1. EoI assesment and presentation NCP 24 October 2002 Confronting the major communicable diseases linked to poverty Health Directorate F3 unit: Poverty related Diseases Anne Degrand-Guillaud

2. EoI assesment and presentation NCP 24 October 2002 Priority 1 Life sciences, genomics and biotechnology for health Functional genomics (fundamental knowledge) Genomics and biotechnology for health Genomic approaches to medical knowledge Cancer Major communicable diseases linked to poverty

3. EoI assesment and presentation NCP 24 October 2002 Poverty related diseases EDCTP Research projects Integrated projects Network of excellence European and developing countries clinical trials partnership Three major communicable diseases HIV/AIDS, TB, Malaria

4. EoI assesment and presentation NCP 24 October 2002 Overall aim: to develop a long-term partnership between Europe and Developing Countries to fight HIV/AIDS, Tuberculosis and Malaria through new clinical interventions Scope: Network of national programmes Clinical trials (drugs, vaccines) conducted in Africa Capacity building in DCs http://europa.eu.int/comm/research/info/conferences/edctp/edctp_en.html EDCTP

5. EoI assesment and presentation NCP 24 October 2002 Global features of EDCTP Long-term sustainable initiative (10-20 years) Shared ownership of European and Developing Countries Dynamic structure with balanced involvement of different stakeholders (DC, MS, Commission, WHO, Industry, International Organisations) Integration of European National Programmes Significant Community contribution during the next 4 years: 200 M€

6. EoI assesment and presentation NCP 24 October 2002 Overall Research Strategy of the 6 th Framework Programme to confront HIV/AIDS, Malaria and Tuberculosis Pre-clinical Discovery Genomics Vaccines Microbicides Vaccines Drugs EUROPEAN DEVELOPING COUNTRIES CLINICAL TRIALS PARTNERSHIP (EDCTP) Clinical Trials (Phase II/III) H I G H R I S K P R O J E C T S Vaccines Drugs HIV/AIDSMalariaTB NEW INSTRUMENTS CROSS-CUTTING TOPICS Phase I trials

7. EoI assesment and presentation NCP 24 October 2002 Confronting the major communicable diseases linked to poverty High level of interest, excellent quality of the EoI: most EU leading researchers represented in one or more EoI

8. EoI assesment and presentation NCP 24 October 2002 EoIs Panel general recommendations (1) Encourage participation of partners from DC Stimulate the training component both for the North and the South Increase the professionalism of management Include in the projects pre-clinical testing in non-human primates and GMP production of candidate drugs or vaccines

9. EoI assesment and presentation NCP 24 October 2002 EoI’s Panel general recommendations (2) Several EoI covered activities of valuable support for the EDCTP, these should be considered for integration in the EDCTP actions A limited number of high-risk innovative research project should be made available to underpin and ensure the full success of the new instruments

10. EoI assesment and presentation NCP 24 October 2002 HIV/AIDS Vaccines –innovative approaches –develop candidates up to phase I Microbicides –systematic studies using a biologically-defined approach 1 st calls –Vaccines –Microbicides Forthcoming calls –Therapy Trials in Europe Topics prioritized in EoI Topics included in WP

11. EoI assesment and presentation NCP 24 October 2002 Development of an HIV vaccine innovative approach to new promising vaccine candidates including partners from DC up to clinical testing in human (phase I) HIV microbicides a biologically defined approach targeting HIV receptors to develop new candidates up to phase I clinical trials. of wide acceptability for empowering women in developing countries HIV-AIDS

12. EoI assesment and presentation NCP 24 October 2002 Malaria 1 st call –Biology and Pathology of Malaria parasite Forthcoming calls –Vaccines –Drugs Biology and Pathology of Malaria parasite direct relevance for search of new drugs, vaccines and diagnostics Vaccines -integration of EU research groups - rational approach for development of new candidates Drugs - exploitation of the genomic information Topics prioritized in EoI Topics included in WP

13. EoI assesment and presentation NCP 24 October 2002 Biology and pathology of the malaria parasite –to ensure coherence and full exploitation of European synergies –to understand the biology of the parasite, the human host-parasite and mosquito-parasite interactions –to be of direct relevance for new drugs, vaccines and diagnostics Malaria

14. EoI assesment and presentation NCP 24 October 2002 Tuberculosis Vaccines –stimulate direct involvement of DC –strengthen management Drugs –exploiting the genome sequence information 1 st call –Vaccines Forthcoming calls –Drugs Topics prioritized in EoI Topics included in WP

15. EoI assesment and presentation NCP 24 October 2002 Tuberculosis vaccine development to develop new candidates vaccines pre clinical testing in non human primates up to phase I clinical trials and GMP production Tuberculosis

16. EoI assesment and presentation NCP 24 October 2002 Cross-cutting topics Mucosal vaccines for PRD –focus on HIV and TB Neonatal vaccination strategies for PRD –focus on neonatal vaccines Dendritic cells and Innate immunity – high relevance in several action lines in priority 1 1 st calls –Mucosal vaccines Forthcoming calls –Neonatal vaccination strategies for PRD Topics prioritized in EoI Topics included in WP

17. EoI assesment and presentation NCP 24 October 2002 Development of mucosal vaccines for poverty-related diseases –to clarify the basic principles of mucosal immunity –to bring candidate vaccines (TB and HIV) to phase I trials Cross-cutting topics