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DIA 2021 Global Annual Meeting
Frameworks for Digital Endpoints via the IND Pathway
Session Chair(s)
Megan Doyle, JD, MPH
- Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product
- Amgen, United States
This panel will discuss current frameworks for digital endpoints that can be used by individual sponsors in their drug development programs, as well as remaining challenges for using digital tools to capture endpoint data.
Learning Objective : Discuss frameworks for digital endpoints that could be used by individual sponsors in their drug development programs; Describe current challenges in using digital tools to capture endpoint data and possible approaches to address this problem.
Speaker(s)
Panelist
Elektra Papadopoulos, MD, MPH
- Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER
- FDA, United States
Panelist
Lindsay Stiles Kehoe, MS
- Project Manager
- Clinical Trials Transformation Initiative (CTTI), United States
Panelist
Andy Coravos
- Co-Founder, Chief Executive Officer
- HumanFirst, United States
Panelist
Lauren Oliva, PharmD, RPh
- Director, Global Regulatory Policy & Digital Health Policy Lead
- Biogen, United States