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Dental Institute at Guy’s, King’s College and St Thomas’ Hospitals

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  1. Dental Institute at Guy’s, King’s College and St Thomas’ Hospitals European Microbicides Project (EMPRO):Coordinator’s experience Charles Kelly

  2. European Microbicides Project (EMPRO) €11.8M 27 Partners in 10 countries 4 SMEs, Tibotec Jan 2004 – Dec 2008 www.empro.org.uk

  3. EMPRO aims to develop novel microbicides against HIV for topical (vaginal) application. UNAIDS 2006: 40 M infected globally 25M sub-Saharan Africa 60% of adults infected are women

  4. What is a microbicide? A compound (drug) that can be formulated e.g.as a gel, cream or vaginal ring that could be applied to genital mucosal surfaces to prevent or significantly reduce the transmission of HIV Why microbicides? Effective vaccine is not available. Microbicides may be developed more rapidly.

  5. Formulation Phase I Discovery Testing in vitro Animal models Other compoundsMabs TMC120

  6. ACTIVITY I: DISCOVERY Lead compounds/technologies • Nanobodies (single domain antibody) • Peptide mimetics • Nanoparticles

  7. ACTIVITY II: Pre-clinical testing • Inhibition of HIV env:host receptor binding • Inhibition of HIV infection of cells • Inhibition of HIV infection of tissue explants (cervicovaginal tissue) • Safety • Stability (40oC, 6 months)

  8. ACTIVITY III: Formulation • Gels (Hydroxyethyl Cellulose) • Intra-vaginal rings

  9. Transgenic plants St George’s University of London ACTIVITY III : Production • Engineered commensal bacteria: lactobacillus University of Siena

  10. ACTIVITY IV: Animal Challenge Models • Mouse cell-associated virus • Macaque trials cell-free and cell associated virus

  11. ACTIVITY V: Clinical Research Phase I trials (Planned for December 2007/Early 2008) • Testing of combination of monoclonal antibodies • TMC120 (Reverse transcriptase inhibitor) collaboration with International Partnership for Microbicides (IPM)

  12. Training • 15 PhD students • Short term exchange of personnel between labs • Transfer of technologies

  13. EMPRO MANAGEMENT STRUCTURE Coordination Group PROJECT ADMIN. COMMITTEE PROJECT STEERING COMMITTEE Coordinators (2) Project Manager 4-5 members: project coordinators, manager, finace,ip 7 members: project coordinators, activity coordinators Coordinating committee Coordinating committee Coordinating committee Coordinating committee Coordinating committee Activity I: Development of new microbicides Activity V: Phase I clinical trials Activity II: In vitro testing of new microbicides Activity III: Production and formulation Activity IV: Testing in vivo Scientific data Admin. information

  14. Management Team • Coordinator(s) • Project Manager (PhD, MBA, experience in technology transfer) • Finance office representative • Intellectual property

  15. Consortium Meetings • “Kick off” held near start of project • Annual meetings • 2-3 days • attended by all members, Project Officer (European Commission), External Reviewer(s) Independent Advisory Board • invited researchers – focus for field (non-disclosure agreement)

  16. Meeting overload • 1 annual consortium meeting/year • 2-3 steering committee/year • 1-2 activity meetings/year • + Coordinate/ necessary?/ hold jointly/teleconference

  17. Dissemination • Scientific publications BUT ALSO To promote European Science • Website (includes secure part ) • Brochure/newsletter • Press releases • Workshops/scientific meetings • Workpackage with specialist partner

  18. Taking prevention of Aids beyond ABC Alok Jha, science correspondentMonday March 22, 2004The Guardian British doctors lead European search for microbicides to stop transmission of HIV Scientists work to block HIV infection - Cape Argus, South Africa 22 April 2004

  19. Dissemination • Scientific publications BUT ALSO To promote European Science • Website • Brochure/newsletter • Press releases • Workshops/scientific meetings • Workpackage with specialist partner

  20. Latest News • 27.06.2007 • Appear announces final event: FROM LAB TO LIFE - Bringing the results of European research to society • 13.06.2007 • Appear: Synergies with the EUSEM project • 03.04.2007 • Empro announces phase one clinical trials • 05.03.2007 • BLOODOMICS discovers new platelet receptors • 22.02.2007 • Last call for BetaCellTherapy Training course - June 26 - 28 2007, Bath, UK www.appear-project.org

  21. Intellectual Property • Must be addressed in Consortium Agreement • Pre-Existing Know How excluded • Ownership by contributing institutions • Periodic audits conducted by project manager

  22. Reporting • Annual report required 45 days after end of reporting period (including audit certificate from each partner) • Components Periodic Activity Report Periodic Management Report Implementation Plan for next period • Project manager • Templates for reporting: Deliverables/Person months

  23. Reporting Problems generally with financial reporting • Understanding of cost models • Under-reporting of actual spend • Auditors not appointed in sufficient time Delays in pre-financing and possible shortfall in funds for next period

  24. Changes to Consortium Composition • New partners, partners move institutions, partners leave consortium • Letter of approval from each partner institution • Modification of technical annex • ?Change to consortium agreement • Approval from European Commission • Timescale ~ 12 months

  25. Coordinator considerations • Time involved (25-50%): meetings,travel … • Overview of entire programme scientific progress intellectual property and exploitation • Must have good project manager,support from institution • Disputes between partners • Requests to join • Extensive scientific collaboration/training