1. Infectous Diseases Threats – EU Research Strategy and Projects
13the Meeting of the Community of Users on Secure, Safe and Resilient Societies
Brussels, 26 March 2019
Cornelius SCHMALTZ, MD
Head of Unit E3: Fighting Infectious Diseases and Advancing Public Health
Directorate E – Health,
European Commission, DG Research & Innovation

2. Outline EC preparedness research strategy and funding instruments
Participation in international initiatives
EU added value
Challenges
Beyond research

3. I. EC research strategy & instruments
Objectives
Improve prevention and early detection of infectious disease threats in Europe and globally (opportunity of new technologies: NGS, Big data…)
Develop the pipeline of medical countermeasures against prioritised (and unexpected/unknown) pathogens
Ensure that a comprehensive research response is swiftly launched in case of an outbreak
Facilitate global collaboration
Promote a 'One Health' approach
Communication
developing the pipeline of medical countermeasures (which include diagnostics, treatments and vaccines);
improving surveillance and early warning systems taking into account new technologies such as next generation sequencing;
using the opportunities from big data, integrating data sets from different sources (taking into account the different drivers of (re-)emerging infections) to feed mathematical models for anticipating threats; etc.

4. Main funding instruments under Horizon 2020 for preparedness research and response
Collaborative research (Countries, Sectors, Disciplines)
SC1 (Health), SC2 (Bio-economy),SC6 (Societies), SC7 (Security), Research infrastructures
Innovative Medicines Initiative (IMI2)
Public-private partnership between EC and pharma industry in Europe
European and Developing Countries
Clinical Trials Partnership (EDCTP2)
Partnership between 14 European and 14 African countries i

5. Instruments for swifter research response to an outbreak
Flexibility built into ongoing projects
Possibility for the EC or the participants to change research agenda in case of an outbreak
Flexibility to top-up ongoing grants
If foreseen in the original call text
Article in the Financial Regulation providing flexibility
Foresees the possibility to award grants without a call for proposals in exceptional and duly substantiated emergencies

6. in Outbreak Preparedness & Response
Research Priorities
'Drivers' of outbreaks (climate change, vectors, host and pathogen factors)
One Health (zoonoses - species barriers)
Vector control, Vaccines
Pathogen prioritization
Improved surveillance systems
Risk modelling/anticipation
Simple, point-of-care diagnostics and diagnostics 'platforms'
Syndromes definitions and differential diagnosis (e.g. Hemor. fever, flu-like)
Advance the pipelines (vaccines/treatments)
Clinical research during outbreaks (e.g. syndrome characterization, risk assessment, phase II/III clinical trials)
Research on disease management
Social Sciences (= communication, community impact/engagement)
Partnerships/coordination/knowledge transfer ↓
Country-owned research capacity (= human resources and infrastructure)
Role of Research
in Outbreak Preparedness & Response
Prevention/ Preparedness
Surveillance/ Early Detection
Control/ Intervention/ Implementation
Health Systems/ capacity building

7. International collaboration
EC Preparedness Research Strategy
Building Capacity and Networks
Building up the pipelines of medical countermeasures
Research response to specific outbreaks
International collaboration

8. EC Preparedness Research Strategy
Capacity/Infrastructure (EVAg)
'One Health'
Risk modelling (e.g. ANTIGONE)
Surveillance (e.g. COMPARE)
Preparedness networks for clinical research
- Europe (PREPARE)
- LAC (through Zika projects)
- Africa (recent EDCTP call)
EC Preparedness Research Strategy
Building Capacity and Networks
Building up the pipelines of medical countermeasures
Research response to specific outbreaks
'Pipeline' projects (e.g. influenza vaccines, Ebola vacines/ diagnostics, antivirals)
'Surge' capacity projects
(e.g. PREPARE, COMPARE)
Projects for specific outbreaks
- Ebola (€ 140 million million EFPIA), ongoing Ebola+ (CEPI)
(+ € 70 million Ebola+ continuation)
- Zika (€ 45 million)

9. Addressing Zika research gaps (H2020)
3 EU funded consortia
Addressing Zika research gaps
Clinical studies: prospective cohorts of pregnant women and newborns, adults with CNS involvement
Studies on natural history and clinical spectrum of disease, transmission modes, pathogenesis & immunological consequences of infection, diagnostics development, mathematical modelling, animal reservoirs, vector competence and control, social studies, …
Harmonization of data collection & data sharing roadmap
Develop LAC region preparedness research network
ZikaPLAN
Budget of € 11M, 4 years duration
25 partners, 5 of which are BR
Coordinated by Umeå University in Sweden
ZIKAction
Budget of € 7M, 5 years duration
14 partners, 3 of which are BR
Coordinated by PENTA Foundation in Italy
ZikAlliance
Budget of € 12M, 3 years duration
52 partners, 6 of which are BR
Coordinated by INSERM in France

10. Building capacity and tools
COMPARE (H2020)
Aims for an enabling analytical framework and globally linked data and information sharing platform system for rapid identification, containment and mitigation of outbreaks
Combine sequence-based pathogen data and associated (clinical, epidemiological, etc.) data
PREPARE (FP7)
A European clinical research framework covering primary care and hospital care in the EU
Implements large inter-epidemic clinical studies and develops new diagnostic tests for diseases
Aims to ensure a rapid, coordinated deployment of clinical investigators within 48 hours of a severe infectious disease outbreak in Europe

11. Building capacity and tools: Infrastructure
EVAg (H2020)
European Viral Archives goes global
TRANSVAC2 (H2020)
European Network of Vaccine R&D
INFRAVEC2 (H2020)
Infrastructures for insect vector biology
VETBIONET (H2020)
Veterinary Biocontained Research facility network
ERINHA (H2020)
EU Research Infrastructure on Highly Pathogenic Agents
EMERGE (Joint Action, EC Health programme)
Efficient response to highly dangerous and emerging pathogens

12. II. Participation in international initiatives
Global Research Collaboration for IDs Preparedness
International Research Consortium on Animal Health
Coalition for Epidemic Preparedness Innovations

13. III. EU added value EU level data collection and analysis
Cf. ECDC risk assessments, EFSA scientific opinions
Gathering of best researchers, across Europe and internationally – e.g. Zika consortia
International exposure of EU funded researchers
Publication in higher impact journals
GloPID-R Zika research workshop in São Paulo, to foster collaboration between research groups
Rapid mobilisation of funds
Complementarity with other funders
European Research infrastructures

14. Cf. EDCTP strong capacity building aspect
IV. Challenges
I. Involvement and capacity of affected countries
Cf. EDCTP strong capacity building aspect
EDCTP governance by 14 European and 14 African Participating States, through the General Assembly

15. IV. Challenges
Big data and data sharing
Great efforts underway
Need appropriate tools and technologies
Need for operational and legal framework
Data Research Infrastructures

16. Data sharing 3 EU funded consortia on Zika GloPID-R working group
Harmonise protocols & tools for data capture & management
Set up joint harmonised platforms for clinical research
Share data in real time between the 3 consortia
Prepare for sharing data with scientific community & public health officials
GloPID-R working group
Aims to design a system for data sharing in public health emergencies to support the research response
Principles for data sharing in public health emergencies
Decision tree to identify data to be shared in particular context
Case studies to document data sharing experience

17. IV. Challenges
Research Infrastructures
How can we achieve better alignment/uptake of research infrastructures services by the research projects?

18. V. Beyond research: Lessons Learnt
Data and sample sharing framework needed
Regulatory : accelerating licensing without compromising safety
Liability and insurance issues in pandemic setting
Large-scale manufacturing, QA, access
IP matters
Infrastructure resources for rapid vaccine deployment
Post-licensure commitments
Strengthening weak health systems/capacity building …

19. Together we can!
Thank You