1. International Partnership for Microbicides Tessa Mattholie, European Liaison Officer, Brussels

2. IPM Mission IPM’s mission is to prevent HIV transmission by accelerating the development and access of safe and effective microbicides for use by women in developing countries.

3. Pathway of Microbicide Development 1. Assess and fund across the microbicide portfolio 4. Optimize clinical trial capacity 2. Help develop the “next generation” of microbicides 3. Provide common capabilities or supports for the field 5. Coordinate effort to ensure worldwide access Discovery Basic research Pre- clinical Clinical trials Launch & Access Multiple mechanisms/ targets/products Formulation capacity In vitro and in vivo models Regulatory Manufacturing

4. IPM Infrastructure 4 areas of initial focus were on the gaps/bottlenecks in microbicide development pathway:  Screening/activity testing  Formulation  NHP testing  Clinical trials material manufacturing

5. IPM Clinical Trials n Vaginal ring Phase I trial of TMC120 completed in Belgium n TMC120 Gel Phase I/II trial in Africa (Developing clinical trial sites) n Male tolerance of TMC120

6. IPM’s Approach to Access n Ensuring availability requires:  Appropriate regulatory approval and licensing infrastructure  Manufacturing capability and sufficient capacity  Logistics and delivery networks in-country n Ensuring adoption requires:  End-user awareness about the product and its benefits  Effective pricing and financing mechanisms to ensure affordability  Supportive social and policy environment (and the research to generate this)

7. European advocacy activities Aims: n Increase political commitment for microbicides n Increase funding for R&D through national research institutions and PPPs n Advance policy environment for development of, and acess to, microbicides

8. Current Donors to the IPM n Canada n Denmark n EC n Gates Foundation n Ireland n Netherlands n Norway n Rockefeller Foundation n Sweden n UK n UN n US n World Bank

9. How to Contact IPM? n Visit our website at www.ipm-microbicides.org n Email Tessa Mattholie at: tmattholie@ipm-microbicide.org