Innovating Works

H2020

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HORIZON-HLTH-2023-TOOL-05-01
Clinical trials of combined Advanced Therapy Medicinal Products (ATMPs)
Expected Outcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to several 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 13-04-2023.
Se espera una próxima convocatoria para esta ayuda, aún no está clara la fecha exacta de inicio de convocatoria.
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:

Expected Outcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to several of the following Expected Outcomes:

Healthcare providers increase their knowledge on the potential of combined ATMPs and get access to innovative treatment options with demonstrated health benefits for unmet medical needs;Developers and manufacturers of combined ATMPs obtain scientific evidence on the proposed therapeutic approach;Patients benefit from new advanced therapies delivered through the combined ATMPs;EU companies get a better market position in the field of combined ATMPs. Scope:The subjects of this topic are combined ATMPs (Advanced Therapy Medicinal Products) according to the definition of the ATMP-regulation (EU 1394/2007, Article 2d). Such combined ATMPs are composed of an ATMP and one or more medical devices or one or more active implantable medical devices, and their cellular or tissu... ver más

Expected Outcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to several of the following Expected Outcomes:

Healthcare providers increase their knowledge on the potential of combined ATMPs and get access to innovative treatment options with demonstrated health benefits for unmet medical needs;Developers and manufacturers of combined ATMPs obtain scientific evidence on the proposed therapeutic approach;Patients benefit from new advanced therapies delivered through the combined ATMPs;EU companies get a better market position in the field of combined ATMPs. Scope:The subjects of this topic are combined ATMPs (Advanced Therapy Medicinal Products) according to the definition of the ATMP-regulation (EU 1394/2007, Article 2d). Such combined ATMPs are composed of an ATMP and one or more medical devices or one or more active implantable medical devices, and their cellular or tissue part must either contain viable cells or tissues, or non-viable cells or tissues liable for exerting the primary action on the human body.

The combined ATMPs should be more effective than current state-of-the-art solutions on the European market owing to improved features like personalisation, accuracy, reliability and usability and contribute to long-term sustainability (faster and affordable) of European health systems.

Research should focus on advanced stages of clinical development with regulatory work on the Medical Device part completed and safety studies of the combination product in an advanced stage.

Proposals should address all of the following activities:

Phase 2 clinical trials and above of combined ATMPs focussing on: technologies ready to undergo interventional clinical trials in patients/end users assessing the usability and clinical performance, and/ortechnologies that have demonstrable safety/performance profiles and should undergo clinical validation in view of their inclusion into guidelines for specific clinical pathways. Delivery of safe and clinically validated combined ATMPs that are compliant with current European regulatory requirements. The related regulatory work should be considered as an essential component and the proposed work should involve consultation/interaction with competent regulatory agencies such as the European Medicines Agency (EMA) or national regulatory agency. Applicants are encouraged to seek regulatory and/or Health Technology Assessment (HTA) advice as appropriate. The topic invites proposals that include innovative treatments for any medical condition excluding rare diseases that are ready to be assessed for clinical efficacy (performance and clinical benefit) in a specific indication on a big number of patient cohorts; already existing market solutions are not in the scope of this topic.

Sex and gender aspects, age, socio-economic, lifestyle and behavioural factors and any other non-health related individual attributes should be taken into consideration. SME participation is strongly encouraged.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

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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: Duración: Requisitos técnicos: Expected Outcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to several 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. leer más.
TRL esperado:

Características de la financiación

Intensidad de la ayuda: Sólo fondo perdido + info
Fondo perdido:
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The funding rate for RIA projects is 100 % of the eligible costs for all types of organizations.
Condiciones: 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 pero en los últimos 6 meses la línea ha concecido
Total concedido en los últimos 6 meses.
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.