In-silico trials for developing and assessing biomedical products
Proposals will develop innovative scientific and technological in-silico trials solutions for product design, development and assessment of drugs and other biomedical products (including products used in nuclear medicine, bioactives, medical foods). The proposals will foresee also the proofs of concepts and methods to demonstrate the capabilities of these solutions to be used in practice. The methods will build on comprehensive biological and biomedical knowledge and advanced modelling paradigms in order to simulate the individual human physiology and physiopathology at the biological levels relevant for the biomedical product under study (e.g. at the cell level, tissue level or organism level) and the interaction with the product. The models and simulations must take into account the variability among individuals (for example, molecular pathways, cellular microenvironments, microbiota, genetics, gender, behaviours, comorbidities, development, lifestyle and environmental conditions). Virtual populations of individuals are to be built for studying the product in single diseases or in particular cases (co-morbidities; composite diseases), for example, from the patient-specific models by variations of different parameters, and must 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 must also explore and inform of the reasons for failure should the product be found not efficient or safe and will suggest improvements. To help adopt such computer simulated trials, measures for validation (human trials, animal studies, validation in cell cultures) of the in-silico trials results must also be included in the proposed projects. The benefit for human health, environment and animal welfare must be analysed and quantified. Engagement 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.
In biomedical, pharmaceutical and toxicology research, the safety and efficacy of biomedical products is ultimately tested on humans via clinical trials after prior laboratory testing in vitro and/or in vivo on animals. 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 address the safety and efficacy issues of clinical human trials, the ethical issues and the imperfection of predictions issued from laboratory and animals studies 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[[http://avicenna-isct.org/wp-content/uploads/2016/01/AvicennaRoadmapPDF-27-01-16.pdf]] on in-silico trials that are the use of individualised computer simulations in testing is currently available showing both strong interest and potential benefit of expanding the computer-modelling in drugs and other biomedical products research.
- Reducing the size and the duration of the human clinical trials
- A more effective human clinical trials design
- Leading to a significant reduction in animal testing
- Lower development costs and/or shorter time-to-market for new medical products.
- 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 for re-use in pre- and post-competitive testing of biomedical products