David Stephens, MD (Emory University)
Contact PI, LG Chair
Dr. Stephens served as the Director of the Division of Infectious Diseases, at Emory 1992-2013 and led the development of very successful programs in clinical infectious diseases, microbial pathogenesis, vaccines and clinical research. He has been a major contributor to the creation and development of the highly successful NIH-funded Emory Vaccine Center, The Hope Clinic and Emory’s Vaccine and Treatment Evaluation Unit (VTEU), the Emory Center for AIDS Research (CFAR) and the Serious Communicable Diseases Unit (SCDU) at Emory. He was the founding principal investigator for Georgia’s Clinical and Translational Science Award (CTSA), a multi-institutional research and
clinical trials partnership funded (2007) and refunded (2012 and 2017) by NIH.
Dr. Stephens has led research initiatives in the School of Medicine (Executive Associate Dean 2005-2008) and currently as the Vice President of Research (2008-present) of the Robert W. Woodruff Health Sciences Center (WHSC). Examples of successful research initiatives in WHSC include, revising Emory’s clinical trials infrastructure, the Emory-Georgia Tech-UGA partnerships in immuno-engineering, regenerative medicine (REM), infectious diseases and glycomics; the recognition of Emory’s Winship Cancer Center as an NCI-designated Comprehensive Cancer Center; the Emory-Children’s Pediatrics Center and the Queensland-Emory Development (QED) Alliance. He is also professor of microbiology and immunology in the School of Medicine and professor of
epidemiology at Emory's Rollins School of Public Health. His laboratory is an international leader in efforts to define the molecular basis for the virulence of and vaccines to prevent bacterial meningitis, especially disease caused by the respiratory tract pathogens Neisseria meningitidis and Streptococcus pneumoniae. He has also contributed to understanding the genital tract and sexually transmitted pathogen Neisseria gonorrhoeae. He has contributed to more than 300 publications in infectious diseases, molecular pathogenesis, epidemiology, vaccinology and immunology.
In 1988 Dr. Stephens co-founded the Atlanta Active Surveillance Project (now the Georgia Emerging Infections Programs), a population-based surveillance and clinical research program focused on emerging infections and vaccine impact. In 2001 he led CDC's clinical emergency response team in defining clinical issues in prophylaxis, diagnosis and treatment of B. anthracis infections and has contributed to efforts to combat other emerging infectious diseases threats such as epidemic meningitis, SARS and recently Ebola viral disease. Dr. Stephens has been engaged as an effective leader of complex consortia including the launching and development of the GaCTSA, was the Emory PI of the NIAID-sponsored Southeastern Regional Center of Excellence for Emerging Infections and Biodefense (SERCEB), led the CDC-supported Southeastern Center for Emerging Biologic Threats (SECEBT), and the NIH-funded Exploratory Center for Interdisciplinary Research in Vaccinology (ECIRVE). He founded and directed the Emory University NIH K30/MSCR Clinical Research Curriculum Award (now an education component of the CTSA), served previously as the interim chair and executive vice chair of the Department of Medicine at Emory (1999-2005) and in 2016-2017 was Interim Dean of Emory University School of Medicine.
He is a member of the Association of American Physicians and the American Academy of Microbiology and is a Fellow of the Infectious Diseases Society of America, the American College of Physicians, and the American Association for the Advancement of Science. He has served on NIH, Veterans Affairs, Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) review panels. He was chair of the FDA National Vaccine Advisory Committee, a liaison member of the Health and Human Services National Vaccine Advisory Committee and is standing Senior Scientific Consultant to the CDC Meningitis and Special Pathogens Branch. He currently serves as a member of the National Advisory Committee on Immunization Practices (ACIP).
404-727-8357
Kathy Neuzil, MD (University of Maryland)
PI, LG Co-Chair
Dr. Neuzil is a globally recognized vaccinologist with expertise ranging from clinical trials, epidemiology, international field trials and vaccine policy, to partnerships with emerging manufacturers and direct experience with Gavi processes, World Health Organization (WHO) policy, and prequalification (PQ). Dr. Neuzil has over two decades of experience in infectious diseases and vaccine science, policy, and leadership experience. Her depth of experience in clinicals trials, expertise in vaccine research and development, track record of partnerships with developing country vaccine manufacturers, and knowledge and experience with domestic and international regulatory practices is extensive. She has led successful multi-year, multi-site, efforts in global health, informing vaccine policy recommendations and catalyzing introductions.
Her research of the past two decades has made major contributions to our understanding of influenza disease and prevention. This research includes pivotal epidemiologic studies of disease burden, clinical trials of vaccine candidates, and studies that employ influenza vaccine as a probe to better understand immunologic priming and the development of immune responses. Beyond influenza, her vaccine research, including rotavirus, pertussis, and typhoid vaccines, among others, has advanced science and influenced policy. These studies have ranged from designing and executing Phase 1 trials to leading pivotal clinical trials, including large multicenter field studies. She is leading a typhoid vaccine acceleration program, funded by the Gates Foundation, for children in Africa and Asia. Since joining the Center for Vaccine Development and Global Health (CVD) as Director in 2015, she has served as Co-PI of the Vaccine Treatment and Evaluation Unit and as PI on 3 protocols at present. Also making mentoring a priority, she serves as PI of CVD’s NIAID T32 Training Grant in Vaccinology and as primary mentor on a K01 Award. She is a board member at the National Foundation for Infectious Diseases, task force chair at the Infectious Disease Society of America and technical advisor to the World Health Organization.
She has significant experience leading large, multiparter initiatives, including directing an international research consortium on typhoid conjugate vaccines, and leading multidisciplinary teams at PATH based in the U.S. and overseas, with funding from private foundations and the U.S. government, in addition to complicated collaborative projects on influenza, rotavirus, and Japanese encephalitis vaccines. These successful initiatives resulted in significant research advances and policy changes. Her two decades of involvement in domestic and international vaccine policy include membership on CDC’s Advisory Committee on Immunization Practices (ACIP) and past and current advisory positions on World Health Organization (WHO) vaccine policy committees, and she is currently the only U.S. member of the WHO Strategic Advisory Group of Experts on Immunization (SAGE).
410-706-4946
Robert L Atmar, MD (Baylor College of Medicine)
COU Co-Director, Expert Working Groups Liaison
has been involved in clinical investigation for more than 30 years. He has worked on vaccines for respiratory and enteric pathogens, malaria and neglected tropical diseases and has worked closely with program and VTEU leadership in the design, implementation, analysis and oversight of multi-site trials conducted through the VTEU network. Dr. Atmar is currently a member of the Advisory Committee on Immunization Practices and has served on other federal advisory panels. He has mentored trainees and junior faculty, including serving as PI of BCM’s T32 training grant. Much of the work he has performed over the past 30 years has been as a member of collaborative teams of clinical and laboratory investigators, including VTEU studies and a USDA-funded multi-institutional collaborative Norocore project (2011-2017). In his research he has worked as an investigator in programs including the Influenza Research Center (1986-1990), the Acute Viral Respiratory Disease Unit (1990-1995), the Respiratory Pathogens Research Unit (1996-2003), the Viral Respiratory Pathogens Research Unit (2003-2012), and the Vaccine and Treatment Evaluation Unit (VTEU, 1991-1998; 2002-present), and is the co-PI of the Baylor VTEU. A major research interest is norovirus infection, including the development of diagnostic assays for norovirus infection, the evaluation of the pathogenesis of norovirus infection, and the evaluation of strategies to prevent infection (including vaccine evaluation). His research also has focused on respiratory infections in adults and in special populations, including persons with asthma and COPD, as well as on vaccine evaluation, with an emphasis on respiratory pathogens.
713-798-4469
Elizabeth Brown, ScD (University of Washington)
Fred Hutchinson, SDSU Director
Dr. Brown has worked on the statistical design and analysis of HIV/AIDS clinical trials since 2002. In 2011, she took on the role of principal investigator of the Statistical and Data Management Center (SDMC) for the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network established by in 2006 by the U.S. National Institutes of Health (NIH). The SDMC is housed within the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at the Fred Hutchinson Cancer Research Center. The focus of Dr. Brown’s research includes the design and analyses of clinical trials for HIV prevention, joint models for longitudinal and survival data, and statistical methods in HIV/AIDS and cardiovascular research. In addition to her role at MTN, Dr. Brown was lead statistician on an HIV Prevention Trials Network Phase III clinical trial called HIVNET 024 to prevent the perinatal mother-to-child transmission of HIV. She also served as protocol statistician on HPTN 046, which found that giving breastfeeding infants of HIV-infected mothers a daily dose of the antiretroviral drug nevirapine for six months reduced the risk of HIV transmission. Dr. Brown is a research associate professor in the Department of Biostatistics at the University of Washington in Seattle and a member of both the Vaccine & Infectious Disease Division and the Public Health Sciences Division at the Fred Hutchinson Cancer Research Center.
206-667-1731
Monica Farley, MD (Emory University)
LOC Co-Director, LG Performance Evaluation Co-Chair
Dr. Farley leads a large infectious diseases division at Emory made up of nearly 70 faculty members with a large research portfolio. She is an international expert in clinical disease and pathogenesis of Haemophilus Influenzae and Streptococcus pneumoniae. She serves as the academic Principal Investigator for the Georgia Emerging Infections Program (EIP), a CDC-funded surveillance network of ten national sites conducting applied epidemiologic and laboratory research focused on invasive bacterial pathogens (many vaccine preventable), influenza, foodborne diseases, and healthcare-associated infections, with a focus on antibiotic resistant infections and C. difficile. She is Past-President of the American Federation for Medical Research and a longstanding council member and Past-President of the Southern Society for Clinical Investigation. She has served on the Women’s Committee, the Program Planning Committee and the Public Health Committee in IDSA. She is a past member of the US Food and Drug Administration (FDA) Advisory Committee on Vaccines and Related Biological Products and she currently serves on the Pneumococcal Vaccine Working Group for CDC’s Advisory Committee on Immunization Practices (ACIP). The collaborative EIP research program has been highly productive, providing population-based assessment of the epidemiology and risk factors for important bacterial infections, including adult and pediatric Group B streptococcal infections, pneumococcal disease and community-associated MRSA, and performing post-licensure vaccine effectiveness studies.
404-727-2279
Michael Gale, PhD (University of Washington)
LOU Co-Director
Dr. Gale focuses his research on understanding the innate immune response to infection by emerging RNA viruses, including SARS-CoV-2, Zika virus, HIV, and emerging influenza A viruses, leveraging this information to build improved vaccines, vaccine adjuvants, and antiviral therapeutics. Dr. Gale is currently developing and testing novel vaccines for protection against SARS-CoV-2 and is developing a new class of innate immune-targeted antiviral drugs for broad spectrum application to enhance vaccine immunity and to treat virus infection. These new therapeutics will improve global health by providing effective treatment to the people infected with SARS-CoV-2, Zika virus, Ebola virus, dengue virus, West Nile virus, and influenza A virus. The laboratory is a component of the Systems Immunogenetics program, and the Emerging Infectious Disease Research Centers program supported by the NIH, and also conducts programs of study focused on understanding immune control of West Nile virus infection, HIV infection, and the immunomodulatory/antiviral actions of interferons and small molecule inhibitors of virus replication. Dr. Gale is the Director of the Center for Innate Immunity and Immune Disease (CIIID), is an Adjunct professor of Microbiology and of Global Health and is an Affiliate Member of the Fred Hutchinson Cancer Research Center. He is a professor of Immunology and is a formally trained immunologist and virologist with expertise in studies of virus/host interactions, innate immunity, and immune signaling of RNA viruses.
206-685-8289
Jeff Lennox, MD (Emory University)
COU Co-Director
Dr. Lennox is chief of infectious disease, Grady Memorial Hospital; vice-chair of medicine for Grady affairs; and medical director of the infectious disease program at the Ponce de Leon Center. His area of specialty HIV/AIDS. As the Principal Investigator of the AIDS Clinical Trials Group (ACTG) Network’s Emory HIV/AIDS Clinical Trials Unit in Atlanta, he researches safer, more effective treatment options for people living with HIV. He is the medical director of the infectious disease program at the Ponce de Leon Center, which provides patients with a wide spectrum of services in one location, including primary care clinics, a clinical research area, subspecialty clinics, HIV education and community referral. Through Dr. Lennox’s leadership, the infectious disease program at the Ponce Center has gained national recognition as one of the premier sites for HIV care in the United States. Grady has the largest population of HIV-infected patients in the United States. Dr. Lennox is also the Director of Quality & Efficiency and Trial Innovation Centers in the GA CTSA.
404-251-8784
Jeanne Marrazzo, MD, MPH (University of Alabama Birmingham)
LOC Co-Director, LG Performance Evaluation Co-Chair
Dr. Marrazzo is a scientific leader in the fields of STI and HIV prevention, microbiology, and the microbiome of the female genital tract. Her extensive experience studying conducting translational research, evaluating the epidemiologic and clinical features of STI in national and international settings combined with my experience studying interventions to improve vaginal health support her important role in this effort. Dr. Marrazzo’s methodological expertise includes HIV/STI epidemiology, molecular microbiology and clinical trials. She has been centrally involved in numerous prospective studies of sexually transmitted infections (STI) and conducted several studies within the framework of the NIH-funded STI Clinical Trials Group (CTG), and currently chairs the Microbicide Trails Network (MTN) Biomedical Science Working Group. Since 2007, she has been the Protocol Co-Chair leading the VOICE (MTN 003) study, a large trial that studied HIV pre-exposure prophylaxis (PrEP) administered vaginally and orally to over 5,000 women at high risk for HIV infection in sub-Saharan Africa. While at the University of Washington, she led the successful application as PI to re-establish the NIH-funded STI Cooperative Research Centers (CRC) U19, whose theme was the interaction between the human genital microbiome, local immunity, and STI susceptibility. She currently services as Co-Director of the UAB STI CRC.
205-975-5500
Julie McElrath, MD, PhD (University of Washington)
Fred Hutchinson, LOU Co-Director
Dr. McElrath is a senior vice president and director of the vaccine and infectious disease division at Fred Hutchinson Cancer Research Center and principal investigator of the HIV Vaccine Trials Network Laboratory Center in Seattle, Washington. She also is a professor at the University of Washington. Dr. McElrath has built and maintains an international HIV vaccine laboratory program, conducted translational immunological research in humans in a multicenter setting. She has assumed a leadership role or been a major contributor in a number of integrated programs at the national and international level to advance a coordinated effort to tackle the HIV epidemic through prevention efforts: the HIV Vaccine Trials Network (PI and Director of the Laboratory Program), the Gates Foundation Innate Immunity Consortium (PI), the Microbicide Trials Network (Director, Immunology Core) and the Seattle Vaccine Trials Unit (PI). Her research has contributed to our fundamental understanding of how HIV-1 enters the mucosa to establish infection, identified persons with very low levels of HIV DNA who otherwise lack all evidence of infection, assembled invaluable cohorts from which to elucidate mechanisms of risk for HIV infection and disease. She has also mentored junior faculty, young investigators, and graduate students. Dr. McElrath's research centers on developing an HIV vaccine and investigates the complex relationships between HIV and the immune system, investigating how components of T-cell immunity elicited early in HIV-1 infection contribute to control of HIV-1 disease, what the influence of antiretroviral therapy is, whether T-cell immune responses are involved in resistance to HIV-1 infection in high-risk persons, how antigen-specific mucosal T cells protect against HIV-1 exposure, and what elements of immunity correlate with protection against HIV-1 infection by vaccine.
206-667-6704
Jonathan Zenilman, MD (Johns Hopkins University)
COU Co-Director
Dr. Zenilman has extensive experience in leadership clinical epidemiology and clinical trials, including sexually transmitted infections, Phase 2-3 trials of antimicrobials and diagnostics in outpatient and inpatient settings, and first-in-human Phase 1 trials conducted under controlled conditions which assessed toxicity and pharmacokinetics. His clinical trial work has been supported by NIAID, CDC, and commercial sponsors, and he has been a principal investigator and has managed sites in the STD Clinical Trials Group, HPTN, the Baltimore City Health Department STD program and the JHU Institute for Clinical and Translational Research. He has served on numerous NOH and CDC advisory committees and has participated in every revision of the STD Treatment Guidelines since 1989. He was previously site PI for the NIAID/DMID funded Phase I clinical studies program that was one of the predecessors for this application and has extensive familiarity experience with DMID processes for quality assurance, site SOPs, FDA IND submissions, and protocol operationalization. Since 2013, he has been a member of the Johns Hopkins IRB, and has substantial experience in human subjects’ issues, ethics and clinical research regulation, and served as a technical expert for the Presidential Commission on Bioethical Issues which investigated the USPHS Guatemala studies.
410-550-9080