Advancing CDISC Standards for Biosensors Assessments in Clinical Drug Trials: 2017 Biometric Monitoring Device Workshop

May 9-10, 2017

Bethesda North Marriott Hotel and Conference Center
Bethesda, MD

Meeting Overview/Objectives:

  • Review contemporary use cases for mobile biosensor assessments of three domains of function that are impacted by Neurological Disorders (mobility/sleep/cognitive performance).
  • Review & address key regulatory considerations for various Contexts-of-Use.
  • Convene CDISC Standard experts to advance a plan that enables data aggregation across technology platforms to define disease progression in terms of these 3 key domains, and to potentially understand the impact of treatment intervention during clinical drug trials.

Notes and action items from this meeting

Meeting Agenda

 

May 9

7:30 – 8:00 am

Continental Breakfast

8:00 – 8:30 am

Welcoming Remarks & Overarching Objectives for Concepts-of-Interest
Stephen Arnerić (Critical Path Institute)

8:30 – 9:25 am

The Potential of BMDs in Assessing Real-World Function
Jeffrey Kaye (Oregon Health Sciences University)

9:25 – 9:45 am

Voice of the Patient-Advocate
David Levine

9:45 – 10:00 am

Questions
10:00 – 10:30 am Break
SESSION I: Mobility/Frailty
10:30 – 10:50 am Luxembourg Centre For Systems Biomedicine (LCSB)
Venkata Satagopam
10:50 – 11:10 am Michael J. Fox Foundation
Lauren Bataille
11:10 – 11:30 am Evidation Health
Luca Foschini
11:30 – 11:50 am APDM Wearable Technologies
Matthew Johnson
12:00 – 1:00 pm Lunch
SESSION II: Sleep
1:00 – 1:30 pm Device Comparisons to Polysomnography
Rebecca Spence (University of Massachusetts)
1:30 – 2:00 pm IXICO
Derek Hill
2:00 – 2:20 pm Break
SESSION III: Cognition
2:20 – 2:40 pm Cerebral Assessment Systems, Inc., Cognivue®
Charles J. Duffy
2:40 – 3:00 pm ImPACT® Applications, Inc.
James Gyurke
3:00 – 3:20 pm Cambridge Cognition
Krystyna Zaluski
3:20 – 3:40 pm Akili
Ashley Mateus
3:40 – 4:00 pm Break
4:00 – 5:15 pm

Panel Discussion:

Michael Davis (FDA, CDER), Jay Gupta (FDA, CDRH), Sean Khozin (FDA, CDER), Leonard Sacks (FDA, CDER)

5:15 – 5:25 pm Summary and Closing Remarks
Stephen Arnerić (Critical Path Institute)

 

May 10

7:30 – 8:00 am

Continental Breakfast

8:00 – 8:10 am

Welcoming Remarks

Stephen Arnerić (Critical Path Institute)

8:10 – 10:00 am

Discussion of Key Themes and Messages from May 9
All
10:00 – 10:30 am Break
Key Metadata and Concept Maps
10:30 – noon Where do we need to focus? Next Steps…
All
12:00 – 1:00 pm Lunch
1:00 pm Adjourn