Conference Program

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All Times EDT

Wednesday, September 21
Wed, Sep 21, 10:00 AM - 11:30 AM
Salon DE
Plenary Session II: Impact of Pandemic, Technology, and Other External Factors on Health Care Research

Plenary Townhall (304763)

*CV Damaraju, Janssen R&D 
*Gail Kongable, Abbott Rapid Diagnostics Division 
*Hong Lu, FDA/CDRH 
*Patricia Mabry, HealthPartners Institute 
*Andrew Potter, US Food and Drug Administration 

This townhall will be an open discussion with invited panelists who have a diverse and wide variety of experience in the pharmaceutical and medical device space using digital technologies. This open TownHall style session will cover many aspects of how digital technologies have changed the way that we do healthcare research. Fitting with the theme of the workshop, we will be prepared to discuss openly how technologies, the effect of the pandemic, war, access to healthcare, have shaped our approaches to healthcare research. From Industry, the statistician who analyzed data from the CHIEF-HF trial will discuss his experiences using technologies that made remote clinical trials possible. Another person from diagnostics will discuss a high-level overview of the modeling process, specifically simulation of disease processes; in particular, diabetes mellitus, and the lifestyle and medication models that have been created. For the FDA, panelists will be able to discuss the regulatory perspectives on statistical challenges from a remote clinical trial and data collection challenges from the use of mobile technologies.