Datum objave: 20.07.2018. 18:13

Poziv za dostavljanje aplikacija u okviru programa Horizon 2020 za nove tehnologije i alate za ispitivanje ljudske imuno-biologije

TOPIC : Emerging translational safety technologies and tools for interrogating human immuno-biology

Topic identifier:IMI2-2018-15-04

Publication date:18 July 2018

Types of action:IMI2-RIA Research and Innovation action

DeadlineModel: two-stage

Opening date: 18 July 2018

Deadline: 24 October 2018 17:00:00

2nd stage Deadline: 15 May 2019 17:00:00

Time Zone : (Brussels time)

Topic Description

Specific Challenge:

For full details of the topic, please see the call text on the IMI website.

There is an urgent need to better understand inherent risks of innovative therapeutics for immuno-oncology and immuno-inflammatory disease indications including cytokine release syndrome, infection, malignancy and autoimmunity during early (non-clinical) stages of drug development. The toxicities induced by immunomodulatory therapeutics in patients are often not detected in the young healthy animal models that are routinely used for toxicology studies either due the lack of expression of appropriate drug targets/pathways or due to differences in drug target genetics, expression and functions between animal models and the intended patient populations. Thus, innovative translational safety assessment tools, technologies, models and resources are needed to facilitate the development of novel immunomodulatory drugs (either immunostimulatory or immunosuppressive).

Scope:

For full details of the topic, please see the call text on the IMI website.

This topic aims to establish a public-private consortium that will enhance translational safety assessment approaches for immunomodulatory therapeutics (spanning oncology and non-oncology indications), with an emphasis on evaluating human-relevance.

The following objectives are within the scope of this proposal:

1.development of innovative comparative (cross-species) in situ and ex vivo molecular, biochemical tools and cellular profiling of immune cells (including patient-derived clinical samples) and association with functional/phenotypic endpoints to enable;

2. establishment, refinement and validation of non-clinical tools and models to enable the development of novel classes of immunomodulatory medicines supporting in vitro-in vivo and cross-species translation.

Expected Impact:

For full details of the topic, please see the call text on the IMI website.

The action generated by this topic will ultimately help deliver safer medicines to patients via:

- provision of new tools and models to enable a better understanding of the inherent safety risks of immunomodulatory therapeutics;

- improvement of drug development processes and regulatory assessments for immunomodulatory therapeutics;

- better definition of limitations in the translatability of non-clinical test systems to patients and will also contribute to the principles of the 3Rs.

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 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

https://ec.europa.eu/research/participants/portal/desktop/en/opportunities/h2020/topics/imi2-2018-15-04.html