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ACoP7 workshop announcement - open source tools for efficient conduct of pharmacometric analyses and reporting

Come and join us for our ACoP7 workshop - few places still available. Please find below a short descripton of the workshop contents. More information can be found here: Workshop Page.

ACoP7-Workshop: Industrialization and Knowledge Management of Pharmacometric Analyses

Main Topics

  • PMXStan and nlmixr: open-source PKPD modeling tools on R (Speaker: Wenping Wang, Novartis)
  • Industrialization of Pharmacometric Analyses and Reporting using R. Hands-on Example (Speaker: Nidal Al-Huniti, AstraZeneca)
  • Application of industrialization approaches and relevant examples in MATLAB, NONMEM, and MONOLIX (Speaker: Henning Schmidt, IntiQuan)

Program

A detailed program can be found here: Workshop program.

Description

Pharmacometric analyses have become an integral part of drug development and the decision making process across the pharmaceutical industry.

Even though, many of the pharmacometric analyses are fairly similar in nature, there is a large heterogeneity in the planning and conduct of these analyses on the level of individual modelers. The outcome of the current approach to modeling and simulation in Pharmacometrics is that even fairly standard analyses are very time and resource consuming, often placing the pharmacometric analysis results on the critical path, potentially leading to the inability to support a go/no go, a phase III dose selection, other investment decisions, or causing potential delays to regulatory filings.

Heterogeneity of approaches is not only observable in the conduct of pharmacometric activities, but also in the way ongoing and finalized activities and associated material (models, code, outputs, documentation, etc.) are stored. In many organizations it would be very difficult to find all required information about an ongoing modeling project if the modeler in charge would leave the company or not be available for some time and the project would need to be taken over by someone else, requiring considerable re-work.

Industrialization and knowledge management approaches have the potential to reduce regulatory risks, leverage excellence, create a platform for improved quality, consistency, compliance, improve turn-around time of pharmacometric deliverables, and reduce costs.

This workshop is designed to provide an introduction to the vision behind industrialization and knowledge management approaches in Pharmacometrics. Relevant examples will be discussed and demonstrated. All examples, code, models, scripts will be provided along with all slides to allow the interested participant to re-use examples for own purposes. Examples will both be R and MATLAB based and use both NONMEM and MONOLIX as a parameter estimation tool at the back-end. No expertise in NONMEM or MONOLIX is required to follow this workshop or for execution and understanding of the provided examples. Experience with R and/or MATLAB is beneficial.