Regulation of Clinical Research Related to HIV CURE

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PROJECT SUMMARY/ABSTRACT The Forum for Collaborative Research at the University of California Berkeley School of Public Health (the Forum) requests support to facilitate the development and regulatory approval of HIV curative strategies by addressing communication gaps among scientists, regulators, ethicists, patient community and industry. This Conference will create a neutral space, provide all stakeholders an equal voice, and allow extensive time for rich and fruitful conversations around treatment interruptions in HIV cure investigational interventions, the inclusion (or not) of specific populations in HIV cure studies, the specific concerns of gene therapy based research, and the ethical community engagement in HIV cure oriented studies. These discussions will help to generate consensus and recommendations to move the regulatory science of HIV cure research forward. This Conference will be a unique setting not available in other contexts; addressing HIV affected community concerns in a safe space, integrating these discussions into the regulatory context so that translation into outcome is more efficient, having academics and regulators hear the same message from community. It will be a space of dialogue where stakeholders will participate equally on the current and future wellbeing of people living with HIV and will discuss how research needs to be prioritized to meet the needs and concerns of the community, so that the community informs every phase of the research. The Forum will organize the “Regulation of Clinical Research Related to HIV Cure” conference, a one day 9- hour meeting consisting of six sessions (panels), five of which are a 60-minute topic-oriented, divided in 30 minutes for a presentation and panelists comments, and 30 minutes for open discussions. By the end of the day, a 20-minute session will be devoted to general discussion, conclusions, recommendations and next steps. The panels, facilitated by a moderator, will consist of a presenter expert on the topic of discussion, and 3 – 4 panelists that will include: a regulatory person, an ethicist and a community representative. Moderators will keep the sessions on time and moderate the open discussions, ensuring that these are conducted collegiately and respectfully. By the end of each session the moderator will elaborate conclusions and produce recommendations on the topic of discussion. The conference aims to have 80-100 participants that will include representatives from the US Food and Drug Administration (FDA), the US National Institutes of Health (NIH), investigators and academics, ethicists, people affected by the HIV epidemic, including people living with HIV, community advocates, pharmaceutical industry representatives and other stakeholders. The Forum and Planning Committee will produce a conference report that will be submitted to a peer reviewed journal for publication shortly after the meeting. The planning committee will develop a plan to produce manuscripts for publications and present recommendations at conferences based on meeting discussions.