Innovating Works

H2020

Cerrada
HORIZON-JU-GH-EDCTP3-2023-02-0...
Advancing point-of-care diagnostics to the market
ExpectedOutcome:Proposal under this topic should aim to deliver results that are directed, tailored towards, and contributing to all of the following expected outcomes:
Sólo fondo perdido 0 €
Europeo
Esta convocatoria está cerrada Esta línea ya está cerrada por lo que no puedes aplicar. Cerró el pasado día 28-09-2023.
Por suerte, hemos conseguido la lista de proyectos financiados!
Presentación: Consorcio Consorcio: Esta ayuda está diseñada para aplicar a ella en formato consorcio..
Esta ayuda financia Proyectos:

ExpectedOutcome:Proposal under this topic should aim to deliver results that are directed, tailored towards, and contributing to all of the following expected outcomes:

Health care providers and professionals have access to novel or improved point-of-care diagnostic (POC) devices that are suited to rapidly detect infectious diseases of relevance in sub-Saharan Africa (SSA) and within the scope of the Global Health EDCTP3 Scientific Research and Innovation Agenda.A diverse and robust pipeline of in vitro diagnostics is available, increasing options for clinical deployment, also in case of an infectious diseases outbreak with epidemic or pandemic potential, that can reach the most vulnerable populations.Health authorities and health care systems have access to health data and evidence to better develop and implement informed health policies and improved clinical surveillance of infectious diseases in SSA.
Scope:POC diagnostic tests that are easy to use, affordable and can rapidly diagnose diseases will lead to more timely treatment and thereby reduce mortality, morbidity, and transmission of diseases. POC diagnostic tests should improve the quality of healthcare f... ver más

ExpectedOutcome:Proposal under this topic should aim to deliver results that are directed, tailored towards, and contributing to all of the following expected outcomes:

Health care providers and professionals have access to novel or improved point-of-care diagnostic (POC) devices that are suited to rapidly detect infectious diseases of relevance in sub-Saharan Africa (SSA) and within the scope of the Global Health EDCTP3 Scientific Research and Innovation Agenda.A diverse and robust pipeline of in vitro diagnostics is available, increasing options for clinical deployment, also in case of an infectious diseases outbreak with epidemic or pandemic potential, that can reach the most vulnerable populations.Health authorities and health care systems have access to health data and evidence to better develop and implement informed health policies and improved clinical surveillance of infectious diseases in SSA.
Scope:POC diagnostic tests that are easy to use, affordable and can rapidly diagnose diseases will lead to more timely treatment and thereby reduce mortality, morbidity, and transmission of diseases. POC diagnostic tests should improve the quality of healthcare for resource-poor communities in developing countries, where the burden of disease is the highest. A diagnostics gap for many diseases affecting SSA still exists and needs to be closed urgently to contribute the global and national disease elimination targets.

Hence, proposals submitted under this topic should implement clinical studies that lead to market authorisation of the relevant POC diagnostic test. The POC diagnostic test device should be aimed at detection of diseases that currently lack POC diagnosis tests or where POC diagnostics are inadequate. Tests that can in the same specimen simultaneously and rapidly detect and thereby distinguish a wide range of diseases for improved clinical decision-making are encouraged (e.g., distinction between bacterial versus viral pathogens). The POC diagnostic tools are expected to be affordable and suitable for use in SSA countries. POC diagnostics for all diseases in scope of the current Global Health EDCTP3 programme[1], for example antimicrobial resistance and emerging diseases, are included in this call (exception is Ebola Virus disease, covered under topic HORIZON-JU-GH-EDCTP3-2023-01-04).

Proposals should address all of the following areas:

Clinical performance studies in several sites across SSA of POC diagnostics that are of high technology readiness level to achieve regulatory approval and market launch (i.e., CE mark); post-market surveillance studies are excluded from this call and are covered by other initiatives such as the African Health Diagnostics Platform[2];Studies need to provide evidence-based practice for the POC diagnostic test especially in terms of the ability to decide on treatment options after diagnosis and improving disease outcome; the possibility of the POC diagnostic to be deployed in the field, its usability by primary care and community health care workers in resource-limited patient communities should be especially considered;Inclusion of a clear regulatory path to market to ensure future compliance with the legal requirements; early engagement with regulatory authorities is expected;Product development plans for translation from prototype to industrial design, to implementation and sustainability of the innovation should be provided, also including a plan for the process of “sample to result to the use of result & treatment option” and how to report data & results (e.g., via mobile health/portable technology);Where available and relevant, World Health Organization target product profiles for diagnostics need to be addressed[3];Involvement of industry, notably of small and medium-sized enterprises (SMEs), especially African SMEs, is expected. Involvement of African SMEs is highly encouraged to contribute to developing the African industry and access to health products.[4] Proposals submitted under this topic are encouraged to consider innovative diagnostics sampling methods or samples bringing a significant improvement, such as less invasive sampling methods and self-testing at home. The POC diagnostic should allow for easy storage, such as at room temperature. Consideration of environmental friendliness of diagnostic tests would be advantageous. Transmission and economic modelling to examine the impact of the POC diagnostic assay on performance of long-term health outcomes and cost-effectiveness could be envisioned. Relevant partnerships with local and international organisation to create solutions for improved deployment of diagnostics for vulnerable populations in low-resource settings could be sought.

In addition, where relevant, the link between the diagnostic devices to relevant infectious disease surveillance strategies to inform public health authorities and advise public health policies should be made. This can include monitoring the impact of relevant POCs on the use of antibiotics.

For all proposed research activities, attention should be paid to critical social factors such as sex, gender, age, socio-economic factors, ethnicity/migration, and disability. Populations for POC diagnostic test development and evaluation of the POC diagnostic test performance and appropriateness should also include vulnerable populations, including children, pregnant women, people with co-infections and co-morbidities, older people, and people living in hard-to-reach communities. Rapid feedback from end-users through community engagement on the performance and acceptance of the technologies and their most effective use in endemic settings is expected.

Applicants need to concisely describe any prior research findings and explain how the proposal builds on these results. Building on relevant results from projects supported under previous EDCTP programmes is encouraged.

Proposals are expected to come from research consortia with a strong representation of institutions and researchers from African countries, including involvement of franco/lusophone countries where possible and relevant.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Global Health EDCTP3 Joint Undertaking may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.

[1]https://commission.europa.eu/system/files/2022-01/ec_rtd_edctp3-sria-2022.pdf

[2]AHDP - AFRICAN HEALTH DIAGNOSTICS PLATFORM (eib.org)

[3]The list of target product profiles that have been developed by the World Health Organization can be accessed at: https://www.who.int/observatories/global-observatory-on-health-research-and-development/analyses-and-syntheses/target-product-profile/links-to-who-tpps-and-ppcs; please note that this list includes target product profiles for different types of healthcare interventions.

[4]The Team Europe initiative (TEI) on Manufacturing and Access to Vaccines, Medicines, and Health Technologies (MAV+) https://europa.eu/capacity4dev/tei-jp-tracker/tei/manufacturing-and-access-vaccines-medicines-and-health-technology-products-africa


Expected Impact:Expected impacts of the calls under the 2023 work programme of the Global Health EDCTP3 JU

Activities funded under the 2023 calls for proposals should contribute to:

Achieve SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African countries;Enable the implementation of the short and medium term actions foreseen by the AU EU Innovation Agenda[1] (expected to be adopted in June 2023) in the area of Public HealthProvide evidence for informed health policies and guidelines within public health systems in sub-Saharan Africa and at international level;Strengthen clinical research capability in sub-Saharan Africa to rapidly respond to emerging epidemics;Enable a regulatory environment that can ensure effective development, delivery, and uptake of new or improved safe health technologies guaranteeing that trials in sub-Saharan African countries meet international standards;Increase cost effectiveness of public investment through collaboration of funders of clinical trials in the area of infectious diseases in sub-Saharan Africa;Strengthen health systems to ensure uptake of effective health technologies and innovations;Enhance sustainable global scientific collaboration in health research and international cooperation across sub-Saharan Africa.Improve opportunities for training of researchers and healthcare professionals in sub-Saharan Africa. [1]Working document of the AU EU Innovation Agenda available online at: https://research-and-innovation.ec.europa.eu/system/files/2022-02/final_au-eu_ia_14_february.pdf


ver menos

Temáticas Obligatorias del proyecto: Temática principal:

Características del consorcio

Ámbito Europeo : La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Tipo y tamaño de organizaciones: El diseño de consorcio necesario para la tramitación de esta ayuda necesita de:
Empresas Micro, Pequeña, Mediana, Grande
Centros Tecnológicos
Universidades
Organismos públicos

Características del Proyecto

Requisitos de diseño: *Presupuesto para cada participante en el proyecto
Requisitos técnicos: ExpectedOutcome:Proposal under this topic should aim to deliver results that are directed, tailored towards, and contributing to all of the following expected outcomes: ExpectedOutcome:Proposal under this topic should aim to deliver results that are directed, tailored towards, and contributing to all of the following expected outcomes:
¿Quieres ejemplos? Puedes consultar aquí los últimos proyectos conocidos financiados por esta línea, sus tecnologías, sus presupuestos y sus compañías.
Capítulos financiables: Los capítulos de gastos financiables para esta línea son:
Madurez tecnológica: La tramitación de esta ayuda requiere de un nivel tecnológico mínimo en el proyecto de TRL 4:. Es el primer paso para determinar si los componentes individuales funcionarán juntos como un sistema en un entorno de laboratorio. Es un sistema de baja fidelidad para demostrar la funcionalidad básica y se definen las predicciones de rendimiento asociadas en relación con el entorno operativo final. + info.
TRL esperado:

Características de la financiación

Intensidad de la ayuda: Sólo fondo perdido + info
Fondo perdido:
The funding rate for RIA projects is 100 % of the eligible costs for all types of organizations. The funding rate for RIA projects is 100 % of the eligible costs for all types of organizations.
Garantías: No existe condiciones financieras para el beneficiario.

Información adicional de la convocatoria

Efecto incentivador: Esta ayuda no tiene efecto incentivador. + info.
Respuesta Organismo: Se calcula que aproximadamente, la respuesta del organismo una vez tramitada la ayuda es de:
Meses de respuesta:
Muy Competitiva:
No Competitiva Competitiva Muy Competitiva
No conocemos el presupuesto total de la línea
Minimis: Esta línea de financiación NO considera una “ayuda de minimis”. Puedes consultar la normativa aquí.

Otras ventajas

Sello PYME: Tramitar esta ayuda con éxito permite conseguir el sello de calidad de “sello pyme innovadora”. Que permite ciertas ventajas fiscales.