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IMI2-2015-07-04
IMI2-2015-07-04: DRY AGE-RELATED MACULAR DEGENERATION: DEVELOPMENT OF NOVEL CLINICAL ENDPOINTS FOR CLINICAL TRIALS WITH A REGULATORY AND PATIENT ACCESS INTENTION
Specific Challenge:Age-related macular degeneration (AMD) is a chronic disease and among the leading causes of blindness world-wide. Currently no effective treatments exist to address the major health problems of transition of intermediate AMD to late stage AMD with ‘geographic’ atrophy (GA). The development of novel pharmaceutical compounds is mainly limited by the lack of validated functional and structural clinical endpoints that can be used.
Sólo fondo perdido 0 €
Europeo
Esta convocatoria está cerrada Esta línea ya está cerrada por lo que no puedes aplicar. Cerró el pasado día 17-03-2016.
Se espera una próxima convocatoria para esta ayuda, aún no está clara la fecha exacta de inicio de convocatoria.
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Presentación: Consorcio Consorcio: Esta ayuda está diseñada para aplicar a ella en formato consorcio.
Número mínimo de participantes.
Esta ayuda financia Proyectos: Objetivo del proyecto:

Specific Challenge:Age-related macular degeneration (AMD) is a chronic disease and among the leading causes of blindness world-wide. Currently no effective treatments exist to address the major health problems of transition of intermediate AMD to late stage AMD with ‘geographic’ atrophy (GA). The development of novel pharmaceutical compounds is mainly limited by the lack of validated functional and structural clinical endpoints that can be used.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.


Scope:To develop clinical endpoints that are meaningful to patients and need to measure visual dysfunction beyond best-corrected visual acuity (BCVA), which is currently the only generally accepted functional clinical endpoint in retinal diseases.

Candidate clinical endpoints need to be systematically validated in adequate patient populations to be acceptable for regulatory authorities, health technology assessment (HTA) bodies, and payers.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.


Expected Impact:An extended toolbox of validated clinical en... ver más

Specific Challenge:Age-related macular degeneration (AMD) is a chronic disease and among the leading causes of blindness world-wide. Currently no effective treatments exist to address the major health problems of transition of intermediate AMD to late stage AMD with ‘geographic’ atrophy (GA). The development of novel pharmaceutical compounds is mainly limited by the lack of validated functional and structural clinical endpoints that can be used.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.


Scope:To develop clinical endpoints that are meaningful to patients and need to measure visual dysfunction beyond best-corrected visual acuity (BCVA), which is currently the only generally accepted functional clinical endpoint in retinal diseases.

Candidate clinical endpoints need to be systematically validated in adequate patient populations to be acceptable for regulatory authorities, health technology assessment (HTA) bodies, and payers.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.


Expected Impact:An extended toolbox of validated clinical endpoints that are acceptable by regulators, HTA bodies/payers and patients will enable the development of therapeutics for dry AMD.

It will greatly facilitate future trial designs in dry AMD, in early clinical trials, which aim to show proof of new therapeutic concepts in patients, as well in late stage development targeting confirmation of efficacy and safety of novel therapeutic approaches in larger patient populations.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.


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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: Specific Challenge:Age-related macular degeneration (AMD) is a chronic disease and among the leading causes of blindness world-wide. Currently no effective treatments exist to address the major health problems of transition of intermediate AMD to late stage AMD with ‘geographic’ atrophy (GA). The development of novel pharmaceutical compounds is mainly limited by the lack of validated functional and structural clinical endpoints that can be used. Specific Challenge:Age-related macular degeneration (AMD) is a chronic disease and among the leading causes of blindness world-wide. Currently no effective treatments exist to address the major health problems of transition of intermediate AMD to late stage AMD with ‘geographic’ atrophy (GA). The development of novel pharmaceutical compounds is mainly limited by the lack of validated functional and structural clinical endpoints that can be used.
¿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.
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Purchase costs.
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
Subcontracting costs.
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Amortizaciones.
Activos.
Otros Gastos.
Madurez tecnológica: La tramitación de esta ayuda requiere de un nivel tecnológico mínimo en el proyecto de TRL 5:. Los elementos básicos de la innovación son integrados de manera que la configuración final es similar a su aplicación final, es decir que está listo para ser usado en la simulación de un entorno real. Se mejoran los modelos tanto técnicos como económicos del diseño inicial, se ha identificado adicionalmente aspectos de seguridad, limitaciones ambiéntales y/o regulatorios entre otros. + info.
TRL esperado:

Características de la financiación

Intensidad de la ayuda: Sólo fondo perdido + info
Fondo perdido:
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Please read carefully all provisions below before the preparation of your application.
You can access the description of the different topics in the Call topics text.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section (page 78), as well as the following information : 
 
List of countries and applicable rules for funding
 
Eligibility and admissibility conditions
 
Evaluation criteria and procedure, scoring and threshold : described in the IMI Manual for Submission, Evaluation and Grant award
 
Indicative timetable for evaluation and grant agreement
 
Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Standard proposal template
Standard evaluation form
IMI2 Model Grant Agreement
Template for Essential Clinical Trials Information
MI2 Coordination and Support Action (IMI2-CSA):
Summary of the most relevant provisions for participating in IMI2 actions
Standard proposal template
Standard evaluation form
IMI2 Model Grant Agreement
Template for Essential Clinical Trials Information
 
 
Please read carefully all provisions below before the preparation of your application.
You can access the description of the different topics in the Call topics text.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section (page 78), as well as the following information : 
 
List of countries and applicable rules for funding
 
Eligibility and admissibility conditions
 
Evaluation criteria and procedure, scoring and threshold : described in the IMI Manual for Submission, Evaluation and Grant award
 
Indicative timetable for evaluation and grant agreement
 
Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Standard proposal template
Standard evaluation form
IMI2 Model Grant Agreement
Template for Essential Clinical Trials Information
MI2 Coordination and Support Action (IMI2-CSA):
Summary of the most relevant provisions for participating in IMI2 actions
Standard proposal template
Standard evaluation form
IMI2 Model Grant Agreement
Template for Essential Clinical Trials Information
 
 
Garantías:
No exige Garantías
No existen condiciones financieras para el beneficiario.

Información adicional de la convocatoria

Efecto incentivador: Esta ayuda tiene efecto incentivador, por lo que el proyecto no puede haberse iniciado antes de la presentación de la solicitud de ayuda. + 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.

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Sin info.
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