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Défi santé, évolu.on démographique et bien-‐être Génopole Evry, 22/09/2015
Virginie Sivan, PhD Affaires européennes, Direc.on des Sciences du Vivant, CEA Représentante CEA au PCN
PCN Santé, évolu.on démographique et bien-‐être
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 foncAonnement du programme
• Interface avec la CE: • Dépôt • PréparaAon des prochains
WP • Au service de tous les parAcipants
français
hMp://www.horizon2020.gouv.fr/pid29768/sante.html
Horizon 2020
+ ERANET + JPI
Fast track to innova.on
Horizon 2020: objec.fs PME
ObjecAf CE 20% du budget des piliers 2 et 3 ciblé sur les PMEs
projets CollaboraAfs
13%:projets collab 7%: Instrument PME
Eurostars II Enhancing InnovaAon
Capacity Market-‐driven InnovaAon
+
• Règles de par.cipa.on et de financement • Le défi santé, évoluAon démographique et bien être
• Instrument PME • Fast track to innovaAon • IMI • Autres appels
• Retours sur rapports d’évaluaAon santé
24/09/2015
Règles de par.cipa.on 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 http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/3cpart/h2020-hi-3cpart_en.pdf • 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 • « Time to grant »: 8 mois (soumission→résultat: 5 mois résultat → financement:
3 mois ) Il n’y a plus de phase de négociation
Excellence Avec ce critère, les experts évaluent : -‐la clarté et la perAnence des objecAfs -‐la crédibilité de l’approche proposée -‐le bien-‐fondé du concept, incluant la mulAdisciplinarité, si c’est perAnent -‐le degré d’ambiAon du projet, le potenAel d’innovaAon, et jusqu’à quel point le projet va au de la de l’état de l’art (ex : objecAfs révoluAonnaires, 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" perAnent ; -‐améliorer la capacité d’innovaAon et d’intégraAon de nouvelles connaissances ; -‐renforcer la compéAAvité et la croissance des entreprises en développant des innovaAons répondant aux besoins des marchés européens et globaux, et si c’est perAnent, en fournissant les innovaAons aux marchés ; -‐prendre en compte les autres impacts environnementaux et sociétaux importants. -‐de plus, la proposiAon doit convaincre de l’efficacité des mesures proposées pour communiquer sur le projet, diffuser et / ou exploiter les résultats du projet, en incluant la gesAon 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’adéquaAon de la réparAAon des tâches et des ressources ; les compétences et expériences des parAcipants et la complémentarité des parAcipants individuellement, ainsi que du consorAum dans son ensemble ; l’adéquaAon des structures de management et des procédures, en incluant la gesAon des risques et de l’innovaAon.
Ne pas négliger les aspects importants
• Aspect éthique (expérimentaAon humaine et animale )
• Aspect genre dans le projet et dans le consorAum Gender balance in research teams, Gender balance in decision-‐making , IntegraAng gender/sex analysis in R&I content
• ImplicaAon des décideurs poliAques, associa.ons de pa.ents et acteurs de la société civile
• NoAon d’open access et d’open data/ Plus globalement de data management
Règles de financement
Topic ouvert
« Non-‐profit » organisa.ons
Entreprises
Recherche et InnovaAon (RIA) 100% 100%
InnovaAon (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 déducAble éligible
Comment lire une ligne d’appel?
Titre et Date du call
Thème
Défi spécifique à relever
jus.fica.on
Périmètre de l’ac.on à adresser
Impact abendu en lien avec le
défi
Type de projet
Area: Understanding health, ageing and disease
Titre et date du call
PM 03 – 2016 -‐ Networking and op.mising the use of popula.on cohorts at EU level [RTD] Specific challenge: PopulaAon cohorts are invaluable resources to obtain detailed descripAon of individual biological variaAons in connecAon with a variety of environmental, […] However, the lack of integraAon of these cohorts hampers the opAmal exploitaAon of these resources, essenAal to underpin and facilitate the development of straAfied and personalised medicine. Scope: The proposals should aim at maximizing the exploitaAon of cohorts by bringing together naAonal and/or European cohorts with common scienAfic […] European infrastructures and addiAonal collaboraAons with relevant internaAonal iniAaAves are encouraged. Proposals should also engage with relevant internaAonal/naAonal/regional authoriAes to ensure that findings are implemented and translated into health policy. The Commission considers that proposals requesAng a contribuAon 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 selecAon of proposals requesAng other amounts. Expected impact: Expected impacts include one of or a combinaAon of the following point(s): • Contribute to providing novel informaAon on health maintenance, onset and course of diseases, or populaAon straAficaAon, with a view to tailor diagnosis or to opAmise treatment. • OpAmise the use of populaAon cohorts in defining/improving clinical pracAce and public health policy. • Make major conceptual, methodological and analyAcal contribuAons towards integraAve cohorts
Type of acAon: RIA
Indica.on Budget
• Règles de parAcipaAon et de financement • Le défi santé, évolu.on démographique et bien être
• Instrument PME • Fast track to innovaAon • IMI • Autres appels
• Retours sur rapports d’évaluaAon santé
24/09/2015
• Changement démographique • Accroissement du fardeau des maladies non-‐transmissibles/
« lifestyle » • AugmentaAon du coût de la santé & de la pression sur les systèmes
de santé • AugmentaAon des coûts du développement des médicaments,
vaccins, disposiAfs médicaux… • Pas assez de preuves des avantages et de l’efficacité, des approches
et praAques actuelles
Contexte du défi Santé
à Promouvoir le vieillissement acAf et en bonne santé à Favoriser une approche « tout au long de la vie » à financement de projets à grande échelle à Soutenir le transfert vers la clinique à Réduire les inégalités dans le domaine de la santé à UAlisaAon des infrastructures européennes
Dral accessible: hMps://ec.europa.eu/programmes/horizon2020/en/dra|-‐work-‐programmes-‐2016-‐17 Calendrier: 21 appels -‐ Appel 2016:
-‐ PublicaAon (ouverture sur PP): 14 octobre 2015 -‐ Appels en 1 étape (PM7, PM8, -‐ Dépôts: dates différentes: janvier, février, avril 2016
-‐ Appel 2017 -‐ PublicaAon le 20 septembre ou le 8 novembre 2016
REVERIFIER! -‐ appels en 1 étapes sauf PM2, 7, 8, 10 en 2 étapes -‐ Dépôts: janvier, mars, avril 2017
à Vérifier dates par ligne dans le WP« condiAons for the call » 24/09/2015
Résumé de l’appel
La majorité en 1 étape
Défi SANTE – WP 2016-‐2017 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,
4-Active ageing and self-management of health TIC, robotique, solutions pour l’autonomie du patient
5- Methods and data
Essais in-silico, sécurité des données numériques, modélisation, big data pour la santé 6-Health care provision and integrated care
TIC
TIC
40% du budget sur appels TIC
Understanding health, well-‐being and disease Budg. projet
Budget total
Type
PM01 2016 Mul, omics for personalised therapies addressing diseases of the immune system
12-‐15 30 RIA
Integrate and use high quality genome-‐epigenome-‐proteome-‐metabolome-‐microbiome data /combine these with disease-‐oriented func.onal analysis -‐ Relevant biomarkers for clinical validaAon à targeted therapies for diseases of the immune system -‐ Omics data (from internaAonal iniAaAves) + lifestyle/env data, funcAonal, imaging… -‐ InternaAonal cooperaAon / mulAdisciplinarity
PM02 2017 New concepts in pa-ent stra-fica-on 4-‐6 40 RIA
= New concepts/models of PS to be clinically validated -‐ Any disease with high economic impact, except rare disease -‐ acAvely involve pa.ent associa.ons and regulators -‐ Longitudinal and mulAdimensional data + omics tools -‐ Models’ cost-‐effecAveness -‐ SMEs
PM03 2017 Diagnos-c characterisa-on of rare diseases ~ 15 15 RIA
= Molecular characterisaAon of undiagnosed RD. Lien IRDiRC. – Group of diseases -‐ GeneAc variability due to gender + ethnicity ; sex + gender + age parameters -‐ ClassificaAon of RD: common standards & terminologies -‐ Data sharing
PM04 2016 Networking and op,mising the use of popula,on and pa,ent cohorts at EU level
8-‐10 30 RIA
-‐ PopulaAon cohorts . Link with INFRA, internaAonal iniAaAves. -‐ Novel informaAon on health maintenance, onset, disease : diagnosAc tool/treatment. -‐ Support to Health policy (prevenAon, early diagnosis, therapies, health economics and inequaliAes)
Défi SANTE – WP 2016-‐2017 Personalized Medicine (PM)
4 oct 16-‐ 11 avr 17
11 avr 17
13 avr 2016
13 avr 2016
Preven.ng disease Budget projet
Budgtotal
Type
PM06 2016 Vaccine development for malaria and/or neglected infec,ous diseases 3 à 5 15 à 20
40 RIA
= large research pla�orms developing mulAple vaccine candidates and/or vaccines for mulAple 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 anAcipated.
PM07 2017 Promo-ng mental health and well-‐being in the young 2-‐4 20 RIA
-‐ PopulaAon-‐oriented primary prevenAon intervenAons . Target group: up to 25 years. -‐ Based on exisAng 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 miAgaAng the impact of risk factors -‐ PrevenAon intervenAons + assessment of their effecAveness (mental health and well-‐being
outcomes + economic and social benefits and impact on reducing inequaliAes) -‐ MulA-‐disciplinary approach. -‐ Includes the young themselves (empowerment) + relevant stakeholders. -‐ Gender and health inequality aspects
Défi SANTE – WP 2016-‐2017 Personalized Medicine (PM)
4 oct 16-‐ 11 avr 17
13 avr 2016
Treating and managing diseases
PM09 2016 New therapies for chronic diseases 4-‐6 60 RIA
Comme PHC 13 avec précisions. Chronic diseases: non-‐transmissible + infec-ous chronic diseases -‐ Dvppt of novel therapies (pharmacological as well as non-‐pharmacological) or the opAmisaAon 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
PM10 2017 Comparing the effec-veness of exis-ng healthcare interven-ons in the adult popula-on
4-‐6
40 RIA
-‐ clinical and safety parameters to be taken into account -‐ Assessment of health and socio-‐economic outcomes (e.g. quality of life, paAent mortality,
morbidity, costs, and performance of the health systems) -‐ costs-‐effecAveness analysis to be done -‐ Gender & socio-‐economic aspects to be included (when relevant for the 2nd item) Examples of studies: randomised controlled trials, pragma-c trials, observa-onal studies, large scale databases and meta-‐analyses
PM11 2016+2017 Clinical research on regenera,ve medicine 4-‐6 30 -‐ 30 RIA
Comme PHC 15 (to be split in 2 topics) -‐ Later clinical stage preferred. Have preliminary results + authorisaAon (or close to) -‐ JusAficaAon of choice of disease
PM08 2017 New therapies for rare diseases 4-‐6 60 RIA
-‐ Link with paAent organisaAons+ Member States health authoriAes -‐ efficacy/potenAal clinical benefit + health economics. -‐ SMEs Préalable: ODD (EMA)
Défi SANTE – WP 2016-‐2017 Personalized Medicine (PM)
4 oct 16-‐ 11 avr 17
13 avr 2016
13 avr 2016
4 oct 16-‐ 11 avr 17
Ac.ve and healthy ageing PM12 2016 PCP-‐eHealth innova,on in empowering the pa,ent 4 18 PCP
PCP for R&D of new services / integraAon of exisAng services Increasing the level of interacAons between the user and the health professional, enabling users to controle their health condiAons and adhere to prescribed medical plans. Ex: telemedicines for follow-‐up of pa-ent (chronic and rare diseases), e-‐mental healthfor pa-ent empowerment, domes-c rehabilita-on (physical and cogni-ve) under remote professional supervision; Key documents: eHealth acAon plan 2012-‐2020 + mHealth green paper.
PM13 2016 PPI for deployment and scaling up of ICT solu.ons for ac.ve and healthy ageing 2-‐5 10,5 PPI
= specify, purchase and deploy ICT-‐based soluAons for acAve and healty ageing Key document: scaling-‐up road map of the EIP. Co-‐fund up to 40% of total costs
PM14 2016 EU-‐JAPAN coopera.on on novel ICT Robo.cs based solu.ons for ac.ve and healthy ageing at home or in care facili.es.
2-‐3 5 RIA
Developing and demonstraAng ICT roboAcs based soluAons for extending acAve and healthy ageing -‐ mulAdisciplinary research (including behaviour/SSH) -‐ Modularity, cost-‐effecAveness, reliability, flexibility (=adaptaAon to needs & lifestyle of older people) -‐ Safety and acceptability -‐ Test site in EU and Japan, with sufficient users (for validaAng) -‐ NoAon of spreading services (use of generalized infrastructure cloud systems, open source) +
interoperability, standardizaAon, open pla�orms, Internet of things approach -‐ Max 36 months, no other third country partner, consorAum 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 acAvity, risk avoidance, leisure.from a physical, mental and cogniAve, and social point of view) -‐ Take into account gender and ethics aspects. -‐ User-‐centred. Cost-‐effecAveness.
Défi SANTE – WP 2016-‐2017 Personalized Medicine (PM)
31 janv 17
16 fev 2016
13 avr 2016
19 janv 2016
TIC
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, Assue, organism) and the interacAon with the product To take into account the variability between individuals (geneAcs, gender, microbiota etc) To build virtual paAents or populaAons for predicAng tratments outcomes >>Personalised medicine MulAdisciplinary approach: computaAonal modelling, systems biology, Assue mechanismes, biology, pharmaceuAcs, medicine -‐ To be included: simulated trials; measures for validaAon (human trials, animal studies, validaAon 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 simulaAons systems able to aggregate various informaAons (biochemical, imaging, medical, lifestyle, …etc) into robust predictors for resilience and recovery -‐ MulAscale (Ame and spaAal scales) approach; paAent-‐specific -‐ MulAdisciplinary : medicine, SSH and ICT -‐ Based on exisAng large database (clinical medicine, biomedical/ocupaAonal research,
environmental sciences and SSH
Défi SANTE – WP 2016-‐2017 Personalized Medicine (PM)
14 mars
2017
14 mars 2017
TIC
Methods and data PM18 2016 Big Data suppor.ng Public Health policies [CNECT] 3-‐5 10 RIA
= AcquisiAon, management, sharing, modelling, processing and exploiAng big data into integrated soluAons to support to health policy (decision marking): ex combined effect of environment, lifestyle and geneAcs 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]
3-‐4 8,26 PPI
EHealth interoperability
PM20 2017 Development of new methods and measures for improved economic evaluaAon and efficiency measures in the health sector
9 RIA
Topic to be developped during the course of 2016
Health care provision and integrated care PM21 2016 Implementa.on research for scaling-‐up of evidence based innova.ons
and good prac.ce in Europe and low-‐ and middle-‐income countries 4-‐6 40 RIA
-‐ Based on implementaAon research concept = « scien-fic study of methods to promote the uptake of research findings ».
-‐ Selected intervenAon to be scale up: to make health systems and services more responsive, person-‐centred, safe, effecAve and efficient. Large scope (in terms of content + geographical coverage)
-‐ Gender issues & Multdisciplinary research -‐ Socio-‐eco-‐poliAcal analysis to be done + organizaAon and business model of the intervenAons -‐ Include stakeholders and end-‐users into the project
Défi SANTE – WP 2016-‐2017 Personalized Medicine (PM)
14 mars 2017
11 avr 2017
16 fev 2016
13 avr 2016
TIC
• Règles de parAcipaAon et de financement • Le défi santé, évoluAon démographique et bien être
• Instrument PME • Fast track to innovaAon • IMI • Autres appels
• Retours sur rapports d’évaluaAon santé
24/09/2015
Condi.ons de par.cipa.on • Seules les PME (définition européenne) peuvent postuler en tant que partenaires, les autres participants éventuels sont des sous-traitants
• PME établie dans un pays membre de l’UE ou associé
• Pour les PME innovantes ayant pour ambition de se développer et d’avoir un impact sur le plan international
Modalités de mise en œuvre
• Une entreprise seule peut déposer un projet
• Les projets peuvent être soumis à tout moment: 4 dates butoir par an
• 100 % ou 70% des coûts directs éligibles en fonction des appels
• Instrument en 3 phases sans obligation de candidater aux 3 phases
• Critères d’évaluation
Impact x 1,5
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
• Miniaturisa.on, design • Market valida.on • Etc.
• Facilitate access to private finance
• Support via networking, training, coaching, knowledge sharing, dissemina.on
• • • • •
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
Business plan+étude de faisabilité
validaAon clinique proposée
Répondre au challenge proposé / strategic business
plan
2016+2017 a) Cell technology in medical applicaAons ; Phase 1 et 2
Cell technology = large scope but focus on mulAple medical area applicaAons (commercial potenAal increased) Cells from eucaryoAc sources /applicaAon human medicine
2017 b) Clinical research for the valida-on of biomarkers and/or diagnos-c medical devices Phase 2 only
-‐ Comme PHC 12, mais phase 2 seulement en 2017 -‐ (cuM of date phase 1 et 2 PHC-‐12 2014-‐2015 le 25 nov 2015)
Défi SANTE – WP 2016-‐2017
INSTRUMENT PME (RTD)
SMEInst-‐05-‐2016-‐2017: Suppor.ng innova.ve 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%
Lien vers le dernier call 2014-‐2015
25/11/2015: phase 1 & 2 cut-‐off 18/01/2017: phase 2 only cut-‐off
2016: 4 cut-‐offs in phase 1 & 2 2017: 4 cut-‐offs in phase 1 & 2
To help to overcome the current gaps in exploita-on 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 solu-ons for consumers and ins-tu-onal healthcare (see e health in digital Agenda ) -‐New ICT solu-ons and innova-on ecosystems for ageing well building on open soYware plaZorms
Défi SANTE – WP 2016-‐2017
INSTRUMENT PME (CNECT)
SMEInst-‐06-‐2016-‐2017: Accelera.ng market introduc.on of ICT solu.ons 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%
2016: 4 cut-‐offs in phase 1 & 2 2017: 4 cut-‐offs in phase 1 & 2
PHC-12: Phase 1 Phase 2
1st cut-off - 18 June
• 208 proposals submitted
• 24 above thresholds – all funded
• Success rate: 11,5%
2nd cut-off - 24 September
• 152 proposals submitted
• 21 above thresholds – all funded
• Success rate: 13,8%
3rd cut-off - 17 December
• 195 proposals submitted • 32 above thresholds – all funded
• Success rate: 16,4%
2014 2014 1st cut-off – 9 October
• 81 proposals submitted
• 30 above thresholds
• 10 projects funded
• Average project size: €3,3 m
• Success rate: 12,3%
2nd cut-off - 17 December
• 91 proposals submitted • 37 above thresholds
• 9 projects funded
• Average project size: €3,3 m
• Success rate: 10,1%
Accompagnement/orienta.on • Points de Contact NaAonaux hMp://horizon2020.gouv.fr • PCN PME H2020: pcn-‐[email protected] • Risk Finance Marie-‐[email protected] • Réseau Entreprise Europe hMp://een.ec.europa.eu/index_fr.htm • SouAen financier au montage de projet hMp://bpifrance.fr
• Règles de parAcipaAon et de financement • Le défi santé, évoluAon démographique et bien être
• Instrument PME • Fast track to innova.on • IMI • Autres appels
• Retours sur rapports d’évaluaAon santé
24/09/2015
… the soluAon or innovaAon proposed must be relaAvely mature / close-‐to-‐market already…!
• Time-‐to-‐market: 36 months or less (from the moment of the start of the FTI pilot acAon!) • Level of development ~ TRL 6 (for technological innovaAons), and similar level of maturity for
the non-‐technological ones • Further development (up to TRL 9 or equivalent for non-‐technological innovaAons) possible in a
relaAvely limited amount of Ame, and underpinned by a technical and a commercial planning • UlAmate objecAve: significant value creaAon at the EU level (and beyond) / hit the market
Nouvel instrument pilote sur 2015-2016 hbps://ec.europa.eu/research/par.cipants/portal/desktop/en/opportuni.es/h2020/topics/9096-‐lipilot-‐1-‐2015.html
Fast Track to Innova.on
Fast Track to Innova.on Type of activity funded: -Advanced and specific research and development activities -Standard setting and advanced performance testing / piloting / demonstration activities -Validation of solutions in real working conditions / certification -Business model validation TRL6, Prototype demonstration in relevant environment. Budget: € 1-2 million (max 3), projet d’un à deux ans Budget total 2015: € 100 million Appels Bottom up Financement 70% (ou 100% pour académique) Time to market: 3 ans Critère impact +++ (business plan à inclure) Consortia: Industriels – Petit consortium (3 à 5 partenaires maximum). Un des deux critères suivants doit être respecté: - at least 60% of the budget must be allocated to consortium partner(s) from industry
-or the minimum number of industry participants must be 2 in a consortium of 3 or 4 partners, and 3 in a consortium of 5 partners.
Bénéficiaires peuvent être start-ups (mais ne finance pas la création d’entreprises), académiques/organisations de recherche, clusters/end-users/incubators, « First-time industry applicants to Horizon 2020 and SMEs are particularly welcome”
Deadlines 2015: 01/12/2015
• Règles de parAcipaAon et de financement • Le défi santé, évoluAon démographique et bien être
• Instrument PME • Fast track to innovaAon • IMI • Autres appels
• Retours sur rapports d’évaluaAon santé
24/09/2015
IMI 2 www.imi.europa.eu
Partenariat Public-‐Privé avec
l’industrie
IMI-2: Innovative Medicine Initiative
• ObjecAf général: “Development of tools and • therapies for the right preven.on and treatment,
to the right pa.ents, at the right .me”
3 Billion euros
1,5 B€ 1,5 B€
→ IniAaAve conjointe de la CE et des industriels de l’industrie pharmaceu.que EFPIA (FédéraAon européenne des associaAons et industries pharmaceuAques)
Budget
More en..es eligible for funding
• Academic insAtuAons
• Research organisaAons
• Small & medium-‐sized enterprises (SMEs)
• NEW Mid-‐sized enterprises (≤ 500M)
• Non-‐profit paAent organisaAons
• Non-‐profit public bodies and intergovernmental
organisaAons including specialised agencies
NEW established in a Member State / associated country
37
Topic definition phase: Iden.fica.on of topics and willingness to collaborate by EFPIA companies (au moins 2 ind)
Appels IMI: le process
Stage 1: Submission of short proposals by applicant consortia & evaluation by independent experts
Pa.ents’ organisa.ons
Academic research teams
Regulators
Hospitals
SMEs
Mid-‐size enterprises
Industry consortium
Stage 2: Preparation of full proposal & evaluation by independent experts/ethical panel
industry consortium
Applicant consortium
Selected consor.um invited to merge with the industry consor.um
call publica.on Au fil de l’eau
IMI2: Call 5 http://www.imi.europa.eu/content/imi2call5launch
• 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
FUTURE TOPICS (CALL 6)
• Development of Quantitative System Toxicology (QST) approaches to improve the understanding of the safety of new medicines
• Establishing impact of RSV (respiratory syncytial virus) infection, resultant disease and public health approach to reducing the consequences
Topics under the Big Data for Better Outcomes programme: • Real World Outcomes Across the AD (Alzheimer’s disease) Spectrum (ROADS) to Better Care
• Development of an outcomes-focused platform to empower policy makers and clinicians to optimise care for patients with haematologic malignancies
hMp://www.imi.europa.eu/content/future-‐topics
8
Submit an idea:
Directement à l’EFPIA: -‐ En ligne avec l’agenda stratégique: The right preven.on and treatment, to the right pa.ent at the right .me -‐ Template
-‐ Réponse sous 2 mois de la possibilité de créer un call
-‐ hbp://imi.efpia.eu/imi2/create-‐your-‐imi2
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24/09/2015
Panorama des financements ERA-‐nets en santé (par.cipa.on FR)
Maladies rares (renouvelé)
Cancer (renouvelé)
Nanomédecine (renouvellement à venir)
Neurosciences
Maladies infecAeuses Humaines Exclusion : VIH, hépa-tes, malaria et tuberculose
Médecine systémique (nouveau – lancé en 2015)
Biologie de Synthèse
Panorama des financements européens ERA-‐nets en santé (par.cipa.on FR)
• Appels lancés au niveau des agence naAonale de financement. àEn FR: ANR, BPI (selon les ERA-‐NEts) • Pays parAcipants à chaque ERA-‐Net peut varier. àCondiAon 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 AnAmicrobial resistance
ERA-‐Net on Cardiovascular disease
Ini.a.ve de Programma.on Conjointe
INITIATIVE CONJOINTE DANS LE DOMAINE DES MALADIES NEURODÉGÉNÉRATIVES
à Me\re en commun de manière plus efficace les forces de recherche sur les maladies neuro
dégénéra,ves
NUTRITION
RÉSISTANCE ANTI-‐MICROBIENNE Appel à projets transnaAonal sur les approches novatrices pour luMer contre la résistance
an.bactérienne
EXCELLENCE SCIENTIFIQUE
PRIMAUTE INDUSTRIELLE DEFIS SOCIETAUX
Projets collabora.fs en Santé
ERC European Research
Council
FET Future Emerging Technologies
AcAons Sklodowska Marie Curie
Infrastructures
TIC Technologies clefs génériques (LEIT)
microélectronique, photonique, nanotechnologies, matériaux avancés,
Systèmes de producAon, biotechnologies
Espace
Accès au financement à risque
InnovaAon dans les PME
Santé Sécurité alimentaire
Energie Transport
Changement climaAque
Sociétés inclusives Sécurité
Call Co-ordination activities (HCO)
Healthy and safe foods and diets for all Budget call
Type
SFS-‐38 2016 Encouraging healthy dietary choices in childhood and measuring its impact on health
9M RIA
SFS-‐39 2017 The impact of consumer pracAces in biological and chemical food safety risks and miAgaAon strategies
10M RIA
SFS-‐40 2016 Impulsivity and compulsivity and the link to nutriAon, lifestyle and the socio-‐economic environment
12M RIA
SFS-‐41 2017 How to tackle the obesity epidemic? 13M RIA
SFS-‐42 2017 Sweeteners and sweetness enhancers 9M RIA
Two-‐stages: -‐ 1st stage: 02/03/2016, -‐ 2nd stage: 14/09/2016
Défi 2: WP 2016-2017
EXCELLENCE SCIENTIFIQUE
PRIMAUTE INDUSTRIELLE DEFIS SOCIETAUX
Projets collabora.fs en Santé
ERC European Research
Council
FET Future Emerging Technologies
AcAons Sklodowska Marie Curie
Infrastructures
Technologies clefs génériques (KET) • TIC • Nanotechnologies, • Matériaux avancés, • Systèmes de producAon,
Biotechnologies • Espace
Accès au financement à risque
InnovaAon dans les PME
Santé Bioéconomie
Energie Transport
Changement climaAque
Sociétés inclusives Sécurité
Key enabling technologies for societal challenges -‐ Advanced materials and nanotechnologies for healthcare
Budget projet
Type
NMBP9 2016 Biomaterials for diagnosis and treatment of mulAple sclerosis . TRL3-‐5
5-‐8 RIA
NMBP10 2016 NanoformulaAon of biologicals TRL 3 /4 to 5 / 6.
5-‐6 RIA
NMBP12 2017 Development of a reliable methodology for beMer 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 raAo of Nanomedicines and Biomaterials. TRL3-‐7
3-‐7 RIA
NMBP15 2017 Nanotechnologies for imaging cellular transplants and regeneraAve 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
24/09/2015
ANALYSES ESR 2014 Calls en 2 étapes
Analyse des ESR (1er lot) Méthode: • Analyse des PHC 2014 en deux étapes • ESR à coordinaAon FR: réussite et échec • ESR toute coordinaAon : réussite • 1er jet avant analyse plus ciblées / existe une base de donnée avec les commentaires par PHC
Excellence: Points posi,fs Points néga,fs
• Clarity/Coherence: objecAves clear, perAnent, 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, potenAal to create a paradigm shi|, several novel concepts ambiAous, original and innovaAve
• Preliminary data: data from exisAng cohorts, based on previous FP projects, biobanks, well-‐supported by cited literature, building on robust preliminary work, build on preclinical data
• Challenge driven: high unmet medical or clinical need, diseases with high prevalence and high, socio-‐economic impact, Cost effecAve, EU added value, knowledge can be applied to different EU policies
• Interdisciplinarity • Intersectorial: SMEs, Hospitals, paAents
organisaAons
• Gender
• Clinical trials: number of paAents in trial small/not sufficient/ no staAsAcal 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 validaAon on animal models/lack of longitudinal studies
• Over ambi.ous within the Ame frame, not
credible, risk management not sufficiently described, going into clinical trials is premature
• Lack descripAon on ethics
• Consor.um do not have the experAse (or not proved)
Impact: Points posi,fs Points néga,fs
• Dissemina.on and exploita.on of the results for the benefit of v The scien.fic community: Data management
plan, open-‐innovaAon pla�orm v The economy: business plan , acAve
parAcipaAon of SMEs, EU compeAAveness, clearly end user driven, clear target applicaAon , cost-‐effecAve, reducing healthcare costs, regulatory registraAon and commercializaAon is appropriate
v The decision makers: lead to prevenAon strategies, connecAon with standardizaAon agencies
v The society: improvement of public health, lead to prevenAon strategies, communicaAon plan impressive, broad potenAal applicaAon, mulAple therapeuAc areas-‐other diseases, Great impact at EU and internaAonal level, strong engagement from the end user community
• Effec.ve IP management plan • Connec.on with relevant na.onal and
interna.onal ini.a.ves
• Low impact on
v The economy: market analysis is unconvincing, potenAal exploitaAon by the partner SMEs is not sufficiently considered, commercializaAon impact is difficult to trust, no Work Package on data management
v the society: disease not that frequent/only bring a change to a relaAvely small paAent populaAon, impact care, public care recommendaAon and health policy are missing, lack of communicaAon towards the final user, impact for the paAent is not sufficiently substanAated
• Intellectual property rights not detailed • Synergies with previous EU funded project
expected
Implementa.on: Points posi,fs Points néga,fs
• Clarity of the descrip.on: management structures, risk management plan, tasks allocaAons: clear, well described and well balanced
• Balance of powers (tasks, budget) between partners: good balances between SME and academic partners/cross-‐disciplinary experAse, scienAfic and ethic board /advisory board with cliniciens, reseachers and ethical experts
• Exper.se of partners: reknown scienAsts complementarity of partners, pre-‐exisAng links, partners already involved in other EU projects,
• Lack of clarity/descrip.on: validaAon of results not enough described, management structure not convincing, proposed business plan insufficient, models should be beMer described, IP descripAon insufficient
• Risk not well evaluated
• Consor.um needs more experAse, some partners are assigned to too many tasks( coordinator
• Se meMre à la place de l’évaluateur: être convainquant
• AMenAon à la parAe « excellence » : ambiAon du projet, pourquoi le projet doit être financé? – En dessous de 4/5, les autres parAes du projet ne sont pas évaluées
24/09/2015
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