CAMD Digital Biomarkers Conference
Use of Biosensors in Clinical Trials:
Barriers & Solutions to the Current Landscape
March 31 – April 1, 2016
Bethesda North Marriott Conference Center
Interest in identifying, evaluating and qualifying innovative technologies for use in drug development is growing. While regulatory guidance documents exist for pursuing novel Drug Development Tools (DDTs) and Medical Devices Development Tools (MDDTs) for Qualification, the use of Digital Biomarkers (i.e., measured biological events or patient function captured through a device or sensor technology) for use in clinical development remains ill-defined. This conference examines the current landscape of our use of Digital Biomarkers in clinical trials, the challenges faced, and the need for solutions to these challenges.
Agenda
Presentations:
- Stephen Arneric: “Assessment of Cognition & Function in Neurodegenerative Diseases”
- Jeffrey Kaye: “Life Kinetics as Outcomes in Clinical Trials”
- Max Little: “Repurposing Consumer Tech for Digital Biomarkers”
- Rebecca Kush: “Why do Standards Matter?”
- John Wilbanks: “transforming clinical study through participant-centric mobile research”
- Sean Khozin: “Information Exchange and Data Transformation (INFORMED) Initiative”
- Jane Rhodes: “Advances towards Remote Assessment of Disease and Relapse in Multiple Sclerosis”
- Spyros Papapetropoulos: “Challenges & Promises of digital biomarkers in the quantification of motor function”
- Paul Maruff: “Use of Internet Based Assessment for Tracking the Course of Early Alzheimer’s Disease with Potential for Determining Response to Treatment”
- Rhonda Au: “Cognitive Assessment in the Digital Era”
- John Hall and Ken Tubman: “Real-world Digital Biomarkers from Symptomatic Community Population with Cognitive Impairment”
- Ray Dorsey: “Digital Biomarkers in Neurology”
- Ottavio Vitolo: “Digital Biomarkers for Huntington’s Disease: Promises and Challenges”