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EDCTP as a model for Europe-Africa
partnership on HIV/AIDS research
–
Achievements & Future Directions
Dr Gabrielle Breugelmans
North-North Networking Manager
11th Annual Conference of the Baltic Network
Against Life-threatening Viral Infections
Vilnius, 25 April 2014
Introducing EDCTP
Background
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Established in 2003 - co-decision of the European Parliament and Council:
Article 185 Initiative
Funding from EU matched by funding from EU MSs, Switzerland and
Norway
Mission
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Reduce burden of poverty related diseases (HIV, malaria, TB, and NIDS)
and improve the health of people living in developing countries
Objectives
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Accelerate research and development of new or improved interventions
against PRDs
Coordination of the European member state national programmes working
in partnership with sub-Saharan African countries
Collaboration with the private sector and like-minded organisations
How we work: in
partnership
• Coordination of European
national programmes
• Partnerships with subSaharan Africa
• Partnership ensures
synergy among R&D
international partners
• Accelerated development
of tools to fight povertyrelated and neglected
infectious diseases
• Support to capacity
development and
networking
The Partnership
Current Participating States (PSs)
16 European Countries (EDCTP1)
• 14 EU countries: Austria, Belgium, Denmark,
France, Germany, Greece, Ireland, Italy, Luxembourg,
Netherlands, Portugal, Spain, Sweden and United
Kingdom
• 2 Associated Countries: Norway and
Switzerland
Affiliated
• Sub-Saharan African countries
New PSs (EDCTP2)
• Cameroon, Congo, Finland, Ghana, Latvia
(TBC), Mozambique, Senegal, South Africa,
Zambia
What we do:
New products development,
clinical trials & capacity building
Diseases: HIV, TB, Malaria and neglected infectious diseases
(NIDs)
New tools and interventions: Diagnostics, drugs, biomarkers,
vaccines and microbicides
Details on EDCTP grants
Non disease
specific
€ 20.7 M
107 grants
(43.5%)
Tuberculosis
Diagnostics
• PoC diagnostics
and markers
Treatment
• Treatment
shortening/simp
lification
Prevention:
• Prep studies for
vaccine
development
and vaccine
development
TB
€ 70.7 M
34 grants
(14%)
HIV
€ 62.4 M
52 grants
(21%)
Malaria
€ 50.9 M
41 grants
(16.6%)
HIV
Treatment:
• Paedriatic
• Second line ARVs
Prevention:
• PMTCT
• Preparatory studies
for microbicides
and vaccine
development
HIV/TB
€ 7.2 M
12 grants
(4.8%)
Malaria
Treatment:
• Malaria in pregnancy
• Severe malaria in children
Prevention:
• Vaccine development
HIV Clinical Trials
supported on EDCTP1 grants
Number of clinical trials
12
10
8
6
HIV
HIV/TB
4
2
0
Non Phase
Phase 1
Phase II
Phase III
Clinical trial phases
Phase IV
HIV: 30 clinical trials/ 13 (43%) completed
HIV/TB: 9 clincial trials/4 (44%) completed
HIV grants by
intervention/topic
Achievements of EDCTP1 HIV
funded grants
• Registration of one paediatric formulation of an antiretroviral
product (Pedimune) in several African countries (CHAPAS)
• Informed WHO policies and guidelines on the PMCT of HIV
(Kesho Bora)
• TaMoVac studies (I&II):
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The prime/boost HIV-1 DNA multigene/multiclade-MVA/CMDR vaccine one of
the most promising candidate HIV vaccines under joint European and African
development programme
Demonstrated that the HIV-1 DNA -MVA/CMDR vaccine is safe and highly
immunogenic when administered intradermally
• Contributed to results on efficacy of a treatment strategy to PMCT
of HIV-1 during 12 months of breastfeeding (PROMISE-PEP)
• A study completed in 2012 found that there is no need to increase
efavirenz dose during concomitant rifampicin based anti-TB
therapy (HIV-TB Pharmagene)
European Parliament
approves EDCTP2
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On April 15 2014 the
European Parliament
approved the participation
of the European Union in
EDCTP2
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In addition to EU
participation, EDCTP2 will
include 8 new members.
•
The European Council will
vote on the proposal on
May 6, 2014
EDCTP2: building on the
current programme
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Support the whole range of clinical research through broad,
non-prescriptive, open calls: phase I-IV clinical trials
Participate in large, multi-funder projects on specific
activities in HIV, TB, malaria, NIDs and implementation
research on health services optimisation
Geographical focus on sub-Saharan Africa
Strengthen the “enabling environment” to conduct
clinical research and implementation research in Africa
Budget of € 683 M from the EU + matched cofunding
from EDCTP PSs
10-year programme: 2014-2023
Funding Mechanisms
1. Integrated Activities (IAs)
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Activities selected and managed by EDCTP, funded
from EU contribution and cash contributions from
the PSs or any third parties
Calls for Proposals in 2014 and 2015 for Clinical
Research Activities and Capacity Development
Activities (i.e., fellowships)
H2020 rules for participation apply – one derogation
• Min requirements: Participation of at least 2 European PSs
and 1 sSA country (collaborators from other EU countries
can also participate)
Other funding schemes
2. Participating States’ Initiated Activities
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(Trans)national activities that fall in scope of EDCTP2
Facilitate collaboration between PSs
Catalyse better integration of national research policies and
programmes
To enable PSs to foster research collaborations with other
European and sSA countries
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Clinical research in PRNIDs
Capacity development
3. Joint Activities with third parties
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Reserved for large, strategically important and pioneering
activities where EDCTP jointly funds an activity with other
funders/3rd parties
EDCTP-funded bibliometric
analysis showed that:
• EDCTP PSs are highly
collaborative with sSA
countries
• Collaborative research on HIV
from institutions in PSs is
highly cited
Opportunities & benefits
for Researchers from
EDCTP PSs
EDCTP offers to researchers from PS:
• Opportunities to participate in large international clinical
research consortia across Europe and Africa
• A raised profile, leading to increased visibility and
competitiveness in global health research
• Greater opportunities for research consortia leadership
and increased citation impact of conducted research
• Greater exposure to clinical research expertise and
better integration with EU research policies
• Increased networking opportunities, including with
major pharmaceutical companies, public and private
funders
Contact information
For additional information, please contact:
Gabrielle Breugelmans
[email protected]; +31 70 349 4422
Ana Lucia Cardoso
[email protected]; +31 70 344 0844
www.edctp.org
Thank you!
What we have done:
EDCTP1 in a nutshell
• Number of projects
• Participants:
246
274 institutions
(118/156 Europe/Africa in 41 different countries: 12/29 Europe/Africa)
• EDCTP contribution:
+ leverage (European and African countries, industry, 3rd parties)
Total =
€ 212 M
€ 228 M
€ 440 M
• Clinical trials
100
• Capacity building, training of scientists:
419
(Malaria: 34; HIV/AIDS: 30; TB: 27; HIV/TB: 9)
(Senior Fellowships: 50; Post docs: 37; PhDs: 143; MSc: 189)
• Publications (so far):
485
Intra-European research
collaboration on HIV/AIDS
2003-11
Data & Analysis: Thomson Reuters (Evidence)
Intra-European research
collaboration on TB
2003-11
Data & Analysis: Thomson Reuters (Evidence)
What we know about
Baltic countries research
in the scope of EDCTP
Based on an EDCTP-funded bibliometric analysis on intraEuropean research collaboration conducted in 2013:
•On HIV/AIDS research, Estonian and Lithuanian research
reveals the principal partners to be the UK, Finland and Sweden
(with the University of Tartu in Estonia leading the research)
•TB research represents 0.4% of the world research output and
0.9% of Latvia’s national research, most of which involving the
Latvian State Agency for TB and Lung Diseases, in relation to
DOTS-Plus sites and MDR-TB research
•The Vilnius University and the Nature Research Center in
Lithuania conduct research on malaria. Lithuanian malaria
research is cited nearly twice the world’s average