R/Adoption Series: Learnings and Reflection from R Validation Case Studies
Slide deck available:
Summary:
The R Validation Hub reviews the implementation of risk-based approaches to assess R package accuracy within a validated infrastructure and presents their learnings from applied case studies. The discussion reflects the thinking of the R Validation Hub working group, which is a cross-industry initiative funded by the R Consortium. The mission of the Validation Hub is to enable the use of R by the bio-pharmaceutical industry in a regulatory setting, where the output may be used in submissions to regulatory agencies.
After introductions, Juliane Manitz leads the presentation by going through learnings and reflections of Rval case studies. Juliane provides background information on PhaRma as well as the work the R Val Hub focuses on. Afterward, Jualiane continues by covering resources and achievements. Furthermore, there is additional information on the R package riskmetric and other partner initiatives. The presentation continues with the RVal leads giving an overview of a variety of case studies including common themes, differences in approach, and common challenges. The presentation wraps up with a Q&A session.
Speakers
Juliane Manitz, Senior Expert Biostatistician at EMD Serono
Juliane Manitz is a statistician in the pharmaceutical industry who currently works in the field of immuno-oncology at EMD Serono, MA USA. In this role, she works on statistical methodology, innovation, and technology. She has contributed to various R packages and is a member of the R validation Hub executive committee working on software validation for usage in pharmaceutical trials.
Panelist
Doug Kelkhoff has been supporting the adoption of R in the pharmaceutical space for the past 6 years. During his time at Roche, he has pushed the adoption of R through pilot clinical trials, showcasing the benefits of using R by crafting internal tools and building services that embed the R Validation Hub’s guidance as part of our software development lifecycle. He is passionate about making the use of open source tools in a regulated setting a viable path not just for large pharmaceutical companies, but for lean startups and the public sector by addressing challenges through open initiatives
Uday Preetham Palukuru is a Standards lead at Merck &Co., providing leadership to develop and maintain global standards for ADaM implementation, R package development, Open Source package qualification, Computing Platform enhancements and compliance management tools. He has contributed to various internal and external R packages and is a member of the R Validation Hub Executive committee. He actively promotes the use of open source software in clinical trial data analysis via forums and paper publications. He has a PhD in Bioengineering from Temple University.
Eric Milliman, Senior Principal Data Scientist at Biogen
The R Adoption Series
This is a new 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.