European & Developing Countries Clinical Trials Partnership (EDCTP)

Towards EDCTP2

22 July 2014Melbourne, Australia

Ole F. Olesen, Ph.D., HDDirector of North-North Cooperation,EDCTP, The Netherlands

Justification for EDCTP2

Objectives• Clinical development of effective, safe, accessible, suitable and

affordable medical interventions for poverty related and neglected diseases (PRNID) in partnership with sub-Saharan African countries

Problem• No economic incentive for private investments in PRNID• Public investments are sparse and fragmented• Know-how is fragmented

Background• EDCTP-1: 2003-2015• EDCTP-2: 2014-2024

Who we are

Participating States13 European CountriesAustria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain and United Kingdom

9 African CountriesCameroon, Congo, Ghana, Mozambique, Senegal, South Africa, Tanzania, Uganda, Zambia

Countries that can receive funding• All sub-Saharan African countries• All EU Member States and Associated Countries

Governance

• Public-Public Partnership between sovereign states

• Operates as an independent legal entity

• Owned by the Participating States

• “Membership fee” of 200,000 EUR/year

General Assembly(1 Member from each Participating State)

Board(5 Members)

EDCTP Secretariat(Hague, NL + Cape Town, ZA)

Scientific Advisory

Committee (SAC, 16 Members)

advice

How it operates

55

>683 M €

683 M € >500 M €

Industry, other funders, NGO’s,

like-minded organisations,

Clinical Trials in Africa on PRNID

Capacity for Clinical Trials in

Africa

What we do

Diseases: HIV/AIDS, TB, Malaria and NIDs

New tools and interventions: Diagnostics, drugs, vaccines and microbicides

Capacity Development: Fellowships, Networks, Ethics, Regulatory

EDCTP in a nutshell

Number of projects - 246• 259 institutions participate

and receiving funds from EDCTP

• 3442 posts are supported on EDCTP grants

Clinical trials - 100 Training of scientists - 514Publications - 485

Funding for HIV: 2003-2013

Clinical trial Non-clinical trial

Clinical trial (€ ‘000)

Non trial (€ ‘000)

Diagnostics - € 291

Microbicides € 2,455 € 6,932

Treatment* € 28,880 € 419

Vaccines € 12,753 € 10,633 Other** - € 4,051 Total € 44,088 € 22,326 *Including € 5.85 million of funding to support projects on prevention of mother-to-child transmission**Including immunology, epidemiology and cross-cutting issues.

HIV/AIDS activities

54 research projects in 23 sub-Saharan Africa countries

Highlights of selected projects

• CHAPAS-1: contributed to the evidence base that led to FDA approval and WHO prequalification of PEDIMUNE, a fixed-dose combination formulation for the treatment of HIV in children

• CHAPAS-3: evaluates three fixed-dose combination first-line antiretroviral drugs

• Kesho Bora: Influenced revision of 2010 WHO guidelines on PMTCT: 43% reduction in HIV infections in infants and >50% reduction of PMTCT

• PROMISE-PEP: Prevention of mother to child transmission of HIV1 during 12 months of breastfeeding

• TaMoVac: Demonstrated that the prime/boost HIV-1 DNA multigene/multiclade-MVA/CMDR vaccine is safe and highly immunogenic when administered intradermally

• HIV-TB Pharmagene: demonstrated that there is no need to increase efavirenz dose during concomitant rifampicin based anti-TB therapy

• PRO2000: showed the microbicide was safe (but not efficacious)

How does it work?

Calls for proposals for Integrated Projects (Selected, funded and managed by EDCTP Secretariat)

National calls for proposals(Selected, funded and managed by PSs according to national rules)

Annual Work Plan with call topics

Thematic Stakeholder meetings (5 in 2013); Scientific advisory Committee; Commissioned studies, other input

First EDCTP2 work plan in August 2014 (tbc)

Integrated Activities

Consortia of 2 European PS and 1 sub-Saharan African country (minimum)

Grants to individuals: Career development, Senior, Industry, Regulatory, other

1. Clinical Trials (collaborative research)

2. Fellowships

3. Capacity Support

Broad non-prescriptive topics, bottom-up

Either full funding (100% of costs) or co-funding (up to 33%) with other funders

100% funding

Individual institutions or consortia for ethics, training, networking and regulatory activities

100% funding

Thank you

www.edctp.org The power of sharing science

Example: Phase 2 trial of Malaria vaccine candidate

• GMZ2: Hybrid of glutamate-rich protein and MSP3 + Alum• Targeting the blood stage of the malaria parasite• 4 clinical trials sites:

• CNRFP (Burkina Faso); Makarere (Uganda); Albert Schweitzer Hospital (Gabon); Navrongo (Ghana)

• 2 European partners:• SSI (Denmark); Tubingen University (Germany)

• 1747 children received 3 doses of 100 microgram or rabies vx

• Close-out: Feb 2014• Total budget: EUR 6.6 M (from EDCTP)

How does it work?

1. Integrated Activities

2. Participating States’ Initiated Activities

3. Joint Actionswith third parties (JA3s)

Participation of at least 2 European Participating States and 1 sub-Saharan African country (collaborators from other EU countries can also participate)

Selected and managed by EDCTP Funding: 100% (+25% overhead)

Projects up to EUR 15 M

Selected, funded and managed by PSs according to national rulesFunding: 33% EDCTP + 66% PS

Co-funding of large activities with other funders Funding: <~25% from EDCTP

Annual Work Plan with call topicsFirst EDCTP2 in July 2014 (tbc)

EDCTP Regional Networks of Excellence for clinical trials

Western Africa: WANETAMWebsite: www.wanetam.org • Burkina Faso• The Gambia• Ghana• Guinea-Bissau• Mali• Nigeria

• Senegal• United States

Southern Africa: TESAWebsite: www.tesafrica.org• Botswana• Malawi • Mozambique • South Africa • Zambia • Zimbabwe • France

• Germany• Netherlands• United Kingdom

Eastern Africa: EACCRWebsite: www.eaccr.org• Kenya• Sudan• Ethiopia• Tanzania• Uganda• Germany• Sweden

• United Kingdom• United States

Central Africa: CANTAMWebsite: www.cantam.org• Cameroon• Congo, Republic of the• Gabon• France• Germany

• Strengthening of capacity for clinical trials

• Addressing inequality• Proliferation and sharing of

expertise and facilities

• 64 institutions in 21 African countries

• Offered short- and long-term training to 1000 researchers

• Leveraged additional € 24 M

• Published 38 peer-reviewed papers

Achievements of EDCTP funded grants

• FDC paediatric formulation: contributed to the evidence base that led FDA approval and WHO prequalification of a fixed-drug combination formulation for the treatment of HIV in children (CHAPAS trial)

• Influenced revision of 2010 WHO guidelines on PMTCT: 43% reduction in HIV infections in infants and >50% reduction of PMTCT (Kesho Bora)

• Informed national policy for the treatment of severe malaria: 3 novel ACT drugs were found to be safe and efficacious in treating children with uncomplicated malaria (4ABC study)

• Establishment of four Regional Networks of Excellence for Conducting Clinical Trials (NoE): the Central African Network for Tuberculosis, HIV/ AIDS and Malaria (CANTAM); the East African Consortium for Clinical Research(EACCR); the Trials of Excellence for Southern Africa (TESA); and the West African Network for TB, AIDS and malaria (WANETAM)

• Establishment of the Pan-African Clinical Trials Registry (PACTR, www.pactr.org), which is the only WHO-endorsed primary registry in Africa.

Thematic project funding: 2003-2013

Area Intervention

HIV/AIDS projects supported by EDCTP

HIV clinical trials•PMTCT (pregnancy and breastfeeding) and paediatric treatment – 9 trials•Nutritional support for patients starting on ARVs – 1 trial•TB/HIV co-infection – 1 trial•Microbicides - 3 trials •HIV vaccine – 7 trials•Adherence to ART – 2 trials•Evaluation of antiretroviral drugs - 7 trials

HIV/aids capacity building (16 projects)• Feasibility studies in preparation

for clinical trials (e.g. preparing for phase III vaginal microbicide trials in Rwanda and Kenya)

• Community and adolescent involvement (e.g. exploring attitudes towards participation in clinical trials)

• Establish baseline ranges of biomarkers (e.g. Related to vaginal environment in women targeted for microbicide trials)

• Epidemiological studies – site characterisation

Funding mechanisms

• Minimum requirement: participation of at least 2 European Participating States and 1 sub-Saharan African country (collaborators from other EU countries can also participate)

• Integrated Activities: selected and managed by EDCTP• Funding: 100% (+25% overhead)

• Participating States’ Initiated Activities: selected, funded and managed by Participating States according to national rules• PSIA cofund: 33% EDCTP and 67% PSs

• Joint Activities: cofunding of strategic activities with other funders• Funding: up to 33% from EDCTP

• Public-Public Partnership

• Operates as an independent legal entity (offices based in the Netherlands and South Africa)

• Financial and structural support to phase I to IV clinical trials in sub-Saharan Africa

• EDCTP2 will operate from 2014-2024 (part of H2020)

The second EDCTP programme (EDCTP2)