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Session 7 Track 1&2: Can You Hear Me Now? How Platform Digital Technologies Can Amplify the Patient Voice
Session Chair(s)
Lauren Oliva, PHARMD, RPH
US Regulatory Policy Lead, Biogen, United States
As our knowledge of disease manifestations and treatment approaches becomes more sophisticated, new opportunities exist to quantify important features of serious diseases for the first time.
There are now digital tools available to sponsors with the potential to create value in the drug development process beyond a specific product or disease state. These so-called platform technologies are tools that enable sponsors to better measure and interpret symptoms that impact many disease indications. Examples include symptoms such as fatigue, pain, cognition, speech, and autonomic measures.
This session will explore the value of adopting platform technologies to drug development programs and the path to regulatory acceptance of data generated by these novel tools.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify case study examples of platform digital technologies tools in drug development programs.
- Propose benefits of data generated by these tools for patients, caregivers, HCPs, regulators, and payers
- Evaluate models for cooperative development and adoption of platform digital technologies in the biopharma ecosystem
Speaker(s)
Kelley Erb, PHD
Director, Digital and Quantitative Medicine, Biogen, United States
Industry Perspectives on a Platform Approach to Digital Endpoint Development
Michelle Campbell, PHD
Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
Industry Perspectives on a Platform Approach to Digital Endpoint Development
Mintu Turakhia, MD, MS
Executive Director, Center for Digital Health; Chief of EP, Palo Alto VA, Stanford University , United States
Operationalizing Digital Health and Virtual Visits for Clinical Trials
Channing Barker
Patient Representative, Advocate, United States
Speaker