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 Established in co-decision of the European Parliament and Council: Article 185 Initiative Funding from EU matched by funding from EU MSs, Switzerland and Norway Mission Reduce burden of poverty related diseases (HIV, malaria, TB, and NIDS) and improve the health of people living in developing countries Objectives 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

Coordination of European national programmes Partnerships with sub- Saharan Africa Partnership ensures synergy among R&D international partners Accelerated development of tools to fight poverty- related and neglected infectious diseases Support to capacity development and networking How we work: in partnership

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 Malaria Treatment: Malaria in pregnancy Severe malaria in children Prevention: Vaccine development HIV Treatment: Paedriatic Second line ARVs Prevention: PMTCT Preparatory studies for microbicides and vaccine development Tuberculosis Diagnostics PoC diagnostics and markers Treatment Treatment shortening/simp lification Prevention: Prep studies for vaccine development and vaccine development

HIV Clinical Trials supported on EDCTP1 grants 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):  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 On April the European Parliament approved the participation of the European Union in EDCTP2 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 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:

Funding Mechanisms 1.Integrated Activities (IAs) 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)

2.Participating States’ Initiated Activities (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 Clinical research in PRNIDs Capacity development 3. Joint Activities with third parties Reserved for large, strategically important and pioneering activities where EDCTP jointly funds an activity with other funders/3 rd parties Other funding schemes

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 Ana Lucia Cardoso

Thank you!

What we have done: EDCTP1 in a nutshell Number of projects 246 Participants: 274 institutions (118/156 Europe/Africa in 41 different countries: 12/29 Europe/Africa) EDCTP contribution: € 212 M + leverage (European and African countries, industry, 3rd parties) € 228 M Total = € 440 M Clinical trials100 (Malaria: 34; HIV/AIDS: 30; TB: 27; HIV/TB: 9) Capacity building, training of scientists: 419 (Senior Fellowships: 50; Post docs: 37; PhDs: 143; MSc: 189) Publications (so far):485

Intra-European research collaboration on HIV/AIDS Data & Analysis: Thomson Reuters (Evidence)

Intra-European research collaboration on TB 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 intra- European 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