synopsis

  • Outlining strategy to develop digital measures to efficiently investigate Parkinson’s disease
  • Objective measurement of task-based motor assessment using signal processing of wearable IMU data
  • Evaluating digital measure clinical validity and sensitivity to disease progression

10:00 am Morning Break & Networking

10:30 am Considering Device Burden & Usability to Maximise Patient Compliance in Neurological Clinical Trials

  • Charlotte Sauter Senior Digital Health Scientist, Digital Health Technologies, Lundbeck
  • Alastair Clewlow Senior Director, Clinical Data Management, Statistical Programming & Digital Solutions, Lundbeck

Synopsis

  • Identifying usability challenges and factors impacting device compliance
  • Outlining strategies for minimizing usability challenges to reduce gaps in collected data
  • Considerations regarding the use of less invasive data collection devices, e.g., non-wearable technologies

11:00 am Utilizing Wearable Technologies for Digital Clinical Measures of Activity & Gait

  • Hao Zhang Senior Manager - Biomedical Engineering, Pfizer

Synopsis

  • Evaluating wearable devices at different body locations to measure gait metrics
  • Balancing different device and location’s measurement performance and usability to select the device best fit for purpose
  • Exploring applications of digital measures to a wide range of indications

11:30 am Demonstrating Fixational & Saccadic Eye Movements as an Objective Biomarker

Synopsis

  • Reviewing the extensive neuropathoanatomy of fixational eye movements (FEMs), including microsaccades, tremor, and drift and their overlap with saccades and smooth pursuits
  • Outlining the differences between involuntary microsaccades and voluntary saccades and how they can and cannot be manipulated by patient subjects
  • Discussing the differences between pupil and retinal eye-tracking technologies and when each technology is best utilized

11:40 am Roundtable Discussion: Dissecting Development of Digital Measures Across CNS Clinical Development

Synopsis

Join tables led by digital biomarker experts to discuss the benefits and challenges of different digital measures of neurological disorders.

  • Evaluating retinal eye motion as a prognostic biomarker for patient stratification and granular monitoring in CNS drug development
  • Debating a standardized measurement package to streamline biomarker validation
  • Balancing device and assessment sensitivity and usability to maximize quality of collected data

12:15 pm Lunch & Networking

UTILIZING PATIENT CENTRIC CO-CREATION TO DESIGN CLINICALLY MEANINGFUL DIGITAL MEASURES

1:15 pm Virtual Panel Discussion: Establishing a Dialogue to Understand Priorities & Experiences from Clinical Trial Participation for Digital Measures

Synopsis

  • What are the priorities that participants are looking to get out of clinical trials for digital measures?
  • Reflecting on experiences from recent clinical trials – what additional burdens did recording digital measures cause or alleviate?
  • How can digital measures further accommodate the patient perspective moving forward?

1:45 pm Utilizing a Patient Centric Approach to Create Valuable Digital Measures

  • Olga Khodakova Senior Digital Health Manager, Ipsen Pharma
  • Lauren Li Global Head, Commercial Digital Innovation, Ipsen

Synopsis

  • Delivering value to patients and minimizing burden to drive adoption in data collection
  • Integrating the patient perspective throughout the solution design process
  • Using ChatGPT to kickstart patient design thinking: tips and pitfalls

2:15 pm Exploring a Digital Cognitive Assessment to Incorporate into Routine Patient Care

  • Mark Gudesblatt Neurologist, South Shore Neurologic Associates/ NYU & Innovative Precision Health

Synopsis

  • Utilizing digital measures to rapidly quantify cognitive ability
  • Outlining the ability of digital tools for early care and intervention
  • Undertaking a patient-centric approach to relate real-world ability and routine care

2:45 pm Chair’s Closing Remarks

3:00 pm End of Conference