Pre-Conference Workshop Day

Workshop A

9:00 am

Tackling Big Data: Exploring the Best Practices to Streamline Data Quality & Identify Digital Measures

Synopsis

Remote and digital biomarker data capture presents advantages over typical patient data collection, with more objective measurements and passive and more frequent data collection. However, there are still challenges to overcome in collecting and handling big data regarding signal: noise ratio, data analysis and selecting measures, and ensuring the correct operational performance of data collection.

 

Workshop Highlights Include:

 

  • Optimizing filtering signal from noise in collected data from high-frequency and passive data collection
  • Neurological complexity: how can frequent data collection identify changes in disease progression?
  • Applying machine learning tools to select clinical measures from collected data

Workshop B

9:00 am

Learning from the Past & Constructing Frameworks to Breakdown the Requirements for Regulatory Acceptance of Digital Measures

Synopsis

With only one digital biomarker approved by regulatory bodies, there is still ambiguity regarding the requirements and pathway needed for a digital biomarker to receive regulatory acceptance. Join this workshop to discuss the current requirements needed for digital biomarker approval, as well as the steps that can be taken by industry developers to best instil confidence from regulatory bodies.

 

Workshop highlights Include:

 

  • Understanding the journey of a digital measure to gain regulatory approval
  • Lessons learned from previous interactions with regulatory bodies: what has worked best historically?
  • Generating frameworks of evidence generation and validation to demonstrate the feasibility to regulatory bodies

Workshop C

1:00 pm

Creating a Common Thread: Debating the Best Strategies for a Standardized Data Analysis

Synopsis

As an emerging field, the current digital biomarkers landscape is seeing a rapid expansion of unique measurements of neurological indications. In alignment with longer-established fields, there is a need to create an agreed set of measurements taken when recording data to streamline downstream analysis and aid the validation of novel digital biomarkers.

 

Workshop highlights Include:

  • Debating multi-stakeholder agreement on the best measurements for neurological digital biomarkers
  • Creating a united measurement package to aid validation of digital measures
  • Exploring the standardization of data collection devices to record more reliable data

Workshop D

1:00 pm 

Solidifying Industry Trust & Investment Post Validation to Accelerate Qualification & Scalability of Digital Measures

Synopsis

Following validation, there are still internal barriers to overcome to encourage scaled-up deployment of digital biomarkers in the industry. Join this workshop to contrast experiences of combatting internal hesitancies and expand the applications of validated biomarkers to pave the way to scaled-up deployment in neuro clinical trials.

 

Workshop highlights Include:

  • Exploring strategies to secure internal industry confidence in digital biomarkers to scale-up investment and dedicated resources
  • Widening the scope: expanding cross-indication applications of qualified measures to supercharge scalability
  • Utilizing consortia and partnerships to de-risk industry investment into validated digital biomarkers