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Défi santé, évolution démographique et bien-être
Dr. Guillaume FUSAI MENESR Point de Contact National Santé
PCN Santé, évolution démographique et bien-être
Qui est on:
http://www.horizon2020.gouv.fr/pid29768/sante.html
5
EXCELLENCE SCIENTIFIQUE
EXCELLENCE SCIENTIFIQUE
Positionner l’UE
comme pôle d’Excellence
scientifique mondial
PRIMAUTE INDUSTRIELLE
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, …)
Horizon 2020 = 3 priorités
Centre commun de recherche (JRC) 6
EXCELLENCE SCIENTIFIQUE
PRIMAUTE INDUSTRIELLE
DEFIS SOCIETAUX
Horizon 2020
ERC European Research
Council
13md€
FET Future Emerging
Technologies
6md€
Marie Curie 2,7md€
Infrastructures 2,5md€
Technologies clefs génériques
TIC, microélectronique, photonique,
nanotechnologies, matériaux avancés,
Systèmes de production,
biotechnologies
Espace
13,6md€
Accès au financement
à risque
616m€
Innovation dans les PME
2,8md€
Santé
7,5md€
Bioéconomie 3,9md€
Energie 5,9md€
Transport 6,3md€
Changement climatique
3,1md€
Sociétés inclusives
1,3md€
Sécurité 1,7md€
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€)
Euratom
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
http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/3cpart/h2020-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
http://ec.europa.eu/research/participants/data/ref/h2020/wp/2014_2015/annexes/h2020-wp1415-annex-h-esacrit_en.pdf
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)
Règles de financement
Topic ouvert
« Non-profit » organisations
Entreprises
Recherche et Innovation (RIA)
100% 100%
Innovation (IA) 100% 70%
- Taux de financement des coûts directs éligibles Taux de financement des
coûts indirects éligibles
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
DRAFT PROVISOIRE Programme de travail en cours de modification
• Publication du WP 2016-2017 le 14 octobre sur le «participant portal» de la CE
http://ec.europa.eu/research/participants/portal
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€
Calendrier publication, soumission et évaluation
• 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
Contexte du défi Santé
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
http://ec.europa.eu/research/participants/portal/desktop/en/opportunities/index.html
Ou trouver les calls? PARTICIPANT PORTAL
PARTICIPANT PORTAL
Comment lire une ligne d’appel?
Titre et
Date du call
Thème
Défi spécifique à
relever justification
Périmètre de l’action à adresser
Impact attendu en lien avec le
défi
Type de projet
Area: Understanding health, ageing and disease
Titre et date
du call
PM 03 – 2016 - 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
Indication Budget
Understanding health, well-being and disease
Preventing disease
Treating & managing disease
Active ageing and self-management of health
Methods & Data
Health care provision and integrated care
DG RTD
DG CNECT (TIC)
Défi SANTE – WP 2016-2017
Focus Personalized Medicine (PM)
Active and healthy ageing
PM12 2016 PCP-eHealth innovation in empowering the 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 2012-2020 + mHealth green paper.
PM13 2016 PPI for deployment and scaling up of ICT solutions for active and healthy ageing 2-5 10,5 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
PM14 2016 EU-JAPAN cooperation on novel ICT Robotics based solutions for active and healthy ageing at home or in care facilities.
2-3 5 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
PM15 2017 Personalised coaching for well-being and care of people as they age 3-4 26 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.
Défi SANTE – WP 2016-2017 Personalized Medicine (PM)
19 janv
16 fev
16 fev
31 janv 17
Methods and data
PM16 2017 In-silico trials for developing and assessing biomedical products 4-6 19 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.
PM17 2017 Personalised computer models and in-silico systems for well-being 4-6 19 RIA
= 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
Défi SANTE – WP 2016-2017 Personalized Medicine (PM)
14 mars
14 mars
Methods and data
PM18 2016 Big Data supporting Public Health policies [CNECT] 3-5 10 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
PM19 2017 PPI for uptake of standards for the exchange of digitalised healthcare records [CNECT]
8,26 PPI
EHealth interoperability
PM20 2017 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
PM21 2016 Implementation research for scaling-up of evidence based innovations and good practice in Europe and low- and middle-income countries
4-6 40 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 - Socio-eco-political analysis to be done + organization and business model of the interventions - Include stakeholders and end-users into the project
Défi SANTE – WP 2016-2017 Personalized Medicine (PM)
16 fev
13 avr
11 avr 17
14 mars
Instrument PME : 3 phases
Phase 3 Phase 1 Phase 2 Idea Market
Feasibility Assessment
Innovation / R&D project Commercialisation
• Clinical trials • Development,
prototyping, scaling-up • Miniaturisation, design • Market validation • Etc.
• Facilitate access to private finance
• Support via networking, training, coaching, knowledge sharing, dissemination
• •
•
•
•
Feasibility of concept Risk assessment IP regime Partner search Design study
No direct funding €1 to 5 million ~36 months
100% funding rate in SC1 (for clinical trials) 70% for ICT calls
(DG connect)
€50,000 ~ 6 months
2016+2017 a) Cell technology in medical applications ; Phase 1 et 2
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
- Comme PHC 12, mais phase 2 seulement en 2017 - (cutt of date phase 1 PHC-12 2014-2015 en déc 2015)
Défi SANTE – WP 2016-2017
INSTRUMENT PME (RTD)
SMEInst-05-2016-2017: Supporting innovative SMEs in the healthcare biotechnology sector
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
Taux de financement des
couts directs 100%
11/09/2015
DS-03-2016
2016 Increasing digital security of health related data on a systemic level 3-5 11 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-01-2016
2016 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
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
Défi SANTE – WP 2016-2017
INSTRUMENT PME (CNECT)
SMEInst-06-2016-2017: 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%
EXCELLENCE SCIENTIFIQUE
PRIMAUTE INDUSTRIELLE
DEFIS SOCIETAUX
Projets collaboratifs en Santé
ERC European Research
Council
FET Future Emerging
Technologies
Actions Sklodowska Marie Curie
Infrastructures
Technologies clefs génériques (KET) • TIC • Nanotechnologies, • Matériaux avancés, • Systèmes de production,
Biotechnologies • Espace
Accès au financement à risque
Innovation dans les PME
Santé
Bioéconomie
Energie
Transport
Changement climatique
Sociétés inclusives
Sécurité
Echelle TRL (Technology Readiness Level)
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)
INNOVATION EMERGING
TECHNOLOGIES
SYSTEM INTEGRATION
MARKET PENETRATION
Key enabling technologies for societal challenges - Advanced materials and nanotechnologies for healthcare
Budget projet
Type
NMBP9 2016 Biomaterials for diagnosis and treatment of multiple sclerosis . TRL3-5
5-8 RIA
NMBP10 2016 Nanoformulation of biologicals TRL 3 /4 to 5 / 6.
5-6 RIA
NMBP12 2017 Development of a reliable methodology for better risk management of engineered Biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices . TRL 4-6
5-8 RIA
NMBP13 2017 Cross-KET for Health 5 RIA
NMPB14 2017 Regulatory Science Framework for assessment of risk-benefit ratio of Nanomedicines and Biomaterials. TRL3-7
3-7 RIA
NMBP15 2017 Nanotechnologies for imaging cellular transplants and regenerative processes in vivo TRL 3-4 to 5-6
5-7 RIA
NMBP16 2017 Mobilising the European nano-biomedical ecosystem 55
1-2 CSA
Two-stages 2016: - 1st stage: 08/12/2015 - 2nd stage: 24/05/2016
Two-stages 2017: - 1st stage: 10/11/2016 - 2nd stage: 25/04/2017
Pilier 2 -LEIT : WP 2016-2017
NMBP Key Enabling Technologies 2016-2017
Photonics: under photonics 21 PPP Micro & nano electronics: under ECSEL JTI
ICT6.1 – 2016: 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 safety-approved 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
ICT Key Enabling Technologies 2016-2017
ICT6.2 – 2017: 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:
ICT Key Enabling Technologies 2016-2017
ICT6.4 – 2017: 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€
EXCELLENCE SCIENTIFIQUE
PRIMAUTE INDUSTRIELLE
DEFIS SOCIETAUX
Projets collaboratifs en Santé
ERC European Research
Council
FET Future Emerging
Technologies
Actions Sklodowska Marie Curie
Infrastructures
Technologies clefs génériques (KET) • TIC • Nanotechnologies, • Matériaux avancés, • Systèmes de production,
Biotechnologies • Espace
Espace
Accès au financement à risque
Innovation dans les PME
Santé
Bioéconomie
Energie
Transport
Changement climatique
Sociétés inclusives
Sécurité
Future and Emerging Technologies (FET)
Dead line: 30-09-2015
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 : [email protected]
Trouver des partenaires Utilisez d’abord VOTRE réseau • Utilisez les réseaux de spécialistes des projets européens
Le service de fitforhealth: www.fitforhealth.eu 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: http://cordis.europa.eu/ 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 www.horizon2020.gouv .fr Devenez évaluateurs
http://ec.europa.eu/research/participants/portal/page/experts
Créer votre réseau avec le financement ANR Montage de Réseaux Scientifiques Européens ou Internationaux ( académiques only)
http://www.agence-nationale-recherche.fr/MRSEI-2015
