JBR: Minutes for June 7 Meeting

minutes/2024-06-07/index.qmd

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+---
+title: "Minutes 2024-06-07"
+date: 2024-06-07
+---
+
+::: {.callout-tip collapse="true"}
+## View Attendee List
+
+- Ben Straub (GSK)
+- Eva Li
+- Heidi Curinckx (Johnson & Johnson)
+- HyeSoo Cho (FDA)
+- Ismael Alejandro Rodriguez (Appsilon)
+- Jane Owens (Phuse & Eli Lilly)
+- Joel Laxamana (Roche/Genentech)
+- Joseph Rickert (R Consortium)
+- Lovemore Gakava (Novo Nordisk)
+- Ning Leng (Roche/Genentech)
+- Paul Schuette (FDA)
+- Saghir Bashir (Argenx)
+- Stephanie Lussier (Moderna)
+- Steven Hasendinckx (Johnson & Johnson)
+- YounKyeong Chang (FDA)
+:::
+
+The meeting was recorded and the [video](https://zoom.us/rec/share/cMcaFb0OOQmcFhdwktFrFu31Bd3ANXFm91ugZqe5WzRM0erMMzQVhYDBd1fa_Am8.ATQgpOrlYiLru6b4?startTime=1717776258000) is available.
+
+## PharmaSUG Conference
+
+* Both Ben Straub (Pilot 3) and Ismael Rodriguez (Pilot 4) gave talks at the recent [Pharma SUG](https://www.pharmasug.org/us/index.html) conference which was held in Baltimore.
+* Both reported that there was a lot of interest in their talks
+* Ben reported that he spoke to several people who thought the the FDA only approves SAS submissions.
+* Both presentations will be placed in the R Submissions WG GitHub repository.
+
+## Coordination with R Package Validation
+
+* Ismael noted that Magnus from a package validation working group approached him about cooperating with the Submissions WG.
+* JBR asked Ismael to ask Magnus to write to him and said that we be happy to invite Magnus to our meetings.
+
+
+## Pilot 3
+
+Hye Soo Cho and YounKyeong Chang provided an update on their review of the Pilot 3 submission.
+
+* The FDA eviewers are wrapping up their review.
+* There are no major issues.
+* They were able to install the Util package from the zip file and review the R programs to drive the ADaM data sets.
+* QC of the ADRG did turn up a minor issue regarding inconsistencies among three date variables.
+ * The discussion of this issue begins at **7:55** in the video and is illustrated in the screen capture below.
+ * The recommended solution is that the date origin should be specified in ISO 8601 date/time format in the ADRG.
+ * Joel agreed to review the record of issues with Pilot 3 and see if there are any other parameters that ought to be explicitly mentioned in the ADRG.
+
+![](dates.png)
+
+
+## Pilot 4
+
+Eric Nantz described progress on the Pilot 4 Submission.
+
+* The end of June is still our target for the WebAssembly version of Pilot 4.
+* The plan is to do the container version at a later time after the WebAssembly version has been reviewed.
+* The question was asked if there are any special rules about package downloads.
+ * Paul Schuette stated that downloading from CRAN is preferable, that in addition to the serialization FDA Security has mentioned downloads as a potential security problem, but that as far as he knows there are no regulations.
+ * Eric pointed out that the Docker version of Pilot 4 also requires an image download.
+ * Eric and Paul will meet to discuss this issue.
+ * Eric will provide ADRG instructions and he and Paul will investigate,
+* Paul noted that the FDA has recently approved WSL (Windows System Linux)
+
+## ADRG
+
+There has been discussion within the working group as to whether we should investigate best practices for writing ADRGs for R based submissions. JBR noted that recent comments in issue #112 suggested that we should coordinated with the PHUSE ADRG working group. Discussion begins at **29:00** into the video.
+
+* As it turned out Jane Owens (Eli Lilly) who is co-lead of the PHUSE ADRG working group was on the call.
+* PHUSE owns the ADRG templates
+* They are actively working on updating the templates with respect to R in section 7.1 of the template.
+* Pilot 3 has documentation on R packages in Section 7 and in an appendix to the ADRG (Section 9). 
+
+![](ADRG.png)
+
+* PHUSE got its starting point for updating the ADRG for R from J&J which Heidi Curinckx confirmed is based on J&J's participation in the Submissions WG.
+* The PHUSE WG will publish their updated template and then send it out for review
+* The Submissions WG and the PHUSE ADRG WG will cooperate and share information.
+* JBR invited Jane and other members of her WG to attend future meetings.
+
+## R Versions Blog Post
+
+A small group led my Ning Leng is working on a blog post aimed at generating consensus about what versions of R might be appropriate for R based submissions at any point in time.
+
+* The post has been revised to reelect the Submissions WG point of view and ends with a request for readers to comment in an issue that that we will open up on our GitHub repository.
+* The post includes paragraphs on how four companies Roche, Lilly, GSK, Pfizer deal internally with versioning and package management issues
+* Unfortunately, we must remove the quote from Paul because including it would require FDA approval.
+* Will also remove the FDA logo.
+
+**ACTION:**
+
+* Ning and the other authors will finalize the text.
+* JBR will send a MS word version of the post to Paul for final review.
+
+## Next meeting
+
+* Because the July meeting is scheduled on the US July 4th holiday weekend and because of travel to the useR! conference the July meeting will be cancelled. * The next meeting of the submissions WG will be at 9AM Pacific Time on Friday August 2, 2022.
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