The FHI Clinical team of Scientific Advisory Experts serves as consultants to support our global programs and operations. Together, we will promote best practices, lessons learned and thought leadership as we advance local solutions and conduct rigorous research.
Our approach rests on the belief that alliances should be mutually beneficial, focus on community needs and spur innovation. Working together, we are able to deliver more sustainable and equitable solutions and amplify our impact.
FHI Clinical Headquarters
359 Blackwell Street, Suite 200
Durham, NC 27701 USA
Anne Blanchard is a Clinical Research Executive Consultant in Latin America. Previously, she was CEO and involved in quality assurance for more than 10 years (11/2008 to 12/2019) at a regional contract research organization (CRO), leading numerous projects in Argentina, Brazil, Chile, Mexico, Bolivia and Colombia. She began her career in clinical research in 1997, when she worked for a multinational CRO in Argentina. Since then, Anne has been involved in clinical monitoring and management for both the biopharmaceutical and medical device industry and academic-based research. As part of her experience, she managed clinical trial implementation for parasitic (Chagas, hookworm, leishmaniasis) and viral (Zika, hepatitis C, HIV, RSV, and several types of influenza) diseases.
Anne is internationally ICH-certified by the Association of Clinical Research Professionals (ACRP) as a clinical research associate (CRA) since 2004 and as a clinical project manager since 2020 and was an Item Writer for the CCRA exam for 4 years. Anne was also part of the editorial group of the Barnett International “GCP Question and Answer Guide” (Section for Latin America) between 2012 and 2019. Anne has authored several articles in publications such as The Monitor and GCP Journal, presented at several international conferences and hosted webinars and in-person trainings related to the implementation of clinical research studies, regulations and oversight for compliance in Latin America. In 2015, she won the Outstanding Leadership in Clinical Research as a CRA Award by ACRP and is now completing her third term as elected member of the Board of Trustees within the organization. Anne has also participated in the writing of local clinical research regulations in Argentina and coordinated the writing of National Plans to support overall clinical research activity.
Since 2005, Anne is the President and Executive Director of Fundacion Dra. Cecilia Grierson, a regional non-for-profit organization dedicated to supporting academic and investigator-initiated research focused mainly in infectious diseases, community awareness about clinical research participation and education about the life of Cecilia Grierson, Anne’s great-aunt and the first woman to become a physician in Argentina in 1889.
Anne studied Biology at the University of Buenos Aires and completed her postgraduate in Monitoring of Clinical Trials and Clinical Research in the AMA (Argentine Medical Association) in 2001.
Dr. Robert W. Frenck is a Professor of Pediatrics in the Division of Infectious Diseases at Cincinnati Children’s Hospital Medical Center (CCHMC). He is Board Certified in General Pediatrics, as well as Pediatric Infectious Diseases. In addition to providing care to children with complex infectious problems, Dr Frenck is the Director of the James Gamble Center for Vaccine Research at CCHMC and the Executive Chair of the CCHMC Institutional Review Board (IRB). Dr. Frenck’s research interests are in evaluating vaccines with a particular focus on enteric diseases. Dr. Frenck is active in the American Academy of Pediatrics and is on the Executive Committee for the Section on Infectious Diseases (SOID). Dr Frenck has published over 100 articles in the peer-reviewed medical literature and presented his research at both the national and international levels.
Dr. Frenck received his undergraduate degree from the University of California at San Diego in 1977 followed by his doctor of medicine degree from the University of Texas Health Science Center at Houston in 1981. He trained at the National Naval Medical Center in Bethesda, Maryland, completing his pediatric residency in 1984. After three years as a general pediatrician at the US Naval Hospital, Japan, he entered pediatric infectious disease fellowship training at the University of Texas Health Science Center at Houston, which he completed in 1990.
Mr. Kevin Hurley provides regulatory affairs guidance for the development of new pharmaceutical products. He holds BA and MS degrees in Organic Chemistry from West Virginia University and completed additional graduate coursework in chemistry at the University of Florida.
Mr. Hurley spent his early career in the pharmaceutical R&D sector in synthetic chemistry and formulation science positions, including significant contributions to the technical development of the antiviral drug Emtriva® (emtricitabine) while working at Triangle Pharmaceuticals (Gilead).
Mr. Hurley transitioned from solely technical roles into the regulatory sciences, including oversight of technical and regulatory functions at several biotech companies. Following this, he moved into consulting (independent and consulting firms) as well as leadership roles in regulatory and quality positions at several large clinical research organizations.
He currently provides guidance in early interaction with regulatory agencies, preparation and submission of clinical investigation applications, and ongoing regulatory development support. In addition, Mr. Hurley assists in technical development of new drug products, including identification and management of third-party contract manufacturing/research organizations.
Dr. Kelly McKee is currently a Senior Scientific and Medical Advisor at Pharm-Olam and an independent consultant; he was formerly the Chief Medical Officer at Pharm-Olam. Dr. McKee has served in various roles at other organizations, including Vice President of Vaccines and Public Health at IQVIA (previously Quintiles IMS) and as research virologist and immunologist in the United States Army.
He has over 30 years of experience in research, development and public health, with expertise in vaccines, respiratory viral infections, viral hemorrhagic fevers and other “emerging” diseases and sexually transmitted infections. Dr. McKee has authored or co-authored over 100 peer-reviewed publications and textbook chapters.
He started his career as a clinical doctor in Pakistan and England. During his initial career, he was registered with the General Medical Council in the United Kingdom and worked in Essex, England with the National Health Service.
As a public health and development specialist, he is well-versed with health programs including project design, management, monitoring and evaluation; strategic information management and planning; logical framework analysis; organizational development; and research, training and facilitation for both international and local governmental and non-governmental organizations (NGOs). He has provided managerial and technical expertise in the fields of sexual and reproductive health (including all aspects of HIV/AIDS/sexually transmitted infection (STI) treatment, prevention and care); the health sector including tuberculosis for various organizations such as community-based organizations, NGOs and international NGOs.
Hasan has cutting-edge experience from two decades in the field of health programs management. Prior to joining USAID, Hasan worked as Country Director in the Pakistan country office with a US-based organization (FHI 360); Project Manager of a Global Fund for AIDS, Tuberculosis and Malaria (GFATM) funded health project; National Project Manager of a World Bank-funded project related to delivery of a package of primary health care and STI management, voluntary counseling and testing, and behavior change communication (BCC); Senior Director with Family Planning Association of Pakistan (FPAP); and full member of the International Planned Parenthood Federation (IPPF), implementing various programs related to maternal-child health (MCH), sexual and reproductive health (SRH) and family planning.
Hasan also has expertise, as a team member and leader, in overall design and implementation of qualitative and quantitative research; baseline, midterm and end evaluations; and behavioral surveillance surveys funded by the World Bank, USAID, DFID, JTF, Groupe Development (GD) and the Pakistan Medical and Research Council. His diverse research experience spans from research on commercial sexual exploitation of children to a multicenter National Study of Reproductive Tract Infections funded by the DFID.
Over the years, owing to his various assignments, he has had opportunities to be trained both locally and overseas in the fields of program monitoring and evaluation, quality assurance and improvement, delivery of quality health/clinical services, development and implementation of targeted BCC strategies and interventions, integration of BCC activities with other program activities, development of BCC materials including documentaries, development of standard operating procedures, and clinical operational guidelines (COGS) for health service delivery. Hasan has experience writing subagreements for grants funded by USAID adhering to the Mandatory Standard Provisions for Non-US and non-governmental recipients As a team leader for health-related projects, he provided guidance and strategic direction to multidisciplinary teams; has been implementing, managing and actively involved in preparation of implementation plans, annual work plans, budgets and monitoring systems; and has maintained contacts and liaised with private and public sector stakeholders and partners at provincial and national levels.
Dr. John Schieffelin is an Assistant Professor of Clinical Medicine and Pediatrics, Section of Infectious Diseases, at Tulane University School of Medicine. Dr. Schieffelin’s research focuses on the natural history, clinical care and immunology of viral hemorrhagic fevers (VHFs). Currently, he is involved in both basic science and clinical research on flaviviruses, such as dengue and Zika, as well as Lassa fever virus and Ebola virus. His laboratory studies how antibody-virus interactions can have both protective and pathogenic effects.
Dr. Schieffelin has a broad background in clinical infectious disease, immunology and virology and international clinical research and capacity building. He has been co-investigator on several National Institutes of Health (NIH)-funded grants and contracts investigating Lassa fever. He has successfully administered the projects (e.g., staffing, human subjects protections, budget), collaborated with a diversity of other stakeholders and produced several peer-reviewed publications with several more in preparation.
He also served as a consultant to the WHO Global Outbreak Alert and Response Network in Sierra Leone participating in both clinical care and local staff training.
Dr. Stephen B. Thomas is a tenured Professor in the Department of Health Policy and Management in the School of Public Health and Director of the Maryland Center for Health Equity (MCHE) at the University of Maryland in College Park. Prior to joining the faculty in 2010, he served as the Director of the Center for Minority Health in the Graduate School of Public Health at the University of Pittsburgh from 2000-2009.
He is a highly experienced principal investigator (PI), having served as PI of multiple five-year NIH-NIMHD P60 grants titled “Excellence in Partnership through Community Outreach, Research on Health Disparities and Training (EXPORT)” (5P60 MD000207; 2002-2007) and the Research Center of Excellence in Minority Health Disparities (7 P60 MD000207, 2007-2012). With Dr. Quinn, Dr. Thomas was the joint PI of the Center of Excellence in Race, Ethnicity and Health Disparities Research (P20 MD006737, 2012-2017, NIMHD). He also served as PI (along with Dr. Quinn) on a prestigious Grand Opportunity (“GO”) grant sponsored by the Office of the Director, NIH, NIMHD, and American Recovery and Reinvestment Act (ARRA) titled “Bioethics Research Infrastructure Initiative: Building Trust between Minorities and Researchers” (7RC2MD004766).
Over the decades, he has developed a significant network of relationships and leadership roles across multiple health disparity-influencing sectors including academic researchers; healthcare providers and service organizations; community leaders; national foundations; and local, state, and federal policymakers. He has specific expertise in the development, implementation and evaluation of community-engaged minority health and health disparity interventions. He also has extensive experience in overcoming barriers associated with the legacy of the Tuskegee Syphilis Study (1932-1972) and conducting scientifically sound and culturally tailored community-based interventions designed to eliminate racial and ethnic disparities to achieve health equity. He believes in team science and building trust with minority communities by first addressing their unmet health needs. Once trust is established, opportunities to conduct research can flourish.
He serves on the Board of Directors for Doctors Community Hospital in Prince George’s County and is a founding member of the leadership team for the Totally Linking Care Coalition composed of five hospital systems. Nationally, he serves on the Institutional Review Board of the All of US research initiative, a major NIH longitudinal study seeking to enroll one million Americans. He currently serves on the Advisory Board of the Health Equity Research Initiative of the Robert Wood Johnson Foundation.
Dr. Gayani Tillekeratne is an Assistant Professor in the Division of Infectious Diseases at Duke University and an Assistant Research Professor in the Duke Global Health Institute. She serves as an attending physician at the Durham Veterans Affairs Medical Center in infectious diseases and general medicine services. She is also an adjunct professor in the Faculty of Medicine, University of Ruhuna, Sri Lanka.
Dr. Tillekeratne serves as the faculty lead for Duke’s infectious diseases program in Sri Lanka, overseeing a program that has performed surveillance for acute febrile and respiratory infections through large longitudinal cohorts over the past decade. Her research interests focus on using novel diagnostics to improve the diagnosis and management of these infections in resource-limited settings, particularly with regards to targeting antimicrobials and improving antimicrobial stewardship.
Dr. Lucas Tina works as the Deputy Director of Clinical Operations and Principal Investigator at the Kenya Medical Research Institute (KEMRI)-Centre for Clinical Research/US Army Medical Research Directorate-Africa.
He has been a clinical investigator in several successful drug and vaccine trials, including the multicenter, multicountry phase III RTS,S malaria vaccine trial in Africa, and the principal investigator for a study evaluating the safety and immunogenicity of a bivalent oral polio vaccine (bOPV) in newborn infants aimed at obtaining World Health Organization (WHO) prequalification.
Dr. Tina’s research and advocacy centers around the discovery, development and delivery of medical interventions to neglected tropical diseases, malnutrition and other emerging infectious diseases.
Dr. Stacey Wooden is currently Regional Medical Scientific Director for Viral Vaccines within Medical Affairs at Merck Research Labs. Dr. Wooden is a vaccine immunologist and global health researcher with over 25 years of experience in infectious disease research. She holds a PhD in immunology from The Johns Hopkins University Bloomberg School of Public Health and conducted a postdoctoral fellowship in pediatric tropical infectious disease at the Center for Vaccine Development at the University of Maryland.
Dr. Wooden was most recently with the Coalition for Epidemic Preparedness Innovations (CEPI) as a systems immunologist involved in the design of early-phase clinical trials to evaluate rapid response vaccine platforms for pandemic pathogens. Prior to CEPI, Dr. Wooden was a Principal Scientist with the Human Vaccines Project, where she served as the scientific lead for experimental systems immunology vaccine trials and directed the conduct of comprehensive immune assays for data integration and systems analyses. Dr. Wooden was also the Chief Scientific Officer (CSO) of a large NIH-funded HIV cure initiative at the University of North Carolina, Chapel Hill, where she provided strategic support and managed the research of 12 principal investigators from across the United States, including collaborating with scientists from Merck. She has extensive experience as a scientific review officer, having managed the peer review of large multi-center vaccine clinical trial proposals and large program grants for infectious disease research for the U.S. Dept. of Defense Congressionally Directed Medical Research Programs (CDMRP).
Prior to pursuing her doctoral studies, Dr. Wooden conducted epidemiology fieldwork in Africa, leading a multiyear country-wide study of cultural factors influencing the spread of HIV in Swazi women. In addition, she has served as a Peace Corps volunteer, a Fulbright Scholar and UNICEF consultant in several countries throughout Southern Africa. She has also been on the faculty at Notre Dame of Maryland University and Stevenson University, teaching health science students about vaccines and global infectious disease.
Dr. Christopher Woods is a professor in the Departments of Medicine and Pathology at Duke University, an adjunct associate professor in Epidemiology at the University of North Carolina-Chapel Hill School of Public Health, and an adjunct associate professor in the Emerging Infections Program at the Duke-National University of Singapore Graduate Medical School.
He is Executive Director of the Hubert-Yeargan Center for Global Health and Associate Director for Applied Genomics in the Duke Center for Applied Genomics & Precision Medicine (CAGPM) as well as the Global Health lead for the Duke Tropical Conservation Initiative. Clinically, he is Chief of Infectious Diseases and hospital epidemiologist for the Durham VA Medical Center.
Dr. Jon “Ben” Woods is a pediatric infectious disease physician and retired United States Air Force Colonel. Before supporting FHI, he was President of HJF Medical Research International (HJFMRI), a subsidiary non-profit of the Henry Jackson Foundation for the Advancement of Military Medicine. Prior to HJFMRI, he was Senior Antimicrobial Resistance (AMR) and Tuberculosis Technical Advisor to the Global Health Bureau at USAID. He has broad US domestic and international infectious disease clinical, programmatic and research experience spanning over two decades. His experience ranges from directing the US Army’s medical research field station in Kisumu, Kenya, overseeing pediatric malaria vaccine trials and infectious disease surveillance, serving as the Defense Intelligence Agency’s lead Medical WMD Advisor and Subject Matter Expert (SME) for design of their deployable microbial forensics laboratory, to supporting investigational new drug (IND) applications for emerging and biological warfare threat agents and running the biosafety level-4 (BSL-4) treatment facility,while at the US Army Medical Research Institute for Infectious Disease (USAMRIID) at Fort Detrick, Maryland.
Dr. Woods received his Doctor of Medicine degree from the Uniformed Services University of the Health Sciences (USUHS), completed residency training in pediatrics at Wright Patterson Air Force Base Hospital/Wright State University and his fellowship in pediatric infectious diseases at the USUHS, where his research focused on animal models of enterohemorrhagic Escherichia coli disease.