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TOPIC : In-silico trials for developing and assessing biomedical products

Topic identifier: SC1-PM-16-2017
Publication date: 14 October 2015

Types of action: RIA Research and Innovation action
DeadlineModel:
Opening date:
single-stage
08 November 2016
Deadline: 14 March 2017 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Societal Challenges
Work Programme Year: H2020-2016-2017
Topic Updates
  • 12 January 2017 14:15

    As of 1st January 2017, Switzerland is associated to the entire H2020 programme. In consequence, it is now also associated to this topic. In a nutshell this means that Swiss partners in a proposal are now on an equal footing with partners from EU Member States or other Associated Countries. For the details, please read this note.

Topic Description
Specific Challenge:

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[1] 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.

Scope:

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.

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 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
Cross-cutting Priorities:

Gender

[1]http://avicenna-isct.org/wp-content/uploads/2016/01/AvicennaRoadmapPDF-27-01-16.pdf

Topic conditions and documents

Please read carefully all provisions below before the preparation of your application.
 

  1. 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 some Horizon 2020 topics (to check funding conditions, follow the links to Australia, BrazilCanada, China, Hong Kong & Macau, IndiaJapan, Republic of Korea, Mexico, Russia, Taiwan, USA*).
    *Note that US participants in projects under the Horizon 2020 "Health, Demographic Change and Wellbeing" Societal Challenge are automatically eligible for EU-funding according to the provisions in the relevant work programme

     
  2. 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. Evaluation

    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 exceptions: 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

          
  4. 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.

     
  5. 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
    H2020 General MGA -Multi-Beneficiary
    Annotated Grant Agreement

    Essential information for clinical studies

     
  6. Additional provisions:

    Horizon 2020 budget flexibility

    Classified information

     
  7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.

    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.

    Open access to research data
    The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.

    Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.

    Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.

    - Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs.

    - Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.

    The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.


     

  8. Additional documents:

    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

 

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