Défi santé, évolution démographique et bien-être. Dr. Guillaume FUSAI MENESR Point de Contact National Santé

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1 Défi santé, évolution démographique et bien-être Dr. Guillaume FUSAI MENESR Point de Contact National Santé

2 PCN Santé, évolution démographique et bien-être

3 Qui est on:

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5 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, ) 5

6 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 6

7 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» sont financés (cf liste ci-dessous ) ou expressément prévu dans le programme de travail hi-3cpart_en.pdf Certains pays ont des programmes nationaux ( ex: Mexique, Australie, Canada, ) Des critères d évaluation simples et uniformes Excellence Impact Mise en œuvre wp1415-annex-h-esacrit_en.pdf

8 Ne pas négliger les aspects importants Implication des PME Aspect éthique (expérimentation humaine et animale ) Aspect genre dans le projet et dans le consortium Implication des décideurs politiques, associations de patients et acteurs de la société civile Notion de data management (+ open access et open data volontaire) (Data Management Plan are incited to identify the existing European research data infrastructures that may be used and how these may be mobilised, in particular for long-term data curation and preservation)

9 Règles de financement - Taux de financement des coûts directs éligibles Taux de financement des coûts indirects éligibles «Non-profit» Entreprises Topic ouvert organisations Recherche et Innovation (RIA) 100% 100% Innovation (IA) 100% 70% Forfait de 25% des coûts directs éligibles TVA déductible éligible Projets de recherche collaborative = 1 coordinateur + partenaires Projet de R&D RIA-Research & Innovation Action: produire de nouvelles connaissances ou explorer la faisabilité de nouvelles technologies, produits, process, service ou solution etc Projet orienté marché IA-Innovation Action: développement de produits, services ou procédés nouveaux etc Instrument PME: dédié au PME

10 Calendrier publication, soumission et évaluation DRAFT PROVISOIRE Programme de travail en cours de modification Publication du WP le 14 octobre sur le «participant portal» de la CE Critères d évaluation: Il existe des seuils de passage Passage à 1 Etape RIA : Seuils : Excellence (4/5), Impact (4/5), Implementation (3 /5) Total: 12/15 (pour innovation action et SME instrument: impact x1,5) «Time to grant»: 8 mois (soumission - résultat 5 mois - phase de négo 3 mois) Budget indicatif : 2016 : 500 M 2017 : 433 M

11 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» la recherche et amplifier sur l existant Soutenir le transfert vers la clinique Réduire les inégalités dans le domaine de la santé Utilisation des infrastructures européennes

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 Défi SANTE WP Focus Personalized Medicine (PM) Understanding health, well-being and disease Preventing disease DG RTD Treating & managing disease Active ageing and selfmanagement of health Methods & Data DG CNECT (TIC) Health care provision and integrated care

16 Active and healthy ageing PM PCP-eHealth innovation in empowering the patient 4 18 PCP 16 fev 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 ,5 PPI = specify, purchase and deploy ICT-based solutions for active and healty ageing 16 Key document: scaling-up road map of the EIP. Co-fund up to 40% of total costs fev PM EU-JAPAN cooperation on novel ICT Robotics based solutions for active and healthy ageing at home or in care facilities. 19 janv 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 31 janv 17 = 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.

17 Methods and data PM In-silico trials for developing and assessing biomedical products RIA 14 mars Défi SANTE WP Personalized Medicine (PM) 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 Personalised computer models and in-silico systems for well-being RIA 14 mars = 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

18 Methods and data Défi SANTE WP Personalized Medicine (PM) PM Big Data supporting Public Health policies [CNECT] RIA 16 fev = 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 14 mars 8,26 PPI PM Development of new methods and measures for improved economic evaluation and efficiency measures in the health sector 11 avr 17 Health care provision and integrated care 9 RIA PM Implementation research for scaling-up of evidence based innovations and good practice in Europe and low- and middle-income countries 13 avr 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

19 Instrument PME : 3 phases Idea 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

20 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 deveopment - 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)

21 DS 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 IoT Large Scale Pilots : Pilot 1: Smart living environments for ageing well 20 1 IA = 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 01/10/2015

22 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

23 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

24 Echelle TRL (Technology Readiness Level) INNOVATION EMERGING TECHNOLOGIES SYSTEM INTEGRATION MARKET PENETRATION TRL 2 technology concept formulated TRL 3 experimental proof of concept TRL 4 technology validated in lab TRL 5 technology validated in relevant environment (industrial environment in the case of KETs) TRL 6 technology demonstrated in relevant environment (industrial environment in the case of KETs) TRL 7 system prototype demonstration in operational environment TRL 8 system complete and qualified TRL 9 actual system proven in operational environment (competitive manufacturing in the case of KETs; or in space)

25 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

26 NMBP Key Enabling Technologies Photonics: under photonics 21 PPP Micro & nano electronics: under ECSEL JTI ICT : Photonics KET 2016 i. Biophotonics: advancing imaging for in-depth disease diagnosis - to develop innovative, compact, easy to operate non- or minimally invasive functional imaging systems that are multi-band and multimodal (including photonics in combination with non-photonic techniques) - in vivo diagnosis of age and life-style related diseases like cancer, cardiovascular, osteoarticular, eye diseases and various neuro-pathologies, after a positive screening. - The imaging system must be either label-free or based on already/rapidly safetyapproved labels - address unmet medical needs or support a diagnostic approach which is significantly superior to existing approaches. - Physicians/clinicians must be closely involved from requirement specifications to the validation. - Validation in clinical settings included, but clinical trials are excluded. Impact: - secured and reinforced industrial technology leadership in the biophotonics related market for Analysis and Diagnostic Imaging Systems - substantially less invasive and improved diagnosis enabling more effective treatment of age and life-style related diseases RIA, Projet de 2 à 4M. Au moins un projet financé

27 ICT Key Enabling Technologies ICT : Photonics KET 2017 Specific Challenge: reinforcing Europe's industrial competitiveness and leadership in photonic market strengthen its manufacturing base in photonics better exploit the innovation capacity of the photonics SMEs Innovation Actions ii. Application driven core photonic devices integrated in systems: validation and demonstration of photonic based systems for the target applications 1. Biophotonics: imaging systems for in-depth disease diagnosis: demonstration and validation in real-settings of innovative, easy to operate, compact, and non- or minimally invasive imaging systems to support diagnosis of diseases. Actions driven by medical equipment manufacturers (committed to the commercialisation of the solutions). Clinical trials are not covered by these actions and will normally take place after these actions. 2. Sensor devices for process and product monitoring and analysis:

28 ICT Key Enabling Technologies ICT : Cross-cutting KETs for health Specific Challenge: - R&D at the interface of micro-nano bio integrated systems and advanced materials science - novel technological platforms to enhance the ability to sense, detect, analyse, monitor and act on phenomena from macro (e.g. body, tissues) to nano scale (e.g. molecules, genes) - facilitating personalised and preventive health, taking into account relevant health policies. Scope: - novel platforms, techniques or systems validated at the lab, integrating advanced multiple KET - diagnosis, treatment, monitoring and drug delivery - e.g. nano-devices and micro-nano robots for drug delivery; nano-diagnostic devices for neurodegenerative diseases; nano-based system for assessing and monitoring therapy and rehabilitation effectiveness in chronic and degenerative diseases. - start at TRL 4 (ready for manufacturing and clinical validation). IA, 5M

29 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

30 Future and Emerging Technologies (FET) Dead line:

31 Future and Emerging Technologies (FET) FET-Proactive 2016: emerging themes and communities Area 1 - Future technologies for societal change: Being human in a technological world, New science for a globalised world Area 2 - Biotech for better life: Intra- and inter-cell bio-nano-chem technologies, Bio-electronic medicines and therapies, Cognitive neuro-technologies, Area 3 - Disruptive information technologies: Area 4 - New technologies for energy and materials RIA entre 4-10 M Budget total de 80 M avec max. 20 M (1 et 4), 30 M (2 et 3) FET Flagships Autres actions (hors appels classiques) Graphene FET Flagship Core Project (88 M mi 2017) Human Brain Project FET Flagship Core Project (88 M mi 2017) PCN FET : pcn-fet@recherche.gouv.fr

32 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)

33 Merci de votre attention 01/10/2015