返回 Agenda
Session 1 Opening Plenary: Turn Collaboration into Better Evidence: Use Digital Endpoints and Biomarkers to Improve Development Decisions
Session Chair(s)
Chris Gorini
Vice President, Global Science Research Programs, DIA, United States
Nimesh Patel
Senior Director of Global Regulatory Systems , Eisai Co., Ltd., United States
Pharma and biotech companies increasingly rely on external partners to generate new types of evidence, from digital endpoints and wearable data to biomarkers and shared development tools. The challenge is not simply generating the data, but ensuring it is credible, meaningful to patients, and able to influence trial design and development decisions. This session will bring together perspectives from industry, technology, collaborative science, and regulators to examine what makes these partnerships work, where they fall short, and what organizations need to change internally to realize their value. Real-world examples will show how collaboration can accelerate science while improving the quality and relevance of evidence used in development.
Learning Objective : At the conclusion of this session, participants should be able to: - Identify at least three factors that enable external partnerships to generate decision-relevant digital endpoint or biomarker data
- Assess how patient-centered measures can influence trial design, endpoint selection, and development strategy
- Apply lessons from industry, collaborative science, and regulatory examples to improve adoption of new evidence approaches within their own organizations
Speaker(s)
Speaker
Zhengrong Ma
Digital Health Specialist, FDA, United States
Speaker
Representative Invited
Head of Biomarker Exploration, Koneksa Health, United States
Speaker
Laura Taraboanta
Director, Digital Medicine & Translational Imaging, Pfizer, United States
Speaker
Representative Invited
Chief Executive Officer, Critical Path Institute, United States