HORIZON EUROPE
Europeo
Specific Challenge:Autism Spectrum Disorders (ASD) are common and severe neurodevelopmental disorders characterised by deficits in social communication and repetitive and restricted behaviours (including sensory anomalies). It is estimated that approximately 1% of children and adults are affected by ASD world-wide; that is nearly 5.5 million patients in the European Union (EU).
Currently, no effective medical treatments for the core symptoms are available and prior drug trials have been largely unsuccessful. Over the past years, major progress in the understanding of the genetics of autism, the development of in vitro and genetic animal models, and identification of several neurobiological phenotypes have opened new avenues for the identification of aetiology-based treatment targets. However, these advances were accompanied by increasing recognition of a further hurdle; namely the profound phenotypic and genetic heterogeneity between patients. For example, approximately 70% of people with ASD have one or more comorbidities. Likewise, hundreds of risk genes have been identified, yet each explains only a small percentage of patients. Last but not least there is poor unde...
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Specific Challenge:Autism Spectrum Disorders (ASD) are common and severe neurodevelopmental disorders characterised by deficits in social communication and repetitive and restricted behaviours (including sensory anomalies). It is estimated that approximately 1% of children and adults are affected by ASD world-wide; that is nearly 5.5 million patients in the European Union (EU).
Currently, no effective medical treatments for the core symptoms are available and prior drug trials have been largely unsuccessful. Over the past years, major progress in the understanding of the genetics of autism, the development of in vitro and genetic animal models, and identification of several neurobiological phenotypes have opened new avenues for the identification of aetiology-based treatment targets. However, these advances were accompanied by increasing recognition of a further hurdle; namely the profound phenotypic and genetic heterogeneity between patients. For example, approximately 70% of people with ASD have one or more comorbidities. Likewise, hundreds of risk genes have been identified, yet each explains only a small percentage of patients. Last but not least there is poor understanding and knowledge on how the condition and the needs of the patients change in the different stages of life (e.g. in children, versus adolescents, versus adults with ASD). This highlights the need to move beyond one-size-fits-all treatment approaches and to develop stratified approaches that are tailored to the specific needs and biological profiles of particular patient subgroups.
Scope:This project offers a unique opportunity to create a European-wide research strategy in collaboration and in alignment with US-based efforts that overcome key bottlenecks in the development and testing of treatments for ASD. It will build the necessary capacity, within Europe, for the conduct of future trials, while also contributing towards a more unified approach to research in ASD within Europe in the clinical sciences.
Specifically, to meet these objectives, the project will:
Validate stratification biomarkers to enable identification of more homogeneous clinical and / or biological subgroups for clinical trials, including for co-morbidities, in particular epilepsy, but excluding psychosis/schizophrenia;
Create a European-wide clinical trials network trained to GCP standards to facilitate large-scale clinical trials;
A fully aligned and integrated global framework for clinical trials in ASD and co-morbidities
Enhance drug discovery efforts by testing translatability of drug effects (new and/or repurposed) between patients with ASD with and without co-morbidities and preclinical models to enable and feed a sustainable pipeline of innovative treatments.
Expected Impact:This project will have a major impact on this field and in parallel contribute towards the Innovative Medicines Initiative 2 (IMI2) goals as outlined in Article 2 of the IMI2 Council regulation:
Identify patient sub-populations for particular treatments through validation and qualification of stratification biomarkers.
Development of a Europe-wide infrastructure to accelerate and tailor patient recruitment to targeted (adaptive) clinical trials.
Based on these deliverables, the project will set new standards for industry and allow potential identification of personalised medicines for patients in highly characterized patient groups.
Development of a unified approach to clinical research in ASD within Europe.
A better understanding of common vs. distinct pathophysiological mechanisms underlying ASD subgroups, i.e. genetic, neurobiological and/or accounting for clinical variables such as comorbidities, developmental stage and sex.
The integration in the IMI action of complementary activities conducted in parallel in Europe and the US will result in a significantly larger patient population studied, in the combination of clinical trial results, and parallel validation and regulatory submissions of R&D tools. All this will not only increase the probability of success, but will also contribute to significantly accelerating R&D in a very complex research field.
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
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
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
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
Características de la financiación
You can access the description of the different topics in the Call 10 topics text.
The budget breakdown for this Call is given at the end of the Call topics text, in the Conditions for this Call for proposals section, as well as the following information :
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and treshold: described in the IMI2 Manual for evaluation, submission and grant award.
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type of actions under the Call topics:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Proposal templates are available after entering the submission tool
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 10 topics text.
The budget breakdown for this Call is given at the end of the Call topics text, in the Conditions for this Call for proposals section, as well as the following information :
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and treshold: described in the IMI2 Manual for evaluation, submission and grant award.
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type of actions under the Call topics:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Proposal templates are available after entering the submission tool
Standard evaluation form
IMI2 Model Grant Agreement
Template for essential clinical trials information
Información adicional de la convocatoria
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