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Advancing Clinical Outcomes through Digital Health Technology Innovation
Session Chair(s)
Tae Hyun Jung, PHD
Senior Statistical Reviewer, CDER, FDA, United States
Digital health technologies are advancing drug development, aligning with FDA's PDUFA VII commitments. This session explores their impact, featuring perspectives from academia, industry, and FDA.
Learning Objective : Describe the evolving application and impact of digital health technologies in clinical research; Identify best practices for integrating digital health technologies with traditional clinical outcome assessments; Discuss the challenges and regulatory considerations associated with the use of digital health technologies.
Speaker(s)
Vadim Zipunnikov, PHD
Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Statistical Considerations for Integrating DHT-Derived Endpoints in Clinical Trials
Sooyoon Shin, PHD
Senior Manager , Verily Health, United States
Wearable Based Digital Measures for Tracking Early-Stage Parkinson’s Disease Progression Show Potential for use as Digital Endpoints in PD Trials
Tarik Yardibi, PHD
Director, Sensing and Measurement, Takeda Pharmaceuticals, United States
Advancing Clinical Development: The Role of Digital Technology Across the Lifecycle
Tae Hyun Jung, PHD
Senior Statistical Reviewer, CDER, FDA, United States
The Moment of Change
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