Panel Discussion: Traversing the Regulatory Road to Qualifying a Digital Endpoint; Twists and Turn

Panel Discussion: Traversing the Regulatory Road to Qualifying a Digital Endpoint; Twists and Turns

Mobile in Clinical Trials 2020 panel discussion, "Traversing the Regulatory Road to Qualifying a Digital Endpoint; Twists and Turns," ActiGraph CEO, Jeremy Wyatt, joined a panel of thought leaders from Pfizer, Boehringer Ingelheim, Biogen, and ICON to discuss a framework for the qualification of novel digital endpoints and the regulatory feedback on these approaches. Topics covered include: 
  • Regulatory engagements that included discussions of NDE(s)
  • Case studies that organizations have put forward, the types of information collected, questions asked to health authorities, their context and objectives, as well as responses from health authorities
  • Insights we can leverage as we go forward

Discussion Panelists

  • Jeremy Wyatt, CEO, ActiGraph
  • Robert Joe Mather, Executive Director, Digital Medicine & Translational Imaging, Early Clinical Development, Pfizer
  • Mohammed Ali, Global Head, Digital Trials & Clinical Operations, Boehringer Ingelheim
  • Kelley Erb, Director, Digital and Quantitative Medicine, Biogen
  • Carrie Northcott, PhD, Director, Early Clinical Development, Digital Medicine and Translational Imaging, Pfizer
  • Marie McCarthy, MBA, Senior Director, Product Innovation, ICON

Duration: 1 Hour