Traversing the Regulatory Road to Qualifying a Digital Endpoint; Twists and Turns
Mobile in Clinical Trials virtual 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
- 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