On-demand webinar
Roche's End-to-End R Journey to Submission
Learn how a team at Roche successfully used R, including open-source packages from the pharmaverse, to support a complete New Drug Application (NDA) submission. They share practical lessons from building a regulatory submission pipeline entirely in R and working closely with health authorities throughout the process.
Key topics covered include:
• How the team addressed early challenges with clinical data and submission workflows
• Using R to clean, analyze, and visualize clinical trial data
• Building a complete eSubmission package within a validated R environment
• Communicating and collaborating with regulatory agencies
• Ensuring R-generated outputs were accepted and validated as part of the submission
• Demonstrating how open-source tools, primarily from the pharmaverse, can support high-stakes regulatory work
• This webinar offers a detailed look at how open source is being applied in real-world regulatory submissions.
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Featured in this webinar
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 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 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.
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.
