In biomedical, pharmaceutical and toxicology research, the safety and efficacy of biomedical products are ultimately tested on humans via clinical trials after prior laboratory testing in vitro and/or in vivo on animal models. The complete development chain of a new biomedical product and its introduction to the market is very long and expensive. Alternative methodologies to reduce the animal and human testing are needed in order to answer both the ethical issues and the imperfection of predictions issued from laboratory and animals when applied to humans. Computer modelling and simulation is currently used to a certain degree in pharmacokinetics, pharmacodynamics or mechanical simulations (e.g. fluid dynamics simulations). A research and technological roadmap for “in-silico clinical trials” is currently being developed. Preliminary results show the strong interest/potential benefit to expand the computer-modelling in drugs and other biomedical products including bioactives, medical foods research by developing new ways for in-silico testing.
Proposals will develop innovative in-silico trials for designing, developing and assessing drugs, radiation and other biomedical and bioactive products. They will build on comprehensive biological and biomedical knowledge management and advanced modelling paradigms in order to be able to simulate the individual human physiology and physiopathology at the biological levels relevant for the biomedical product under study (at the cell level, tissue level or organism level) and the interaction with the product, thus taking into account the variability among individuals (for example, molecular pathways, cellular microenvironments, microbiota, genetics, gender characteristics, behaviours, comorbidities, development, diet). Virtual populations of individual patients will be built for simple or composite diseases, for example, from the patient-specific models by variations of different parameters and will allow simulating the action of the products and predicting the treatments outcomes in order to develop a personalised medicine approach. The proposed in-silico trials will be the result of a multidisciplinary effort (e.g. within the fields of computational modelling, systems biology, tissue mechanics, biology, pharmaceutics, medicine) and will also explore and inform of the reasons of fails and suggest improvements. To help establishing such computer simulated trials, measures for validation (human trials, animal studies, validation in cell cultures) of the in-silico models shall also be included in the proposed projects. The benefit for human health, environment and animal welfare should be analysed and quantified. Contact with regulators and consideration of the regulatory framework issues are highly recommended.
The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
- Reducing the size and the duration of the human clinical trials
- A more effective human clinical trials design
- Leading to a significant reduction of animal testing
- Innovative medical products on the market with lower development costs and/or shorter time-to-market
- Improving prediction of human risks for new biomedical products including medical foods
- Improving drug repositioning
- Potential of re-use of the developed in-silico models in the chemical testing.
- Setting standards for in-silico trials.
- Providing libraries of virtual patients that can be re-used in pre- and post-competitive testing of biomedical products
19 miljoen euro (indicatief)
Research & Innovation action (RIA): At least three legal entities. Each of the three must be established in a different EU Member State or Horizon 2020 associated country. All three legal entities must be independent of each other.
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