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 |
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 |
