Introduction to the NLME Consortium

Modelling and Simulation (M&S), specifically Pharmacometrics, has now established itself as a discipline with key input to informed decision-making during drug development in most medium- to large-sized pharmaceutical companies. The Non Linear Mixed Effects Consortium (NLMEc) is a collaboration between a number of Pharmaceutical companies whose participants share a common desire to optimize the information technology environment to address the needs of the community.

The Challenge

The participants share a common belief that there are currently significant gaps in information technology available for model-based drug development. Software systems currently used for modelling and simulation are fragmented in nature and only very limited support exists for the reuse of data and exchange of methods and methodologies between systems.

Proposed Solution

The participants advocate tools to better support and accelerate the development of new safe medicines and have identified a clear opportunity to improve the efficiency and value of modelling and simulation in drug development by reusing data and exchange of methods across different systems. The participants are, therefore, pioneering the development of a software “framework” to enable interoperability of both the existing information technology platforms and future applications in this area.

Such a Framework will be designed to save on significant time and effort, and will act as an environment to enable integration of existing applications and methodologies, as well as to improve the efficiency of integration of new methods. The Framework is also expected to act as a catalyst for the development of new and innovative methods in this discipline.

In support of this idea, the participants have already begun working on the XML-based data interchange standards that would be required to provide a consistency to definitions and syntax across independent applications to facilitate interoperability of these applications.

Another of the goals of this proposal is to tighten the links between industry, academia, and healthcare regulatory authorities. The academic participants propose to adapt existing and new tools to work with the Framework through the use of these standards, which will enable much greater penetration of these tools to the general community.

A further opportunity relates to the current regulatory drive for the development of common standards for data used in the submission of new drugs for approval. Regulators currently perform re-analysis of data used in modelling, and such standards would significantly reduce the amount of time and resources required for their review activities.

Figure 1: Proposed Framework concept diagram. Monolix, NONMEM, BUGS and S-Plus are commonly-used software tools in the pharmacometric domain.

Expected Benefits

Ultimately, the Framework provides an opportunity to better and more efficiently apply modern quantitative techniques to assess and predict the pharmacological and system properties of both new and established drugs, specifically as they relate to efficacy and safety. The Framework will innovate by implementing a question-based approach (workflow) by defining assessment criteria upfront within a clinical drug development context.

Should other Pharmaceutical companies share in the stated and published aims of the NLMEc we would invite them to join us in realising our goals. If you would like to register your interest in the consortium please click here.