Hi Everyone,
The DIA Statistics and Data Science Community is pleased to announce a new webinar which will be held on Thursday 9th May, 2024. The "Open Source Software for Clinical Trial Reporting and Regulatory Submissions" webinar will feature presentations from industry and regulatory experts. Further details are given below. Registration for this free webinar is now open and is accessible via this web address: https://diaglobal.zoom.us/meeting/register/tJcqd-GurjkrGtwVlzPSc67AfVe58a9domMW
Webinar Abstract: Validated proprietary software systems and packages have traditionally been the norm for statistical analyses underlying regulatory submissions for approval of new therapeutic products. While academic institutions and other industries have embraced open-source software, the pharmaceutical industry has been slower to adopt the open-source counterpart. This webinar brings in several industry and regulatory experts to share their experiences and perspectives on using open source software for clinical trial reporting and regulatory submissions.
Webinar presentations and abstracts:
1. Eric Nantz (Director, Eli Lilly and Company): Highlights of the Successful R-Consortium Pilot Submissions
Abstract: Within the life sciences industry, the usage of open-source statistical software has made tremendous gains across the lifecycle of clinical studies in many organizations. One particular area that open source has encountered challenges historically is the clinical submission process. The R Consortium R Submissions working group, with representatives from industry sponsors and regulatory agencies, was created to assess the feasibility of using the R statistical programming language to create clinical submission deliverables while adhering to current guidelines used in submissions. This presentation will highlight the successful pilot submissions that cover a wide spectrum of using R to produce traditional clinical outputs, sophisticated Shiny applications, and analytical data sets. Additionally, we will highlight the ongoing efforts that aim to push the envelope even further with the use of web-assembly and container technology to distribute a Shiny application in a future pilot.
2. Ning Leng (People and Product Leader (Director), Genentech): Embracing open source language and modernized technologies - Roche's journey in clinical trial reporting
Abstract: In 2024, Roche embarks on a transformative journey aimed at modernizing our clinical studies by embracing cloud-based system, container and modernized version control solutions. This transition also empowers individuals to utilize the R language for generating SDTM, ADaM, and TLG outputs. This presentation will delve into Roche's transformational path, highlighting our inaugural milestone of leveraging end-to-end R solutions for pivotal readouts and filings. Additionally, we will discuss our dedication to the open-source community and our endeavors to enhance data science efficiency through the adoption of LLM.
3. Regulatory Expert: Open-Source Software for Regulatory Submissions and Regulatory Environments
Abstract: Regulatory submissions and regulatory computing environments have traditionally been associated with the use of proprietary software packages. While academic institutions have embraced open-source software, both industry and government have been slower to adopt open-source alternatives. I will discuss some of the challenges and issues with using open-source software in a regulatory environment, followed by some of the lessons learned in the ongoing R Consortium R Submission Pilot, as well as emerging issues