dental institute at guy’s, king’s college and st thomas’ hospitals european microbicides...
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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 countries4 SMEs, Tibotec
Jan 2004 – Dec 2008
www.empro.org.uk
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 I
Discovery
Other compounds
MabsTMC120
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 (40oC, 6 months)
ACTIVITY III: Formulation
• Gels (Hydroxyethyl Cellulose)
• Intra-vaginal rings
ACTIVITY III : Production
• Engineered commensal bacteria: lactobacillus
University of Siena
• Transgenic plantsSt 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 GroupCoordinators (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 committeeScientific 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 ABCAlok 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 Africa22 April 2004Innovative work at Stellenbosch University could help turn the tide of HIV infection, as scientists here work with others across the world to pin downa cheap and effective product that promises womencontrol 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 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
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 progressintellectual property and exploitation
• Must have good project manager,support from institution
• Disputes between partners• Requests to join• Extensive scientific collaboration/training