New drugs and vaccines for priority pathogens in antimicrobial resistance 2019

8th September 2019

Call budget: € 18 million

Funding level: 100% of eligible costs

Open date: 3 June 2019, 00:00

Close date: 7 November 2019, 17:00

Description

Background
Antimicrobials are designed to kill or stop the growth of disease-causing pathogens, but many of them have become increasingly ineffective due to emerging resistance by the targeted bacteria, viruses, protozoa or fungi. Selection pressure naturally leads to the emergence of resistance whenever microbes are exposed to agents who are meant to kill them or inhibit their growth, and the potential spreading resistance can take days or years. Pathogens can also develop resistance to multiple agents, and as a result, very hard to control multi-drug resistant infections emerge and spread.

To guide and promote research and development of new antibiotics and vaccines, the WHO has established a list of antibiotic-resistant priority pathogens.* While new or improved antimicrobials is an essential tool to combat resistant pathogens at the patient level, the first line of defense for containing the spread of antimicrobial resistance (AMR) at the population level is an effective system to diagnose, detect, collect and integrate information about antimicrobial resistance on a large scale. In the context of large programmes to address AMR, isolated efforts will have very limited impact, and only coordinated actions will lead to a successful response against the emergence and spread of AMR.

Scope
The purpose of this call for proposals is to provide funding for clinical trials to be conducted in sub-Saharan Africa which aim to develop new or improved medicinal products (drugs and vaccines) or combinations thereof against pathogens from the WHO priority list that also fall within the scope of the EDCTP2 programme, specifically Campylobacter, Salmonella, Streptococcus pneumoniae, and Mycobacterium tuberculosis.

Proposals should include at least one clinical trial (phase I to IV) in sub-Saharan Africa. Proposals should clearly define the activities and mechanisms to be used within the project, including details of any collaboration with public authorities, international organisations or commercial partnerships that will be established in order to achieve the expected impact.

The proposal must include full details of the product development milestones including specific go/no-go criteria for the proposed clinical trial(s) as well as specific plans for the subsequent regulatory approval process.

Projects should include a detailed exploitation plan that describes how project results will be translated into products, policy or practice. The EDCTP Association considers that proposals for actions of between 36- to 60-months duration would allow this specific challenge to be addressed appropriately.

Expected impact
Projects funded under this call for proposals should contribute towards national and international plans for containment of antimicrobial resistance.

Eligibility
A proposal/application will only be considered eligible if:

  1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted;
  2. it complies with the eligibility conditions for participation set out below, depending on the type of action:
    • At least three legal entities. Two of the legal entities shall be established in two different Participating States (European Partner States)** and one of the legal entities must be established in a sub-Saharan African*** country. All three legal entities must be independent of each other.
    • ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.
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