Landscape of long-acting formulations and delivery platforms for HIV prevention and treatment

Anton Pozniak is an Immediate Past President of the International AIDS Society. He is Consultant Physician in HIV Medicine at the Chelsea and Westminster Hospital and Professor in the Department of Clinical Research at the London School of Hygiene and Tropical Medicine UK. He became a Fellow of the Royal College of Physicians in 1996 and a life member of the British HIV Association in 2014.

Helen McDowell is Head of Government Affairs & Global Public Health at ViiV Healthcare and was elected as the Industry Liaison Forum industry co-chair in July 2021. Helen, who has worked in HIV for over 15 years, leads global public policy, access to medicine, advocacy and global public health initiatives, including public-private partnerships, for ViiV Healthcare. She is also an active member of GSK’s (ViiV’s majority shareholder) Global Health Leadership team.

Brent Allan resides on Da Da Wjurng lands of the Kulin Nation in the lands which most know as Australia.

They currently occupy a number of ongoing senior advisor positions focusing upon programs and policy for a number of global and domestic agencies and industry partners. They have been working in the community response to HIV/AIDS for over 30 years across a number of countries and have qualifications in health education, business, community services management as well as public and social health experience with local, state and federal governments, as well as global industries.

Brent identifies as a non-binary person who has been living with HIV for over 25 years. They have been active in efforts to build the capacity of people living with HIV through advocacy, education and representation, and they regularly provides technical assistance to global networks, governments, civil society and industry on matters of best practice in community-based services, research and development.

Brent is a passionate advocate for civil society and consumer representation in health service policy, programming and evaluation, and has been a vocal advocate and champion for the rights sex workers, people who use drugs as well as vulnerable and marginalised people working on the front-lines with gender and sexually diverse communities.

Rahab Mwaniki is a civil society leader and public health specialist with vast experience in the TB and HIV fields. She has worked in different capacities with various agencies, including government, UN and civil society organizations. She also has experience working with people living with HIV networks in Kenya, Uganda and Tanzania to generate evidence for advocacy and engage in high-level advocacy on HIV and TB with policy makers and legislators at the national, regional and global levels. In 2018, Rahab was among the stakeholders who developed and ratified the 2018 Nairobi Strategy on Tuberculosis and Human Rights: Measuring Progress and Planning for the Future.

Rahab has worked with various committees globally and nationally. These include the WHO Child and Adolescent Core TB Working Group and TB and HIV ICCs. She is an IAS Member.

Moses "Supercharger" Nsubuga is a musician, radio and TV presenter and HIV advocate who has lived with HIV since 1994. He has used the courage from the early days of his diagnosis to propel himself to the global stage as one of the most formidable HIV prevention, treatment and cure research community advocates. He currently chairs the Joint Clinical Research Centre's Community Advisory Board and represents the African community on the ACTG, INSIGHT and AIGHD boards. He is currently training new prevention and cure research advocates and is also fundraising and constructing an HIV treatment and adherence center in Uganda.

Charles Flexner is Professor of Medicine in the Divisions of Clinical Pharmacology and Infectious Diseases, and Professor of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. He is also Professor of International Health at the Bloomberg School of Public Health. Dr. Flexner is an expert on the basic and clinical pharmacology of drugs for HIV/AIDS and related infections, including viral hepatitis and tuberculosis. His scientific contributions include work on the important roles of pharmacokinetic enhancement, medication adherence, and dosing frequency in the long-term management of HIV/AIDS. He has published extensively on anti-infective drug transport and metabolism, and metabolic drug interactions. His current research includes the discovery and development of new molecules and formulations for long-acting parenteral administration for treatment and prevention of HIV infection. He directs the Long Acting/Extended Release Antiretroviral Research Resource Program (LEAP; www.longactinghiv.org), and the Johns Hopkins Baltimore-India Clinical Trials Unit. He is a member of the editorial board of 11 scientific journals. He is a consultant to the Bill and Melinda Gates Foundation and the Clinton Health Access Initiative, and serves on the WHO Clinical Guidelines Development Group for Treatment and Prevention of HIV in Adults, Adolescents, and Children.

Alex Rinehart is Medicines Development Leader, Prevention at ViiV Healthcare. Alex has been involved in HIV clinical research since 1996 while working at ViiV Healthcare and formerly at both GlaxoWellcome and Tibotec Therapeutics, where he served as an Associate Medical Director and was involved in the successful launches of both darunavir and etravirine. Since joining the Global Medical Strategy group at ViiV Healthcare in 2010, he has assumed key roles in developing and executing the global HIV prevention strategy and leads the HIV prevention medicines development team for the R&D organization, which includes global regulatory submissions and the successful FDA approval of cabotegravir for PrEP (Apretude).

Alex received his PhD in Biochemistry and Molecular Biology from SUNY Stony Brook and his Bachelor of Science from Bowling Green State University.

Kathleen E. Squires, MD joined the Global Center of Scientific Affairs in Merck Research Laboratories as the new Global Director of Scientific Affairs (GDSA) for HIV in August, 2017. Previously, she was the W. Paul and Ida H. Havens Professor of Infectious Diseases at the Sidney Kimmel Medical College of Thomas Jefferson University (TJU), Director of the Division of Infectious Diseases, Thomas Jefferson University Hospitals and Medical Director, Strategic Clinical Programs and Infectious Disease Population Health, Jefferson Enterprise. Dr. Squires graduated from Princeton University, completed medical school and an internal medicine residency at the Medical College of Pennsylvania and then pursued a fellowship in the Division of Infectious Diseases at the New York Hospital, Weill Cornell University Medical College. Before joining TJU in 2005, she was on the faculty of the University of Alabama at Birmingham and the University of Southern California where she was the Medical Director of the LAC/USC HIV Clinic and the PI of the USC ACTG CSU. She is board certified in Internal Medicine and Infectious Diseases. Her primary field of academic interest lies in the field of HIV infection and she has extensive experience in the treatment of HIV-infected patients as well as in clinical research. Major areas of interest within this field include identification of novel antiretroviral agents, development of novel treatments strategies, and HIV infection in women. Dr. Squires has been conducting HIV clinical trials for almost 30 years and has authored or co-authored over 120 articles on varied topics in the research and treatment of HIV/AIDS. She has provided peer review as a standing member on several NIH committees including the NIH Fogarty International Scholar Review Panel, as the Chairperson for the AIDS Clinical Studies and Epidemiology Study Section from 2008-2010 and a member of the Department of Health and Human Services Panel on the Treatment of HIV-infected Pregnant Women and Prevention of Peri-natal Transmission.

Martin Rhee is currently an Executive Director in Clinical Research in Virology at Gilead Sciences, leading the clinical development of lenacapavir, the first-in-class long acting HIV capsid inhibitor. Over the past decade, Dr Rhee made significant contributions in bringing many of Gilead’s novel HIV medicines to people with HIV. Dr. Rhee received a medical degree from Seoul National University in Korea and completed his residency in internal medicine at Dartmouth Hitchcock Medical Center and fellowship in infectious disease at Tufts Medical Center.

Michelle Rodolph is a technical officer with the Testing, Prevention, and Populations team of the WHO HIV, Hepatitis, and STI Department. She works on pre-exposure prophylaxis (PrEP) for HIV prevention with a particular PreP delivery for women, future prevention products and integration of HIV prevention into SRH programs. Prior to her work on PrEP and SRH integration, Michelle was involved with harm reduction and HIV prevention programs for key populations.

Brent Allan resides on Da Da Wjurng lands of the Kulin Nation in the lands which most know as Australia.

They currently occupy a number of ongoing senior advisor positions focusing upon programs and policy for a number of global and domestic agencies and industry partners. They have been working in the community response to HIV/AIDS for over 30 years across a number of countries and have qualifications in health education, business, community services management as well as public and social health experience with local, state and federal governments, as well as global industries.

Brent identifies as a non-binary person who has been living with HIV for over 25 years. They have been active in efforts to build the capacity of people living with HIV through advocacy, education and representation, and they regularly provides technical assistance to global networks, governments, civil society and industry on matters of best practice in community-based services, research and development.

Brent is a passionate advocate for civil society and consumer representation in health service policy, programming and evaluation, and has been a vocal advocate and champion for the rights sex workers, people who use drugs as well as vulnerable and marginalised people working on the front-lines with gender and sexually diverse communities.

Rahab Mwaniki is a civil society leader and public health specialist with vast experience in the TB and HIV fields. She has worked in different capacities with various agencies, including government, UN and civil society organizations. She also has experience working with people living with HIV networks in Kenya, Uganda and Tanzania to generate evidence for advocacy and engage in high-level advocacy on HIV and TB with policy makers and legislators at the national, regional and global levels. In 2018, Rahab was among the stakeholders who developed and ratified the 2018 Nairobi Strategy on Tuberculosis and Human Rights: Measuring Progress and Planning for the Future.

Rahab has worked with various committees globally and nationally. These include the WHO Child and Adolescent Core TB Working Group and TB and HIV ICCs. She is an IAS Member.

Moses "Supercharger" Nsubuga is a musician, radio and TV presenter and HIV advocate who has lived with HIV since 1994. He has used the courage from the early days of his diagnosis to propel himself to the global stage as one of the most formidable HIV prevention, treatment and cure research community advocates. He currently chairs the Joint Clinical Research Centre's Community Advisory Board and represents the African community on the ACTG, INSIGHT and AIGHD boards. He is currently training new prevention and cure research advocates and is also fundraising and constructing an HIV treatment and adherence center in Uganda.

Kenly Sikwese coordinates the African Community Advisory Board (AfroCAB) and collaborates with the Treatment Advocacy and Literacy Campaign to promote GIPA in the national HIV response.

Kenly has been a member of several Global HIV treatment access processes including the WHO Treatment Guidelines, UNAIDS 90-90-90 target setting and monitoring of progress. He is also a Board Member (Alternate) at UNITAID representing Communities affected or living with HIV, TB, HCV and malaria.

Kenly is also regular speaker on African treatment access issues. He is motivated by the AIDS related death of his two brothers and his own HIV diagnosis 2003. Kenly joined the HIV movement in the UK with the Uganda AIDS Action Fund and Terrence Higgins Trust (East).

Returning to Zambia in 2007, Kenly has volunteered in HIV treatment at Our Lady’s Hospice and worked at the Zambian Action Against HIV and AIDS in Lusaka, and the Network of Zambian People Living with HIV (NZP+). At the NZP+ Kenly worked as the Country Coordinator implementing the PLHIV Stigma Index and other research tools in partnership with GNP+ and World AIDS Campaign.

Kenly attended The National Institute for Public Administration (NIPA), Business School in Manchester, Thames Valley University, the Chainama College of Health Sciences and The Foundation for professional Development. He is a member of the International AIDS Society Steering Committee on Treatment as Prevention and a member of the Robert Carr Civil Society Networks Fund International Steering Committee among. He speaks in different forums on the issues affecting PLHIV among others.

Charles Flexner is Professor of Medicine in the Divisions of Clinical Pharmacology and Infectious Diseases, and Professor of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. He is also Professor of International Health at the Bloomberg School of Public Health. Dr. Flexner is an expert on the basic and clinical pharmacology of drugs for HIV/AIDS and related infections, including viral hepatitis and tuberculosis. His scientific contributions include work on the important roles of pharmacokinetic enhancement, medication adherence, and dosing frequency in the long-term management of HIV/AIDS. He has published extensively on anti-infective drug transport and metabolism, and metabolic drug interactions. His current research includes the discovery and development of new molecules and formulations for long-acting parenteral administration for treatment and prevention of HIV infection. He directs the Long Acting/Extended Release Antiretroviral Research Resource Program (LEAP; www.longactinghiv.org), and the Johns Hopkins Baltimore-India Clinical Trials Unit. He is a member of the editorial board of 11 scientific journals. He is a consultant to the Bill and Melinda Gates Foundation and the Clinton Health Access Initiative, and serves on the WHO Clinical Guidelines Development Group for Treatment and Prevention of HIV in Adults, Adolescents, and Children.

Alex Rinehart is Medicines Development Leader, Prevention at ViiV Healthcare. Alex has been involved in HIV clinical research since 1996 while working at ViiV Healthcare and formerly at both GlaxoWellcome and Tibotec Therapeutics, where he served as an Associate Medical Director and was involved in the successful launches of both darunavir and etravirine. Since joining the Global Medical Strategy group at ViiV Healthcare in 2010, he has assumed key roles in developing and executing the global HIV prevention strategy and leads the HIV prevention medicines development team for the R&D organization, which includes global regulatory submissions and the successful FDA approval of cabotegravir for PrEP (Apretude).

Alex received his PhD in Biochemistry and Molecular Biology from SUNY Stony Brook and his Bachelor of Science from Bowling Green State University.

Kathleen E. Squires, MD joined the Global Center of Scientific Affairs in Merck Research Laboratories as the new Global Director of Scientific Affairs (GDSA) for HIV in August, 2017. Previously, she was the W. Paul and Ida H. Havens Professor of Infectious Diseases at the Sidney Kimmel Medical College of Thomas Jefferson University (TJU), Director of the Division of Infectious Diseases, Thomas Jefferson University Hospitals and Medical Director, Strategic Clinical Programs and Infectious Disease Population Health, Jefferson Enterprise. Dr. Squires graduated from Princeton University, completed medical school and an internal medicine residency at the Medical College of Pennsylvania and then pursued a fellowship in the Division of Infectious Diseases at the New York Hospital, Weill Cornell University Medical College. Before joining TJU in 2005, she was on the faculty of the University of Alabama at Birmingham and the University of Southern California where she was the Medical Director of the LAC/USC HIV Clinic and the PI of the USC ACTG CSU. She is board certified in Internal Medicine and Infectious Diseases. Her primary field of academic interest lies in the field of HIV infection and she has extensive experience in the treatment of HIV-infected patients as well as in clinical research. Major areas of interest within this field include identification of novel antiretroviral agents, development of novel treatments strategies, and HIV infection in women. Dr. Squires has been conducting HIV clinical trials for almost 30 years and has authored or co-authored over 120 articles on varied topics in the research and treatment of HIV/AIDS. She has provided peer review as a standing member on several NIH committees including the NIH Fogarty International Scholar Review Panel, as the Chairperson for the AIDS Clinical Studies and Epidemiology Study Section from 2008-2010 and a member of the Department of Health and Human Services Panel on the Treatment of HIV-infected Pregnant Women and Prevention of Peri-natal Transmission.

Martin Rhee is currently an Executive Director in Clinical Research in Virology at Gilead Sciences, leading the clinical development of lenacapavir, the first-in-class long acting HIV capsid inhibitor. Over the past decade, Dr Rhee made significant contributions in bringing many of Gilead’s novel HIV medicines to people with HIV. Dr. Rhee received a medical degree from Seoul National University in Korea and completed his residency in internal medicine at Dartmouth Hitchcock Medical Center and fellowship in infectious disease at Tufts Medical Center.

Gustavo Doncel, MD, PhD, is CONRAD Scientific and Executive Director. He is also Professor of Obstetrics and Gynecology and Microbiology and Molecular Cell Biology at Eastern Virginia Medical School. With his pioneer work on microbicides, HIV prevention products, and contraceptives, Dr. Doncel laid the foundation for CONRAD’s expansion into HIV and multipurpose prevention technologies. He is an accomplished researcher with skills that span basic and clinical science. Dr. Doncel currently is the principal investigator of grants totaling more than $80 million. He is a reviewer for the US National Institutes of Health and the European Commission Directorate General for Research and Innovation, and an expert advisor to the World Health Organization. He is also a member of scientific advisory boards of several national and international research organizations. Dr. Doncel received multiple awards for his work on HIV prevention and is the author of more than 160 peer-reviewed scientific publications and several U.S. and international patents on antimicrobial contraceptives and microbicides.