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

Budgets of the EU Framework Programmes

PRDs Political Context 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 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 Funding 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 Funding 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 Funding 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 Funding 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 Funding 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

EDCTP 2005 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

EDCTP Microbicides 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

FP7 What’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:  EDCTP:  Information requests: