Appendix D

Biographical Sketches of Committee Members and Staff

COMMITTEE

Gerald T. Keusch, M.D., FRCP (Co-Chair), is a graduate of Columbia College and Harvard Medical School. He has been involved in academic medicine for his entire career, currently as a professor of medicine and global health at Boston University, where he serves as an associate director of the National Emerging Infectious Diseases Laboratory. Prior to this he was the chief of the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center in Boston from 1979 to 1998 and the associate director for international research and the director of the Fogarty International Center at the U.S. National Institutes of Health from 1998 to 2004. Dr. Keusch is a fellow of the Infectious Diseases Society of America and an elected member of the American Society for Clinical Investigation, the Association of American Physicians, and the National Academy of Medicine, where he has served on the Board on Global Health and the Forum on Microbial Threats and co-chaired an Institute of Medicine/ National Research Council report, Sustaining Global Surveillance and Response to Emerging Zoonotic Diseases, released in September 2009. He has experience in both laboratory and clinical field research on infectious diseases in Latin America, Africa, and Asia. He has been a member of multiple committees for the Tropical Diseases Research Program at the World Health Organization and the Wellcome Trust, including a recent review committee for the Wellcome Trust on Global Clinical Trials.

Keith McAdam, DL, MB BCh, FRCP, FWACP (Co-Chair), is the founding director of the Infectious Diseases Institute (2004–2007) at Makerere University in Kampala, Uganda. He is an emeritus professor of clinical tropical medicine at the London School of Hygiene & Tropical Medicine, where he was a professor of clinical tropical medicine from 1985 to 2004. From 1994 to 2003 Dr. McAdam was seconded to West Africa to serve as director of the UK Medical Research Council Laboratories in the Republic of The Gambia. Dr. McAdam grew up in Uganda, where his father, Sir Ian McAdam, was a professor of surgery at Makerere. He did his schooling in Kenya and went on to study medicine at Cambridge University and the Middlesex Hospital in London. After training in internal medicine in London, he spent 3 years at the Institute of Medical Research in Papua New Guinea, working on leprosy, malaria, and filariasis as causes of secondary amyloidosis. For 2 years, from 1975 to 1977, Dr. McAdam developed his laboratory and clinical research focus on inflammation, acute phase proteins, and cytokines at the Immunology Branch of the National Cancer Institute in Bethesda, Maryland, and he continued this focus over the next 7 years in Boston as a clinical scientist in the Department of Medicine at Tufts New England Medical Center. Dr. McAdam was medical advisor to the UK Parliamentary Select Committee on AIDS in 1987 and a member of the Nuffield Council on Bioethics working party that produced an authoritative publication, The Ethics of Healthcare Related Research in Developing Countries. He has been associate international director at the Royal College of Physicians in London and is currently its special advisor on East Central and Southern Africa. He has just rotated off the International Board of the African Medical and Research Foundation and is currently on the board of trustees of the charity BBC Media Action.

Abdel Babiker, Ph.D., received his doctoral degree in mathematical analysis from the University of London. In the 1980s he worked on a number of cancer studies at the Institute of Cancer Research and with the Imperial Cancer Research Fund. He joined the MRC HIV Clinical Trials Centre (HIV CTC) as deputy head in 1992 and was directly responsible for overseeing all statistical aspects of the center’s research program. When the HIV CTC became part of the MRC Clinical Trials Unit in 1998, he was appointed head of the HIV Group. HIV research has expanded greatly since 1998, through wider national and international collaborations addressing key questions in treatment and prevention of HIV, and has affected international guidelines for the treatment of HIV. Dr Babiker is a member of the executive committee of the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) and co-chair of the START study. He is a fellow of the Royal Statistical Society and the World Academy of Sciences for the advancement of science in the developing world and has served as

associate editor for Sexually Transmitted Infections and Controlled Clinical Trials.

Mohamed Bailor Barrie, M.B.Ch.B., grew up in poverty in rural Sierra Leone. After finishing secondary school, he received one of two scholarships in the country to study medicine at the College of Medicine and Allied Health Sciences in Freetown, Sierra Leone. Dr. Barrie trained in general medicine, building his skills in all areas of medicine. The civil war in Sierra Leone forced him to suspend his studies, and, after 1 year as a refugee in neighboring Guinea, he graduated with his degree in medicine in 2004. After obtaining his degree Dr. Barrie worked as a medical officer at a rural nonprofit hospital and was one of four physicians in his graduating class to continue to practice medicine in Sierra Leone. He has also acted as a consultant for UNICEF and the World Health Organization. In 2006 Dr. Barrie co-founded and became the executive and medical director of Wellbody Alliance, a nonprofit health care organization based in Kono District, Sierra Leone. His current role there is as chief strategic officer. Dr. Barrie is the recipient of the 2013 Grace Humanitarian Award from Thomas Jefferson University. For 2013–2015, Dr. Barrie was awarded a Fulbright Fellowship to study global health delivery at Harvard University.

Janice Cooper, Ph.D., M.P.A., is the country lead for the Liberia Mental Health Initiative. She oversees a national training, policy, and support program to expand capacity for mental health services delivery. She also is responsible for interacting with national and international colleagues and partners of the program. During the Ebola outbreak in Liberia she led the psychosocial pillar for the Incident Management System, the national Ebola virus disease response system. A native Liberian and health services researcher specializing in children’s mental health, Dr. Cooper has worked in the private, public, and nonprofit sectors in the United States and Liberia. Prior to joining The Carter Center in 2010, Dr. Cooper was the interim director of the National Center for Children in Poverty as well as an assistant clinical professor in health policy and management at Columbia University’s Mailman School of Public Health. From 2005 to 2009, she also served as the center’s director of child health and mental health, receiving the distinguished Calderone Prize for Junior Faculty in 2007. Dr. Cooper received her Ph.D. in health policy from Harvard University. She was a 2001 fellow in medical ethics at Harvard Medical School and a 1999 Archibald Bush Foundation Leadership Fellow. She holds additional undergraduate and graduate degrees from the University of Essex in Colchester, England, and Columbia and Harvard Universities in the United States. In 2016 she received the Beyond Health Award from Boston University.

Sheila Davis, D.N.P., ANP-BC, FAAN, is the chief of Ebola response and the chief nursing officer at Partners In Health (PIH), for which she led the Ebola response efforts in Sierra Leone and Liberia. At peak of the effort, PIH was operating in collaboration with the ministries of health at over 20 facilities for the screening and treatment of Ebola. Currently she is leading the effort to transition from Ebola response to health system strengthening in Liberia and Sierra Leone as part of PIH’s long-term commitment to both countries. Dr. Davis has been a nursing leader in the field of HIV/AIDS since its emergence in the mid-1980s, and she served on the national board of the Association of Nurses AIDS Care (ANAC). She entered the global health arena in 1999 when she began working for Partners AIDS Research Center as part of Massachusetts General Hospital on community outreach and HIV treatment efforts. Partnering with global nursing colleagues, she co-founded a small nongovernmental organization that worked in South Africa and Boston from 2004 to 2010 on health projects including a rural village nurse clinic and an urban vulnerable-children feeding program.

Dr. Davis received her B.S.N. from Northeastern University in 1988, her masters in nursing as an adult nurse practitioner from the MGH Institute of Health Professions in 1997, and her doctorate in nursing practice with a concentration in global health in 2008 also from the MGH Institute of Health Professions. She was a faculty member at the School of Nursing at the MGH Institute of Health Professions for 4 years and an adult nurse practitioner at MGH Infectious Diseases outpatient practice for over 15 years. She is currently adjunct faculty at the University of California, San Francisco, School of Nursing.

Inducted as a fellow of the American Academy of Nursing in 2008, Dr. Davis is a frequent national speaker on global health, clinical topics including Ebola and HIV/AIDS, and the role of nursing in human rights. In 2009 she was inducted as one of the inaugural class of 12 Carl Wilken’s Fellows working on antigenocide global efforts as part of the Genocide Intervention Network. Dr. Davis has published in a number of domestic and global journals and is on the editorial board of Health and Human Rights: An International Journal. She was part of the 2012 cohort of the Robert Wood Johnson Executive Nurse Fellowship, a 3-year fellowship that prepares 20 national nursing leaders to contribute to the national health care strategy.

Kathryn Edwards, M.D., is the Sarah H. Sell and Cornelius Vanderbilt Professor of Pediatrics at the Vanderbilt University School of Medicine. She graduated from the University of Iowa College of Medicine and completed her pediatric residency and infectious disease fellowship at Northwestern University and her postdoctoral training in immunology at Rush Medical

School in Chicago. Dr. Edwards joined the Vanderbilt Vaccine Program in 1980. She has had an extensive experience in leading National Institutes of Health (NIH)-funded and Centers for Disease Control and Prevention (CDC)-funded multicenter investigations and in conducting pivotal Phase I, II, and III clinical trials on vaccines and therapeutics. In 1998 Dr. Edwards was awarded a contract from the CDC to conduct active population-based surveillance to monitor the impact of newly licensed vaccines, which evolved into the existing New Vaccine Surveillance Network. She has also led the CDC-funded Center for Immunization Safety Assessment (CISA) to monitor the safety of vaccines. In 2012 Dr. Edwards conducted comprehensive pneumonia surveillance studies in children and adults.

Dr. Edwards has served on many CDC, NIH, World Health Organization, and Infectious Diseases Society of America (IDSA) committees. She received the IDSA Mentor Award in 2006, the Distinguished Physician Award from the Pediatric Infectious Diseases Society in 2011, the Maureen Andrew Mentoring Award from the Society for Pediatric Research in 2014, and the Charles Mérieux Award in Vaccinology from the National Foundation for Infectious Diseases in 2016. In 2008 she was elected to the National Academy of Medicine.

Susan Ellenberg, Ph.D., joined the biostatistics faculty at the University of Pennsylvania as a professor of biostatistics in the fall of 2004. She also has a secondary appointment in the Department of Medical Ethics and Health Policy. Dr. Ellenberg directs the Biostatistics Core for the Penn Center for AIDS Research and is also collaborating on projects in pulmonary research, breast cancer, anesthesiology, endocrinology, and HIV. Prior to arriving at Penn, Dr. Ellenberg held leadership positions at the U.S. National Institutes of Health and the U.S. Food and Drug Administration. Her areas of research have included surrogate endpoints for treatment effects in clinical trials, operational issues for data monitoring committees, clinical trial designs, adverse event monitoring, vaccine safety, and special issues in cancer and AIDS trials. Dr. Ellenberg is a fellow of the American Statistical Association, the Society for Clinical Trials, and the American Association for the Advancement of Science and is an elected member of the International Statistical Institute. She has served as the president of the Eastern North American Region of the International Biometric Society and of the Society for Clinical Trials and also as the chair of the board of trustees of the National Institute of Statistical Sciences. She is an associate editor of Clinical Trials and the Journal of the National Cancer Institute. Her book Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets, was named Wiley Europe Statistics Book of the Year for 2002.

Roger Lewis, M.D., Ph.D., received a doctorate in biophysics and a medical degree from Stanford University. He is a professor at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), and the chair of the Department of Emergency Medicine at Harbor–UCLA Medical Center. Dr. Lewis’s expertise centers on adaptive and Bayesian clinical trials, including platform trials; translational, clinical, health services, and outcomes research; interim data analysis; data monitoring committees; and informed consent in emergency research studies.

In 2009 Dr. Lewis was elected to membership in the National Academy of Medicine. He is a past president of the Society for Academic Emergency Medicine, a current member of the board of directors for the Society for Clinical Trials, and the senior medical scientist at Berry Consultants, LLC, a group that specializes in adaptive clinical trials.

Dr. Lewis has served as a grant reviewer for the Agency for Healthcare Research and Quality, the Canadian Institutes of Health Research, the U.S. Centers for Disease Control and Prevention, the National Cancer Institute of France, the U.S. National Institutes of Health, the Patient-Centered Outcomes Research Institute, and foundations. He is also a member of the Medicare Evidence Development & Coverage Advisory Committee of the Centers for Medicare & Medicaid Services. Dr. Lewis serves as the chair of data and safety monitoring boards for both federally funded and industry-sponsored clinical trials, including international trials. He is a research methodology reviewer for JAMA and an editor of the JAMA series titled “JAMA Guides to Statistics and Methods.” He has served as a content reviewer for many other peer-reviewed journals. He has authored or coauthored more than 200 original research publications, reviews, editorials, and chapters.

Alex John London, Ph.D., is a professor of philosophy and the director of the Center for Ethics and Policy at Carnegie Mellon University. Professor London is an elected fellow of the Hastings Center and a recipient of the Distinguished Service Award from the American Society of Bioethics and Humanities.

Dr. London’s research focuses on foundational ethical issues in human-subjects research, issues of social justice in the transnational context, and on methodological issues in theoretical and applied ethics. His papers have appeared in Mind, Science, The Lancet, PLoS Medicine, Statistics in Medicine, The Hastings Center Report, and numerous other journals and collections. He is co-editor of Ethical Issues in Modern Medicine, one of the most widely used textbooks in medical ethics.

In 2012 he joined the working group on the revision of the Council for International Organizations of Medical Sciences 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects, and in 2011

he was appointed to the steering committee on forensic science programs for the International Commission on Missing Persons. Since 2007 he has served as a member of the ethics working group of the HIV Prevention Trials Network. He has testified before the Presidential Commission for the Study of Bioethical Issues and has been commissioned to write papers for the Centers for Disease Control and Prevention and the Institute of Medicine. He has served as an ethics expert in consultations with numerous national and international organizations including the U.S. National Institutes of Health, the World Health Organization, the World Medical Association, and the World Bank.

Jens Lundgren, M.D., D.M.Sc., is a professor of infectious diseases and a practicing infectious disease specialist. He founded and directs the Centre of Excellence for Health, Immunity and Infections at the Department of Infectious Diseases, based at the Copenhagen University Hospital (Rigshospitalet), University of Copenhagen, where he also directs the Centre of Excellence for Personalized Medicine of Infectious Complications in Immune Deficiency, serves as a member of the executive committee of the NIH/NIAID-funded International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) network, chairs its scientific steering committee, and is co-principal investigator for the START study. He is co-editor-in-chief of the HIV Medicine journal and was awarded the European AIDS Clinical Society Award for Excellence in HIV Medicine in 2015. He is a member of the American Society of Clinical Investigation and the Association of American Physicians. His list of publications over the past three decades in the scientific literature is extensive, and he has mentored several younger colleagues in their research development.

Michelle M. Mello, J.D., M.P.H., is a professor of health research and policy at Stanford University School of Medicine and a professor of law at Stanford Law School. She holds doctoral degrees in law and health policy and conducts research on issues at the intersection of health policy, law, and bioethics. Ms. Mello’s scholarship includes work on ethical issues arising in industry-sponsored clinical trials, legal and ethical barriers to clinical trial data sharing, legal concerns as a hindrance to clinical volunteerism during the Ebola epidemic, and a range of legal and ethical issues in pharmaceutical regulation and human-subjects research. For 7 years she served as the chair of the institutional review board at the Harvard School of Public Health, which is responsible for oversight of numerous clinical trials in African countries.

Olayemi Omotade, M.B.B.S., M.A., FMCPaed, FRCPCH, is a professor of pediatrics and child health at the Institute of Child Health, College of Medicine, University of Ibadan. He is a consultant pediatrician to the Uni-

versity College Hospital, Ibadan, Nigeria. As part of his residency training in pediatrics at the University College Hospital, he was on attachment to the University Hospital of Wales, Cardiff, where he was trained as a clinical geneticist.

At the Institute of Child Health, his research interests span community/ preventive pediatrics, and while combining this with his clinical genetics, he has been able to carry out research on infectious and communicable diseases. He has been involved in program planning and monitoring with international organizations including the World Health Organization (WHO), the United Nations International Children’s Fund, and the United Nations Development Programme both at the country and international levels.

Through a Fogarty Fellowship (2001–2002) he was able to undertake a course of study leading to the award of a master of arts at Case Western Reserve University, Cleveland, Ohio, during which he was instrumental to the drawing up of the initial works for Nigeria’s national ethical guidelines. He was for some time a member of the National Ethics Review Board for Nigeria as well as for the Joint IRC University of Ibadan/University College Hospital. He has more than 80 publications in international and regional journals, and he is a member of many professional associations including the Paediatrics Association of Nigeria, American Society for Bioethics and Humanities, Puebla Group of Networks Collaborating on Health Research for Development, Clinical Genetics Society of Great Britain, and International Association for Tropical Paediatrics. He is the foundation director for the Centre for HIV/AIDS Intervention, Nigeria (CEHAIN). He has also coordinated several studies for the Nigerian Academy of Sciences, and he has been a reviewer for several books and journals, including reviewing some chapters of two books for the Institute of Medicine.

He is also a member of the task force Multilateral Initiative on Malaria (MIM)/Special Programme for Research and Training in Tropical Diseases (TDR)/WHO, the scientific review committee for the European & Developing Countries Clinical Trials Partnership (EDCTP), for the EDCTP Senior Fellowships Training Awards, and the WHO/MIM/TRD Task Force on Malaria Research Capability Strengthening in Africa. Dr. Omotade is also a member of several expert technical groups, including the WHO expert technical group on Intermittent preventive treatment in infants, and the international advisory board of the Institute for Research on Unlimited Love.

He has been on the University College Hospital board of management (2010–2015), and he is a member of the National Child Health Technical Working Group (2015 to date). He has been the chairman of the postgraduate committee at the College of Medicine, University of Ibadan, since 2010.

David H. Peters, M.D., M.P.H., Dr.P.H., is a specialist in international health systems who has worked as a researcher, policy advisor, educator,

bureaucrat, manager, and clinician in a number of developing countries over the past 25 years and has been on faculty at Johns Hopkins University since 2001. At Johns Hopkins he oversees a department of more than 150 full-time faculty and about 300 graduate students who are involved in more than 250 projects around the world. He is the research director for the Future Health Systems research consortium, which is working to improve access to and the affordability and quality of health services for the poor, with field sites in five countries in Africa and Asia. He led the development and implementation of the first national Balanced Scorecard to assess and manage health services (in Afghanistan) and conducted research that directly led to the ending of user fees in primary care facilities. He is currently leading a program to strengthen public health systems in Liberia in the wake of the Ebola epidemic. He has written 7 books and more than 100 scientific articles, mostly focusing on health systems in low- and middle-income countries. His teaching and research focus on the performance of health systems; implementation research methods; poverty and health systems; innovations in organization, technology, and financing of health systems; the role of the private sector; human resource management; and ways to use donor assistance to strengthen local capacity in low-income countries.

While at the World Bank as a senior public health specialist, he pioneered the development of sector-wide approaches (SWAps) in health, with the purpose of improving national leadership and coherence over health strategies and improving coordination and accountability of policy implementation. In India he led a research program that included local researchers, government, and civil society in examining health systems and inequities and which was used as a basis for new policies and major programs to improve access and financing for health, notably the Rural Health Mission.

He is the chair of the board of the World Health Organization Alliance for Health Policy and Systems Research, is a member of the scientific advisory board for the President’s Emergency Plan for AIDS Relief (PEPFAR), and has served on advisory and technical bodies for the Canadian Institutes of Health Research–Institute of Population and Public Health; Gavi (The Vaccine Alliance); the Global Fund to Fight AIDS, Tuberculosis and Malaria; and the World Economic Forum.

Fred Wabwire-Mangen, M.B.Ch.B., DTM&H, M.P.H., Ph.D., was trained in human medicine at Makerere University, in tropical medicine at Liverpool University, and in immunology and infectious diseases and infectious disease epidemiology at Johns Hopkins University, where he obtained a Ph.D. in 1994. He is an associate professor of epidemiology and public health at the Makerere University School of Public Health, where he teaches infectious disease epidemiology, intervention trials, and health services research. He

also has a secondary appointment as a senior research scientist and executive chair at the Makerere University Walter Reed Project (MUWRP). MUWRP is one of the few projects that is conducting Ebola and Marburg vaccine trials in Uganda. Dr Wabwire-Mangen has more than 25 years of conducting research on emerging and reemerging diseases of public health importance in Uganda, including malaria, sexually transmitted infections, HIV/AIDS, influenza, and other emerging viral infections. He also has demonstrated experience leading and managing multidisciplinary research teams. He served as a co-investigator on a cluster randomized trial on sexually transmitted disease control for AIDS prevention and on an individual randomized controlled trial on male circumcision for HIV prevention while working at the Rakai Health Sciences Project between 1994 and 2008, and also served as co-investigator of a Phase 2 and a Phase 2a HIV vaccine trial at MUWRP. As principal investigator of the Surveillance of Influenza Viruses among Human and Non-Human Hosts in Uganda study and the Antimicrobial Resistance Surveillance in Uganda study, funded by Global Emerging Infections Surveillance, Dr. Wabwire-Mangen leads a team of medical doctors, laboratorians, epidemiologists, veterinarians, ornithologists, and other scientists. Dr. Wabwire-Mangen has published widely on public health issues in peer-reviewed journals.

Charles D. Wells, M.D., currently serves as the head of development and the associate vice president for the Infectious Diseases Therapeutic Unit at Sanofi, based in Bridgewater, New Jersey, having joined the organization in September 2015. Prior to joining Sanofi he served as the senior medical director for the Novel Product Opportunities group at Otsuka Pharmaceuticals in Rockville, Maryland. He joined Otsuka in May 2007 to provide the medical and clinical leadership for developing Otsuka’s antituberculosis compound, delamanid, which was successfully registered as Deltyba^® in 2014 in the European Union, Japan, and Korea for treatment of multidrug resistant (MDR) tuberculosis (TB). In his role at Otsuka he oversaw the clinical development program for delamanid, including clinical operations charged with conducting the global clinical trials in 14 countries across 5 continents, and served on the regulatory submission team responsible for the product’s registration. Additionally, he led the publication strategy for reporting results from the clinical development trials for delamanid and led the data submission process to the World Health Organization required for development of interim global guidelines for the use of delamanid in MDR-TB treatment.

Prior to joining Otsuka, he served as the chief of the International Research and Programs Branch of the Division of Tuberculosis Elimination at the U.S. Centers for Disease Control and Prevention (CDC) during 2000–2007. The branch he led at CDC conducted extensive epidemiologic,

clinical, and diagnostics research on TB which fed supportive data into evolving global policy and provided direct technical assistance internationally for implementation and scale-up of public health programs for control of TB, HIV-associated TB, and MDR-TB in sub-Saharan Africa, Southeast and South Asia, Eastern Europe, and South America. During this time he also served as CDC’s lead representative on the strategic advisory group for the STOP-TB Department at the World Health Organization (WHO) and also the U.S. Agency for International Development (USAID)-supported TB Coalition for Technical Assistance. Additionally, he served as a technical expert on disease control program reviews in numerous countries for the WHO, USAID, and the President’s Emergency Plan for AIDS Relief (PEPFAR).

Early in his career he began work in clinical development serving as a research associate at Burroughs Wellcome and Glaxo in Research Triangle Park, North Carolina, in the late 1980s and as an associate medical director at PathoGenesis Corporation in Seattle, Washington, in the late 1990s working on clinical development for anti-infectives, including new drugs for TB.

He is a native of North Carolina and attended North Carolina State University where he received a bachelor of science degree in chemical engineering in 1987. He then completed his medical studies at the University of North Carolina at Chapel Hill in 1992 and his postgraduate medical training in internal medicine and infectious diseases at Emory University and the CDC in Atlanta from 1992 to 1998.

CONSULTANTS

Janet Darbyshire, CBE FMedSci, joined the UK Medical Research Council Tuberculosis and Chest Diseases Unit, after training in respiratory medicine, to coordinate a program of clinical trials and observational epidemiological studies in East Africa and the United Kingdom which led to the short-course chemotherapy regimens which are now the basis of tuberculosis treatment worldwide. She subsequently moved into HIV research at the time when the first antiretroviral drugs were becoming available and led the MRC HIV Clinical Trials Centre, developing a program of clinical trials and observational studies in the United Kingdom and in collaboration with research groups across Europe, Australia, and North and South America and subsequently in Africa.

In 1998 Ms. Darbyshire became the Director of the newly established MRC Clinical Trials Unit (CTU) which incorporated the HIV program and the MRC Cancer Trials Office. The remit of the CTU also extended into other disease areas where there was no strong tradition of clinical trials, such as arthritis and blood transfusion. She retired as director of the CTU in March 2010 but the Unit continues directed by Professor Max Parmar.

In 2005 with Professor Peter Selby she became Joint Director of the UK Clinical Research Network (UKCRN) coordinated jointly between the MRC CTU and the University of Leeds. The UKCRN (which became the NIHR CRN) was set up to support both commercial and noncommercial research in the United Kingdom by providing clinical infrastructure in the NHS. The aim was to increase the quality and quantity of clinical research with the overall goal of improving both the health and wealth of the United Kingdom. They retired as Joint Directors in September 2010 and Dr. Jonathan Sheffield has been appointed as Chief Executive.

She has been involved in drug regulation for many years initially on the Committee on Safety of Medicines and then on the Commission on Human Medicines which replaced it. She has served on many research and funding committees and advisory boards and on the World Health Organization and other expert committees as well as numerous trial oversight, data monitoring, and scientific advisory committees. Although she has never lived in Africa she has spent much time there as much of her career has involved collaborative research in resource-poor countries to improve the treatment initially of tuberculosis and subsequently of HIV infection although the two are inextricably linked.

Erin Hammers Forstag, J.D., M.P.H., is a writer, consultant, and attorney in the public health and nonprofit arenas. She received her law degree from Georgetown University Law Center, and her master’s of public health from Columbia University. She currently serves as the executive director of Common Good Consulting, which she founded in order to provide small nonprofits with legal, policy, and strategic guidance. She has worked on issues including school food, factory farming, and disaster recovery, and has authored several papers on the intersection between public health and the First Amendment. Erin served as a health volunteer in the Peace Corps in Uzbekistan in 2003.

STUDY STAFF

Michael J. Berrios is a senior program assistant on the Board of Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine. Mr. Berrios joined the National Academies in 2014 and has worked on the consensus studies Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk and Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations. He is currently working on the Forum on Drug Discovery, Development, and Translation. Mr. Berrios received a B.A. in international relations from Michigan State University and is currently a candidate for a master’s in Asian studies from the George Washington University.

Emily R. Busta, M.S., is an associate program officer on the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine. Ms. Busta joined the National Academies staff in October 2014 as staff on the Forum for Drug Discovery, Development, and Translation. Prior to joining the National Academies, she held positions as a research assistant in a placentology lab at the University of Colorado and as a Toxicology Review Fellow at the Center for Food Safety and Applied Nutrition (CFSAN), U.S. Food and Drug Administration. At CFSAN she helped develop and test predictive computational toxicology models and assisted in the safety review of new food contacts. Ms. Busta holds a master’s of science degree in biomedical basic sciences from the University of Colorado at Denver–Anschutz Medical Campus and a bachelor of science degree in molecular toxicology from the University of California, Berkeley.

Anne B. Claiborne, J.D., M.P.H., is a senior program officer in the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine, where she is staff director of the Forum on Drug Discovery, Development, and Translation and was the responsible staff officer for Integrating Clinical Research into Epidemic Response: The Ebola Experience. She has advised or worked on numerous studies and projects relating to drug discovery and development, clinical research, and biomedical ethics, including Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations; Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary; and Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Before joining the National Academies in April 2010, Ms. Claiborne was a practicing health care attorney in the Washington, DC, office of an international law firm. Ms. Claiborne received her bachelor of arts degree, with distinction, from Stanford University; her juris doctorate, cum laude, from Harvard Law School, where she was an editor of the Harvard Law Review; and her M.P.H. from the Johns Hopkins Bloomberg School of Public Health, where she was elected to the Delta Omega honorary society. Prior to her graduate studies, Ms. Claiborne spent several years working in public health planning and health services research at the San Francisco Department of Public Health and at the University of California, San Francisco.

Patricia A. Cuff, M.S., M.P.H., is a senior program officer for the Board on Global Health within the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine. Her roles involve directing the Global Forum on Innovation in Health Professional Education, and co-directing the study on Clinical Trials During the 2014–2015 Ebola Outbreak. She was the Country Liaison to the Uganda National Academy

of Sciences where she worked for 11 years with African academy staff and members in developing their capacity to provide evidence-based science advice to their governments and to their nations. Prior to her role with the African academies, she was the Study Director for the Committee on the Options for Overseas Placement of U.S. Health Professionals and with the Board on Neuroscience and Behavioral Health. Ms. Cuff joined the National Academies staff to work on the report Emerging Microbial Threats to Health in the 21st Century under the Board on Global Health. Before coming to Washington, DC, Ms. Cuff worked at St. Luke’s-Roosevelt Hospital Center in New York City in the field of HIV nutrition as a counselor, researcher, and lecturer on topics of adult and pediatric HIV. She received an M.S. in nutrition and an M.P.H. in population and family health from Columbia University, and performed her undergraduate studies at the University of Connecticut.

Michelle Mancher, M.P.H., is a program officer on the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine. She served as staff co-Director for the Integrating Clinical Research into Epidemic Response: The Ebola Experience report and liaison for the Sharing Clinical Trial Data Action Collaborative. Ms. Mancher joined the National Academies in 2009, and has since worked on many consensus studies and workshops related to health care services delivery, clinical trial data sharing, and medical product research and development, including Initial National Priorities for Comparative Effectiveness Research; Clinical Practice Guidelines We Can Trust; Variation in Health Care Spending: Target Decision Making Not Geography; Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk; and Global Health Risk Framework: Research and Development of Medical Products: Workshop Summary. Prior to joining the National Academies, Ms. Mancher held positions at the Arthritis Foundation: Metro DC Chapter, Clinton Foundation’s Alliance for a Healthier Generation and the New York City Health and Hospital Corporation’s office of managed care. Ms. Mancher holds a master’s in public health in health care management and policy from Columbia University, and a bachelor of arts in international relations from the George Washington University.

Julie Pavlin, M.D., Ph.D., M.P.H., is the director, Board on Global Health, Health and Medicine Division, the National Academies of Sciences, Engineering, and Medicine. Prior to joining the National Academies, she was the Research Area Director for Emerging Infectious Diseases and Antimicrobial Resistance and Deputy Research Area Director for HIV at the Infectious Disease Clinical Research Program, part of the Uniformed Services University, and before that the Deputy Director of the Armed Forces

Health Surveillance Center. She is a retired Colonel in the U.S. Army and previous assignments included the Chief of the Global Emerging Infections Department at the Armed Forces Research Institute of Medical Sciences in Bangkok, Thailand, where she developed surveillance programs for infectious diseases in Asia, the Chief of the Field Studies Department at the Walter Reed Army Institute of Research where she played a pivotal role in developing the Electronic Surveillance System for the Early Notification of Community-based Epidemics (ESSENCE), the U.S. Department of Defense real-time surveillance system, and Assistant Chief of the Operational Medicine Division at the U.S. Army Medical Research Institute for Infectious Diseases. Dr. Pavlin received her A.B. from Cornell University, her M.D. from Loyola University, her M.P.H. from Harvard University, and her Ph.D. in emerging infectious diseases at the Uniformed Services University.

Andrew M. Pope, Ph.D., is director of the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine. He has a Ph.D. in physiology and biochemistry from the University of Maryland and has been a member of the National Academies staff since 1982 and of the Health and Medicine Division staff since 1989. His primary interests are science policy, biomedical ethics, and environmental and occupational influences on human health. During his tenure at the National Academies, Dr. Pope has directed numerous studies on topics that range from injury control, disability prevention, and biologic markers to the protection of human subjects of research, National Institutes of Health priority-setting processes, organ procurement and transplantation policy, and the role of science and technology in countering terrorism. Since 1998, Dr. Pope has served as Director of the Board on Health Sciences Policy, which oversees and guides a program of activities that is intended to encourage and sustain the continuous vigor of the basic biomedical and clinical research enterprises needed to ensure and improve the health and resilience of the public. Ongoing activities include Forums on Neuroscience, Genomics, Drug Discovery and Development, and Medical and Public Health Preparedness for Disasters and Emergencies. Dr. Pope is the recipient of the Health and Medicine Division’s Cecil Award and the National Academy of Sciences’ President’s Special Achievement Award.

Olivia C. Yost, M.S., is a research associate on the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine. She provided research support to the consensus report Integrating Clinical Research into Epidemic Response: The Ebola Experience, as well as the Committee on Preventing Dementia and Cognitive Impairment and the Committee on Issues in Organ Donor Intervention Research. Prior to joining the National Academies in 2015, Ms. Yost worked as a research officer

for ARCHIVE Global, a global health organization based in New York City, where she oversaw the implementation of monitoring and evaluation programs and field studies focused on the deployment of environmental strategies for malaria, tuberculosis, and gastrointestinal infection control in Haiti, Cameroon, and Bangladesh. Ms. Yost received her M.S. in the control of infectious diseases from the London School of Hygiene & Tropical Medicine in 2012. Her graduate research focused on developing alternative methodologies for assessing small-scale wastewater infrastructure decay in rural Alabama. She received her B.A. in history and communications from Franklin University in Switzerland in 2011.