7:00- 7:30 PM - The Journey to a Successful Shiny Application Submission to FDA

Eric Nantz

Within the life sciences industry, Shiny has enabled tremendous innovations to produce web interfaces as frontends to sophisticated analyses, dynamic visualizations, and automation of clinical reporting across drug development. While industry sponsors have widely adopted Shiny as part of their analytics and reporting toolset, a relatively unexplored frontier has been the inclusion of a Shiny application inside a clinical submission package to regulatory agencies such as the FDA. After a successful pilot of an R-based clinical analysis submission package, the R Consortium R Submissions Working Group launched a second pilot in 2022 to test whether a Shiny application created with R could be assembled into a submission package and successfully transferred to FDA reviewers. In this talk, I will share the development journey of the Shiny application with key highlights of open-source collaboration, novel tooling in the Shiny ecosystem, challenges in the overall process, and the key milestones that led to a successful submission to the FDA. This project has the potential of becoming the first key reference of using Shiny in a regulatory context, paving the way for new innovations in how the life sciences industry can leverage R in new and innovative ways as part of clinical submissions.

"Eric Nantz is a director within the statistical innovation center at Eli Lilly and Company, creating analytical pipelines and capabilities of advanced statistical methodologies for clinical design used in multiple phases of development. Outside of his day job, Eric is passionate about connecting with and showcasing the brilliant R community in multiple ways. You may recognize his voice from the R-Podcast that he launched in 2012. Eric is also the creator of the Shiny Developer Series where he interviews authors of Shiny-related packages and practitioners developing applications, as well as sharing his own R and Shiny adventures via livestreams on his Twitch channel. In addition, Eric is a curator for the RWeekly project and co-host of the RWeekly Highlights podcast which accompanies every issue."
Mon 9:01 am - 12:00 am
Case Study
App, Eric Nantz