R Submission Pilot 4

Goal: Utilize alternative methods of distributing a self-contained submission bundle of the Pilot 2 Shiny application with container and web-assembly technologies.

Key evaluation aspects:

• For Submitter
  • Generation of a reproducible execution environment containing both the system and R-specific dependencies using Podman as the container runtime.
  • Generation of a web-assembly version of the Pilot 2 Shiny application (with small modifications) that can be executed in an existing R process running a web server using the {httpuv} R package
  • Preparation of submission materials with detailed instructions on setting up the execution environments
• For FDA Staff
  • Reproduce the ability to use the Shiny application by building the specific Podman container and viewing the web-assembly version of the application using the Edge internet browser.

Timeline: Targeting a first submission in Q2 2024

Data and analysis scope:

• A shiny app that replicates most of the functionality from the pilot 2, with small modifications to account for the web-assembly constraints.
• Simulated data from CDISC Pilot (the same data set as in pilot 1)

Links:

R Submission Pilot 4 Container Development Repository

R Submission Pilot 4 Web-Assembly App Repository

Key team members

Developer team:

• Eric Nantz (Eli Lilly)
• Sam Parmar (Pfizer)
• Pedro Silva (Appsilon)
• Ismael Rodgriguez (Appsilon)
• Andre Verissimo (Appsilon)
• Robert Devine (J&J)
• Nate Mockler (Biogen)
• Andrew Borgman (Bristol Myers Squibb)
• Ben Straub (GSK)

FDA Staff:

• Paul Schutte
• Hye Soo Cho