Roche’s end-to-end R submission for a new drug application
VIRTUAL EVENT
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.
They will unfold the journey of overcoming the initial challenges to achieving the filing goal and emphasize the practicalities of processing, analyzing, and visualizing clinical trial data in R, leading to a comprehensive eSubmission package.
They will also share our strategic communication and collaboration with regulatory agencies, highlighting how R-generated data and documentation were effectively presented and validated within the submission framework. The successful end-to-end NDA submission using R packages, the majority of which are open-source packages (from pharmaverse), not only demonstrates the feasibility and benefits of leveraging such a powerful tool in the regulatory realm but also sets a precedent for its wider adoption in the pharmaceutical industry.
PRESENTERS
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Ning Leng is the ad-interim Global Head of the Data Science Acceleration Enabling Platform, under Roche Product Development Data Sciences. Ning has been driving a number of internal and cross-industry projects on modernizing Data Science solutions in pharma. |
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Hinal Patel is a Principal Data Scientist in Roche. She is a Project lead in Analytical Data Science and has worked primarily on oncology molecule submissions, 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 submission. |
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Jingyuan Chen is a Principal Data Scientist in 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.
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VIRTUAL EVENT