×
Back to Agenda
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)
Statistical Considerations for Integrating DHT-Derived Endpoints in Clinical Trials
Vadim Zipunnikov, PhD
Johns Hopkins Bloomberg School of Public Health, United States
Associate Professor
Wearable Based Digital Measures for Tracking Early-Stage Parkinson’s Disease Progression Show Potential for use as Digital Endpoints in PD Trials
Sooyoon Shin, PhD
Verily, United States
Senior Manager, Digital Biomarkers
Advancing Clinical Development: The Role of Digital Technology Across the Lifecycle
Tarik Yardibi, PhD
Takeda Pharmaceuticals, United States
Director, Sensing and Measurement
The Moment of Change
Tae Hyun Jung, PhD
FDA, United States
Senior Statistical Reviewer, CDER
Have an account?