Webinar

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Novo Nordisk: Journey to an R-based FDA submission

The leading pharmaceutical company behind life-changing medicines such as Ozempic, joined Posit to share their celebratory milestone in drug development - an NDA submission using open-source tooling.
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What you’ll learn

Topic: Novo Nordisk’s achievement of their first NDA submission using entirely open-source R-based tooling and infrastructure.

Problem: Novo Nordisk, the leading pharmaceutical company behind life-changing medicines such as Ozempic, faced the critical challenge of transitioning from traditional proprietary tools to open-source software for regulatory submissions. The company needed to establish a validated computing platform that could meet stringent regulatory requirements while producing NDA submission packages entirely in R, including complex ADaM datasets. This transformation required building robust internal infrastructure, developing specialized R packages, and ensuring their open-source workflows could withstand the rigorous scrutiny of regulatory authorities for drug approval processes.

Solution: Novo Nordisk developed a comprehensive approach to achieve their milestone NDA submission using open-source tools:

  1. Built a validated computing platform specifically designed for regulatory submissions, establishing the technical foundation and compliance framework necessary to support R-based workflows in a highly regulated environment.
  2. Developed internal R packages and infrastructure tools that could handle the complexities of pharmaceutical data processing and regulatory reporting, while addressing challenges encountered during the submission process through iterative improvements.
  3. Established scalable processes and system setups that enable future NDA submissions using R-based workflows, creating a replicable model for expanding open-source adoption across their drug development pipeline.
     

Speakers

Steffen Falgreen Larsen (MSc, PhD)

Statistical Specialist at Novo Nordisk
Steffen Falgreen Larsen (MSc, PhD) is a Statistical Specialist with over 8 years of experience in driving the shift towards R and Python at Novo Nordisk. He has a master’s degree in mathematics with a specialization in life sciences and a PhD in biostatistics and informatics. Steffen has designed and co-developed a Statistical Computing Environment for R and the internally developed package ecosystem. He is a seasoned R user and developer.

Anders Ellern Bilgrau (MSc, PhD)

Statistical Specialist at Novo Nordisk
Anders Ellern Bilgrau (MSc, PhD) is a Statistical Specialist at Novo Nordisk and an Adjunct Associate Professor at the Department of Mathematical Sciences, Aalborg University. He holds a master’s degree in applied mathematics and a PhD in biostatistics and informatics. Anders is not only a skilled statistician but also an experienced software developer, with a special focus on R development for many years. He has played a key role in co-developing the R platform and internal packages used in Biostatistics at Novo Nordisk.

Ari Siggaard Knoph

International Lead Programmer, Statistical Programming Specialist
Ari Siggaard Knoph is an International Lead Programmer and Statistical Programming Specialist at Novo Nordisk. He is part of the Novo Nordisk package development team where he develops and maintains packages for clinical reporting and submission. He is the primary driver for the use of R in clinical submissions at Novo Nordisk and holds a council seat on the pharmaverse council.