News

The article, Advancing the inclusion of pregnant and lactating populations in HIV PrEP research: ethical, regulatory, and surveillance recommendations from a multisectoral working group, a perspective from the Forum for Collaborative Research/HIV Forum is now available in Frontiers in Public Health.

In 2024 and 2025 the HIV Forum convened a multisectoral working group across academia, industry, community, government organizations, and regulatory agencies to formulate evidence-based, representative recommendations to advance the inclusion of pregnant and lactating people in HIV PrEP Research. The group identified several major barriers to inclusion, including ethical complexities, limited pre-clinical and clinical safety data, minimal community engagement, regulatory gaps, and weak surveillance capacity. To achieve equitable inclusion the working group highlighted specific recommendations such as establishing standardized digital data systems, implementing regulatory incentives modeled after pediatric research acts, and utilizing regional bodies like the African Medicines Agency to harmonize global regulatory standards. These topics, among others, are further explored in the article.

Thank you to the authors, collaborators, and members of the HIV Forum - Long-acting PrEP during pregnancy and lactation working group, whose active contribution and expertise enable this work.

Read the article in Frontiers in Public Health: https://doi.org/10.3389/fpubh.2026.1811039

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!

Members of the Forum for Collaborative Research’s TAVI (Transplantation Associated Viral Infections) Forum published “Refractory mucocutaneous infections by herpes simplex virus (HSV) in hematopoietic cell transplant recipients: A real-world, multicenter study,” in Open Forum Infectious Diseases (OFID). (June 19, 2026).

Based on a collaboration among investigators across seven U.S. transplant centers, this study draws on real-world clinical data from 125 patients to analyze treatment approaches and outcomes in a population that continues to face significant therapeutic challenges.

Reflecting on the importance of this work, Dr. Camille Kotton, the US Academic TAVI Forum co-chair, said:

“This multicenter study is the largest and most comprehensive investigation to date of refractory mucocutaneous herpes simplex virus (HSV) infection in hematopoietic cell transplant (HCT) recipients. The findings of the analysis of 125 patients highlight the significant challenges of managing refractory HSV with currently available therapies and emphasize the ongoing need for safer and more effective treatment options. Together with recently reported phase 3 data for pritelivir, these results suggest that improved therapeutic options for refractory HSV may soon become available”.

Dr. Per Ljungman, the EU Academic TAVI Forum co-chair, added:

“This work also highlights the value of the TAVI Forum’s collaborative model and the contributions of the HSV Resistance Working Group in bringing together experts across academia, clinical practice, industry, and regulatory perspectives to iteratively identify evidence gaps and advance meaningful work to improve outcomes for transplant recipients.”

Dr. Genovefa (Zenia) Papanicolaou, first author and member of the TAVI Forum Steering Committee, shared an additional perspective on the clinical implications of the findings:

“This multicenter study across seven major transplant centers highlights the real-world challenges of treating refractory HSV in transplant recipients. Current therapies often require prolonged intravenous treatment, are limited by toxicity and poor efficacy, and many patients experience delayed healing or die before infection resolves. These findings underscore the urgent need for safer, effective, well-tolerated oral therapies such as pritelivir.”

Refractory HSV remains an important unmet need in transplant medicine. Existing treatment approaches may require prolonged therapy and can be limited by toxicity and variable effectiveness, underscoring the need for improved management strategies and additional therapeutic options for immunocompromised patients.

The Forum congratulates all authors, collaborators, and members of the TAVI HSV Resistance Working Group whose contributions helped advance this important work.

“This publication reflects the value of sustained cross-stakeholder collaboration to address unmet needs in transplant infectious diseases and to generate evidence to inform future research and clinical care,” added Dr. Veronica Miller, Director of the Forum for Collaborative Research.

Read the publication in Open Forum Infectious Diseases here: Refractory mucocutaneous infections by herpes simplex virus (HSV) in hematopoietic cell transplant recipients: A real-world, multicenter study | Open Forum Infectious Diseases | Oxford Academic

The Forum for Collaborative Research joins the HIV community in mourning the death of Dr. Victor De Gruttola, professor emeritus of biostatistics at the Harvard Chan School of Public Health, and valued member of the HIV Forum. His work on statistical modeling of HIV progression has had lasting influence on infectious disease epidemiology. At The Forum, he introduced us to the intricacies of high-dimensional data and their analysis, in his uniquely “Victor” way of explaining with humor, humility, and humanity, so we could all understand.

“He was a true mensch and is sorely missed. He knew to ask the right questions — questions of great significance — always moving the field forward,”  said Dr. Veronica Miller, the director of the Forum for Collaborative Research.

We join his colleagues, family, and friends in remembering his life and work with gratitude and affection.

According to the latest estimates from the World Health Organization, hepatitis B (HBV) affects 240 million people worldwide and 64 million people in Africa. But only 1 percent of HBV clinical trials worldwide have been conducted in Africa, despite diverse HBV genotypes across the continent, as well as other circumstances that differentiate HBV in Africa from other regions.

Drs. Ekene Osakwe, a Research Associate with the HBV arm of the Forum for Collaborative Research, and Danjuma K. Adda, former president of the World Hepatitis Alliance, met on Zoom and discussed the challenges and opportunities for hepatitis B research in Africa. Both are among the authors of “Strengthening hepatitis B virus clinical research in Africa: the need for multistakeholder collaboration, funding, and political will,” in the journal Lancet Microbe. The article distills the insights from a series of multistakeholder conversations on barriers and solutions to the disparities in HBV research.

The wide-ranging conversation in this video interview, which was recorded in February 2026, touched on topics including the reasons that African countries are underrepresented in HBV clinical trials, why HBV research receives less funding than other conditions, and who should have central roles in designing and conducting clinical trials in Africa.

Dr. Adda emphasized some key themes throughout the conversation, including: the need for long-term investment by governments and pharmaceutical companies, the importance of harmonizing and streamlining regulatory approval processes, and the need to recruit African investigators and engage people living with HBV as research partners.

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.

The approval of Rezdiffra (resmetirom) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) by the US FDA (accelerated, March 2024) the European Medicines Agency (conditional, November 2025) represents a historic milestone in a field facing considerable challenges in getting drugs approved for a condition affecting an estimated 5% to 7% of the population. MASH is a leading cause of liver cirrhosis and hepato-cellular cancer, with a projected global cost between $1.8 billion (in Germany) and $78.6 billion (in the United States) by 2040. MASH is not a new disease, but its formal recognition, evolving nomenclature, and emergence as a therapeutic target have introduced new complexity in clinical development, regulatory alignment, and diagnostic standardization.

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