Déﬁsanté,évoluondémographique etbienêtre · 2015-09-28 · Excellence$ Avec!ce!critère,!les!experts!évaluent:!! alaclarté!etlaperAnence!des!objecAfs! alacrédibilité!de!l’approche!proposée!

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



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


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)


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.


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


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


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



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


•  21 above thresholds – all funded


3rd cut-off - 17 December

•  195 proposals submitted • 32 above thresholds – all funded


2014 2014 1st cut-off – 9 October


•  30 above thresholds

•  10 projects funded

•  Average project size: €3,3 m


2nd cut-off - 17 December

•  91 proposals submitted • 37 above thresholds

•  9 projects funded

•  Average project size: €3,3 m


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


•  Instrument PME •  Fast track to innova.on •  IMI •  Autres appels


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




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

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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

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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

24/09/2015

Merci de votre aben.on

[email protected]

www.horizon2020.gouv.fr

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Déﬁsanté,évoluondémographique etbienêtre · 2015-09-28 · Excellence$ Avec!ce!critère,!les!experts!évaluent:!! alaclarté!etlaperAnence!des!objecAfs! alacrédibilité!de!l’approche!proposée!