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TOPIC : Systems approaches for the discovery of combinatorial therapies for complex disorders

Topic identifier: SC1-BHC-02-2019
Publication date: 27 October 2017

Types of action: RIA Research and Innovation action
DeadlineModel:
Planned opening date:
two-stage
26 July 2018
Deadline:
2nd stage Deadline:
02 October 2018 17:00:00
16 April 2019 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Societal Challenges
Work Programme Year: H2020-2018-2020
Topic Description
Specific Challenge:

Many complex disorders pose a challenge to identify the most effective therapeutic interventions because current therapies often target specific aspects of a disease, without achieving complete control or the best possible results for patients. Due to the multiple causes of such diseases and the heterogeneity between patients, approaches directed at single targets have had limited efficacy, overlooking important factors involved in disease pathophysiology. Hence, a promising therapeutic approach to meet this challenge is to combine different therapies, while increasing therapeutic efficacy in a cost-effective manner.

Scope:

Research should aim to understand at systems level the pathophysiology of a disorder in groups of patients responding well or poorly to particular therapies and further develop combinatorial therapies tailored to the needs of individuals or stratified patient groups.

Projects should focus on already available and/or authorised therapies and have access to standardized biobank samples derived from retrospective or currently running clinical studies. These patient samples should be re-analysed with modern high-throughput technologies. The existing and newly produced data should be integrated using systems approaches, which could combine sub-cellular/cellular and/or organ level in-silico models and network analysis as appropriate, and used to build more sophisticated computational frameworks to predict patient responses to combinatorial therapies. These predictions should be validated in pre-clinical and clinical studies[1] taking into account sex and gender differences. Funding of late stage clinical trials is not within the scope of this topic.

Applicants should include a thorough data management plan for transnational data sharing to enable the computational analysis and it is strongly recommended to adhere to the state-of-the-art international standards and to the general concepts of the FAIR[2] principles.

The topic invites proposals in complex disorders of high prevalence and of a high economic burden (rare diseases are excluded). SME participation is strongly encouraged.

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:
  • New concepts of combinatorial therapies for complex disorders tailored to the needs of individuals or stratified patient groups.
  • Improved efficacy and take-up in the clinical setting in comparison to established therapeutic interventions.
  • Enable the development of personalised medicine.
  • Increased research & innovation opportunities in this industry intensive field, particularly for SMEs.
Delegation Exception Footnote:

https://www.nature.com/scitable/topicpage/complex-diseases-research-and-applications-748

Cross-cutting Priorities:

Gender

[1]http://ec.europa.eu/research/participants/data/ref/h2020/other/legal/templ/h2020_tmpl-clinical-studies_en.pdf

[2]https://www.force11.org/group/fairgroup/fairprinciples

Topic conditions and documents

1. Eligible countries: described in Annex A of the Work Programme.
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. See the information in the Online Manual.

2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.

Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.

The thresholds for each criterion in the second stage of a two-stage process will be 4, 4 and 3. The cumulative threshold will be 12.

3. Evaluation:

  • Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
  • Submission and evaluation processes are described in the Online Manual.

4. Indicative time for evaluation and grant agreements:

Information on the outcome of evaluation (two-stage call):

For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.

5. Proposal templates, evaluation forms and model grant agreements (MGA):

Research and Innovation Action:

Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement

Essential information for clinical studies

6. Additional provisions:

Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.

Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.

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. See the Online Manual.

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:

Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020

Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme

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