Les opportunités dans le domaine de la santé - Horizon-2020 appels 2016-2017 Les slides seront disponibles sur le site web du NCP-Wallonie - NCP ...
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Horizon-2020 appels 2016-2017
Les opportunités dans le domaine de la santé
Les slides seront disponibles sur le site web du NCP-Wallonie
François LOUESSE & Pierre FIASSE
Programme H2020
trois priorités
-2-
Disclaimer
Cette présentation se base sur les drafts publiés par la commission européenne en
septembre 2015.
https://ec.europa.eu/programmes/horizon2020/en/draft-work-programmes-2016-17
Ces documents n’ont pas encore été adoptés officiellement par la Commission
Européenne et n’ont pas de valeur légale. Publication annoncée pour le 14/10/2015.
This paper is made public just before the adoption process of the work programme to provide
potential participants with the currently expected main lines of the work programme 2016-
2017.
24/09/2015 -3-
Timing idéal
Drafts fiables
Consortia déjà en formation
Agir avant la fin d’année
24/09/2015 -4-
Ligne du temps approximative
Evaluation
RIA-IA
CSA ~4 5 3
(mois)
14/10/2015 02/2016 07/2016 10/2016
04/2016 09/2016 12/2016
Modèle SC1-PM
24/09/2015 -5-
Programme H2020
trois priorités
-6-
Societal Challenge 1
SC1 “Health, demographic change and well-being”
Call "Personalised Medicine"
- Tendance à la personnalisation, stratification, …
- Importance croissante de l’e-santé (DG-CNECT)
- Grandes initiatives européennes (moins de topics, -38%)
- Budget total moindre (-14% pour 2 ans)
- 2016 uniquement des single stages
- Essais cliniques finançables dans certains sujets (formulaire)
- USA finançables (réciprocité NIH)
- 100% financement (RIA, CSA, SME)
24/09/2015 -7-Societal Challenge 1
SC1 “Health, demographic change and well-being”
Deadlines 2016
- 19/01/2016 un seul topic PM14 (Robotic, Japan, AHA)
- 16/02/2016 Majorité des topics PM 2016
- 13/04/2016 Majorité des topics HCO 2016 (Coordination)
Deadlines 2017
- 04/10/2016 (1st stage)
- 31/01/2017
- 14/03/2017
- 11/04/2017
24/09/2015 -8-Societal Challenge 1
Horizon-2020 SC1 – Quelques projets avec des wallons
• BIOlogical therapy CYCLEs towards tailored, needs-driven, safer and cost-effective management
of Crohn’s disease
• OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly
• Repair of tissue and organ damage in refractory chronic graft versus host disease after
hematopoietic stem cell transplantation by the infusion of purified allogeneic donor regulatory T
lymphocytes
• Enhancing the effectiveness of programs and strategies to prevent youth smoking: a comparative
realist evaluation of 7 European cities
• Clinical Proof of concept for a RNA-targeting Oligonucleotide for a Cystic fibrosis-F508del
MEDication
• Etc.
24/09/2015 -9-Societal Challenge 1
Theme # topic # topic Budget Budget
2016 2017 2016 M€ 2017 M€
Understanding health, well-being and disease 2 2 60 55
Preventing disease 2 1 90 20
Treating and managing diseases 2 3 90 130
Active ageing and self-management of health 3 1 33,5 25
Methods and data 1 4 10 55,3
Health care provision and integrated care 1 0 40 0
Coordination activities 13 3 22,5 30
SME instrument 3 2 53 57,5
24/09/2015 - 10 -Societal Challenge 1
Theme # topic # topic Budget Budget
2016 2017 2016 M€ 2017 M€
Understanding health, well-being and disease 2 2 60 55
Preventing disease 2 1 90 20
Treating and managing diseases 2 3 90 130
Active ageing and self-management of health 3 1 33,5 25
DG CNECT
Methods and data 1 4 10 55,3
Health care provision and integrated care 1 0 40 0
Coordination activities 13 3 22,5 30 DG CNECT
SME instrument 3 2 53 57,5
24/09/2015 - 11 -Societal Challenge 1
Theme # topic # topic Budget Budget
2016 2017 2016 M€ 2017 M€
Understanding health, well-being and disease 2 2 60 55
Preventing disease 2 1 90 20
Treating and managing diseases 2 3 90 130
Active ageing and self-management of health 3 1 33,5 25
Methods and data 1 4 10 55,3
Health care provision and integrated care 1 0 40 0
Coordination activities 13 3 22,5 30 CSA
SME instrument 3 2 53 57,5
24/09/2015 - 12 -Societal Challenge 1
Theme # topic # topic Budget Budget
2016 2017 2016 M€ 2017 M€
Understanding health, well-being and disease 2 2 60 55
Preventing disease 2 1 90 20
Treating and managing diseases 2 3 90 130
Active ageing and self-management of health 3 1 33,5 25
Methods and data 1 4 10 55,3
Health care provision and integrated care 1 0 40 0
Coordination activities 13 3 22,5 30
SME instrument 3 2 53 57,5
Sélection 15 topics
24/09/2015 - 13 -Understanding health,
well-being and disease
SC1-PM-01-2016: Multi omics for personalised therapies addressing diseases of the
immune system
• Use existing data deposited in databases and combine these data with lifestyle and
environmental data,
• International Cancer Genome Consortium (ICGC),
• International Human Epigenome Consortium (IHEC)
• International Human Microbiome Consortium
• final objective development of new targeted therapies for diseases of the immune
system
• International cooperation is requested
• Proposals addressing rare diseases of the immune system are excluded
RIA / 12-15M€ / 2 grants / (CT)
24/09/2015 - 14 -Understanding health,
well-being and disease
SC1-PM-02-2017: New concepts in patient stratification
• deliver novel concepts for disease-mechanism based patient stratification
• integrate multidimensional and longitudinal data and harness the power of -omics,
systems biomedicine approaches, network analysis and of computational modelling.
• validation in pre-clinical and clinical studies
• should focus on complex diseases having high prevalence and high economic impact
• Implication of SMEs
RIA / 4-6M€ / 6-10 grants / CT
24/09/2015 - 15 -Understanding health,
well-being and disease
SC1-PM-03–2017: Diagnostic characterisation of rare diseases
• Rare = not more than 5 per 10 000 persons in the European Union
• apply omics and/or other high-throughput approaches for the molecular
characterisation of rare diseases
• In view of developing molecular diagnoses for a large number of undiagnosed rare
diseases
• shall contribute to the objectives of, and follow the guidelines and policies of the
International Rare Diseases Research Consortium (IRDiRC)
• scientific exchange between stakeholders from countries and regions
RIA / ~15M€ / 1 grant
24/09/2015 - 16 -Understanding health,
well-being and disease
SC1-PM-04–2016: Networking and optimising the use of population and patient cohorts
at EU level
• Maximizing the exploitation of cohorts by bringing together national and/or European
cohorts with common scientific interests
• Taking advantage of new technologies and new type of data
• Synergies with relevant existing European infrastructures and relevant international
initiatives
• Provide the evidence for the development of policy strategies for prevention, early
diagnosis, therapies, addressing health inequalities.
RIA / 8-10M€ / 3 grants
24/09/2015 - 17 -Preventing disease
SC1-PM-06–2016: Vaccine development for malaria and/or neglected infectious diseases
• Address bottlenecks in the discovery, preclinical and early clinical development of new
vaccine candidates (antigens/adjuvants)
• Filoviral diseases excluded
• From a) large research platforms developing multiple vaccine candidates and/or
vaccines for multiple diseases,
• To b) proposals specifically focused on one disease.
• Should take into account existing roadmaps
RIA / a) 15-20 b) 3-5 M€ / Tot 40M€
24/09/2015 - 18 -Preventing disease
SC1-PM-07–2017: Promoting mental health and well-being in the young
• develop population-oriented primary prevention interventions to promote mental well-
being of young people
• young up to 25 years (or a subgroup there of)
• multidisciplinary approach and involve the young themselves and other relevant
stakeholders
• results should be disseminated throughout Europe and beyond
RIA / 2-4M€ / 5-10 grants
24/09/2015 - 19 -Treating and
managing diseases
SC1-PM-08–2017: New therapies for rare diseases
• Rare = not more than 5 per 10 000 persons in the European Union
• Clinical trials on substances (orphan designation / protocol assistance given by the
EMA)
• May also include limited elements of late stage preclinical research and/or
experimental evaluation of potential risks
• From small molecule to gene or cell therapy, novel interventions and/or repurposing of
existing and known interventions
• Available published and preliminary preclinical or clinical results
• Objectives and guidelines of IRDiRC
RIA / 4-6M€ / 10-15 grants / CT
24/09/2015 - 20 -Treating and
managing diseases
SC1-PM-09–2016: New therapies for chronic diseases
• Clinical trials supporting proof of concept of clinical safety and efficacy in humans
• Novel therapies or the optimisation of available therapies (e.g. repurposing)
• For chronic non-communicable or chronic infectious diseases
• Preclinical research should be completed before the start of the project
• Rare diseases and regenerative medicine are not within the scope of this topic
RIA / 4-6M€ / 10-15 grants / CT
24/09/2015 - 21 -Treating and
managing diseases
SC1-PM-10–2017: Comparing the effectiveness of existing healthcare interventions in the
adult population
• Compare the use of currently available preventative or therapeutic interventions
• Preference to interventions with high public health relevance and socio-economic
impact (frequency, costs, quality of life)
• A cost effectiveness analysis must be included
• Make recommendations
• Randomised controlled trials, pragmatic trials, observational studies, large scale
databases and meta-analyses may be considered
RIA / 4-6M€ / 6-10 grants
24/09/2015 - 22 -Treating and
managing diseases
SC1-PM-11–2016-2017: Clinical research on regenerative medicine
• New approach compared to any existing treatment
• Regenerative medicine therapies which are ready for clinical (in-patient) research
• Focus on one specific clinical phase of work (later stages are preferred)
• Preference to proposals which are closest to having approvals for clinical work
• Any disease or condition but a justification for the choice must be provided
• Take into account projects previously funded under this topic in Horizon 2020 (PHC 15
– 2014/2015)
RIA / 4-6M€ / 10-15 grants / CT
24/09/2015 - 23 -Active ageing and
self-management of health
SC1-PM-15-2017: Personalised coaching for well-being and care of people as they age
DG CNECT
• Multi-disciplinary research
• Developing and validating radically new ICT based concepts and approaches
(CNECT) …guidance and care due to age related conditions, in cooperation with their
carers
• Preserving their physical, cognitive, mental and social well-being
• Access to relevant physiological and behavioural data
RIA / 3-4M€ / 6-8 grants
24/09/2015 - 24 -Methods and data
SC1-PM-16–2017: In-silico trials for developing and assessing biomedical products
DG CNECT
• Drugs, radiation and other biomedical and bioactive products
• Simulate human physiology and the interaction with the product at the relevant levels
(cell level, tissue level or organism level)
• Multidisciplinary effort (e.g. computational modelling, systems biology, tissue
mechanics, biology, pharmaceutics, medicine)
• Measures for validation (human trials, animal studies, validation in cell cultures) shall
also be included
RIA / 4-6M€ / 2-3 grants / (CT)
24/09/2015 - 25 -Methods and data
SC1-PM-18–2016: Big Data supporting Public Health policies
DG CNECT
• Better acquire, manage, share, model, process and exploit the huge amount of data
• Develop integrated solutions that support public health authorities
• e.g. systems for monitoring the combined effects of environment, lifestyle and genetics
on public health
RIA / 3-5M€ / 2-3 grants
24/09/2015 - 26 -Health care provision
and integrated care
SC1-PM-21-2016: Implementation research for scaling-up of evidence based innovations
and good practice in Europe and low- and middle-income countries
• Multidisciplinary
• Within Europe as well as outside
• Does not cover micro-level interventions, e.g. to promote a specific therapeutic
regimen for a single disease
• Contextual, financial and political-economy analysis should be provided (facilitating a
wider adoption)
RIA / 4-6M€ / 6-10 grants
24/09/2015 - 27 -Coordination activities
SC1-HCO-01-2016: Valorisation of FP7 Health and H2020 SC1 research results CSA
SC1-HCO-02-2016: Standardisation of pre-analytical and analytical procedures for in vitro
diagnostics in personalised medicine CSA
SC1-HCO-05–2016: Coordinating personalised medicine research CSA
SC1-HCO-06–2016: Towards an ERA-NET for building sustainable and resilient health system
models CSA
SC1-HCO-08–2017: Actions to bridge the divide in European health research and innovation CSA
SC1-HCO-09–2016: EU m-Health hub including evidence for the integration of mHealth in the
healthcare systems CSA
SC1-HCO-11–2016: Coordinated action to support the recognition of Silver Economy opportunities
arising from demographic change CSA
24/09/2015 - 28 -SME instrument
SMEInst-05-2016-2017 - Supporting innovative SMEs in the healthcare biotechnology
sector (100%)
A. PHC-12 Clinical research for the validation of biomarkers and/or diagnostic
medical devices
• Finalisation 2014-2015
• 01/2017 Phase-2 uniquement
B. Cell technologies in medical applications
• 4 calls/an Phase-1 & Phase-2
• Phase-1 (50k€), Phase-2 (1-5M€)
SME-boosting biotechnology-based industrial processes driving competitiveness and
sustainability (70%)
• 4 calls/an Phase-1 & Phase-2
24/09/2015 - 29 -Programme H2020
trois priorités
- 30 -Autres parties H2020
SC2: Healthy and safe foods and diets for all
SFS-37-2016: The impact of consumer practices in food safety: risks and mitigation
strategies (RIA)
SFS-38-2016: Impulsivity and compulsivity and the link with nutrition, lifestyle and the socio-
economic environment (RIA)
SFS-39-2017: How to tackle the childhood obesity epidemic? (RIA)
SFS-40-2017: Sweeteners and sweetness enhancers (RIA)
SC2: Linking healthy oceans and seas for healthy people
BG-06-2017: Interaction between people, oceans and seas: a strategic approach towards
healthcare and well-being (CSA)
24/09/2015 - 31 -Programme H2020
trois priorités
- 32 -Autres parties H2020
SC7: Secure societies
• Disaster-resilience: safeguarding and securing society
• SEC-03-DRS-2016: Validation of biological toxins measurements after an incident:
Development of tools and procedures for quality control (IA 70%)
• SEC-05-DRS-2016-2017: Chemical, biological, radiological and nuclear (CBRN) cluster
(RIA & CSA)
• Fight against crime and Terrorism (FCT)
• SEC-08-FCT-2016: Forensics techniques on: a) trace qualification, and b) broadened use
of DNAS (RIA)
• SEC-09-FCT-2017: Toolkits integrating tools and techniques for forensic laboratories (PCP)
24/09/2015 - 33 -Programme H2020
trois priorités
- 34 -Autres parties H2020
LEIT-NMBP: Advanced materials and nanotechnologies for healthcare
12/2015 NMBP-09-2016: Biomaterials for diagnosis and treatment of demyelination disorders of the Central
Nervous System
12/2015 NMBP-10-2016: Nanoformulation of biologicals
10/2016 NMBP-12-2017: Development of a reliable methodology for better risk management of engineered
biomaterials in Advanced Therapy Medicinal Products and/or Medical Devices
01/2017 NMBP-13-2017: Cross-cutting KETs for diagnostics at the point-of-care
10/2016 NMBP-14-2017: Regulatory Science Framework for assessment of risk benefit ratio of
Nanomedicines and Biomaterials
10/2016 NMBP-15-2017: Nanotechnologies for imaging cellular transplants and regenerative processes in vivo
NMBP-16-2017: Mobilising the European nano-biomedical ecosystem CSA
24/09/2015 - 35 -Advanced materials and nanotechnologies
for
healthcare
Call 2016
NMBP 09 : Biomaterials for diagnosis and treatment of demyelination disorders € 5-8
RIA of the Central Nervous System
new multifunctional biomaterials, as part of eventual Medical Devices or Advanced
Therapies 3→5
participation of industrial partners and clinicians = aded value
NMBP 10 : Nanoformulation of biologicals € 5-6
RIA Nanoformulation of biologicals (proteins, peptides, nucleic acids and enzymes) to
efficiently cross biological barriers and to reach targeted organs, tissues and cells 3→6
achieve excellent quality control of the assembly by using self-assembling systems
provide a solid pre-clinical proof of concept,
address scale-up to the quantities needed for late pre-clinical and clinical study and
prepare for future clinical testing
Focus : age related diseases, neglected diseases and rare diseases or
inflammatory diseases, but excluding cancer and infectious diseases.
24/09/2015 36Advanced materials and nanotechnologies
for
healthcare
Call 2017
RIA NMBP 12: Development of a reliable methodology for better risk management of € 5-8
engineered biomaterials in Advanced Therapy Medicinal Products and/or
Medical Devices
4→6
validating, adapting and/or developing a reliable methodology for risk
assessment and hazard identification for engineered biomaterials :
Nanomedicine > human health / toxicity, modelling toxicity behaviour
Biomaterials > environment (bioaccumulation, etc), management of accidental risk
RIA NMBP 13 : Cross-cutting KETs for diagnostics at the point-of-care € 3-5
Micro-Nano–Bio integrated Systems (MNBS) platforms for
In vitro/in vivo diagnostics that are deployed at the point of care and /or 3→6
Therapy monitoring at the point of care.
Asked : translation from the pre-clinical phase to early clinical testing, including
design and pilot manufacturing in appropriate volume 37Advanced materials and nanotechnologies
for
healthcare
Call 2017
NMBP 14 : Regulatory Science Framework for assessment of risk-benefit ratio of
RIA Nanomedicines and Biomaterials
develop new methodologies for the quality, safety and efficacy of the novel€ 5 - 8 → 5/6
nanomedicines and medical devices.
Focus on development of new regulatory standards and tools / based on
scientific principles that already have a Proof-of-Concept at the laboratory scale
new and better methodology for pre-clinical and clinical evaluation
NMBP 15 : Nanotechnologies for imaging cellular transplants and regenerative € 5-7
processes in vivo
RIA
Development of highly sensitive imaging approaches enabling discrimination of
living cell and tissue transplants based e.g. on optical imaging, magnetic 3→6
resonance imaging and / or nuclear medicine techniques / Possibility non-
invasive
CSA NMBP 16 : Mobilising the European nano-biomedical ecosystem 38A vous de jouer 24/09/2015 - 39 -
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24/09/2015 - 45 -Diffuser son profil
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24/09/2015 - 46 -Fin
Merci pour votre attention
François LOUESSE Pierre FIASSE
European Project Developer European Project Developer
Horizon 2020 Health, Biotechnology, Horizon 2020 Nano, Materials, Transport &
Agriculture & Food NCP Aero NCP
Tél : +32 (0) 10.48.50.33 Tél : +32 (0) 10.47.19.49
francois.louesse@ncpwallonie.be pierre.fiasse@ncpwallonie.be
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