FP7-Programa de trabajo Cooperación: Salud-2012 Dra. María Alejandra Alvarez

Contexto Objetivo: Incentivar la investigación e innovación dirigidas a enfrentar los grandes desafíos actuales. Herramientas para alcanzar este objetivo : –Financiamiento de tópicos que permitan desarrollar productos, procesos y servicios nuevos y más innovadores (incluyendo actividades piloto, demostración y validación) –Identificación y apoyo a la capacidad de innovación y diseminación. –Promoción del uso del conocimiento generado. La comisión proveerá asistencia a los consorcios para acceder a los instrumentos financieros adecuados (por ejemplo: eventos de brokerage con inversores)

Contexto (2) Énfasis en la participación de pequeñas y medianas empresas (PyMEs) con un mayor foco en el sector de las tecnologías médicas. Apoyo a la investigación colaborativa de gran calidad cubriendo requisitos de excelencia científica, administración profesional de fondos y alto impacto socio-económico. Presupuesto: € 620 millones. Gran interrelación entre las temáticas.

Temas clave Envejecimiento activo y saludable (tecnología médica, enfermedades crónicas, sistemas de salud, ensayos clínicos, recolección de datos), Investigación relevante para las PyMEs ( aprox. 50% de los tópicos, p.ej.: tecnologías médicas. Se espera así el desarrollo de nuevas tecnologías, nuevas drogas y nuevas terapias para mejorar la calidad de vida), Tecnologías médicas (transplante de órganos, órganos artificiales, diagnóstico de enfermedades infecciosas, discapacidades sensoriales, manejo de la diabetes, enfermedad inflamatoria crónica), Enfermedades raras (nuevas tecnologías de diagnóstico y tratamiento y nuevas drogas, uso de las “ómicas”, desarrollo clínico y preclínico de drogas huérfanas), Ensayos clínicos (ensayos clínicos destinados a la optimización del tratamiento de los adultos mayores, medicinas para la diabetes pediátrica y adolescente, drogas huérfanas para el tratamiento de enfermedades raras) Acciones de diseminación (estimulación de la formación de una red que promueva al transferencia de conocimiento en actividades financiadas por el FP)

Cooperación internacional Todos los tópicos están abiertos a la cooperación internacional con los terceros países. Desafíos globales. Enfermedades de la pobreza. Enfermedades raras. Mejora de la competitividad a través de la cooperación internacional. Apoyo de las relaciones con la UE. Reconociendo la apertura del NIH a investigadores europeos los grupos de USA son elegibles para recibir financiamiento.

Enfoques temáticos cruzados Hay enfoques cruzados con los temas de: –Tecnologías de las comunicaciones (ICT) –Alimentación, Agricultura, Pesca y Biotecnología (KBBE) –Ciencias Sociales y Humanas (SSH)

A destacar! €620 millones. Dos llamados: FP7-HEALTH-2012-INNOVATION-1 con un presupuesto de €546 millones FP7-HEALTH-2012-INNOVATION-2 llamado piloto con un presupuesto de €108 millones y condiciones muy específicas (sección III) Presentación en dos etapas. Al menos 50% de los temas están dirigido a las PyMEs. Un numero de socios mayor del número mínimo de participantes debe estar justificado, especificando la importancia que tiene para alcanzar los objetivos propuestos. Aspectos éticos (tanto en la metodología como en las posibles implicaciones de los resultados. Ver Guía del Aplicante). Uso de animales en investigación (Protocolo de protección y bienestar de animales, Principio de las 3R: reducción, refinamiento y reemplazo). Cuestión de género (participación balanceada de hombres y mujeres). Impacto socio-económico de la investigación. Esquemas de financiación (ajustarse a los esquemas a los que se presentan es un criterio de elegibilidad).

Los tres pilares del programa de trabajo en la prioridad temática SALUD 1.Biotecnología, herramientas genéricas y tecnología médica para salud humana. 2.Investigación translativa para salud humana. 3.Optimización del servicio de cuidado de la salud a ciudadanos europeos.

1. Biotecnología, herramientas genéricas y tecnología médica para salud humana. 1.1 Cerrado en Detección, diagnóstico y monitoreo. Desarrollo de herramientas y tecnologías para la visualización, detección y análisis de imágenes dirigido a investigación biomédica, predicción, diagnóstico, monitoreo y prognosis de enfermedades y para dar apoyo y guía a intervenciones terapéuticas. Enfoque hacia la multidisciplinariedad que involucre biología molecular y celular, fisiología, genética, física, química, ingeniería biomédica, nanotecnologías, microsistemas, tecnologías de dispositivos e información. Se enfatiza el uso de métodos no, o mínimamente, invasivos. 1.3 Cerrado en Enfoques e intervenciones terapéuticas innovadoras. Tema central: transplantes. Tópicos subsidiarios en cooperación internacional en stem cells y transferencia de AN). Todos los temas requieren de realización de ensayos clínicos y participación de PyMEs. Mejoramiento de técnicas de transplante y para la mejor inmunotolerancia con menos efectos colaterales. Tecnologías médicas, tanto para transplante de órganos sólidos como para células y tejidos. Puede incluir el trabajo con órganos artificiales. El uso de AN provee la base para aplicaciones terapéuticas y profilácticas en vacunas, transferencia de genes, inmunomodulación y RNAi)

1.2 Detección, diagnóstico y monitoreo. HEALTH Development of technologies with a view to patient group stratification for personalised medicine applications FP7-HEALTH INNOVATION-1. The aim of this topic is to support research and development and/or proof of principle of technologies for application in the area of personalised medicine, i.e. tailored medical interventions which are more effective and have fewer undesirable adverse effects in specifically defined patient groups. These technologies should be of use for research, screening, diagnostics and/or guidance of therapeutic interventions. The projects must include quality control aspects for data generated and where appropriate use statistical tools. Potential end-users should actively be included in the project, at least for proof of principle projects. Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria. Funding scheme: SME-targeted Collaborative Project (medium-scale focused research project) Requested EU contribution per project: Maximum EUR One or more proposals can be selected. Expected impact: The development of new and improved tools and technologies will contribute to enabling the uptake of personalised medicine into clinical practice and support the competitiveness of Europe in this area. The applications are expected to advance research in personalised medicine and have an impact in the relevant industry (in particular for SMEs). Specific feature: SME-targeted research is designed to encourage SME efforts towards research and innovation. Priority will be given to proposals demonstrating that research intensive SMEs play a leading role. The projects will be led by SMEs with R&D capacities but the coordinator does not need to be an SME. The expected project results should clearly be of interest and potential benefit to SME(s). Additional eligibility criterion: Projects will only be selected for funding on the condition that the estimated EU contribution going to SME(s) is 30% or more of the total estimated EU contribution for the project as a whole. This will be assessed at the end of the negotiation, before signature of the grant agreement. Proposals not fulfilling this criterion will not be funded.

1.4 Enfoques e intervenciones terapéuticas innovadoras. HEALTH : Innovative approaches to solid organ transplantation FP7-HEALTH-2012-INNOVATION-1. The aim of this topic is the practical exploitation of recent research findings to improve the outcome, increase efficiency or widen the scope of solid organ transplantation. Projects are required to include clinical work and the necessary regulatory work as appropriate. Full attention needs to be paid to safety and immunological aspects of the work. Research should be translational, and may include improvement of understanding of mode of action if needed. For projects on xenotransplantation, if the work is not yet ready for clinical application, proposals should include a reasoned plan indicating the main development and regulatory steps needed to move the technology to the clinic. Research should involve European industry, in particular the SME sector. Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria. Funding scheme: Collaborative Project (medium-scale focussed research project) Requested EU contribution per project: Maximum EUR One or more proposals can be selected. Expected impact: Results should lead to improved treatment outcome for transplantation patients, better understanding of mode of action of treatments or potential treatments and be of use to the industrial, especially SME, sector. Additional eligibility criterion: Projects will only be selected for funding on the condition that the estimated EU contribution going to SME(s) is 15% or more of the total estimated EU contribution for the project as a whole. This will be assessed at the end of the negotiation, before signature of the grant agreement. Proposals not fulfilling this criterion will not be funded.

HEALTH : Medical technology for the transplantation sector and bioartificial organs FP7-HEALTH-2012-INNOVATION-2. Work on transplantation may involve the use of cells, tissues or organs. Work on bioartificial organs should take into account the fact that these are composed of both biological and artificial components. Funding scheme: Collaborative project (small or medium-scale focused research project). One or more proposals can be selected. Expected impact: Results should lead to development of new tools, technologies or devices for use in transplantation and for replacing essential organ function by bioartificial organs. Specific feature: –Specific SME innovation initiative designed to encourage stronger SME efforts towards research and innovation. –SMEs will need to have a leading role in the project. – Applicants invited to present a full proposal for stage 2 are requested to submit a detailed exploitation plan clearly describing the valorisation of the technology to be developed. Expected project results should be of clear interest and potential benefit to SME(s). Additional eligibility criteria: The requested EU contribution per project should depend on the needs of the project and shall not exceed a maximum of EUR The proposed project duration indicated in the proposal should be up to 3 years. Projects will only be selected for funding on the condition that the estimated EU contribution to SME(s) is 50% or more of the total estimated EU contribution to the whole project. This will be assessed at the end of the negotiation, before signature of the grant agreement. Proposals not fulfilling this criterion will not be funded. The financial viability of all partners in projects needs to fulfil the Commission requirements. This will be checked at the stage 2 evaluation. Number of participants: minimum 3 up to maximum 5, established in at least three different EU Member States or Associated Countries. Participation is restricted to entities established in EU Member States and Associated Countries. Any project activity must be performed by an entity in the EU Member States or Associated Countries (see also section III). SME(s) need to be 1) at least 51% owned and controlled by one or more individuals who are citizens of one of the EU Member States or Associated Countries or permanent residents in one of those countries, or 2) at least 51% owned and controlled by another business concern that is itself at least 51% owned and controlled by individuals who are citizens of, or permanent residents in those countries..

HEALTH : Innovative strategies for translation of stem cell based therapies in regenerative medicine (European Union- Australia cooperation). FP7-HEALTH-2012-INNOVATION-1. Projects should aim to develop innovative strategies to stem cell-based therapies based on various approaches including allogeneic and/or autologous sources, with an emphasis on understanding the mechanisms of action and nature of the host response. Proposals should include thorough characterisation, quality control of the product(s), efficacy and safety in relevant pre-clinical models and, if possible, early assessment in humans or relevant bridging studies. The selected project should capitalise on the strong expertise and synergistic opportunities available in Australia and Europe in the fields of stem cell biology, cell-host interactions, and bioengineering, bio-processing and clinical trial management. Therapeutic products and clinical protocols should be developed through collaboration with industry partners and in consultation with appropriate regulatory bodies and health economic advisors. Part of the research project will be conducted by Australian researchers in Australia while the other part would be conducted by collaborative partners in the EU. (…) Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria. Funding scheme: SME-targeted Collaborative Project (medium-scale focused research project) Requested EU contribution per project: Maximum EUR Only up to one proposal can be selected. Expected impact: The main impact of this work should be the extent to which new, innovative therapeutic approaches for these diseases can be tested in relevant preclinical models or humans. Projects are expected to lead to closer cooperation between the EU and Australia in the stem cell research field.

HEALTH : Targeted nucleic acid delivery as an innovative therapeutic or prophylactic approach. FP7-HEALTH-2012-INNOVATION-1 The aim of this research is to exploit technology for nucleic acid delivery through testing in clinical trials carried out within the lifetime of the project. Recent innovative developments in DNA vaccination, immunotherapy, gene therapy or RNA interference are very encouraging but remain challenging and more proof-of-principle is needed. Any justified disease or disorder may be targeted. Detailed safety, immunogenicity, toxicity and feasibility studies in a preclinical setup (animal models) should preferably be already available or addressed before the beginning of the project. The necessary regulatory work should be included as appropriate. Proposals should develop multidisciplinary and translational research with potential for exploitation by the clinical and/or industrial sectors. Active participation by SMEs (minimum 30% of the EC contribution to the budget) is required and this will be considered in the evaluation of the proposal. Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria. Funding scheme: SME-targeted Collaborative project (medium-scale focused research project) One or more proposals can be selected. Expected impact: Building on recent results the project should link promising emerging technologies with clinical application in the area of nucleic acid delivery for prophylactic or therapeutic purposes. This would enhance European expertise and competitiveness in an important emerging market. Research will also support the European biotechnology industry, especially the SME sector. Specific feature: SME-targeted research is designed to encourage SME efforts towards research and innovation. Priority will be given to proposals demonstrating that research intensive SMEs play a leading role. The projects will be led by SMEs with R&D capacities but the coordinator does not need to be an SME. The expected project results should clearly be of interest and potential benefit to SME(s). Additional eligibility criteria: Requested EU contribution per project: Maximum EUR Projects will only be selected for funding on the condition that the estimated EU contribution going to SME(s) is 30% or more of the total estimated EU contribution for the project as a whole. This will be assessed at the end of the negotiation, before signature of the grant agreement. Proposals not fulfilling this criterion will not be funded.

2. Investigación translativa para salud humana. 2.1 Integrating Biological Data and Processes: Large-scale data gathering, System biology Large-scale data gathering System biology 2.2 Research on the brain and related diseases, human development and ageing Closed on Human development and ageing 2.3 Translational research in major infectious diseases: to confront major threats to public health Cross-cutting HIV/AIDS, malaria and tuberculosis 2.4 Translational research in other major diseases Diabetes and obesity Rare diseases Other chronic diseases

2.1 Integrating Biological Data and Processes: Large- scale data gathering, System biology Large-scale data gathering HEALTH : Omics for rare diseases. Projects funded under this heading should contribute towards the ambitious 2020 goals of the International Rare Diseases Research Consortium (IRDiRC): 200 new therapies for rare diseases (orphan drugs) and diagnostics tests for all rare diseases. HEALTH A: Support for international rare disease research. FP7-HEALTH-2012-INNOVATION-1. HEALTH B: Clinical utility of -omics for better diagnosis of rare diseases. FP7-HEALTH-2012-INNOVATION-1. HEALTH C: Databases, biobanks and 'clinical bio-informatics' hub forrare diseases. FP7-HEALTH-2012-INNOVATION-1. HEALTH Validation of -omics-based biomarkers for diseases affecting the elderly. (1) HEALTH Statistical methods for collection and analysis of -omics data. (1) System biology HEALTH Systems medicine: SME-driven research applying systems biology approaches to address medical and clinical needs. (1) HEALTH Systems medicine: Applying systems biology approaches for understanding complex human diseases and their co-morbidities. (1) HEALTH : Preparing for the future research and innovation activities in systems medicine. (1)

2.2 Research on th brain and related diseases, human development and ageing Human development and ageing Research on the basic mechanisms of development and ageing is required to improve health and quality of life during the life course through the use of a wide variety of methodologies and tools aimed at better understanding the processes of life-long development and healthy ageing, preventing and curing a series of the most common age-related diseases. HEALTH : Integrative systems biology and comparative genomics for studying human ageing and/or most common age-related diseases.(1) Expected impact: Projects are expected to translate knowledge to humans and contribute directly to bio-gerontology. By studying the interactions between genetic, epigenetic and environmental factors, and how these give rise to the ageing phenotype in health and disease, the project(s) should improve the lives of older people. HEALTH : Investigator-driven clinical trials for optimisation of management of elderly patients with multiple diseases. (1) The aim of the projects should be the comparison of outcomes of various treatment regimens for those diseases that are most common in elderly populations.

2.3 Translational research in major infectious diseases: to confront major threats to public health Cross-cutting HEALTH : Diagnostics for infectious diseases in humans. FP7-HEALTH-2012-INNOVATION- 2. This topic covers the development and/or validation of diagnostic tests for infectious diseases with the aim of meeting real clinical and public health needs. Funding scheme: Collaborative project (small or medium-scale focused research project). One or more proposals can be selected. Expected impact: Projects should deliver new or improved diagnostic tools which will lead to more appropriate patient management in the clinical setting and/or help reducing the spread of infections of global importance. HEALTH : ERA-NET on infectious diseases. FP7-ERANET-2012-RTD HIV/AIDS, malaria and tuberculosis The focus will be on promoting translational research aiming at bringing basic knowledge through to clinical application in developing new therapies, diagnostic tools and vaccines for HIV/AIDS, malaria and tuberculosis. HEALTH : Co-infection of HIV/AIDS, malaria, tuberculosis and/or hepatitis. (1) HEALTH : Co-morbidity between infectious and non-communicable diseases. (1) HEALTH : Prevention and treatment for HIV/AIDS, malaria and tuberculosis. (1) HEALTH : Low-cost interventions for disease control in resource poor settings. (1)

2.4 Translational research in other major diseases Diabetes and obesity For both diabetes and obesity, special attention will be given to juvenile diseases and factors operating in childhood. Considering the reduction in life expectancy resulting from these diseases, particular attention should be given to paediatric aspects, whenever possible. HEALTH : Innovative approach to manage diabetes. (1) HEALTH : Investigator-driven clinical trials for type 1 diabetes research. (1) Rare diseases For this call for proposals the topics will focus on the preclinical and clinical development of orphan drugs, and on the conduction of observational trials for those rare diseases treated offlabel, aiming to improve clinical practices in the management of these diseases. These efforts will be complemented with coordination action activities aimed at identifying and exchanging best practices in the clinical management of rare diseases. HEALTH : Preclinical and/or clinical development of substances with a clear potential as orphan drugs. (1) HEALTH : Best practice and knowledge sharing in the clinical management of rare diseases. (1)

2.4 Translational research in other major diseases Other chronic diseases For this call for proposals the focus will be on non-lethal diseases and chronic conditions with a high impact on the quality of life at old age such as functional and sensory impairment and chronic inflammatory diseases. It is expected that collaborative research in this area will lead to improved diagnostics of the chronic conditions, develop tools and/or intervention strategies, which may contribute to delaying the onset of chronic diseases, their efficient treatment, and improving quality of life. HEALTH : Technological approaches to combating sensory impairments. FP7-HEALTH INNOVATION-2. Examples of possible areas to be considered: strategies aiming at prevention of damage and rejuvenation of sensory cells and systems, treatment of sensory diseases, implantable devices, cell based approaches, including stem cells, and development of artificial organs or their parts. Full attention needs to be paid to safety, bio-compatibility, interoperability and regulatory aspects as appropriate. Note: Limits on the EU financial contribution apply. These are implemented strictly as formal eligibility criteria. Funding scheme: Collaborative Project (small or medium-scale focused research project) HEALTH : Biomarkers and diagnostics for chronic inflammatory diseases of the joints and/or digestive system. (1)

3. Optimising the delivery of healthcare to European citizen 3.2 Quality, efficiency and solidarity of healthcare systems including transitional health systems HEALTH : Improving the organisation of health service delivery. (1) HEALTH : New methodologies for health technology assessment. (1) HEALTH : Social innovation for active and healthy ageing. (1) 3.4 International Public health and Health systems The specific cooperation actions in this area focus on the priorities agreed through bi-regional dialogues in third countries/regions and international fora, as well as within the context of Millennium Development Goals (MDGs). It has been long recognised at the global level that research is needed to improve the efficiency and effectiveness of health systems in many low and middle income countries. This call will focus on health systems/services research while at the same time strengthening research capacity building in terms of human resources. Note: For the topic described below, applicants will have to follow the rules for two-stage submission procedure (see also respective call fiche in section III). HEALTH : Research on health systems and services in low- and middle income countries. FP7-HEALTH-2012-INNOVATION-1. Projects should allow national and regional decision makers to better translate knowledge, empirical data and operational experience into policies and planning for more effective, efficient and equitable health systems and services. Funding scheme: Specific International Cooperation Action (SICA), Collaborative Project (small or medium-scale focused research project) target regions: All international cooperation countries (ICPC)

4 Otras acciones 4.1 Coordination and support actions across the theme The objective of these actions is to contribute to the implementation of the Framework programme and the preparation of future European Union innovation, research and technological development policy. For this call for proposals the focus of this area will be on technology transfer and dissemination of results. HEALTH : Network to encourage knowledge transfer activity in FP-funded health research (especially in academic and governmental organisations). (1) HEALTH : Training actions linked to intellectual property rights management and knowledge transfer. (1) HEALTH : Support for Presidency events: Organisation of supporting actions and events related to the Presidency of the European Union. (1) HEALTH : Communicating the benefits of European research to the general public. (1) HEALTH : Preparing the future for health research and innovation. (1) HEALTH : Setting health-related development goals beyond (1)

Algunas Condiciones para los FP7-HEALTH INNOVATION-1

Evaluación- etapa 1 CriterioUmbral Mínimo Calidad CyT4/5 Impacto3/5 Umbral total8/10 Las evaluaciones serán realizadas por evaluadores externos Los coordinadores de las propuestas que alcancen la etapa 1 serán invitados a enviar la propuesta completa (etapa 2) que luego será evaluada nuevamente en forma completa de acuerdo a los objetivos, criterios de eligibilidad, etc. Indicados en el programa de trabajo.

Evaluación- etapa 2 CriterioUmbral mínimo Calidad CyT4/5 Implementación3/5 Impacto3/5 Umbral total12/15 El deadline se indicará al momento de invitar a enviarla. En línea con los objetivos de cada tópico se pueden agregar criterios de evaluación en la sección II del programa de trabajo En el caso de los proyectos colaborativos con PYMEs es importante que se cumplan los requerimientos indicados en el programa de trabajo en cuanto a condiciones y % del presupuesto que la UE destina a las PYMEs. La PYME puede o no ser el coordinador del proyecto, lo que sí debe es tener un rol fundamental en la toma de decisiones referidas al management del proyecto. El producto debe ser beneficioso para la PYMEs participante y las PYMEs a las que va dirigido.

Tiempos estimados Estadio 1: debe estar finalizado en Diciembre de 2011 Evaluación etapa 2: deberá ser en Marzo de 2012 Resultados generales: se estima estarán 3 meses después de la fecha de cierre del llamado de proyectos en etapa 2. Se espera que las negociaciones de los grant- agreements comiencen en Mayo Acuerdos de consorcio: para proyectos con financiación a partir de EUR Para proyectos colaborativos con financiación mayor de EUR el acuerdo no es mandatario pero sí recomendable.

Algunas Condiciones para los FP7-HEALTH INNOVATION-2

Estadio 1: La contribución de la UE dependerá de las necesidades del proyecto y no debe ser superior a EUR La duración del proyecto debe ser de hasta 3 años La participación ESTA RESTRINGIDA a 3-5 entidades establecidas en Estados Miembro de la UE y Países Asociados. Estadio 2: Los participantes incluidos las PYMEs: 1)Al menos el 51% debe ser propiedad de 1 o más individuos que sean ciudadanos de uno de los Estados Miembro de la UE y Países Asociados 2)Al menos el 51 % debe ser propiedad de otra empresa que a su vez tenga un 51% de control por parte de ciudadanos o residentes permanente de los países antes mencionados. 3)Los fondos de la UE deben ser destinados a las PYMEs en valores iguales o superiores a los especificados en la sección II. 4)La viabilidad financiera de los participantes será chequeada en el estadio 2 de la evaluación. 5)Los aplicantes deben presentar una propuesta completa con todos los detalles del plan de explotación, describiendo claramente la valorización de la tecnología a ser desarrollada.

Muchas gracias!