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

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