The consortium is concerned with the progress of standards, methodologies and tools within the M&S field. The current technical landscape is lacking in many ways and the NLMEc sees the best way of addressing this as collaborating with industry partners to help drive the advances and changes needed to arrive at a situation where M&S departments have state of the art tools and a stable and integrated environment in which to work.

The original Consortium disbanded due to legal/contractual obstacles. It was re-formed in 2006 by key industry leaders.

Click here to view the Pharmaceutical companies that participate in the Consortium and their representatives.

From a legal perpective, the Consortium is run as a group of companies. There is no consortium agreement in place at this time. From a financial perspective, each member company contributes towards the cost of a project manager. Each member company sends a representative to a monthly Consortium Meeting.

The representatives at each monthly meeting make joint decisions about the direction and priorities of the Consortium. Individual members volunteer to undertake various activities, such as update sections of a document or do some required research.

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The Consortium currently seeks European funding for the development of the framework. A number of software providers have agreed to partner with the Consortium in its application for funding.

The consortium is engaging with a number of software/service providers who are currently participating in a Proof of Concept.

The objectives are to confirm the viability of the Framework as a platform, enable the consolidation of independent modules onto one platform and use XML as a standard format for models, data, and related metadata. Based on the demonstrated progress made on the PoCs so far, the Consortium is confident of the feasibility of the Framework concept. Once the PoC process is complete, the consortium will engage with software/service providers to support the development of the Framework.

To support the concept of inter-operability, the NLMEc formed a focused Standards Working Group to develop a Pharmacometrics  Markup Language (PharML). The purpose of this working group is to develop a comprehensive Modelling & Simulation Standards document to enable the storage and system-to-system interchange of data, models and related metadata in the area of Pharmacometrics.

Yes - some of the leading Academics in the field of Pharmacometrics have agreed to collaborate actively with the Consortium and support the Standards Working Group by reviewing and critiquing the M&SML Standards document. They have offered their full support in the application for EU funding.

The NLMEc has been in discussion with CDISC to integrate M&SML into the overall CDISC program. Merging into the CDISC program will provide the NLMEc standards with affiliation to generally accepted existing standards and will allow greater integration with related standards. The Consortium was pleased to have had the opportunity to present at the CDISC Interchange in Copenhagen in April 2008.

The Consortium has had frequent dialogue with the FDA. The Consortium looks to align with and gain the support of the EMEA / FDA.