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DIA 2021 Global Annual Meeting

Frameworks for Digital Endpoints via the IND Pathway

Session Chair(s)

Megan Doyle, JD, MPH

Megan Doyle, JD, MPH

  • Global Policy Lead, Digital Health, Diagnostics, and Combination Products
  • 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)

Elektra Papadopoulos, MD, MPH

Panelist

Elektra Papadopoulos, MD, MPH

  • Deputy Director (acting) Division of Clinical Outcome Assessment, OND, CDER
  • FDA, United States
Lindsay Stiles Kehoe, MS

Panelist

Lindsay Stiles Kehoe, MS

  • Project Manager
  • Clinical Trials Transformation Initiative (CTTI), United States
Andy Coravos

Panelist

Andy Coravos

  • Co-Founder, Chief Executive Officer
  • HumanFirst, United States
Lauren Oliva, PharmD, RPh

Panelist

Lauren Oliva, PharmD, RPh

  • Global Regulatory Policy Lead, New Technologies
  • Biogen, United States