Dr. Manuel ROMARÍS Poverty-related Diseases European Commission Research DG Microbicides BXL, 07 October 2005 HIV/AIDS Research in the Sixth Framework.

Dr. Manuel ROMARÍSPoverty-related Diseases

European CommissionResearch DG

Microbicides BXL, 07 October 2005

HIV/AIDS Researchin the

Sixth Framework Programme

3,27

5,366,6

13,1214,96

17,5

0

2

4

6

8

10

12

14

16

18

20

1984-1987 1987-1991 1990-1994 1994-1998 1998-2002 2002-2006

Billion €

Budgets of the EU Framework Programmes

PRDsPolitical Context

Programme for Action (2001)Programme for Action (2001)

•Trade: Make pharmaceuticals more affordable for Developing Countries (TRIPS, Doha, etc.)

• Development: Health-related interventions (Global Fund ATM, etc.)

• Research: New interventions against HIV/AIDS, malaria and tuberculosis

Sixth Framework ProgrammeSixth Framework Programme

What’s new for HIV/AIDS Research?

• Earmarked funds for PRDs

• Increase in budget (4x)

• Funding of phase II/III trials: EDCTP

• New Administrative Unit for PRDs

• HIV/AIDS: broader product portfolio

Microbicides

EC Project Funding

Therapeutic approaches: – Drugs targeting replication / integration of HIV (IP)– Production of neutralising antibodies in plants (IP)

– Therapeutic vaccine based on apoptotic T cells (STREP)– MVA-based gene therapy (STREP)– New therapies targetting latency and budding (STREP)

EC Project Funding

Vaccine approaches: – Mucosal vaccines focussed on HIV and TB (IP)– Prophylactic vaccines based on the measles vector (IP)– Therapeutic vaccines based on dendritic cells (IP)

– New vaccine delivery systems and adjuvants (STREP)– New antigen design (STREP)– Standardisation of neutralisation assays (STREP)

EC Project Funding

Microbicide approaches

EMPRO (C. Kelly/R. Shattock, London) (IP)

– New microbicides to block HIV entry to mucoses

– 30 partners from 7 EU countries + Sw + SAf + Gb

SHIVA (P. La Colla, U. Cagliari) (IP)

– NNRTIs (MC1220) to stop HIV replication in mucoses

– 12 partners from 5 EU countries + Gabon

VirApt, RNA aptamers against HIV (STREP)(Dorothee von Laer, Vision7, Frankfurt)

EC Project Funding

Cohort Studies (Network): – Mother to Child Transmission (CA)– Infected Children (CA)– Infected Adults (CA)– Seroconversion (CA)– HIV resistance (CA)

Monitorisation of HIV drug resistance (WHO)

EC Project Funding2005. Fourth Call for Proposals

STREPs (SMEs): • Highly innovative research for PRD• Development of fast tests for diagnosis• Delivery mechanism for treatment and depot

therapy

EC Project Funding2005. Fourth Call for Proposals

NoEs: • HIV/AIDS Therapeutic Clinical Trials Network• HIV/AIDS Vaccines/Microbicides Network (!)

STREPs: • Undesirable consequences of drugs/vaccines• Host-pathogen interaction (!)

EC Project Funding2005. Fourth Call for Proposals

HIV/AIDS Vaccines/Microbicides Network (NoE)

• Use complementarity of the different approaches • Strengthen the coherence of European actions • Cooperation with global initiatives• Projects may include:

- standardisation activities- clinical activities

EC Project Funding2005. Fourth Call for Proposals

Host-pathogen interaction (STREP)

• Small-scale, high-risk, innovative projects • Drugs, vaccines and microbicides• Small consortia, about €1M• Maximum 2 years • Researchers from disease-endemic countries

EC Project Funding2005. Fourth Call for Proposals

WHEN?

Already published!!Call deadline: 9th November 2005

LAST CALL UNDER FP6!!

EDCTP

EUROPEAN AND DEVELOPING COUNTRIES CLINICAL TRIALS

PARTNERSHIP

Long-term partnership between

Europe and Developing Countries

to fight HIV/AIDS, Malaria and

Tuberculosis through new clinical

interventions

EDCTP

• Independent legal entity

• Budget: 600 M Euro

• Coordination of EU research programmes

• Focus: – Phase II/III clinical trials in Africa– Training and Capacity-building– HIV/AIDS, malaria and tuberculosis

EDCTP

EDCTP2005 call for

proposals

1. Clinical Trial grants

2. Networking grants

3. Capacity Building grants

4. Training Awards

(Published 27 September 2005)

EDCTP

Combination of ARV with TB drugs in coinfected patients

Capacity building for phase III trials of TB vaccines:

High risk populations Children under 1 year

Capacity building for phase I/II trials of vaginal microbicides against HIV

Clinical Trial grants

EDCTPMicrobicides Call

• Available funds: € 7M (max 2.5M/project)

• Minimun 1 African + 2 EU countries

• Two-stage procedure

• Deadline for Letter of Intent: 12 December 2005

• Deadline for Full Proposal: 1st March 2006

FP7What’s new?

Main new elements compared to FP6:

• Annual budget doubled (€ 5 ►10 billion)• Basic research (~ € 1.5 billion per year)• Simplification of procedures• Logistical/administrative tasks to external structures

HIV/AIDS in FP7

• Increase in budget (?) • Focus on prevention and treatment• Highly innovative research• Link with health delivery (patients)• International Collaboration (IPM, GHAVE)

Additional Information

DG Research: http://europa.eu.int/comm/research

EDCTP: http://www.edctp.org

Information requests: [email protected]