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This workshop focuses on the challenges of designing studies to assess the efficacy of new prevention strategies (PrEP, vaccines, antibodies) in humans. Due to the high efficacy of oral PrEP with TDF/FTC when adherence is appropriate and due to multiple drugs/vaccine and modes of delivery to assess, large non-inferior randomized trials will take years to provide results and will require significant funding. These challenges need to be addressed by investigators, regulators and pharmaceutical companies to foster the development of new preventive strategies. This session is targeted at prevention researchers, ethicists, regulators, research agencies, private and public funders, pharmaceutical companies, and community representatives. Participants will leave with an understanding of the challenges faced by future preventive studies aimed at assessing their efficacy in the prevention of HIV-infection, along with insights into potential ways of addressing them.

14:30
WEWS0201
Introduction
14:35
WEWS0202
Are animal models a good surrogate of efficacy?
Gerardo Garcia-Lerma, United States
Slides
14:45
WEWS0203
Discussion and questions
14:55
WEWS0204
Can pharmacology help?
Peter Anderson, United States
Slides
15:05
WEWS0205
Discussion and questions
15:15
WEWS0206
Role of explant tissue infection assays
Ian McGowan, United States
Slides
15:25
WEWS0207
Discussion and questions
15:35
WEWS0208
Requirements for approval: a perspective from regulatory agencies
Charu Mullick, United States
Slides
15:45
WEWS0209
Discussion and questions
15:55
WEWS0210
Measuring the effectiveness of experimental PrEP agents
David Dunn, United Kingdom
Slides
16:05
WEWS0211
Discussion and questions
16:15
WEWS0212
Feedback from the HPTN/HVTN networks
Sinead Delany-Moretlwe, South Africa
Slides
16:25
WEWS0213
Discussion and questions
16:35
WEWS0214
The community perspective
Nikos Dedes, Greece
16:45
WEWS0215
Discussion and questions
16:55
WEWS0216
Closing remarks