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#105: Advancing Clinical Outcomes through Digital Health Technology Innovation
Monday June 16, 2025 11:00am - 12:00pm EDT
209ABC
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-511-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Tae Hyun Jung, PhD

Speaker

Statistical Considerations for Integrating DHT-Derived Endpoints in Clinical Trials
Vadim Zipunnikov, PhD

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

Advancing Clinical Development: The Role of Digital Technology Across the Lifecycle
Tarik Yardibi, PhD

The Moment of Change
Tae Hyun Jung, PhD


Speakers
avatar for Tae Hyun Jung

Tae Hyun Jung

Senior Statistical Reviewer, CDER, FDA, United States
Tae Hyun (Ryan) Jung, Ph.D., is a Senior Statistical Reviewer in the Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA. He specializes in regulatory reviews of NDA/BLA/PMR submissions, with particular focus on RWE in rare diseases... Read More →
avatar for Sooyoon Shin

Sooyoon Shin

Senior Manager, Digital Biomarkers, Verily, United States
Sooyoon Shin, PhD, is the Senior Manager of Digital Biomarkers at Verily, where she leads the research and evidence generation for digital measures and AI/ML capabilities. She oversees the development, validation, and implementation of the technology in internal and external clinical... Read More →
avatar for Tarik Yardibi

Tarik Yardibi

Director, Sensing and Measurement, Takeda Pharmaceuticals, United States
Tarik Yardibi is the Director of Sensing and Measurement at Takeda Pharmaceuticals, operating within the Digital Health Sciences department at Takeda R&D. As a digital health and data science technical leader, Tarik has contributed extensively across both medical device and pharmaceutical... Read More →
avatar for Vadim Zipunnikov

Vadim Zipunnikov

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Vadim Zipunnikov is an Associate Professor of Biostatistics at Johns Hopkins Bloomberg School of Public Health and co-leads the Wearable and Implantable Technology (WIT) group. His research focuses on developing statistical methods for analyzing digital health data from wearables... Read More →
Monday June 16, 2025 11:00am - 12:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

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