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Modelling & Simulation, how to improve informed decision making?
Modelling & Simulation is seen as the core technology in Model-Based Drug Development, to describe and predict the behaviour of complex diseases, biological systems and drug actions, essential to knowledge integration, and through inference providing the quantitative basis for well informed decision making. But the current path to model based knowledge integration is hampered by a lack of common tools, languages and standards for M&S, with limited or time consuming access to stored information, creating unnecessary hurdles to exploit knowledge.
Set the DDMoRe standard
The DDMoRe consortium was founded early in 2011 by a group of enthusiastic EFPIA partners, academics and SMEs across Europe. Its project aims to establish a set of standards that allow the efficient exchange and re-use of knowledge between all stakeholders - a gold standard for collaborative drug and disease modelling and simulation. The set of standards will be designed both for model and workflow encoding, as well as for storage and transfer of models and their associated metadata.

To facilitate knowledge integration for decision making DDMoRe is developing a public platform consisting of a drug and disease model repository supported by an open source interoperability framework which will provide access to existing modelling tools and those of the future. DDMoRe is also developing the Modelling Description Language (MDL), a single, unified language which will capture the definition of models together with their parameter and data attributes irrespective of the target software for performing the modelling and simulation task.

It may be ambitious; however, DDMoRe envisages that the standards and tools developed over the course of the project will become the reference for future collaborative drug and disease M&S work, serving internal and external stakeholders, regulators, academics, and the pharmaceutical industry in addressing the current bottlenecks in the drug development process.
Naturally, such an initiative can only show its potential, if it’s accompanied early by a comprehensive training programme to influence the environment in a persistent way. Training will cover the methodological and technological aspects of the project, and model based training exercises will cover a number of drug-development scenarios across a variety of therapeutic areas.

Community acceptance
It was a considerable effort to bring more than two dozen organizations into a common enterprise, with many more colleagues being actively involved in the various developments, but it is also important to notice that this initiative can only succeed on its set goals if the community not directly involved is kept informed, allowed to comment and interact.  In that regard we conducted an Advisory Board meeting with external stakeholders, to gain feedback on plans and progress.