Webinars

Novo Nordisk: Journey to an R-based FDA submission

2023-08-11

Man looking at data visualizations on two monitors

VIRTUAL EVENT

September 12, 2023

10 AM ET | YouTube Live

Novo Nordisk is pushing the possibilities of open source in drug development, having recently submitted its first R-driven package to the FDA.

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Join us on September 12th at 10 AM ET for a live presentation as the data science team at Novo Nordisk details this incredible NDA milestone.

You will get an in-depth look at Novo Nordisk’s computing platform and internal R package suite, including insights regarding its development. The team at Novo Nordisk will reflect on this process, setup, and journey to achieving such an infrastructure, and provide a sneak peek into what the future holds.

You’ll get an exclusive look into Novo Nordisk’s journey towards an R-driven submission, the challenges faced and how they were overcome, and how the team plans to innovate and streamline this process moving forward. Don’t miss this opportunity to gain insight into this incredible milestone regarding NDA submissions.

PRESENTERS

	Ari Siggaard Knoph (MSc) is a Principal Statistical Programmer and International Lead Programmer at Novo Nordisk with a seat on the pharmaverse council. He is a driving force behind the adoption of R in clinical deliverables and submissions at Novo Nordisk. Ari is also the author and maintainer of multiple R packages and leads the Novo Nordisk pharmaverse team.
	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) 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.