Veronica Miller featured at the Healthcare Conference Taipei 2024
Veronica Miller, director of the Forum for Collaborative Research at Berkeley Public Health, was recently a featured panelist on February 21 and 22 at the Healthcare Conference Taipei 2024, hosted by UC Berkeley School of Public Health in partnership with J.P. Morgan, Stanford, and the Regent Taipei. Read More
Dr. Robin Schaefer of the Forum for Collaborative Research was invited to speak at the 14th Jornadas de Atualização em Doenças Infeciosas do Hospital de Curry Cabral, the largest conference on infectious diseases in Portugal, with over 600 participants. His talk “The future of pre-exposure prophylaxis (PrEP) for HIV prevention” focused on recent advances in the delivery of PrEP for HIV prevention, new PrEP products, and how to reach global HIV prevention goals. An article summarizing the presentation was published in the conference proceedings and is reprinted below.
The future of pre-exposure prophylaxis (PrEP) for HIV prevention
Globally, numbers of new HIV infections remain unacceptably high. There has been significant progress in reducing HIV incidence in some regions, notably in eastern and southern Africa, where there are the largest numbers of new infections; however, in other regions, epidemics have been stable or increasing.
Pre-exposure prophylaxis (PrEP) is the use of antiretroviral drugs by HIV-negative people to reduce their risk of HIV infection. It is a vital tool in efforts to combat HIV epidemics. The first PrEP product, an oral pill, was approved by the US Federal Drug Administration in 2012 and recommended by the World Health Organization (WHO) for all people at substantial risk of HIV in 2015. At the time of the WHO recommendation, PrEP use was nearly fully limited to the US. Since then, there has been a global increase in PrEP use, and, in 2022, there were an estimated 2.5 million people who used PrEP at least once. Despite this considerable increase in PrEP use, further growth is needed to meet the global target of 10 million PrEP users by the end of 2025.
PrEP is increasingly delivered through differentiated services, a trend accelerated by the COVID-19 pandemic, which often required service adaptations such as providing PrEP outside of healthcare facilities. Building on this experience, WHO published guidance to support differentiated PrEP services, defined as person- and community-centred approaches that adapt services to the needs and preferences of the people who are interested and could benefit from PrEP. Such adaptations can make services more acceptable and accessible and thus support uptake, persistence, and effective use. Examples of service adaptations include community-, pharmacy-, and home-based PrEP delivery (“where” to provide services), multi-month dispensing to reduce follow-up visits (“when”), integrated services (“what”), and task sharing with various health worker cadres and lay providers (“who”).
In addition to changing service delivery, another axis of differentiated PrEP is to allow for choice between PrEP products so that clients can choose the product that best suit their needs and preferences. Indeed, more PrEP products are becoming available. In addition to oral PrEP, WHO now recommends offering a vaginal PrEP ring and a two-monthly injection. More products are being investigated, including a six-monthly injection, which is evaluated in phase 3 clinical trials, and multipurpose prevention technologies (MPTs) that commonly combine contraception with an HIV prevention drug.
While the pipeline of new biomedical HIV prevention products is exciting, there are cross-cutting challenges. This includes how to demonstrate efficacy as placebo-controlled trials are no longer ethical, how to collect sufficient safety data, for instance for use of these products during pregnancy, and how to ensure efficient regulatory approval and product introduction. To address these cutting-edge scientific and regulatory questions through consensus-building, the Forum for Collaborative Research, a public-private partnership based at the University of California, Berkeley, has formed multiple working groups consisting of experts and representatives from regulatory agencies, industry, community, and normative bodies.
Differentiating PrEP situates PrEP services within the broader Political Declaration on HIV and AIDS, adopted by the United Nations General Assembly in 2020, which calls for person-centred HIV prevention approaches. Adapting services and offering choice is not just “nice-to-have”; it is necessary to ensure equitable access to PrEP and support effective use. Differentiated PrEP is the future of PrEP – it has to be to achieve global goals and combat the HIV epidemic globally.
African Hepatitis Summit 2023
From left to right: Philip Kwame Yeboah (Hepatitis B Foundation Community Advisory Board), Peter Ramge (Roche Diagnostics), Wendy Spearman (University of Cape Town), John Ward (Coalition for Global Hepatitis Elimination), Philippa Easterbrook (World Health Organization), Danjuma Adda (World Hepatitis Alliance), Veronica Miller (Forum for Collaborative Research), Nicaise Ndembi (Africa CDC), Mitchell Leus (Forum for Collaborative Research), Edith Okeke (University of Jos)
Forum for Collaborative Research facilitates dialogue on bringing hepatitis B clinical trials to Africa
The Forum attended the 2023 African Hepatitis Summit and hosted a session that facilitated a discussion on the urgent need to bring hepatitis B clinical research to the African continent. Held in Abuja, Nigeria from October 24 – 26, 2023, the Summit convened civil society organizations, policy makers, global funders, medical professionals, and advocacy organizations to strengthen political will for putting Africa on track towards viral hepatitis elimination.
Hepatitis B is a viral infection of the liver, caused by the hepatitis B virus (HBV), that can cause both acute and chronic liver disease. Chronic hepatitis B (CHB), frequently leading to cirrhosis and liver cancer, affects nearly 300 million people globally, with around 70% of worldwide HBV infections occurring in Africa. The HBV vaccine—which requires that the first dose be administered within 24 hours of a newborn’s birth—is safe and effective, but implementation across Africa is low. In 2021, only 14 of 47 African countries had introduced routine HBV vaccination, and only 17% of African newborns received a timely vaccination. Diagnosis and linkage to care across Africa are alarmingly low. In 2021, only 2% of persons infected with hepatitis B were diagnosed, and only 0.1% received antiviral treatment that suppresses virus replication to prevent cirrhosis and cancer.
Despite the continent’s high burden of disease, clinical trials for hepatitis B are generally not conducted in Africa. According to Dr. Nicaise Ndembi, Chief Science and Senior Advisor to the Africa Centres for Disease Control and Prevention Director General, only 5 hepatitis B clinical trials were conducted in Africa from 2016 – 2021, and these were Phase IV trials focused on post-marketing surveillance for already-approved therapies. The dearth of hepatitis B clinical trials in Africa can partially be attributed to suboptimal research and development (R&D) investment, with Dr. John Ward, Director at the Coalition for Global Hepatitis Elimination of the Task Force for Global Health, stating that hepatitis B received $16 million in R& investment for new products and technologies in 2021, about 1% of R&D investment for HIV in the same year. Through the Forum’s model of multi-stakeholder discussion and deliberation, panelists from the World Health Organization, Roche Diagnostics, World Hepatitis Alliance, and the Hepatitis B Foundation Community Advisory Board provided an array of perspectives including capacity-building, health equity, and patient-centered clinical research.
Inclusion of African patients in hepatitis B clinical trials is important for promoting global health equity and ensuring that these communities are engaged in efforts to develop new treatments for hepatitis B. There are clear benefits to participation in clinical research. At the individual-level, patients have access to screening and potentially beneficial treatments, which may improve psychosocial and clinical outcomes associated with hepatitis B. At the community-level, clinical research may increase community-level knowledge and awareness of the disease, which could be important for addressing stigma and discrimination associated with hepatitis B.
“We feel strongly that clinical research is so important for communities,” said Dr. Veronica Miller, Director of the Forum and Adjunct Professor in the Division of Infectious Diseases and Vaccinology. Presentations at the Summit focused on implementation of hepatitis B vaccination, screening, and linkage to care; Dr. Miller emphasized that “we need to go back one step and bring the clinical research infrastructure to this continent, because clinical research is a stepping stone that is so important for implementation.”
About the Forum for Collaborative Research
Founded in 1997, The Forum for Collaborative Research at the UC Berkeley School of Public Health is a public/private partnership with a mission to catalyze clinical development and improve global health by facilitating research, informing policy, and advancing regulatory science. The Forum’s three-pronged approach (practice, research, education) accelerates safe drug development by increasing clarity, cooperation and innovation, while maintaining standards of evidence. Forum members work in clinical practice, research, academia, industry, regulatory authorities, and patient advocacy. Using proven models for stakeholder engagement they enhance clinical trial efficiency, support fair participation, and expand access programs. Current projects focus on transplantation associated virus infections (TAVI), viral hepatitis B (HBV), human immunodeficiency virus (HIV), metabolic dysfunction-associated steatotic liver disease (MASLD)/ metabolic dysfunction-associated steatohepatitis (MASH), primary sclerosing cholangitis (PSC), ocular diseases, and rare diseases.
Remembering Adaora Adimora
We learned with great sadness about the passing of Dr. Adaora Adimora, the Sarah Graham Kenan Distinguished Professor of Medicine and Epidemiology at the University of North Carolina at Chapel Hill. Dr. Adimora was an exceptional scientist and leader in the fight to end the HIV epidemic in the US and globally. In her career of over 25 years as a physician and researcher, she highlighted the social drivers of HIV transmission and the need for structural interventions to address HIV epidemics. "Ada was a longstanding collaborator of the Forum and a dear friend. She will be deeply missed by the global health community," said Dr. Veronica Miller, the director of the Forum for Collaborative Research. Her many contributions to the HIV field and beyond were recognized in 2019 when she was elected to the National Academy of Medicine. We send our condolences to her family and friends as they remember a true inspiration to us all.
Advancing Therapeutic Development for COVID-19 Treatment: Part One
Washington DC, November 2, 2023 --The Forum for Collaborative Research is hosting its first open, public meeting on COVID-19 therapeutic drug research, with regulatory agency participation. Please register here.
Advancing Therapeutic Development for COVID-19 Treatment
In November 2010, Dr. Anthony S. Fauci presented the Forum’s inaugural C. Everett Koop HIV/AIDS Health Leadership Award to VADM C. Everett Koop, the 13th U.S. Surgeon General for “Advancing the Nation’s Progress in Fighting HIV/AIDS through Distinguished Service, Vision and Leadership”. It was meant to acknowledge public health leaders with courage. Accepting the award, Dr. Koop gave a memorable speech The Early Days of AIDS: As I remember them describing his days as Surgeon General during the Reagan administration and how the 1986 Surgeon General’s Report on AIDS Report sent to every one of the 107 million household in America, came to be. We named the award after C. Everett Koop because of his commitment to service and leadership throughout his career, but especially at a time when others were loath to refer to the virus and its disease by name. We asked Dr. Fauci to present the award because of his similar commitment to service and leadership throughout the HIV epidemic. In his presentation, Dr. Fauci commented: “Personally, and to many of us in the medical and public health fields, Dr. Koop is a courageous hero……. Chick Koop…. always seemed to do what was the most correct, honorable, and appropriate thing for the health of the Nation and the world”.
In September 2011, Dr. Koop returned to Washington to present the award to Tony Fauci – an appropriate sequel honoring the mutual respect between the two men from Brooklyn. In his presentation, Dr. Koop commented on Tony’s character, work ethic, and devotion to constantly contribute to the health of mankind – the kind of leader the AIDS epidemic was made for
As we salute Tony Fauci for his Distinguished Service, Vision and Leadership not just in HIV/AIDS but across Infectious Diseases, adding our appreciation for his service to the Nation during the COVID-19 pandemic, it is fitting that we reflect on the award named after the most famous Nation’s Doctor for courage in leadership.
- Veronica Miller
A Tribute
Appreciation and Thanks
2022 Year in Review
2022 Year in Review: Cheers and Happy Holidays from The Forum!
Forum for Collaborative Research
HBV | HIV | Liver | PSC | Rare Diseases | TAVI-CMV | Ocular Diseases | Data & Analysis Center
Dear Forum Stakeholders,
2022 was a year of remarkable growth for the Forum. Truly a special year because we were able to convene many of our projects in-person. As we get ready to welcome 2023, we want to pause and share some highlights of 2022:
New Team Members:
Chris Hoffman, PhD IT and Operational Director
Logan Donaldson, MPH Research Associate
Sehyr Khan, BA Research Associate
Mitchell Leus, MPH Research Associate
Shilpa Mitra, MPH Research Associate
Zach Rooney, MSCS Research Associate
Alicia Jellinek Program Financial Analyst
Nayri Alajaji Graduate Student Researcher
Mayland Treat Graduate Student Researcher
HIV Forum Research Grants and Gifts:
Bill and Melinda Gates Foundation: $1,584,618 to further work on novel trial designs for HIV prevention and conversations related to making new HIV prevention products available to the public.
Gilead Sciences, Inc.: $1,638,338 to help accelerate HIV PrEP research by strengthening counterfactual incidence estimates using a collaborative approach to combine data from multiple sources, informing future trials and bolstering current ones, while simultaneously leading conversations in responsible and ethical use of trial data and its future implications.
Facilitating next-generation pre-exposure prophylaxis (PrEP) clinical trials using HIV recent infection assays: a consensus statement from the Forum HIV Prevention Trial Design Project.Clinical Pharmacology & Therapeutics. Accepted, in print.
Projects Launched:
Data & Analysis Center: to serve the needs of stakeholders in advancing data science for drug development, thus serving patients most of all.
Ocular Diseases Forum: to advance the regulatory sciences for the treatment of inherited retinal diseases and macular degeneration. Co-chaired by Jim Wang and Claire M. Gelfman.
Towards Accelerating Strategies for Hepatitis B Elimination: Increasing Vaccination Among Adults in High-Impact Settings Symposium: as part of the Forum’s Policy Series, a symposium for strengthening implementation of adult hepatitis B vaccination was convened on November 1, 2022 in Atlanta, GA. The symposium convened clinicians, industry, health departments, viral hepatitis programming agencies, harm reduction coalitions, and community-based organizations to facilitate dialogue aimed at producing strategies for implementing universal hepatitis B vaccination among US adults aged 19 to 59, in support of April 2022 guidance by the Advisory Committee on Immunization Practices (ACIP). An output of this meeting will be a special issue in the Journal of Virus Eradication.
Expanding Inclusion for Long-Acting HIV Treatment Trials: this meeting convened on November 10th, 2022 in Washington DC discussed the need for approaches to and regulatory considerations for expanding inclusion of patients who will benefit most from LA treatment options. The Forum brought together stakeholders from the US FDA’s Division of Antivirals, NIH Office of AIDS Research, NIH National Institute of Drug Abuse, NIH National Institute of Mental Health, AIDS Clinical Trial Group (ACTG), Merck, ViiV, Gilead, among other academic institutions and patient advocate groups. Outputs of this meeting include a series of recommendations to be released in 2023.
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?
The Use of External Controls in FDA Regulatory Decision Making
Washington DC, June 21, 2021 – The Forum for Collaborative Research announced the publication of “The Use of External Controls in FDA Regulatory Decision Making” in Therapeutic Innovation & Regulatory Science. This review describes the circumstances for approval of 45 products based on pivotal studies leveraging external controls, with retrospective natural history studies as the most common source of control data.
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