R/Adoption Series: R and Shiny in Regulatory Submissions Webinar

Slide deck available:

Summary

The R adoption series – a curated set of webinars focusing on the growing adoption of the R programming language in the data science community. Each webinar provides insights through a compelling case study and offers an interactive platform for attendees to pose questions and learn. This series was a collaborative effort by the R consortium, PhUSE, and PSI. In the past webinar, the FDA and industry speakers shared their unique experiences with R-based and shiny-based submissions.

Agenda Highlights:

Opening Remarks by Ning Leng, People and Product Lead in Product Development Data Sciences at Roche.
Presentation on Open Source Software for Regulatory Submissions by Paul Scheutte, FDA.
Dive into R Consortium R Submission Pilot 2 with Eric Nantz from Eli Lilly. Discover how an R-based submission with a shiny component unfolded.
Reviewing Experience of R-based Submissions with Hye Soo Cho, FDA. Understand the nuances and challenges faced during the review process.
Interactive Panel Discussion moderated by Ning Leng. Join Paul Schuette, Hye Soo Cho, and Eric Nantz as they delve deep into the R adoption journey and discuss practical challenges and solutions.

Speakers

Ning Leng, People and Product Lead in Product Development Data Sciences in Roche-Genentech.

Ning joined Roche-Genentech in 2016 as a statistician in the oncology early development and personalized healthcare group. Ning has worked on both early and late phase oncology development, with a special interest in utilizing diverse data sources and advanced methodologies to generate insights for personalized healthcare. Ning is an advocate of automation, open sourcing and open collaboration in pharma. She is also passionate in connecting people and helping people find new interests and opportunities. She serves as Roche representative on the R consortium board, co-leads the R consortium R submission working group, and co-leads the Meetup series of the Bay-area Biotech-pharma Statistics Workshop (BBSW). Ning holds a B.S. in Information and Computing Science from Beijing Institute of Technology and a Ph.D. in Statistics from University of Wisconsin-Madison.

Panelists

Paul Scheutte is Mathematical Statistician at FDA.

Scientific Computing Coordinator for the Office of Biostatistics. Prior to joining the FDA, he taught statistics and mathematics primarily at the undergraduate level.

Eric Nantz has a broad background in statistics, computer science, and system administration which gives him a unique set of skills for using state-of-the-art technology and techniques to accomplish important and innovative data analyses. In his professional role as a statistician, he supports the design and analyses of clinical trials evaluating treatments for auto-immune disorders. He also performs statistical analyses of specialized biomarkers utilizing cutting-edge statistical software such as R and high-performance computing infrastructures.

Hye Soo Cho is a statistician in the Office of Biostatistics at CDER/FDA.

She has regularly been involved in the review of IND/BLA/NDA applications. In addition to review work, she has been involved with the standardization of programs for data analysis, the development of a R Shiny application, and digital health technology and rare disease working groups.

The R Adoption Series

This is a series of webinars focused on the adoption of R. Each session will include a case study and often include panels or discussions to enable those starting their journey to ask questions.

R Consortium will keep this page updated with information on future webinars in the R Adoption series. If there is some information that you are looking for specifically and you don’t see it here, feel free to email us at info@r-consortium.org.