Independence Day
Our office will be closed Monday, July 4th in observance of American Independence Day. We will reopen at regular business hours on Tuesday, July 5th.
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