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TOPIC : New anti-infective agents for prevention and/or treatment of neglected infectious diseases (NID)

Topic identifier: SC1-BHC-15-2018
Publication date: 27 October 2017

Types of action: RIA Research and Innovation action
DeadlineModel:
Opening date:
two-stage
07 November 2017
Deadline:
2nd stage Deadline:
06 February 2018 17:00:00
04 September 2018 17:00:00

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

Neglected Infectious Diseases (NIDs) diseases are responsible for a significant health and socioeconomic burden in large parts of the world, particularly in resource-poor countries, however some (e.g. leishmaniasis, Chagas disease) are increasingly becoming a concern for Europe too, driven by factors like the climate change and globalization. Despite a significant effort to develop new drugs to treat these diseases over the past 10 years, existing therapies suffer from various shortcomings, namely, a high degree of toxicity and unwanted effects, as well as treatment regimens often lengthy or parenteral that discourage compliance and increase the emergence of resistance. Vaccines can also be a major tool for the control of NIDs, particularly given the limitations of mass drug administration strategies, but currently the only major NIDs for which licensed vaccines exist are rabies and dengue. Development of new, more effective, safe and affordable treatments and vaccines for NIDs is therefore an urgent need.

In the last few years, increased awareness and funding for NIDs has resulted in the identification and preclinical development of several treatment and vaccine candidates against various NIDs. However, the typical NIDs 'market failure' (i.e. high risk and low potential return) discourages the uptake and costly further development of these candidates by pharmaceutical and biotechnology companies. Targeted public funding is therefore necessary to bridge the gap between preclinical and clinical development, and help advance existing candidates along the development pipeline.

Scope:

The topic bridges the gap between preclinical and early clinical development of drugs and/or vaccines against neglected bacterial and parasitic diseases[1]. Therefore, the proposed actions should focus on late preclinical (e.g. validation in animal models, toxicology, Good Manufacturing Practices (GMP) production, preparation of Investigational Medicinal Product Dossier) and early clinical (up to phase 1) development of already existing lead drug and vaccine candidates. Multidisciplinary platforms bringing together academic and industry research teams, from European and disease-endemic countries, with the capacity to exploit existing experience and propose innovative solutions addressing several relevant pathogens are particularly encouraged. Sex and gender differences should be taken into account where relevant.

The downstream constraints of candidates for the effective deployment and uptake by limited-resources public health systems should be taken into account by the proposed action:

  • It should address the following key elements of the target-product profile (TPP): suitability, acceptability, adaptability of the intervention to be developed for different population groups, including particularly vulnerable ones (e.g. women and children), served by under-resourced health systems.
  • It should also address issues that permeate and often impede access such as: optimal route and dosing or immunization regime, up-scaling of manufacturing, registration and pre-qualification, distribution and field-deployment logistics (e.g. storing temperatures), and the predicted cost per patient of the final product.
  • Ultimately, the proposed action should include a clear pathway through the different necessary steps (research, manufacturing, regulatory approvals and licensing, IP management, pricing etc.) in order to allow uptake by health systems in limited-resource settings.

Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals shall include at least one participant from disease-endemic countries.

Please note that this topic is part of the lump sum funding pilot scheme. Funding for grants awarded under this topic will take the form of lump sums as defined in Commission Decision. Details of the lump sum funding pilot scheme are published on the Participant Portal together with the specific Model Grant Agreement for Lump Sums applicable.

The Commission considers that proposals requesting a contribution from the EU of between EUR 5 and 10 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected Impact:
  • Increase the number and quality of treatment and vaccine candidates for neglected infectious diseases appropriate for implementation and uptake by health systems with limited resources.
  • Reduce the NIDs disease burden and their social and economic consequences, and thus contribute to achieving the United Nation's Sustainable Development Goals 1 (No Poverty), 3 (Good Health and Well-being), 5 (Gender Equality), 10 (Reduced Inequalities) and 13 (Climate Change).
  • Strengthen the pipeline of products available to proceed into further development and clinical testing and, if appropriate, within the context of the European and Developing Countries Clinical Trials Partnership (EDCTP2).
Cross-cutting Priorities:

Socio-economic science and humanities
International cooperation
Gender

[1]For the purpose of this call, eligible neglected diseases are: childhood diarrhoeal diseases, kinetoplastid diseases (human African Trypanosomiasis, leishmaniasis, Chagas disease) and helminth (Schistosomiasis, soil-transmitted helminthiases, food-borne trematodiases, filariasis, Onchocerchiasis, taeniasis/cysticercosis, dracunculiasis, echinococcosis) diseases, as well as bacterial diseases like Buruli ulcer, leprosy, yaws and mycetoma. Neglected viral diseases are specifically excluded from this topic.

Topic conditions and documents

1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.

2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme. 

Due to the specific challenge of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals shall include at least one participant from disease-endemic countries.

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

The thresholds for each criterion in the second stage of a two-stage process will be 4, 4 and 3. The cumulative threshold will be 12.

3. Evaluation:

  • Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
  • Submission and evaluation processes are described in the Online Manual.

4. Indicative time for evaluation and grant agreements:

Information on the outcome of evaluation (two-stage call):

For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.

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

Research and Innovation Action:

Specific provisions and funding rates
Standard proposal template
Standard evaluation form
Lump sum pilot MGA - Multi-Beneficiary
Lump sum pilot - Methodology
Annotated Grant Agreement

Essential information for clinical studies

6. Additional provisions:

Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.

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

7. 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 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.

8. Additional documents:

Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020

Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme

Submission Service

To access the Electronic Submission Service of the topic, please select the type of action that is most relevant to your proposal from the list below and click on the 'Start Submission' button. You will then be asked to confirm your choice of the type of action and topic, as these cannot be changed in the submission system. Upon confirmation you will be linked to the correct entry point.

To access existing draft proposals for this topic, please login to the Participant Portal and select the My Proposals page of the My Area section.

Type of Action Research and Innovation action [RIA]
Topic New anti-infective agents for prevention and/or treatment of neglected infectious diseases (NID) - SC1-BHC-15-2018
Guidance on proposal submission: H2020 online manual
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