Research & Innovation - Participant Portal

Search

TOPIC : Microenvironment imposed signatures in tissue and liquid biopsies in immune- mediated diseases

Topic identifier: IMI2-2018-15-03
Publication date: 18 July 2018

Types of action: IMI2-RIA Research and Innovation action
DeadlineModel:
Opening date:
two-stage
18 July 2018
Deadline:
2nd stage Deadline:
24 October 2018 17:00:00
15 May 2019 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:

Biological therapies have provided significant therapeutic benefit to patients with immuno-inflammatory diseases, but many patients fail to respond completely and efficacy is lost in many patients over time. The tissue microenvironment interacts with and influences immune cells to form functional cellular niches that play a role not only in the onset and progression of disease but also in the response to therapy. Inaccessible tissue and invasive biopsy procedures have prevented in-depth interrogation of these microenvironments, resulting in a major gap in our basic understanding of immune cell action mechanisms. Therefore, how they interact with each other and their environment, and how they can be monitored and pharmacologically manipulated to better control disease, remain elusive.

This topic aims to profile tissue-specific microenvironments to improve knowledge of pathophysiology of various immune-mediated diseases (such as inflammatory bowel disease: Crohn’s disease and ulcerative colitis; and skin related diseases e.g. atopic dermatitis, cutaneous lupus, psoriasis) and identify signatures that can be correlated in body fluids (i.e. blood), ‘circulating signatures’, to inform on disease progression and to monitor treatment.

Scope:

The ultimate goal to be achieved by the consortium is to identify key organ and disease-specific signatures with correlates in body fluids that may predict disease, track progression and/or therapeutic response. These signatures will enable tailored treatment pathways to the disease mechanism and ultimately provide superior therapeutic benefit to patients.

In order to achieve the ambitious overall objective, a set of specific objectives should be addressed by the applicants.

1. Identify and evolve the state-of-the-art novel technologies to interrogate both immune and non-immune cells in target tissues at single cell level to better understand pathways regulating disease and to define tissue/disease-specific signatures, which can be correlated in peripheral blood. The technologies for the identified signature need to be adaptable and of sufficient robustness for use in clinical trial.

2. Evaluate above technologies in existing clinical retrospective cohorts as well as samples from ongoing clinical trials made accessible by both academic and industry partners.

3. Perform a bespoke, enabling clinical study to verify signatures. This will be a non-interventional prospective study, run as a collaborative effort between industry and academic partners.

Expected Impact:

In-depth characterisation of the tissue microenvironment will provide better disease understanding, which represents a significant advance in the assessment of both immune and non-immune markers in relevant diseases. The signatures, but potentially also the relevant (novel) underlying technology, will advance clinical monitoring in both clinical trials and standard patient care. These tools will allow earlier detection of disease progression or identify patients at risk and therefore will allow earlier or more tailored treatment. In clinical trials, these less invasive tools will allow better or earlier detection of treatment response, but may also allow better patient stratification and prediction of treatment response. The proposed non-interventional clinical study will allow verification of signatures and facilitate the implementation of these signatures as decision-making tools for other clinical studies. The less invasive nature of the detection of these signatures is highly attractive, as it will significantly reduce the burden to patients in clinical trials and can complement diagnosis.

The multi-partner, multi-stakeholder and cross-sector approach of this consortium will also allow for a more standardised future adoption of these signatures across industry and pave the way for regulatory approval of improved, clinically relevant tools to monitor disease progression.

Applicants should indicate how their proposal will impact the competitiveness and industrial leadership of Europe by, for example engaging suitable SMEs. In particular, the inclusion of SMEs into the consortium will maximise the opportunity for suitable technology for the identification of disease-specific signatures of the tissue microenvironment to be identified and, more importantly, ultimately implemented in multi-centre clinical trial settings under good laboratory practice (GLP) conditions.

Topic conditions and documents

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

The IMI2 JU 15th 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

3rd Amended IMI2 Annual Work Plan 2018

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

 

Submission Service

No submission system is open for this topic.

Get support

H2020 Online Manual is your guide on the procedures from proposal submission to managing your grant.

Participant Portal FAQ – Submission of proposals.

National Contact Points (NCP) - contact your NCP for further assistance in your national language(s).

Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.

Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding.

IT Helpdesk - contact the Participant Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc.

Ethics – for compliance with ethical issues, see the Online Manual and Science and Society Portal

European IPR Helpdesk assists you on intellectual property issues

CEN and CENELEC, the European Standards Organisations, advise you how to tackle standardisation in your project proposal. Contact CEN-CENELEC Research Helpdesk at research@cencenelec.eu

The European Charter for Researchers and the Code of Conduct for their recruitment

Partner Search Services help you find a partner organisation for your proposal.

IMI2 States Representative Group (SRG) – contact you SRG member for assistance.

IMI2 JU Applicants Helpdesk – contact the IMI2 Programme Office