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HORIZON-HLTH-2021-TOOL-06-02: Next generation advanced therapies to treat highly prevalent and high burden diseases with unmet medical needs
ExpectedOutcome: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, tailored 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 21-09-2021.
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:

ExpectedOutcome: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, tailored and contributing to all of the following expected outcomes:

Competent authorities, researchers and developers use assays for the valorisation and/or assessment of efficiency, delivery, safety, potency or mode of action of novel advanced therapeutic interventions based on either pluripotent stem cells, genome editing or RNA, that are aligned with regulatory standards.Clinicians, researchers and developers test several new advanced therapies based on pluripotent stem cells, gene editing or RNA ready through clinical trials meeting the regulatory requirements.
Scope:The recent development of advanced therapies has been hampered by the lack of robust research on certain key parameters e.g. safety, upscaling, immunity, potency assays, cost-effectiveness, and early on in development. This topic aims to ensure that the next wa... ver más

ExpectedOutcome: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, tailored and contributing to all of the following expected outcomes:

Competent authorities, researchers and developers use assays for the valorisation and/or assessment of efficiency, delivery, safety, potency or mode of action of novel advanced therapeutic interventions based on either pluripotent stem cells, genome editing or RNA, that are aligned with regulatory standards.Clinicians, researchers and developers test several new advanced therapies based on pluripotent stem cells, gene editing or RNA ready through clinical trials meeting the regulatory requirements.
Scope:The recent development of advanced therapies has been hampered by the lack of robust research on certain key parameters e.g. safety, upscaling, immunity, potency assays, cost-effectiveness, and early on in development. This topic aims to ensure that the next wave of advanced therapies, based on either pluripotent stem cells, gene editing or RNA, are established in a timely fashion and in accordance with the appropriate regulatory standards for further clinical testing. It will support preclinical research platforms for disorders with high prevalence and burden[1] that tackle the bottlenecks currently encountered in the field, ensuring that promising advanced therapies can reach the market within the next decade. Applicants should justify the disease or disorder to be targeted with its prevalence level, the related burden and unmet needs. Applicants could propose activities in one or several of the following areas, and should take into consideration the Oviedo Convention, eligible actions and ethical principles as defined by the Horizon Europe Framework Programme [2]:

Method development for the production and differentiation of pluripotent stem cells[3] (defined as cells that can give rise to cells from all three embryonic germ layers), to include defining appropriate potency assays. Complementary activities to assess mode of action, safety, in vivo validation or upscaling procedures could be considered.Development and validation of biological assays and methods that can demonstrate efficacy, delivery, specificity, and safety (including off-target effects) of genome editing products in targeted cells and tissues (e.g. base editing, prime editing, transcription activator-like effector nucleases, zinc-finger nucleases, clustered regularly interspaced short palindromic repeats). Complementary activities to assess in vivo validation or upscaling procedures could be considered.Development and validation of novel RNA-based therapeutics targeting non-communicable diseases. Complementary activities to assess mode of action, delivery, safety, in vivo validation and/or upscaling procedures could be considered.Study, analysis and tackling of different immune responses, taking into account factors like sex and age, generated by any of the above-mentioned advanced therapies in vivo, facilitating regulatory approval for next phase of research and development.
[1]As defined by www.who.int/medicines/areas/priority_medicines/en/

[2]https://data.consilium.europa.eu/doc/document/ST-6692-2021-ADD-3/en/pdf

[3]Definition: Embryonic stem cells and induced pluripotent stem cells are pluripotent stem cells. www.nature.com/subjects/pluripotent-stem-cells.

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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:

Características del Proyecto

Requisitos de diseño: Duración:
Requisitos técnicos: ExpectedOutcome: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, tailored and contributing to all of the following expected outcomes: ExpectedOutcome: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, tailored 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:
Personnel costs.
Subcontracting costs.
Purchase costs.
Other cost categories.
Indirect costs.
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:
0% 25% 50% 75% 100%
Para el presupuesto subvencionable la intensidad de la ayuda en formato fondo perdido podrá alcanzar como minimo un 100%.
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 exige Garantías
No existen 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.
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