Advances in HIV post-exposure prophylaxis (PEP): Regulatory challenges and clinical trial designs

We’re presenting!
If you are attending AIDS2026 in Rio de Janeiro, make sure to add the satellite session, "Advances in HIV post-exposure prophylaxis (PEP): Regulatory challenges and clinical trial designs," to your calendar for Monday, July 27, 2026, from 9:30 to 11:00 AM in Room 103.
The Forum for Collaborative Research at UC Berkeley and Wits RHI are convening this timely symposium to tackle complex regulatory hurdles and data collection strategies critical to the future of HIV PEP.
We welcome Veronica Miller, Ken Mayer, Sinead Delany-Moretlwe, Andrew Mujugira, Max Latiallade, Adaobi Olisa, Adriano Queiroz da Silva, Kenneth Ngure, and Boitumelo Semete to the session to share their perspectives.
The session features a strong cross-sector lineup of global leaders, including representatives from academia, funders, regulatory authorities, and community advocates, who will build on momentum from the May 11-12 HIV PEP Summit in Johannesburg, ZA.
We warmly invite all attendees to join us for this interactive session and moderated Q&A to help pave the way for more efficient, ethical HIV PEP research!
Hear the Resmetirom Approval Story

Join us on the UC Berkeley campus on Tuesday, April 14, at 2 p.m. PDT for a seminar and fireside chat with one of the Forum’s most prominent members, Dr. Rebecca Taub. She is the Founder, Director, and SeniorMedical and Scientific Advisor at Madrigal Pharmaceuticals, as well as the Industry Co-Chair of the Liver Forum Steering Committee. The seminar will explore the development and approval journey for new drugs, particularly Madrigal's Rezdiffra (resmetirom), the first disease-specific treatment for metabolic dysfunction-associatedsteatohepatitis (MASH).
For more information on the seminar, visit forumresearch.formstack.com/forms/forum_april.
Please join us on Tuesday, January 28 and Wednesday, January 29 for a virtual summit featuring a keynote address by Dr. Klaus Romero, Chief Executive Officer and Chief Science Officer at Critical Path Institute
Tuesday, Jan 28, 10 AM-12 PM EST Data Reuse: Navigating the Regulatory Environment Featuring a keynote address by Dr. Klaus Romero, the first day of the summit will explore the current state of patient data reuse in the regulatory approval process. Learn why responsible data reuse is a critical tool in future trial design, how the totality of evidence can inform the drug development process, and what’s needed to meet regulatory use challenges
Wednesday, Jan 29, 10AM-12 PM EST Demystifying the EU Data Sharing Space The second day of the summit is all about the European data space. What will be the impact of the European Health Data Space? What’s on the horizon for IHI/IMI projects like FACILITATE and IDEHRA? How will EMA’s DARWIN EU be used to inform regulatory decision-making? Sessions will address how these initiatives work together (and where they don’t), with a focus on the role of industry, both as data providers and data users
IQ DILI & Liver Forum Webinar BEST PRACTICES FOR DILI: A REVIEW OF RECENT PUBLICATIONS
The IQ DILI & Liver Forum was held on Tuesday, 22 October 2024
Meeting Flyer
Meeting Slides
Advancing Therapeutic Development for COVID-19 Treatment

TITLE
Next Generation PrEP: Science, policy, and community impact
CODE
SA039
SESSION TYPE
Satellite
ROOM/CHANNEL
Room 517b/Channel 4
DATE TIME
29 July 18:15 - 19:45
ORGANIZER
The Forum for Collaborative Research
Engaging multiple stakeholders across industry, regulatory agencies, patient groups, and academic research to discuss important considerations for trials in next-generation PrEP products. How do clinical trials best assess efficacy for PrEP when standards of care are highly efficacious? How do regulators approach groundbreaking new trial designs in HIV prevention? How do these trial designs affect patients in the trials and those that may benefit from candidate drugs?
Registration
https://www.aids2022.org/
Virtual Award Ceremony honoring the memory of Dr. John G. Bartlett and Dr. Jeffrey Murray's 29 years of service at DAVP, FDA
June 29, 2021 1-2 PM EDT
The John G. Bartlett Award "Catalyzing Clinical Research to Improve Global Health" Presented to
 Jeffrey Murray
Deputy Director, Division of Antiviral Products, FDA
The Forum for Collaborative Research (The Forum) invites you to join a celebration to honor the memory of Dr. John G. Bartlett, a pioneer in HIV/AIDS study and treatment, and acknowledge Dr. Jeffrey Murray's twenty-nine years of service at the Division of Antiviral Products at the FDA. During this special celebration, the Forum will inaugurate the John G. Bartlett Award for Catalyzing Clinical Research to Improve Global Health to be presented to Dr. Jeffrey Murray by the FDA Acting Commissioner Dr. Janet Woodcock.
Dr. Murray, a visionary and forward-thinking leader, has promoted and contributed to innovations for approvals of new therapeutics to treat and prevent infectious diseases. For many years, he has inspired and championed the Forum for Collaborative Research’s work-- most recently, inspiring efforts towards advancing the regulatory path for new PrEP agents and developing expert consensus on the use of counterfactual HIV incidence estimates to serve as external controls. Dr. Murray has co-authored seminal peer-reviewed publications and FDA guidance documents for HIV drug development, HIV fixed-dose combinations for the President’s Emergency Plan for AIDS Relief (PEPFAR), and the development of drugs for the treatment of Influenza and Hepatitis C.
Dr. John J. Bartlett served as academic co-chair of the HIV Forum's Executive Committee. He was an internationally recognized visionary leader, a pioneer in HIV/AIDS study and treatment, and a receiver of many awards, including the Alexander Fleming Award for Lifetime Achievement, the Maxwell Finland Award for Scientific Achievement, and the Forum’s C. Everett Koop Public Health Leadership Award. Dr. Bartlett was at the forefront of fighting the AIDS epidemic since the early 1980s; he started an AIDS clinic at Johns Hopkins in 1983, directed clinical trials in Baltimore of new treatments that prevent HIV from replicating, and was co-chair and one of the founding members of the national committee that drafted the first and all subsequent treatment guidelines for HIV-infected patients. Dr. Bartlett was the Stanhope Bayne-Jones Professor of Medicine and Director of the Division of Infectious Diseases at the Johns Hopkins University School of Medicine, where he successfully built the infectious diseases division at the Johns Hopkins Hospital, one of the largest divisions at Johns Hopkins and one of the world's premier centers.
While serving as the HIV Forum’s co-chair, he frequently commented that Jeff Murray should receive an award for his commitment to improving treatment of HIV, viral hepatitis and other viral diseases through innovation in development.
It is an honor for the Forum to take Dr. John Bartlett’s words to heart and present this award, in his name, to Dr. Jeffrey Murray.
We hope you are able to join us in celebrating Dr. John Bartlett's legacy and pay tribute to Dr. Jeffrey Murray for their significant contributions to the fight against infectious diseases and their dedication to the Forum's mission.
To view the program click here.
For questions, please contact Tamar Tchelidze at
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If you require an accommodation for effective communication (ASL interpreting/CART captioning, alternative media formats, etc.) please contact Astrud Reed at
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7-10 days in advance of the event.
External Event: Design Approaches For Current And Future HIV Prevention Efficacy Trials
The Global HIV Vaccine Enterprise in partnership with the HIV Vaccine Trials Network and the Forum for Collaborative Research will host a virtual workshop series starting on October 27, 2020 with the first workshop on “Design Approaches for Current and Future HIV Prevention Efficacy Trials”. Register here.
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