Open Source Solutions to Next-Generation Submissions, After 30 Years of Industry Experience
summary
Pharma is shifting submissions from static PDFs to interactive HTML submissions and web visualizations built with R, Quarto, webR, echarts (and sometimes Shiny), driven by shared R packages (the "phae" ecosystem) and consortium work (R Consortium, PhUSE, Open Source Pharma) with FDA involvement. Evidence: NDA filed with R by Novo Nordisk, showing R can replace SAS for tables/listings/figures. Historical baseline: 90–95% SAS in 1993. Change is happening now and consortium tooling is already usable.
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chapters (21)
- 0:00Introduction
- 1:03DeLorean
- 2:26SAS
- 3:03R
- 3:27Regulatory Submissions
- 4:02Electronic Submissions
- 4:37Pharma Companies
- 5:04Change is Happening
- 6:17What does this change look like
- 7:08Training Modules
- 7:47Consortium
- 9:01Intellectual Property
- 9:58Predictions
- 10:20Reproducible Reporting
- 12:03Data is All Around Us
- 12:55Patients Have a Greater Say
- 13:56Building Trust
- 14:48Encyclopedias
- 15:25Advent
- 15:52Open Community Encyclopedia
- 16:44The change is here
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