TOPIC : In-silico trials for developing and assessing biomedical products
|Publication date:||14 October 2015|
|Types of action:||RIA Research and Innovation action|
|DeadlineModel: Planned opening date:||single-stage 08 November 2016||Deadline:||14 March 2017 17:00:00|
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
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.Scope:
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.Expected Impact:
- 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
Topic conditions and documents
Please read carefully all provisions below before the preparation of your application.
- List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
Note also that a number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects (follow the links to China, Japan, Republic of Korea, Mexico, Russia, Taiwan, USA).
- Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme.
Proposal page limits and layout: Please refer to Part B of the standard proposal template.
3.1 Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme, with the following expections:
The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
3.2 Submission and evaluation process: Guide to the submission and evaluation process
- Indicative timetable for evaluation and grant agreement:
Information on the outcome of single-stage evaluation: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
- Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Specific evaluation form (Document not available yet)
H2020 General MGA -Multi-Beneficiary
Annotated Grant Agreement
- Additional provisions:
Horizon 2020 budget flexibility
- Open access must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
- Additional documents:
H2020 Work Programme 2016-17: Introduction
H2020 Work Programme 2016-17: Health, demographic change and wellbeing
H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation
H2020 Work Programme 2016-17: General Annexes
Legal basis: Horizon 2020 - Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
The submission system is planned to be opened on the date stated on the topic header.
H2020 Online Manual your online guide on the procedures from proposal submission to managing your grant.
Participant Portal FAQ – Submission of proposals.
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Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
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CEN and CENELEC, the European Standards Organisations, advise you how to tackle standardisation in your project proposal. Contact CEN-CENELEC Research Helpdesk at firstname.lastname@example.org.
The European Charter for Researchers and the Code of Conduct for their recruitment
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