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

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

EoI assesment and presentation NCP 24 October 2002

Poverty related diseases

EDCTPResearch projectsIntegrated projects

Network of excellence

European and developing countries clinical trials partnership

Three major communicable diseases HIV/AIDS, TB, Malaria

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

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€

EoI assesment and presentation NCP 24 October 2002

Overall Research Strategy of the 6th 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/AIDS Malaria TB

NEW INSTRUMENTS

CROSS-CUTTING TOPICS

Phase I trials

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

Fields of research Number of EoIsTuberculosis 13Malaria 17HIV 22Horizontal topics coveringthe three diseases

11

Not relevant1 6TOTAL 69

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

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

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

1st calls– Vaccines

– Microbicides

Forthcoming calls– Therapy Trials in

Europe

Topics prioritized in EoI

Topics includedin WP

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

EoI assesment and presentation NCP 24 October 2002

Malaria

1st 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 includedin WP

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

EoI assesment and presentation NCP 24 October 2002

Tuberculosis

Vaccines– stimulate direct

involvement of DC – strengthen

management

Drugs– exploiting the genome

sequence information

1st call– Vaccines

Forthcoming calls– Drugs

Topics prioritized in EoI

Topics includedin WP

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

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

1st calls– Mucosal vaccines

Forthcoming calls– Neonatal vaccination

strategies for PRD

Topics prioritized in EoI

Topics includedin WP

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