From 525ca25e12feed0149eaae1eda5eb76715fb8c4c Mon Sep 17 00:00:00 2001 From: Amanda L Martin Date: Mon, 7 Aug 2023 19:00:02 -0400 Subject: [PATCH] 2023-08-04 minutes --- docs/minutes/2023-08-04/index.html | 570 +++++++++++++++++++++++++++++ 1 file changed, 570 insertions(+) create mode 100644 docs/minutes/2023-08-04/index.html diff --git a/docs/minutes/2023-08-04/index.html b/docs/minutes/2023-08-04/index.html new file mode 100644 index 0000000..1e2d55b --- /dev/null +++ b/docs/minutes/2023-08-04/index.html @@ -0,0 +1,570 @@ + + + + + + + + + + + +R Submissions Working Group - Minutes 2023-08-04 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
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Minutes 2023-07-07

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Joseph Rickert

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August 4, 2023

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  • Ben Straub (GSK)
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  • Li Eva
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  • Christopher Kania (Biogen)
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  • Eric Nantz (Eli Lilly)
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  • HyeSoo Cho (FDA)
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  • Jizu Zhi (FDA)
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  • Joel Laxamana (Roche/Genentech)
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  • Joseph Rickert (R Consortium)
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  • Nan Xiao (Merck)
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  • Ning Leng (Roche/Genentech)
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  • Paul Schuette (FDA)
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  • Sam Parmar (Pfizer)
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  • Shannon Lewis (BeiGene)
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  • Stephanie Lussier (Moderna)
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Add Minutes Here

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The meeting was recorded and the video is available.

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Pilot 2

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HyeSoo Cho reported that she is working with the Pilot 2 re-submission and that it looks good.

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HyeSoo expects that the final on this pilot submission will be available at the end of August.

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Everyone recognized and thanked Eric Nantz for the sustained and last-minute efforts to get the submission out.

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Pilot 3

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Paul Schuette brought the attention of the group to section 4.i.2.10 of the [Study Data Technical Conformance Guide - Technical Specification Document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document) and noted that .r and .zip files are listed as acceptable file formats for submissions.

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After some discussion, the WG decided not to use [pkglite](https://cran.r-project.org/package=pkglite) to wrap the R code as has been done in previous submissions, but to use .r files for the code. (Note that the FDA is unable to use .R internally.)

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In the end, the WG decided to stick with using GitHub repos for Pilot 3 as there is currently no apparent advantage testing the .zip file method at this time.

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Joel Laxama reported that preparations for Pilot 3 are going well, and that a submission using .r files could be made in early September.

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The WG thought it best to wait for the report of Pilot 2 before submitting Pilot 3.

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Pilot 4

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Eric reported that thanks to the contributions form the [Appsilon](https://appsilon.com/) team significant progress has been made on using both mechanisms for packaging R submissions: Containers and [Webassembly](https://webassembly.org/).

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Appsilon has a prototype submission using [Podman](https://podman.io/) container technology working and has confirmed that it does not cause files to be written to the hard-drive.

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Eric and the Appsilon engineers also have a very preliminary prototype of using Webassembly to wrap a small Shiny app working.

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Posit engineers have contributed [webr](https://cran.r-project.org/package=webr) expertise.

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Eric is optimistic about having Pilot submissions based on at least one, and possibly both, of these technologies ready by the end of the year.

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Action:

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  • Paul will confer with the proper FDA authorities to determine what preparations need to be undertaken by the FDA to use the Podman containers.
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  • Eric will invite an Appsilon representative to come to a future meeting of this working group
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July 21 San Jose State R Foundation Event

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The R Foundation [SummeR Bay Area R Meetup](https://bbsw-tickets.ticketleap.com/summer-r-day2/) was held at San Jose State University on July 21. Ning Leng reports that:

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  • The 50 plus attendees indicated that quite a few Bay Area companies are moving towards using R in preclinical and genomics research.
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  • Representatives from several small CROs attended the meeting.
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  • R Consortium recognition was not good among this group.
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Action:

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  • JBR and Ning to discuss what can be done to promote the RC. +
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Speaking Opportunities

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Action:

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  • Eric will submit an abstract to speak about Pilot 3 and Pilot 4 at the [R/Pharma](https://bbsw-tickets.ticketleap.com/summer-r-day2/) virtual conference to be held in on October 24 - 26.
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  • Paul will be presenting at both at the [PHUSE/FDA CSS 2023](https://advance.phuse.global/pages/viewpage.action?pageId=70778947) conference on September 18 -20 and the [ASA Biopharmaaceutical Section Regulatory-Industry statistics Workshop](https://advance.phuse.global/pages/viewpage.action?pageId=70778947) to be held in Rockville, MD on September 27 - 29 and intends to use the activities of this working group as a case study.
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  • Ning suggests that it would be very nice if the RC could hold and R Adoption Webinar in the November time frame to describe the Pilot 2 and Pilot 3 submissions. +
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Action:

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  • Paul will check with FDA authorities to see whether it is appropriate for the R Consortium to publicize his speaking opportunities on social media. +
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  • JBR will work with the RC Community development committee to make preparations for the promoting the speaking activities and setting up the webinar. +
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The next meeting of the Submissions working group will be at 9AM PST on Friday, September 1st. +

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