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

European Microbicides Project (EMPRO) €11.8M 27 Partners in 10 countries 4 SMEs, Tibotec Jan 2004 – Dec

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

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.

Testing in vitro Formulation Animal models Phase IDiscovery Other compounds Mabs TMC120

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

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 (40 o C, 6 months)

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

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

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

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)

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

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

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

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)

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

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

Taking prevention of Aids beyond ABC Alok Jha, science correspondent Monday March 22, 2004 The Guardian British doctors lead European search for microbicides to stop transmission of HIV The Guardian Scientists work to block HIV infection - Cape Argus, South Africa 22 April 2004 Innovative work at Stellenbosch University could help turn the tide of HIV infection, as scientists here work with others across the world to pin down a cheap and effective product that promises women control of their sexual health

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

Latest News Appear announces final event: FROM LAB TO LIFE - Bringing the results of European research to society Appear: Synergies with the EUSEM project Empro announces phase one clinical trials BLOODOMICS discovers new platelet receptors Last call for BetaCellTherapy Training course - June , Bath, UK

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

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

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

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

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