Roche's End-to-End R Journey to Submission

On-demand webinar

Roche’s End-to-End R Journey to Submission

In the rapidly evolving landscape of pharmaceutical development, Roche showcases the use of open-source R in the regulatory submission process. In this webinar, the Roche team will share a pioneering experience of end-to-end R submission for a new drug application to the FDA, EMA, and NMPA.

Topic: Roche’s pioneering end-to-end R submission for New Drug Application to FDA, EMA, and NMPA using open-source tools

Problem: In the rapidly evolving pharmaceutical development landscape, Roche faced the groundbreaking challenge of conducting a complete regulatory submission using open-source R tools instead of traditional proprietary software. The team needed to navigate uncharted territory by building an entire NDA submission pipeline in R while ensuring regulatory agencies would accept and validate R-generated outputs. This required overcoming early challenges with clinical data workflows, establishing a validated R environment that met stringent regulatory standards, and demonstrating that open-source tools could support high-stakes regulatory work where drug approval decisions worth billions of dollars hung in the balance.

Solution: Roche developed a comprehensive approach to achieve their landmark regulatory submission entirely through open-source R tools:

Built a complete eSubmission package within a validated R environment, addressing early workflow challenges by using R to clean, analyze, and visualize clinical trial data while incorporating open-source packages from the pharmaverse ecosystem.
Established robust communication and collaboration processes with regulatory agencies (FDA, EMA, and NMPA), ensuring R-generated outputs would be accepted and validated as part of the official submission process.
Created a replicable regulatory submission pipeline that demonstrates how open-source tools can successfully support critical pharmaceutical regulatory work, providing a proven model for the industry’s transition from proprietary to open-source submission workflows.

Featured in this webinar

Ning Leng

Ad-interim Global Head, Data Sciences Acceleration at Roche-Genentech

Ning Leng is the ad-interim Global Head of the Data Science Acceleration Enabling Platform, under Roche Product Development Data Sciences. Ning joined Roche-Genentech in 2016 as a statistician and 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. Since then she has been driving a number of internal and cross-industry projects on modernizing Data Science solutions in pharma. Prior to joining Roche-Genentech, Ning obtained her PhD in Statistics from University of Wisconsin-Madison and worked at the Morgridge Institute for Research.

Jingyuan Chen

Principal Data Scientist at Roche

Jingyuan Chen is a Principal Data Scientist at Roche, taking the positions of Project lead in Analytical Data Science and study statistician in oncology studies. In the end-to-end R filing project, she takes the role of data science filing lead.

Hinal Patel

Principal Data Scientist at Roche

Hinal Patel is a Principal Data Scientist at Roche. She is a project lead in analytical data science and has worked primarily on oncology molecule submissions. She was previously a product owner for admiralonco. She was an early adopter of Nextgen Tools & System and led a data science team to deliver end-to-end R submissions.

portrait of smiling Rachael Dempsey standing in front of off-white wall

Rachael Dempsey - Host

Community Manager at Posit, PBC

I love connecting people across the data science community to share what they're accomplishing with data and help others do the same through community discussions, industry meetups, and more.

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