Défi santé, évolution démographique et bien-être

Transcription

1 Défi santé, évolution démographique et bien-être Rouen, 3/09/2015 Virginie Sivan, PhD Affaires européennes, Direction des Sciences du Vivant, CEA Représentante CEA au PCN

2 PCN Santé, évolution démographique et bien-être

3 Qui est on? Que fait on? -Informer, sensibiliser les équipes sur:.les opportunités de financement de projet d Horizon 2020 en santé.les modalités de fonctionnement du programme

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5 Horizon 2020 Le programme cadre Européen de recherche et d innovation Programme phare de la stratégie Europe 2020, de l initiative «innovation union» et de l EER Répondre à la crise économique et investir dans la croissance et l emploi Adresser les problématiques de la vie des citoyens UE, leur sécurité et l environnement Accroitre la position mondiale de UE dans la recherche, l innovation et les technologies

6 PRIMAUTE INDUSTRIELLE EXCELLENCE SCIENTIFIQUE Horizon 2020 = 3 priorités EXCELLENCE SCIENTIFIQUE Positionner l UE comme pôle d Excellence scientifique mondial LEADERSHIP INDUSTRIEL Favoriser plus d innovation et renforcer le leadership industriel de l UE dans le monde DEFIS SOCIETAUX Répondre aux défis sociétaux de l UE (vieillissement démographique, changement climatique, sécurité, développement durable, ) 6

7 Horizon 2020 EXCELLENCE SCIENTIFIQUE PRIMAUTE INDUSTRIELLE DEFIS SOCIETAUX ERC European Research Council FET Future Emerging Technologies Marie Curie Infrastructures 13md 6md 2,7md 2,5md Technologies clefs génériques TIC, microélectronique, photonique, nanotechnologies, matériaux avancés, Systèmes de production, biotechnologies Espace Accès au financement à risque Innovation dans les PME 13,6md 616m 2,8md Diffusion de l excellence et élargissement de la participation (817m ) Institut Européen d Innovation et Technologie (EIT) (2,7md ) Science pour et avec la société (462m ) Centre commun de recherche (JRC) Euratom Santé Bioéconomie Energie Transport Changement climatique Sociétés inclusives Sécurité 7,5md 3,9md 5,9md 6,3md 3,1md 1,3md 1,7md 7

8 Règles de participation des défis Toute entité légale peut participer 3 entités légales de 3 Etats-membres ou Etats associés différents (exception pour outils PME - mono bénéficiaire et action de coordination) Entités légales financées : établies dans les Etats-membres ou Etats associés + Exception unique du défi santé: USA financés pour les Etats tiers : certains «low-income» financés (cf liste ci-dessous ) ou expressément prévu dans le programme de travail 3cpart_en.pdf Des critères d évaluation simples et uniformes Excellence Impact Mise en œuvre annex-h-esacrit_en.pdf «Time to grant»: 8 mois (soumission résultat: 5 mois résultat financement: 3 mois ) Il n y a plus de phase de négociation

9 Excellence Avec ce critère, les experts évaluent : -la clarté et la pertinence des objectifs -la crédibilité de l approche proposée -le bien-fondé du concept, incluant la multidisciplinarité, si c est pertinent -le degré d ambition du projet, le potentiel d innovation, et jusqu à quel point le projet va au de la de l état de l art (ex : objectifs révolutionnaires, nouveaux concepts ou nouvelles approches) Impact En vue de répondre à ce critère, il convient de décrire jusqu à quel point les résultats du projet contribuent à : -combler les impacts listés dans le programme de travail et sous le "topic" pertinent ; -améliorer la capacité d innovation et d intégration de nouvelles connaissances ; -renforcer la compétitivité et la croissance des entreprises en développant des innovations répondant aux besoins des marchés européens et globaux, et si c est pertinent, en fournissant les innovations aux marchés ; -prendre en compte les autres impacts environnementaux et sociétaux importants. -de plus, la proposition doit convaincre de l efficacité des mesures proposées pour communiquer sur le projet, diffuser et / ou exploiter les résultats du projet, en incluant la gestion des droits de propriétés intellectuelles. Qualité et efficacité de la mise en œuvre Ce critère évalue : la cohérence et l efficacité du plan de travail ("workplan"), incluant l adéquation de la répartition des tâches et des ressources ; les compétences et expériences des participants et la complémentarité des participants individuellement, ainsi que du consortium dans son ensemble ; l adéquation des structures de management et des procédures, en incluant la gestion des risques et de l innovation. 14/09/2015

10 Ne pas négliger les aspects importants Aspect éthique (expérimentation humaine et animale ) Aspect genre dans le projet et dans le consortium Gender balance in research teams, Gender balance in decision-making, Integrating gender/sex analysis in R&I content Implication des décideurs politiques, associations de patients et acteurs de la société civile Notion d open access et d open data/ Plus globalement de data management

11 Règles de financement - Taux de financement des coûts directs éligibles Topic ouvert «Non-profit» organisations Entreprises Recherche et Innovation (RIA) 100% 100% Innovation (IA) 100% 70% TVA déductible éligible -Taux de financement des coûts indirects éligibles Forfait de 25% des coûts directs éligibles

12 Ou trouver les calls? PARTICIPANT PORTAL ndex.html

13 PARTICIPANT PORTAL

14 Comment lire une ligne d appel? Area: Understanding health, ageing and disease PM Networking and optimising the use of population cohorts at EU level [RTD] Specific challenge: Population cohorts are invaluable resources to obtain detailed description of individual biological variations in connection with a variety of environmental, [ ] However, the lack of integration of these cohorts hampers the optimal exploitation of these resources, essential to underpin and facilitate the development of stratified and personalised medicine. Scope: The proposals should aim at maximizing the exploitation of cohorts by bringing together national and/or European cohorts with common scientific [ ] European infrastructures and additional collaborations with relevant international initiatives are encouraged. Proposals should also engage with relevant international/national/regional authorities to ensure that findings are implemented and translated into health policy. The Commission considers that proposals requesting a contribution from the EU of between EUR 8 and 10 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts. Expected impact: Expected impacts include one of or a combination of the following point(s): Contribute to providing novel information on health maintenance, onset and course of diseases, or population stratification, with a view to tailor diagnosis or to optimise treatment. Optimise the use of population cohorts in defining/improving clinical practice and public health policy. Make major conceptual, methodological and analytical contributions towards integrative cohorts Type of action: RIA Thème Titre et Date du call Titre et date du call Défi spécifique à relever justification Périmètre de l action à adresser Indication Budget Impact attendu en lien avec le défi Type de projet

15 Contexte du défi Santé Changement démographique Accroissement du fardeau des maladies non-transmissibles/ «lifestyle» Augmentation du coût de la santé & de la pression sur les systèmes de santé Augmentation des coûts du développement des médicaments, vaccins, dispositifs médicaux Insuffisance d évidences sur les avantages et l efficacité, des approches et pratiques actuelles Promouvoir le vieillissement actif et en bonne santé Favoriser une approche «tout au long de la vie» volonté de «scale-up» Soutenir le transfert vers la clinique Réduire les inégalités dans le domaine de la santé Utilisation des infrastructures européennes

16 Défi SANTE WP Focus Personalized Medicine (PM) 1-Understanding health, well-being and disease: Multi-omics pour thérapies personnalisées, stratification des patients, maladies rares (diagnostic), mise en réseau de cohortes EU 2-Preventing disease EHBI (exposition aux agents chimiques), vaccins (malaria, NID), santé mentale (jeunes) 3-Treating and managing diseases Nouvelles thérapies pour maladies rares, maladies chroniques (+ infectieuses), efficacité comparée des interventions préventives ou thérap., médecine régénerative, TIC 4-Active ageing and self-management of health TIC, robotique, solutions pour l autonomie du patient TIC 5- Methods and data Essais in-silico, sécurité des données numériques, modelisation, big data pour la santé 6-Health care provision and integrated care

17 Défi SANTE WP Personalized Medicine (PM) Understanding health, well-being and disease Budg. projet Budget total PM Multi omics for personalised therapies RIA Integrate and use high quality genome-epigenome-metabolome-microbiome data /combine these with disease-oriented functional analysis - Relevant biomarkers for clinical validation targeted therapies for complex diseases with high prevalence - Omics data (from international initiatives) + lifestyle/env data, functional, imaging - International cooperation / multidisciplinarity PM New concepts in patient stratification RIA = New concepts/models of PS to be clinically validated - Any disease with high economic impact, except rare disease - actively involve patient associations and regulators - Longitudinal and multidimensional data + omics tools - Models cost-effectiveness - SMEs PM Diagnostic characterisation of rare diseases RIA = Molecular characterisation of undiagnosed RD. Lien IRDiRC. Group of diseases - Genetic variability due to gender + ethnicity ; sex + gender + age parameters - Classification of RD: common standards & terminologies - Data sharing PM Networking and optimising the use of population and patient cohorts at EU level Type RIA - Population cohorts. Link with INFRA, international initiatives. - Novel information on health maintenance, onset, disease : diagnostic tool/treatment. - Support to Health policy (prevention, early diagnosis, therapies, health economics and inequalities)

18 Défi SANTE WP Personalized Medicine (PM) Preventing disease Budget projet PM Vaccine development for malaria and/or neglected infectious diseases 3 à 5 15 à 20 Budg total Type 40 RIA = large research platforms developing multiple vaccine candidates and/or vaccines for multiple diseases OR = vaccine dvppt for one specific disease. - Eligible: Malaria + 17 Neglected Tropical Diseases (WHO) + childhood diarrhoeal diseases and neglected viral emerging epidemic diseases. Filoviral diseases EXCLUDED. - Costs - Link with mapping exercises on vaccine candidates + vaccine development roadmaps - Link with EDCTP2 (clinical trials, Africa) to be anticipated. PM Promoting mental well-being in the young RIA - Population-oriented primary prevention interventions. Target group: up to 25 years. - Based on existing state of the art knowledge and beyond (biological, psychological and social determinant of mental well being such as cultural, work life, lifestyle, epidemio, economic, environmental ) - Aim at increasing resilience and mitigating the impact of risk factors - Prevention interventions + assessment of their effectiveness (mental health and well-being outcomes + economic and social benefits and impact on reducing inequalities) - Multi-disciplinary approach. - Includes the young themselves (empowerment) + relevant stakeholders. - Gender and health inequality aspects

19 Défi SANTE WP Treating and managing diseases Personalized Medicine (PM) PM New therapies for rare diseases RIA - Link with patient organisations+ Member States health authorities - efficacy/potential clinical benefit + health economics. - SMEs Préalable: ODD (EMA) PM New therapies for chronic diseases RIA Comme PHC 13 avec précisions. Chronic diseases: non-transmissible + infectious chronic diseases - Dvppt of novel therapies (pharmacological as well as non-pharmacological) or the optimisation of available therapies (e.g. repurposing) - Preclinical research should be completed -Phase 3 and phase 4 clinical trials excluded. - Feasibility assessment to be done - Gender and age to be taken into account PM Comparing the effectiveness of existing healthcare interventions in the adult population RIA - clinical and safety parameters to be taken into account - Assessment of health and socio-economic outcomes (e.g. quality of life, patient mortality, morbidity, costs, and performance of the health systems) - costs-effectiveness analysis to be done - Gender & socio-economic aspects to be included (when relevant for the 2 nd item) Examples of studies: randomised controlled trials, pragmatic trials, observational studies, large scale databases and meta-analyses PM Clinical research on regenerative medicine RIA Comme PHC 15 (to be split in 2 topics) - Later clinical stage preferred. Have preliminary results + authorisation (or close to) - Justification of choice of disease

20 Active and healthy ageing PM PCP-eHealth innovation in empowering the hospitalised patient 4 18 PCP PCP for R&D of new services / integration of existing services Increasing the level of interactions between the user and the health professional, enabling users to controle their health conditions and adhere to prescribed medical plans. Ex: telemedicines for follow-up of patient (chronic and rare diseases), e-mental healthfor patient empowerment, domestic rehabilitation (physical and cognitive) under remote professional supervision; Key documents: ehealth action plan mhealth green paper. PM PPI for deployment and scaling up of ICT solutions for active and healthy ageing PPI = specify, purchase and deploy ICT-based solutions for active and healty ageing Key document: scaling-up road map of the EIP. Co-fund up to 40% of total costs PM EU-JAPAN cooperation on novel ICT Robotics based solutions for active and healthy ageing at home or in care facilities. Défi SANTE WP Personalized Medicine (PM) RIA Developing and demonstrating ICT robotics based solutions for extending active and healthy ageing - multidisciplinary research (including behaviour/ssh) - Modularity, cost-effectiveness, reliability, flexibility (=adaptation to needs & lifestyle of older people) - Safety and acceptability - Test site in EU and Japan, with sufficient users (for validating) - Notion of spreading services (use of generalized infrastructure cloud systems, open source) + interoperability, standardization, open platforms, Internet of things approach - Max 36 months, no other third country partner, consortium agreement PM Personalised coaching for well-being and care of people as they age RIA = dvppt of radically new concept for a virtual coach (ex diet, physical activity, risk avoidance, leisure.from a physical, mental and cognitive, and social point of view) - Take into account gender and ethics aspects. - User-centred. Cost-effectiveness.

21 = dvppt of computer models and simulations systems able to aggregate various informations (biochemical, imaging, medical, lifestyle, etc) into robust predictors for resilience and recovery - Multiscale (time and spatial scales) approach; patient-specific - Multidisciplinary : medicine, SSH and ICT - Based on existing large database (clinical medicine, biomedical/ocupational research, environmental sciences and SSH Methods and data Défi SANTE WP Personalized Medicine (PM) PM In-silico trials for developing and assessing biomedical products RIA To simulate human physiology and physiopathology at the relevant biological level (ex cell, tissue, organism) and the interaction with the product To take into account the variability between individuals (genetics, gender, microbiota etc) To build virtual patients or populations for predicting tratments outcomes >>Personalised medicine Multidisciplinary approach: computational modelling, systems biology, tissue mechanismes, biology, pharmaceutics, medicine - To be included: simulated trials; measures for validation (human trials, animal studies, validation in the cell cutlture) - Contact with regulators - Key document: Research and technological road map for in-silico trials. PM Increasing digital security of health related data on a systemic level RIA = security related to storage and exchange (including cross-border) of health/personal data protection of personal data and data collected via mobiles Based on existing projects: DECIPHER, open NCP, EPSOS, STORK. - Legal & societal aspects (for deployment) - Respect national regulation regarding data protection + standards - To be at least tested in 3 EU MS. Anticipate the technological deployment in other countries PM Personalised computer models and in-silico systems for well-being RIA

22 Methods and data Défi SANTE WP Personalized Medicine (PM) PM Big Data supporting Public Health policies [CNECT] RIA = Acquisition, management, sharing, modelling, processing and exploiting big data into integrated solutions to support to health policy (decision marking): ex combined effect of environment, lifestyle and genetics on public health - Big data governance - Secury and privacy issues PM PPI for uptake of standards for the exchange of digitalised healthcare records [CNECT] EHealth interoperability 8,26 PPI PM21 - Development of new methods and measures for improved economic evaluation and efficiency measures in the health sector 9 RIA Health care provision and integrated care PM Implementation research for scaling-up of evidence based innovations and good practice RIA - Based on implementation research concept = «scientific study of methods to promote the uptake of research findings». - Selected intervention to be scale up: to make health systems and services more responsive, person-centred, safe, effective and efficient. Large scope (in terms of content + geographical coverage) - Gender issues & Multdisciplinary research

23 Idea Instrument PME : 3 phases Business plan+étude de faisabilité validation clinique proposée Répondre au challenge proposé / strategic business plan Phase 1 Phase 2 Phase 3 Market Feasibility Assessment Innovation / R&D project Commercialisation Feasibility of concept Risk assessment IP regime Partner search Design study Clinical trials Development, prototyping, scaling-up Miniaturisation, design Market validation Etc. Facilitate access to private finance Support via networking, training, coaching, knowledge sharing, dissemination 50,000 ~ 6 months 1 to 5 million ~36 months 100% funding rate in SC1 (for clinical trials) 70% for ICT calls (DG connect) No direct funding

24 Défi SANTE WP INSTRUMENT PME (RTD) SMEInst : Supporting innovative SMEs in the healthcare biotechnology sector a) Cell technology in medical applications ; Phase 1 et 2 Taux de financement des couts directs 100% Budget 2016: 35 M Budget 2017: 45 M phase 1: 50k /projet phase 2: 1 à 5 M /projet Cell technology = large scope but focus on multiple medical area applications (commercial potential increased) - Analysis of safety and regulatory (cell procurement, GMP, ethics, clinical trials and devices) of the technology under development - Only Eucaryotic Cells /application human medicine - Link with regulators (scientific advice and protocol assistance) 2017 b) Clinical research for the validation of biomarkers and/or diagnostic medical devices ; Phase 2 only Taux de financement des couts directs 100% - Comme PHC 12, mais phase 2 seulement en (cutt of date phase 1 PHC en déc 2015)

25 Défi SANTE WP INSTRUMENT PME (CNECT) SMEInst : Accelerating market introduction of ICT solutions for Health, Well-being and Ageing Well Budget 2016: 18 M Budget 2017: 12,5 M phase 1: 50k /projet phase 2: 0,5 à 2,5 M /projet Taux de financement des couts directs 70% To help to overcome the current gaps in exploitation of promising research results in ICT for health, well-being and ageing well market uptake of ICT products and services This concerns -Interoperable and secure e health solutions for consumers and institutional healthcare (see e health in digital Agenda ) -New ICT solutions and innovation ecosystems for ageing well building on open software platforms

26 Trouver des partenaires Utilisez d abord VOTRE réseau Utilisez les réseaux de spécialistes des projets européens Le service de fitforhealth: Rapprochez vous des organismes/universités/chu Si vous cherchez des PME utilisez les réseaux régionaux : EEN, ARI, Pôles de compétitivités CCI, Régions et via le PCN PME Cordis portal: Trouver ce qui a été financé Participez aux évènements autour de Horizon2020 ou internationaux Infodays 18 Septembre 2015 à Bruxelles Brokerage event 17 Septembre 2015 à Bruxelles Infos sur Devenez évaluateurs Créer votre réseau avec le financement ANR Montage de Réseaux Scientifiques Européens ou Internationaux ( académiques only)

27 Opportunités de financements EU en R&I (Santé) Commission Européenne Sujets ouverts Sujets ciblés-marché Sujets «sociétaux» larges Innovative Medicine Initiative Partenariat public-privé CE + EFPIA Dvpt nouvelles molécules thérapeutiques European-Developing Countries Clinical Trials Partnership Partenariat public-public EM + CE + E.Africains Essais cliniques sur les maladies infectieuses en collaboration NORD-SUD Programmation Conjointe ERA-NETs (Joint Programming Initiative (Appels transnationaux Consortia D Etats- Membres Thématiques Variées/ Standardisation des Agenda de recherche

28 IMI 2 Partenariat Public-Privé avec l industrie

29 IMI-2: Innovative Medicine Initiative Initiative conjointe de la CE et des industriels de l industrie pharmaceutique EFPIA (Fédération européenne des associations et industries pharmaceutiques) Objectif général: Development of tools and therapies for the right prevention and treatment, to the right patients, at the right time Budget 3 Billion euros 1,5 B 1,5 B

30 Appels IMI: le process call publication Au fil de l eau Selected consortium invited to merge with the industry consortium Topic definition phase: Identification of topics and willingness to collaborate by EFPIA companies (au moins 2 ind) Stage 1: Submission of short proposals by applicant consortia & evaluation by independent experts Stage 2: Preparation of full proposal & evaluation by independent experts/ethical panel Industry consortium Academic research teams Mid-size enterprises SMEs Hospitals Regulators Patients organisations Applicant consortium industry consortium

31 IMI2: Call 5 Patient perspective elicitation on benefits and risks of medicinal products from development through the entire life cycle, for integration into benefit risk assessments by regulators and health technology assessment bodies Diabetic kidney disease biomarkers (DKD-BM) Inflammation and Alzheimer s disease (AD): modulating microglia function focussing on TREM2 and CD33 Understanding the role of amyloid biomarkers in the current and future diagnosis and management of patients across the spectrum of cognitive impairment (from pre-dementia to dementia) Evolving models of patient engagement and access for earlier identification of Alzheimer s disease: phased expansion study Apolipoprotein E (ApoE) biology to validated Alzheimer s disease targets Dead line 13 octobre 2015

32 Submit an idea: Directement à l EFPIA: - En ligne avec l agenda stratégique: The right prevention and treatment, to the right patient at the right time - Template - Réponse sous 2 mois de la possibilité de créer un call - 8

33 Keep up to date Visit Sign up to the IMI Newsletter Follow us on Join the IMI group on LinkedIn Questions? infodesk@imi.europa.eu Youtube IMI channel XkB0kLpyGgxUh2HkaVC_&index=2 Guidance IPR help Desk Helpdesk@imi.europa.eu

34 EDCTP2: Mission and objectives EDCTP aims to support collaborative research that accelerates the clinical development of new or improved interventions to prevent or treat HIV/AIDS, tuberculosis, malaria and neglected infectious diseases in sub-saharan Africa Objectives: 1.Increase the number of medical interventions for poverty-related diseases 2. Strengthen capacity for clinical trials in sub-saharan Africa 3. Coordinate and align European national programmes 4.Cooperate with other public and private partners 5. Cooperation with EU initiatives, incl. development assistance 11

35 What EDCTP2 funds Diseases: HIV/AIDS, TB, Malaria, NIDs, emerging infectious diseases of particular relevance for Africa, including Ebola New tools and interventions: Diagnostics, drugs, vaccines and microbicides Capacity Development: Fellowships, Networks, Ethics, Regulatory 12

36 Panorama ERA-nets des en financements santé (participation FR) Maladies rares (renouvelé) Cancer (renouvelé) Nanomédecine (renouvellement à venir) Neurosciences Maladies infectieuses Humaines Exclusion : VIH, hépatites, malaria et tuberculose Médecine systémique (nouveau lancé en 2015) Biologie de Synthèse

37 Panorama ERA-nets des en financements santé (participation européens FR) Appels lancés au niveau des agence nationale de financement. En FR: ANR, BPI (selon les ERA-NEts) Pays participants à chaque ERA-Net peut varier. Condition d éligibilité à vérifier pour chaque call Nouveaux ERA-NETs à venir (financement H2020, appel 2015 ) : ERA-NET : brain-related diseases and disorders of the nervous sytsem ERA-NET on Antimicrobial resistance ERA-Net on Cardiovascular disease

38 Initiative de Programmation Conjointe INITIATIVE CONJOINTE DANS LE DOMAINE DES MALADIES NEURODÉGÉNÉRATIVES Mettre en commun de manière plus efficace les forces de recherche sur les maladies neuro dégénératives RÉSISTANCE ANTI-MICROBIENNE Appel à projets transnational sur les approches novatrices pour lutter contre la résistance antibactérienne NUTRITION

39 EXCELLENCE SCIENTIFIQUE ERC European Research Council FET Future Emerging Technologies Actions Sklodowska Marie Curie Infrastructures Projets collaboratifs en Santé PRIMAUTE INDUSTRIELLE TIC Technologies clefs génériques (LEIT) microélectronique, photonique, nanotechnologies, matériaux avancés, Systèmes de production, biotechnologies Espace Accès au financement à risque Innovation dans les PME DEFIS SOCIETAUX Santé Sécurité alimentaire Energie Transport Changement climatique Sociétés inclusives Sécurité

40 Défi 2: WP Healthy and safe foods and diets for all SFS Encouraging healthy dietary choices in childhood and measuring its impact on health SFS The impact of consumer practices in biological and Call Co-ordination chemical food activities safety risks (HCO) and mitigation strategies SFS Impulsivity and compulsivity and the link to nutrition, lifestyle and the socio-economic environment Budget call 9M 10M 12M Type RIA RIA RIA SFS How to tackle the obesity epidemic? 13M RIA SFS Sweeteners and sweetness enhancers 9M RIA Two-stages: - 1st stage: 02/03/2016, - 2 nd stage: 14/09/2016

41 EXCELLENCE SCIENTIFIQUE ERC European Research Council FET Future Emerging Technologies Actions Sklodowska Marie Curie Infrastructures Projets collaboratifs en Santé PRIMAUTE INDUSTRIELLE Technologies clefs génériques (KET) TIC Nanotechnologies, Matériaux avancés, Systèmes de production, Biotechnologies Espace Accès au financement à risque Innovation dans les PME DEFIS SOCIETAUX Santé Bioéconomie Energie Transport Changement climatique Sociétés inclusives Sécurité

42 Pilier 2 -LEIT : WP Key enabling technologies for societal challenges - Advanced materials and nanotechnologies for healthcare NMBP Biomaterials for diagnosis and treatment of multiple sclerosis. TRL3-5 NMBP Nanoformulation of biologicals TRL 3 /4 to 5 / 6. NMBP Development of a reliable methodology for better risk management of engineered Biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices. TRL 4-6 Budget projet Type 5-8 RIA 5-6 RIA 5-8 RIA NMBP Cross-KET for Health 5 RIA NMPB Regulatory Science Framework for assessment of risk-benefit ratio of Nanomedicines and Biomaterials. TRL RIA NMBP Nanotechnologies for imaging cellular transplants and regenerative processes in vivo TRL 3-4 to RIA NMBP Mobilising the European nano-biomedical ecosystem CSA Two-stages 2016: - 1st stage: 08/12/ nd stage: 24/05/2016 Two-stages 2017: - 1st stage: 10/11/ nd stage: 25/04/2017

43 Projets collaboratifs en Santé EXCELLENCE SCIENTIFIQUE ERC European Research Council FET Future Emerging Technologies Actions Sklodowska Marie Curie Infrastructures PRIMAUTE INDUSTRIELLE Technologies clefs génériques (KET) TIC Nanotechnologies, Matériaux avancés, Systèmes de production, Biotechnologies Espace Espace Accès au financement à risque Innovation dans les PME DEFIS SOCIETAUX Santé Bioéconomie Energie Transport Changement climatique Sociétés inclusives Sécurité

44 Pilier 1: programme Future Emerging Technologies FET OPEN-1 Future and Emerging Technologies (FET) Project size: 2 to 4M 1 step submission and evaluation of a 16 pages proposal Deadlines 11/05/ /01/ /09/2017 Budget 84M 84M 84M 4 février 2015 PAGE 44

45 14/09/2015 ANALYSES ESR 2014 Calls en 2 étapes

46 Analyse des ESR (1 er lot) Méthode: Analyse des PHC 2014 en deux étapes ESR à coordination FR: réussite et échec ESR toute coordination : réussite 1 er jet avant analyse plus ciblées / existe une base de donnée avec les commentaires par PHC

47 Points positifs Clarity/Coherence: objectives clear, pertinent, well described, methodology convincing, large number of subjects, using a good model, Design and methodology are clearly laid out Novelty: Beyond the state of the art, potential to create a paradigm shift, several novel concepts ambitious, original and innovative Preliminary data: data from existing cohorts, based on previous FP projects, biobanks, wellsupported by cited literature, building on robust preliminary work, build on preclinical data Excellence: Points négatifs Clinical trials: number of patients in trial small/not sufficient/ no statistical power, safety issues not sufficiently detailed Lack of novelty: state of the art not clear, no real breakthrough, not well aligned with current treatment guidelines Lack of preliminary data: lack of validation on animal models/lack of longitudinal studies Challenge driven: high unmet medical or clinical need, diseases with high prevalence and high, socioeconomic impact, Cost effective, EU added value, knowledge can be applied to different EU policies Interdisciplinarity Intersectorial: SMEs, Hospitals, patients organisations Gender Over ambitious within the time frame, not credible, risk management not sufficiently described, going into clinical trials is premature Lack description on ethics Consortium do not have the expertise (or not proved)

48 Points positifs Dissemination and exploitation of the results for the benefit of The scientific community: Data management plan, open-innovation platform The economy: business plan, active participation of SMEs, EU competitiveness, clearly end user driven, clear target application, cost-effective, reducing healthcare costs, regulatory registration and commercialization is appropriate The decision makers: lead to prevention strategies, connection with standardization agencies The society: improvement of public health, lead to prevention strategies, communication plan impressive, broad potential application, multiple therapeutic areas-other diseases, Great impact at EU and international level, strong engagement from the end user community Effective IP management plan Connection with relevant national and international initiatives Impact: Low impact on Points négatifs The economy: market analysis is unconvincing, potential exploitation by the partner SMEs is not sufficiently considered, commercialization impact is difficult to trust, no Work Package on data management the society: disease not that frequent/only bring a change to a relatively small patient population, impact care, public care recommendation and health policy are missing, lack of communication towards the final user, impact for the patient is not sufficiently substantiated Intellectual property rights not detailed Synergies with previous EU funded project expected

49 Implementation: Points positifs Points négatifs Clarity of the description: management structures, risk management plan, tasks allocations: clear, well described and well balanced Lack of clarity/description: validation of results not enough described, management structure not convincing, proposed business plan insufficient, models should be better described, IP description insufficient Risk not well evaluated Balance of powers (tasks, budget) between partners: good balances between SME and academic partners/cross-disciplinary expertise, scientific and ethic board /advisory board with cliniciens, reseachers and ethical experts Consortium needs more expertise, some partners are assigned to too many tasks( coordinator Expertise of partners: reknown scientists complementarity of partners, pre-existing links, partners already involved in other EU projects,

50 Se mettre à la place de l évaluateur: être convainquant Attention à la partie «excellence» : ambition du projet, pourquoi le projet doit être financé? En dessous de 4/5, les autres parties du projet ne sont pas évaluées 14/09/2015

51 Merci de votre attention 14/09/2015