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Challenges and Solutions to Building the Right Patient-Centered Evidence to Support Fit-For-Purpose Sensor-Based Outcomes
Session Chair(s)
Katelyn R Keyloun, PharmD, MS
Director, R&D Digital and Data Strategy
AbbVie, United States
Challenge areas for developing patient-centered sensor-based outcomes (SBOs) will be identified, along with solutions and key considerations using real-world examples of SBO development.
Learning Objective : Describe key challenges to leveraging the patient-focused drug development (PFDD) guidance series to develop fit-for-purpose, patient-centered sensor-based outcomes (SBOs, eg, wearables) to support medical product development and decision making; Identify potential solutions to inform development of fit-for-purpose, patient-centered SBOs.
Speaker(s)
Sensor-Based Outcome Measure Development: Challenge Areas for Concept Elicitation and Interpretation of Endpoints
Bill Byrom, PhD
Signant Health , United Kingdom
Vice President, Product Intelligence and Positioning; Principal, eCOA Science
FDA Update
Anindita N Saha
Alembic Pharmaceuticals Ltd., India
Research Scientist - PV
EMA Update
Steffen Thirstrup, MD, PhD
European Medicines Agency, Netherlands
Chief Medical Officer
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