1. European and Developing Countries Clinical Trials Partnership AEMI Seminar 13-15 Dec 2010 Dr Thomas Nyirenda South-South Networking and Capacity Development Manager, EDCTP

2. EDCTP MISSION: To fight poverty sub-Saharan Africa by accelerating the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis, and to improve generally the quality of research in relation to these diseases Through equal and effective partnership with Africa and African researchers Through integration of EU Member States national health research programmes

3. EDCTP Partnership 16 European Countries (joined under article 169) 14 EU countries (Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom) + Norway+ Switzerland 46 sub-Saharan Africa Countries Funding sources European Commission European Member States Third Party: Public and private like minded organisations.

4. Partnership Structure

5. EDCTP Scope Discovery & Pre-clinical Research First in humans Lab and animal testing Phase I: Safety C a p a c i t y d e v e l o p m e n t & n e t w o r k i n g C l i n i c a l T r i a l s Regulatory Clinical studies Regulatory Clinical studies Phase II: Safety & limited efficacy Phase III: Safety & efficacy Pharmaco- vigilance Policy, Practice Policy, Practice Phase IV: Long-term safety & Post-registration monitoring to inform policy Regulatory Clinical studies Regulatory Clinical studies Phase II: Safety & limited efficacy Phase III: Safety & efficacy Developer of products have to declare accessibility and affordability to poor populations Before funding is provided to successful projects

6. S-S Networking N-S Networking N-N Networking Personnel & Infrastructure Short-term training MSc PhD Career Development Fellowship Capacity Development Networking EDCTP Strategy Senior Fellowship Ethics Review Regulatory Framework Clinical Trials

7. EDCTP Activities in Africa To date EDCTP Portfolio of funded projects: 142 Total value: 269 EUR M Clinical Trials: 44 Projects  HIV/AIDS:20 (Vaccines: 7, Treatment: 9 Microbicides: 4)  Malaria:10 (Vaccines: 2, Treatment: 8)  Tuberculosis:14 (Vaccines: 6, Treatment: 8) Capacity Development  Career and Senior Fellowships: 27  Ethics & Regulatory: 41  TA, JPA, CT Register: 14 Networking & NOE:11

8. EDCTP Activities Benin Botswana Burkina Faso Cameroon Congo Brazzaville Congo DRC Cote d’Ivoire Ethiopia Gabon Ghana Guinea Guinea-Bissau Guinea-Conakry Kenya Madagascar Malawi Mali Mozambique Nigeria Rwanda Senegal South Africa Sudan Tanzania The Gambia Uganda Zambia Zimbabwe

9. African Vaccine Regulatory Forum (AVAREF)

10. Pan-African Clinical Trials Registry (PACTR) PACT Registry African Vaccines Regulatory Forum (AVAREF) AFRICA CLINICAL TRIALS PORTAL CONSOLIDATED REPORTING OF TRIALS GROUP (CONSORT)

11. Current EDCTP Collaborations Organisation TypeNumber European Public42 African Public123 Non Profit39 Industry12 Total216 11

12. PDPs cofunding EDCTP funded Projects HIV/AIDS International AIDS Vaccine Initiative (IAVI): (919,782 Euro) International Partnership for Microbicides (IPM): (1,477,443 Euro) TB AERAS Global TB Vaccine Foundation: (10,430,027 Euro) Global TB Alliance: (8,970,066 Euros) Malaria Medicines for Malaria Venture: (601,578 Euro) Drugs for Neglected Diseases initiative (DNDi): (13,295 Euro) European Vaccine Initiative (EVI): (1,984,738 Euro) 12

13. Contributions of third party

14. Challenges Ownership: Few African countries put funds in clinical trial activities (while EU prepares renewed support to 2018/20) African leadership: Lack of critical mass of African researchers on continent Enabling environment: Very few centres with adequate conditions to attract and retain the best trained researchers Supportive environment: Ethics & regulatory framework still needs strengthening in many parts of the continent Networking: South-South networking is still weak

15. The East African Community (EAC) The Secretary General of EAC (Associate Member) The Economic Community of Central African States (ECCAS) The Secretary General of Organisation for the Coordination of the Struggle Against Epidemics in Central Africa (OCEAC) The African Regional Committee of Health Ministers: Ministry of Health – Ghana deputised by Ministry of Health - Zambia African Ministers of Finance or Ministers of Science and Technology To be nominated The African Union (AU) Commission of Social Affairs Commissioner of Social Affairs, Bience Gawanas,01 Dec 2009 African representation on EDCTP General Assembly since 2010

16. Thank you for your attention