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TOPIC : Targeted immune intervention for the management of non-response and relapse

Topic identifier: IMI2-2018-14-01
Publication date: 15 March 2018

Types of action: IMI2-RIA Research and Innovation action
DeadlineModel:
Opening date:
two-stage
15 March 2018
Deadline:
2nd stage Deadline:
14 June 2018 17:00:00
11 December 2018 17:00:00

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

For full details of the topic, please refer to the call text

A large number of patients suffering from immune-mediated diseases fail to respond well or at all to current standard-of-care treatments or quickly relapse while on, or following, treatment. Currently, one of the most challenging questions in human immunology is to understand whether it is possible to accurately predict which patients will fail to respond to treatment, which patients will sustain a longer term treatment response, or which patients will suddenly flare up during periods of disease control. At present, there is a lack of a mechanistic understanding of non-response combined with an absence of biomarkers to predict clinical responses. Detailed analysis of clinical samples before and during treatment would enable breakthrough discoveries on the mechanisms, the clinical management of non-response, and the identification of patients prone to relapse. The topic addresses the challenge of translating insights from treatment non-response and disease exacerbation into new treatment paradigms at the individual patient level.

Scope:

For full details of the topic, please refer to the call text

The action generated by this topic aims to provide better control of immune-mediated diseases, in particular:

  • characterise human immune-mediated diseases;
  • profile and analyse immune cells obtained from non-blood tissues;
  • discover individual disease and cross-disease biomarkers predictive of treatment response, non-response, relapse and flare-up;
  • perform early phase clinical trials (e.g. enriched study populations for certain molecular pathways; adaptive and basket trial designs etc.) and identify potential novel patient-centric treatment approaches. The focus will be on patients from well-characterised immune-mediated diseases (SLE, RA, MS, UC, CD, Asthma and COPD).

The ultimate goal is to develop a translational research platform that will improve patient management and personalised treatment by identification/validation of predictive biomarkers for non-response, rapid progression and remission. This would lead to an increased likelihood of treatment success with decreased costs for both patients & society and pharmaceutical companies.

Expected Impact:

For full details of the topic, please refer to the call text

The proposed precision-immunology approach is expected to achieve a reduction in failure rates in early clinical trials and to provide access for novel therapeutics to the most appropriate patient populations. Insights gained from this study will inform the design of platform trials for single indications with multiple mechanisms, further supporting precision medicine approaches. In addition, a more accurate definition of subcategories of auto-immune disorders and their responses to particular therapies on an individual patient level will fuel novel target discovery, decrease phase 2 proof of concept (POC) attrition, and decrease the costs of development to achieve regulatory approval and appropriate reimbursement.

To this end, the action generated by this topic would be a powerful and unique instrument, with the capability to significantly move forward the development of a consensus on the best treatment options for defined subgroups of patients with high unmet medical needs, such as patients suffering from immune-mediated diseases. Furthermore, beyond advancing our understanding of the disease, informing personalised approaches to patient care, and delivering potential novel treatments, the topic has the potential to establish Europe in a leadership position in this field of biology and medicine.

Small and medium-sized enterprises (SMEs) can be of great benefit to IMI2 JU projects. Their involvement in the action might offer a complementary perspective to industry and academia, and help deliver the long-term impact of the action.

Topic conditions and documents

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

The IMI2 JU 14th Call for proposals topics text as well as the Call Conditions are available here

The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information : 

 

1.   Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.

 

2.   Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.

 

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

 

3.   Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.

 

4.   Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.

Signature of grant agreements: maximum 3 months from the date of informing successful applicants.

 

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

IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):

Proposal templates are available after entering the submission tool

Standard evaluation form

IMI2 Model Grant Agreement

Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !

 

6.   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 H2020 main 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.

 

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

7. Additional documents:

Summary of the most relevant provisions for participating in IMI2 actions

IMI2 Amended Annual Work Plan 2018

IMI2 JU Annotated Model Grant Agreement

IMI2 Regulators Guidance tool for researchers

IMI JU derogation to H2020 Rules for Participation  

Horizon 2020 Rules for Participation 

Horizon 2020 Regulation of Establishment

Horizon 2020 Specific Programme

 

Additional documents

  • IMI2 Call 14 stage 1 - Flash Call Info Report en

Submission Service

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