HORIZON-JU-GH-EDCTP3-2025-04-ACCESS-02-two-stage
General information
Programme
Horizon Europe (HORIZON)
Call
Type of action
HORIZON-JU-RIA HORIZON JU Research and Innovation Actions
Type of MGA
HORIZON Action Grant Budget-Based [HORIZON-AG]
Forthcoming
Deadline model
two-stage
Planned opening date
30 January 2025
Deadline dates
20 March 2025 17:00:00 Brussels time
02 September 2025 17:00:00 Brussels timeTopic description
Expected Outcome:
Background
Novel and emerging transformative (disruptive) innovations[1] are a concept which applies to innovations that make products and services more accessible and affordable, thereby making them available to a larger population. These interventions or innovations should offer more accessible, cost-effective, and efficient solutions and be preferably beyond proof of concept. Funding under this topic will be aimed at encouraging research and innovations targeting those overlooked segments in R&D and products implementation delivering more patient-centric and context-specific delivery forms, improved functionality and new products and systems at a lower price or overall value-for-money advantage when combined with existing interventions.
Expected Outcome
This topic aims at supporting activities that contribute to one or several of the expected outcomes for this call. Proposals under this topic should aim to deliver results that are contributing to at least one of the following expected outcomes:
- Generate beyond proof of concept data with innovative ideas or inventions that will improve the uptake, adherence or implementation of preventative/treatment/diagnostic solutions;
- Progress an innovative approach that makes products and services (more) accessible and affordable to commercially unattractive markets or serves vulnerable populations in SSA;
- Progress an innovative approach that addresses community-driven and trusted demand for new or repurposed tools, including those needed by hard-to-reach communities;
- Deliver innovative technologies which can generate accelerated cross-disease solutions, including communicable disease specific solutions;
- Repurpose or extend the use of an existing preventative/treatment/diagnostic intervention.
[1] Disruptive Technologies: Catching the Wave (hbr.org)Scope:
Scope
The objective of the topic is to progress a development which meet at least one of the below:
- Innovations in R&D or products implementation focusing on new or improvement of existing medicinal products and delivery systems of new or improved medical technologies within the health systems. This may include but not limited to use of new technologies;
- Development of a new intervention or improvements of an existing intervention for age-appropriate formulations or underserved populations. This may include but not limited to development of paediatric or geriatric formulations generating data for patients with co-morbidities;
- Development of tools to improve the affordability or accessibility of preventative/ treatment/ diagnostic solutions in SSA or specific vulnerable populations as relevant. This may include but not limited to development of thermostable or humid resistant formulations, lower cost of goods, dose sparing approaches;
- Accelerate the development of delivery systems which will improve the efficacy or uptake of the preventative/treatment/diagnostic solutions in SSA. This may include but not limited to assessing different route of administration ensuring easier access, new or improved devices or equipment ensuring higher efficacy or uptake, etc;
- Leverage existing data to repurpose and expand the use of the preventative/ treatment/ diagnostic intervention. This may include but not limited to using well-established safety and pharmacological data from its use in one disease area into the infectious disease field in the scope of the Global Health EDCTP3.
Scope includes infectious diseases in scope of the Global Health EDCTP3 including HIV/AIDS. Proposalsare to generate beyond proof-of-concept data.
Out of scope: infectious diseases not in scope of the Global Health EDCTP3, potential solutions tacklingchronic diseases potentially caused by infections, and non-communicable diseases.
Applicants are invited to address the following in the proposals:
- Proposals should clearly define the challenge or unmet need they are addressing. Applicants must provide a rationale explaining why this gap has not yet been successfully addressed and how their innovation will overcome these barriers. The proposal should highlight the unique value proposition and potential transformative impact of the innovation. Special attention should be paid to how the innovation serves vulnerable or underserved populations as relevant.
- Proposals should present a comprehensive strategy for engaging communities and relevant stakeholders, most notably (local) key opinion leaders, researchers, health care professionals, policy makers, regulatory bodies, public health authorities, supply chain actors and end-users. Applicants should provide methodologies for translating research findings into public health practice and policy guidelines when relevant.
- For innovations with a technological component, applicants should outline a clear roadmap for technology transfer, ensuring that the innovation can be scaled sustained by local or regional entities. The roadmap should include productisation pathways outlining how the innovation will transition from development to practical application. Proposals should also encourage local ownership by ensuring that the necessary skills and capacity building for long-term sustainability are embedded in the project.
- Proposals should clearly describe the desired target product profile. Applicants need to concisely describe any prior relevant research findings and explain how the proposal builds on available data (including data generated in scope of earlier EDCTP programmes if available). Full details of the development milestones, including specific go/no-go criteria for the implementation of the proposed clinical trial(s) must be included, as well as specific plans for the subsequent regulatory approval process, which should aim at obtaining relevant market authorisation, and an access strategy that will allow patients in low-resource settings to access the final product.
- Where relevant, proposals should demonstrate early engagement with regulatory bodies and manufacturers to facilitate the timely translation of innovations into affordable, regionally available products. Where possible, collaboration and coordination with the Team Europe Initiative on Manufacturing and Access to Vaccines, medicines and health products (TEI-MAV+) or similar African initiative is encouraged. The applicants could show, for example, willingness to enter into technology transfer agreements with African counterparts – including the provision of patents, technical knowledge and know-how -, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.
Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from sub-Saharan African countries, including involvement of Franco/Lusophone countries, if possible. Collaboration with other international research groups with relevant experience is very much encouraged. Applicants are also reminded of the expectation of reaching out to institutions/organisations in countries with high disease burden but with relatively lower research capacities.