Minutes 2023-05-05


Joseph Rickert


May 5, 2023

  • Andrew Borgman (Bristol Myers Squibb)
  • Ben Straub (GSK)
  • Brandon Suchon
  • Eric Nantz (Eli Lilly)
  • HyeSoo Cho (FDA)
  • Jizu Zhi (FDA)
  • Joel Laxamana (Roche/Genentech)
  • Joseph Rickert (R Consortium)
  • Kui Shen (Bayer)
  • Nan Xiao (Merck)
  • Nate Mockler (Biogen)
  • Paul Schuette (FDA)
  • Renping Zhang (Johnson & Johnson)
  • Robert Devine (Johnson & Johnson)
  • Saghir Bashir (Argenx)
  • Sam Parmar (Pfizer)
  • Sean Healey (Pfizer)

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The meeting was recorded and the video is available.

Joseph Rickert brought the meeting to order.

Pilot 2

  • Hye Soo Cho of the FDA reported that her review of the Pilot 2 submission is going well and that she expects to be finished in June.
  • She is not sure how long it will take the FDA to produce a written response.

Pilot 3

Joel Laxamana reported on Pilot 3 work.

  • The execution team isfocusing on documentation particularly in the ADRG.
  • The WG confirmed that Pilot 3 should follow the Pilot 2 approach and send the renv.lock file in the R package text.
  • There was a question about SDTM Versions. The WG confirmed that the Pilot 3 should use the same 1.4 STDM version as Pilots 1 and 2. See Issue #104.
  • QC Findings will go as Appendix to the ADRG.
  • The WG agreed that the second week in July would be a good target for Pilot 3 Submission.

Pilot 4

Eric Nantz provided an update on Pilot 4 work.

  • Eric expects to have the first meeting of the execution team volunteers in the next few weeks.
  • Eric is taking a step back from committing to a container based approach in order to consider the possibility of using a self executing app in the browser using WebAssembly.
  • George Stagg from Posit is providing some assistance.
  • The idea is that the R submission code would run in a browser on the local machine of an FDA analyst.
  • Paul Schuette indicated that this approach would likely be possible at the FDA.
  • Eric said that he would be happy to try and replicate the FDA web browser environment.
  • The group suggested that a Webinar for the R Adoption series and other venues would be valuable for promoting the project.
  • Paul speculated that this web browser technology might also be useful to FDA field inspectors.
  • Eric noted that a selection core of R packages is being identified to have them run run “out of the box”.
  • If you would like to be part of the Pilot 4 team please contact Eric Nantz.
  • Paul noted that recent events where outside entities can re-litigate FDA approvals decades after the approval could make it even more necessary to be able to run analysis software many years after the submission.
  • JBR surmised that there may be interest in WG to explore long term archiving.

Other discussions

  • Nan Xiao brought attention to a document describing the submission WG in Japan. It refers to a survey about open source that mentions the Pilot 1 Submissions.
  • We are exploring the possibility of arranging for the authors of this document to participation in an R Adoption Series webinar.

The next meeting of the Submissions WG will be on Friday, June 2, 2023 at 9AM Pacific Time.