Model informed-drug development (MIDD) is acknowledged as a vital approach in understanding drug-related benefits and risks. At the core of MIDD lies modelling and simulation (M&S), a technology providing the basis for informed, quantitative decision-making. M&S facilitates the continuous integration of information related to a drug or disease into constantly evolving mathematical models that are capable of describing and predicting the behaviour of systems. As such, M&S helps researchers, regulators and public health care bodies to answer the questions they face when bringing drugs to patients. The full adoption of MIDD is hindered by a lack of common tools, languages and ontologies, which often leads to inefficient reuse of data and duplication of effort by academic, industrial and regulatory stakeholders. IMI’s DDMoRe project set out to address that challenge.
The project’s main achievement was the development of a repository for clinical trial data models, the largest of its kind to date, which members of the modelling community can use to store and access an assortment of computational models. The repository is publicly available and contains more than 120 models so far.
As different models are executed in different software programmes, this may cause model structures to be very different too. In order to address this, DDMoRe also designed a set of common standards for developing, describing and storing models. These standards are now also available for everyone to use and are facilitating model sharing and communication between researchers.
An interoperability framework
Additionally, the project developed an interoperability framework in which scientists can perform a modelling exercise. The framework is free for anyone to download and enables scientists to re-run models, thereby replicating each other’s work. The framework uses new standards and connectors for many commonly used programming tools and languages. As such, the interoperability framework provides a consistent environment in which researchers can work, using modelling tools they know, while opening up their work to others through a standard language for describing models.
Training programme and other achievements
Other important project achievements include:
- The development of computer models in different therapeutic areas such as oncology and diabetes;
- a training programme to support the adoption of the standards, repository and the interoperability framework;
- new tools which enable scientists to build and evaluate models and use them for specific purposes, such as optimising clinical trials.
For the benefit of industry, academia and SMEs
Thanks to their participation in this project, the academic community gained access and insights into industry bottlenecks, which helped them to develop methods and models which are useful for drug development. Additionally, as part of the project, many PhD students received invaluable training and access to industry, and many of them landed jobs in the industry.
When it comes to the industry, model-informed approaches have become very important in designing clinical trials and other stages of drug development. The interoperability framework, standards and model repository have already and will further enhance the way industry implements model-informed drug development projects.
SMEs within the project benefited from expanding their customer base and gaining insights into their customers’ needs. Additionally, three SME spin-offs were created as a direct result of the project.
Before the project ended, the DDMoRe project partners set up a foundation, which is continuing some of the work. The foundation is now the primary caretaker of all important project outputs including the repository, the interoperability framework and the data standards.
Read the interview with project coordinators