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Novo Nordisk's Journey to an R based FDA Submission

Abstract: Join Novo Nordisk, leading pharmaceutical company in diabetes, obesity and other chronic diseases, as we celebrate reaching our NDA milestone, having recently submitted our first submission package featuring outputs exclusively written in R, along with select ADaM datasets also written in R. In this webinar, we will provide you with an in-depth look at our computing platform and our internal R package suite, including insights into their development. We will reflect on the process and setup we have in place and provide you with a sneak peek into what the future holds for us. You'll get an exclusive look at our journey and learn how we overcame challenges, as well as how we continue to innovate and streamline our processes. Don't miss this opportunity to gain insight into our approach to NDA submissions. Speakers: Ari Siggaard Knoph (MSc): Ari 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): Steffen 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): Anders 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.