Datum objave: 20.07.2018. 18:50

Poziv za dostavljanje aplikacija u okviru programa Horizon 2020 za razvoj mreže lijekova za tuberkolozu

TOPIC : AMR Accelerator programme Pillar B: Tuberculosis drug development network to accelerate and validate scientific discoveries and advance the R&D pipeline of new and innovative agents to address the global tuberculosis epidemic

Topic identifier:IMI2-2018-15-08

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:

There are significant scientific challenges to the discovery and development of new agents to treat and prevent AMR infections, including those caused by Gram-positive and Gram-negative bacteria, Mycobacterium tuberculosis, and non-tubercular mycobacteria (NTM). The AMR Accelerator will provide, under one operational structure, a wide-ranging series of projects that will address many of the scientific challenges in AMR.

TB is the leading cause of death from a single infectious agent worldwide. The lack of efficiency of current TB drugs is emphasised by the nearly 1.8 million annual deaths reported by World Health Organisation (WHO). Of these, 200 000 were confirmed cases of drug resistant TB, although real estimates could be much higher. As expressed by the United Nations (UN), a massive scale-up and a dynamic, global, multi-sectoral approach is needed if the global target of eradicating tuberculosis by 2030 is to be met. At present, there is a strong consensus both in private and public research sectors working on TB that having a large number of new drug candidates, which are ready to enter into clinical combination studies, is the most critical step to achieving this aspirational goal that will have a tremendous impact on global health.

Scope:

The TB drug development Network (TBDDN), pillar B of the IMI2 AMR Accelerator programme, will function as a platform based on the principles of open innovation to advance discovery, preclinical and early clinical projects in the field of TB and MDR-TB. One of the objectives of the TBDDN is to become a worldwide reference for the development of novel candidates and regimens by sharing results generated by partners and peers from small and medium-sized enterprises (SMEs), public institutions and pharmaceutical companies

Specifically, the scope of this action is to: (1) coordinate, profile and progress the portfolio of anti-TB compounds existing within the industry consortium (EFPIA companies and Associated Partners) from the advanced lead stage through Phase 1 (candidates ready to enter into Ph-2 clinical studies); (2) identify preferred drug partners for preclinical combination studies that will facilitate the design of combination regimens consisting of new TB drugs with an indication for the treatment of any form, including MDR, of TB (pan-TB regimen); (3) create additional tools and technologies to progress anti-TB compounds, and to provide learnings derived from the analysis of shared anti-TB clinical trial data; (4) develop new alternative anti-tubercular drugs (host-defence or virulence approaches); (5) act as an interface with stakeholders in the TB field and explore synergies and collaboration with the action resulting from IMI2 JU Call 15, topic 7 and potential TB-focused actions from IMI2 JU Call 16 as well as other AMR initiatives.

Expected Impact:

The impact of the TBDDN will help attain the UN 2030 objective by: (1) providing new tools and understandings to progress TB science for the discovery of new preclinical candidates and novel combination regimens across the TB R&D landscape; (2) contributing to the development of a vibrant TB research environment in the EU and strengthening the competitiveness and industrial leadership of Europe; (3) contributing to EU’s ambition of being a ‘best practice region’ for addressing AMR; (4) enabling the progression of potential new treatment solutions for TB patients worldwide using a preferential pricing approach for low- and middle-income countries, with the intent to improve the quality of life and life expectation of TB patients; (5) strengthening interaction of TB R&D stakeholders from across the EU and globally.

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/imi2-2018-15-08.html