Edward Acosta, PharMD, University of Alabama at Birmingham
Dr. Acosta is Professor and Director of the Division of Clinical Pharmacology at the University of Alabama at Birmingham School of Medicine. He was appointed to the faculty in 1999 and Division Director in 2011. He is Director of the UAB Clinical Pharmacology Laboratory (CPL), which focuses primarily on antiviral pharmacometrics, and Director of the Comprehensive Cancer Center Pharmacometrics Core Laboratory.
Dr. Acosta is Principal Investigator of the UAB Adult and IMPAACT Pharmacology Support Laboratories (PSL), and network pharmacologist for the Collaborative Antiviral Study Group headquartered at UAB. The long-term goals of the laboratory are to optimize drug dosing strategies in adult and pediatric patients through development of novel assay methodologies and the integration of pharmacometrics and biomarkers of treatment response.
Peter L. Anderson, PharMD, University of Colorado
Dr. Anderson is Professor of Pharmaceutical Sciences at the University of Colorado Anschutz Medical Campus. His research interests are in the clinical pharmacology of anti-HIV medications with a focus on pharmacological approaches to monitor medication adherence. He is co-Principal Investigator of the Colorado Antiviral Pharmacology Laboratory, which is CLIA-certified and provides assay support for NIH-supported national and international trial networks and independent multi-national clinical trials.
Dr. Anderson directed the pharmacology support and adherence interpretation for iPrEx, an international trial of Truvada for HIV chemoprophylaxis (PrEP) in men who have sex with men (MSM). This trial was one of two that led to approval of Truvada for PrEP. The lab also supported the DISCOVER study, a regulatory trial of Truvada versus Descovy for PrEP in MSM.
Courtney Fletcher, PharMD, University of Nebraska Medical Center
Dr. Courtney Fletcher received his Bachelor of Science in Pharmacy, with honors, from the University of Wyoming, Laramie, WY, and his Doctorate of Pharmacy from the University of Minnesota in Minneapolis, MN. Dr. Fletcher served as the Dean of the College of Pharmacy at the University of Nebraska Medical Cener for 10 years and is now a Professor in the College. Dr. Fletcher has previously held faculty and leadership positions at the School of Pharmacy, University of Colorado Health Sciences Center, the University of Minnesota and Drake University.
Dr. Fletcher has been an active researcher in the area of clinical pharmacology of antiviral agents and has authored or co-authored more than 165 articales in peer-reviewed scientific journals, 25 book chapters and more than 170 research presentations at national and international meetings. Dr. Fletcher has been continuously funded by the NIH since 1993 as a principal investigator. Dr. Fletcher has supervised 9 post-doctoral fellows and supervised or co-supervised the education programs of 10 graduate students. Dr. Fletcher is a past member of the FDA Antiviral Drug Advisory Committee, the AIDS Discovery and Development of Therapeutics (ADDT) Study Section, Center for Scientific Review, NIH, and the United States Department of Health and Human Services Panel on Clinical Practices for the Treatment of HIV infection. Dr. Fletcher is an elected Fellow of the American Association for the Advancement of Science (AAS).
Charles W. Flexner, MD, Johns Hopkins University School of Medicine
Charles W. Flexner, MD, is Professor of Medicine in the Divisions of Clinical Pharmacology and Infectious Diseases, and Professor of Pharmacology and Molecular Sciences in the Johns Hopkins University School of Medicine. He is also Professor of International Health in the Johns Hopkins University 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 led clinical development teams for seven HIV-related new molecular entities, as well as randomized, prospective trials of once-daily versus twice-daily combination antiretroviral regimens. 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 is Co-Principal Investigator of the Johns Hopkins University Baltimore-Washington-India Clinical Trials Unit (BWI CTU).
Dr. Flexner is the Deputy Director of the Institute for Clinical and Translational Research at Johns Hopkins. He also serves as Associate Vice-Chair for Academic Fellowship Programs in the Department of Medicine, and Associate Director of the Graduate Training Programs in Clinical Investigation of the Johns Hopkins University School of Medicine and Bloomberg School of Public Health. He was Chair of the AIDS Clinical Trials Group (ACTG) Translational Research and Drug Development (TRADD) Committee from 2009-2011, and is currently Chair of the ACTG Antiretroviral Treatment Strategies Translational Sciences Group (ARTS TSG). Dr. Flexner served as President of the American Federation for Medical Research (AFMR) from 1999-2000, and was President of the AFMR Foundation from 2001-2002. He is a member of the editorial board of 11 scientific journals. He currently serves as a consultant to the Bill and Melinda Gates Foundation and the Clinton Health Access Initiative, and served as a consultant on FDA reform to the United States House of Representatives.
Thomas Kakuda, PharMD, Janssen BioPharma
Dr. Thomas Kakuda, PharMD is Scientific Director of Clinical Pharmacology at Janssen BioPharma, part of the Janssen Pharmaceutical Companies within Johnson & Johnson. At Janssen, Dr. Kakuda has supported the infectious diseases therapeutic area for the past 14 years focusing on developing novel antiviral therapies for HBV, HCV, HIV, influenza, RSV, and other viral infections.
Dr. Kakuda received his PharMD from the University of Pacific, completed a Pharmacy Practice Residency at the National Institutes of Health, and an Infectious Diseases Clinical Pharmacology Fellowship under the mentorship of Dr. Courtney Fletcher, PharMD at the University of Minnesota.
Dr. Kakuda has done extensive work on understanding antiretroviral pharmacology including the development of darunavir (Prezista/Prezcobix), etravirine (Intellence), and simeprevir (Olysio). Current projects include JNJ-56136379 and JNJ-64530440 (HBV capsid assembly modulators), and JNJ-73763989 (HBV siRNA). Dr. Kakuda is primarily responsible for the development and implementation of phase 1 studies and pharmacokinetic/pharmacodynamic analyses related to the compounds.
Jennifer Kiser, PharMD, University of Colorado
Jennifer J. Kiser, PharmD, PhD, is an Associate Professor at the University of Colorado in the Department of Pharmaceutical Sciences. Her research is focused on the clinical pharmacology of antiviral medications used in the treatment of viral hepatitis and in “special populations” living with HIV including pregnant women and children. Dr. Kiser co-directs the Colorado Antiviral Pharmacology (CAVP) Laboratory with Dr. Peter Anderson. The CAVP provides pharmacology and analytical support for several local, national, and international studies. Dr. Kiser is a member of the AASLD/IDSA Hepatitis C guidelines panel and the DHHS pediatric HIV guidelines panel, and serves on the Editorial Board for the University of Liverpool Hepatitis drug interactions database.
Yuri Lyubchenko, PhD, University of Nebraska Medical Center
Professor Yuri L. Lyubchenko received his PhD in Molecular Biophysics from the Moscow Institute Physics and Technology (Russia) and DSc degree in Molecular Biology from Institute of Molecular Genetics (Moscow, Russia). Currently, he is Professor of Pharmaceutical Sciences University of Nebraska Medical Center, Omaha, NE. His research spans a broad range of biomedical problems aimed at unraveling molecular mechanisms of such diseases as cancer, Alzheimer’s and Parkinson’s diseases.
Dr. Lyubchenko has authored 259 research articles/book chapters. He was named UNMC distinguished scientist (2008). He is an Academic Editor for Nature-Scientific Reports, associate editor for New Journal of Science, Frontiers in Bioscience, Journal of Molecular Pharmaceutics and Precision Nanomedicine and serves as editorial member of a number of reputed journals. He also serves on NIH and NSF grant proposal review panels.
Timothy Schacker, MD, University of Minnesota
Timothy Schacker, MD, is a professor of Medicine, Vice Dean for Research, Medical School and Director of the Program in HIV Medicine at the University of Minnesota. He joined the faculty in 1996. Dr. Schacker received his MD from the University of Minnesota in 1986 and completed a residency in Internal Medicine at the Oregon Health Sciences University and Infectious Disease Fellowship at the University of Washington in 1993. He then joined the faculty of the University of Minnesota.
Dr. Schacker is interested in how HIV causes immune suppression and why antiretrovirals do not fully restore immunity. His group focuses on inflammatory damage in lymphatic tissues; the principal site of HIV infection, that results in fibrosis of the lymphatic structures required to maintain a normal population of CD4 cells. They are testing novel therapies to prevent and/or reverse this process and slow T-cell depletion in HIV and improve their reconstitution when antiretroviral is begun. He is also the principal investigator of a federally funded program of projects designed to determine barriers to HIV eradication. In addition, Dr. Schacker has established a collaboration with the Joint Clinical Research Center in Kampala, Uganda to study how constant exposure to common infections like tuberculosis, malaria, and helminthic infections affect rates of HIV transmission and progression.
Susan Swindells, MBBS, University of Nebraska Medical Center
Susan Swindells is a Professor of Internal Medicine in the Section of Infectious Diseases at the University of Nebraska Medical Center, USA. A native of England, Dr. Swindells earned her medical degree from University College London in 1977, with postgraduate training in England and at the University of Washington in Seattle. She has been involved in HIV care since 1984. A clinician and active researcher, Dr. Swindells has many years’ experience in translational and clinical research in the field of HIV/AIDS, with a special interest in tuberculosis co-infection. Dr. Swindells is on the leadership of the AIDS Clinical Trials Group of the National Institutes of Health, and is a member of the U.S. Department of Health & Human Services Panel on Antiretroviral Guidelines.