Proposals will develop innovative scientific and technological computer modelling solutions for testing medicines and/or medical devices. The proposed computer modelling solutions will be the result of a multidisciplinary effort (e.g. within the fields of computational modelling, chemo/bio-informatics, systems biology, pharmacology, -omics (genomics, epigenomics, metabolomics), tissue mechanics, biology, pharmaceutics, medicine, physiology, toxicology, social science aspects such as gender) and should also explore and inform of the reasons for failure should the drug or medical device be found not efficient or safe and will suggest improvements. To help adopt such in-silico methods, measures for validation (human trials, animal studies, in vivo and in vitro validation, including the use of biobanks if appropriate) of the in-silico results should be included in the proposed projects. The benefit for human health, environment and animal welfare should be analysed and quantified. Engagement with regulators and consideration of the regulatory framework issues for computer simulations are highly recommended. Participation of SMEs is encouraged.
The Commission considers that proposals requesting a contribution from the EU of between EUR 6 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
The development of medical devices and pharmaceutical products are associated with high costs. A new pharmaceutical product and its introduction into the market is estimated to cost today over 2 billion EUR, from which nearly 75% is spent at the late stages of the drug development process in the various phases of the clinical trials.
As biomedical knowledge increases and bioinformatics capability likewise grows, there is hope that greater predictive power may be obtained from individualised computer simulations used in in-silico medicine research, such as predictive toxicology and pharmacokinetics.
The adoption of individualised computer models and simulations to develop and assess drugs and devices , their translation into the clinic and penetration on the market of ICT solutions, depend on the trust of users (healthcare professionals and patients), the industry and investors and the competent authorities and regulatory bodies. The users need proofs of validation in the real clinical contexts.
The specific challenge of this call is accelerating the uptake of individualised computer simulations in the regulatory evaluation of medicines and/or medical devices to become closer to the market., Applicants will provide proofs of validation of computer modelling solutions that gain the trust of regulatory bodies for innovation, in order to, in collaboration with academic and industrial experts, develop the framework of standards, protocols and shared resources required to evaluate the safety and the efficacy of medical devices and/or medicines at the end of the drug development process.
The proposal should provide appropriate indicators to measure its progress and specific impact in the following areas by contributing to:
- Accelerating the adoption of computer simulations for testing medicines and/or medical devices, their translation into the clinic and the market.
- Increasing the trust of users (healthcare professionals and patients), investors and stakeholders at industry and academia to adopt computer simulations for testing medicines or medical devices as a substitution or complement of current clinical trials when appropriate.
- Contributing to redesigning current drug clinical trials by integrating in-silico methods for testing medicines or medical devices and creating a unique, digitised, personalised testing environment.
- Engagement with regulators and consideration of the regulatory framework for computer modelling solutions.
- Contributing to reducing the size and the duration of the human clinical trials and/or contributing to significantly reducing animal testing in clinical trials.
- Contributing to increased efficacy and patient safety in clinical trials.
- Contributing to reducing development costs and/or shorter time-to-market for new drugs or new medical devices.
- Contributing to setting standards for computer modelling solutions for testing.
- Contributing to the European Cloud Initiative, notably by providing open, reusable data and in silico models for clinical trials.