Appendix B
Participant Biographies1

Yanis Ben Amor, Ph.D., is an Associate Research Scientist at the Earth Institute and the Tuberculosis Coordinator for the Millennium Villages Project (MVP). The TB initiative at MVP focuses on delivering a comprehensive package of TB interventions in remote health centers in rural settings across 10 African countries. By promoting community-based directly observed treatment, short course (DOTS), the TB initiative aims to decrease death rates by improving case detection and treatment success rates. Dr. Ben Amor’s TB-related research is focused on finding ways to improve TB diagnosis in developing countries. He analyzes new, rapid diagnostic tools being investigated, and develops ways to allow their implementation in resource-poor settings, where electricity and clean water can be limiting factors. In 2006, Dr. Ben Amor validated the use of line probe assays in Rwanda for the detection of multidrug-resistant TB in that country. In October 2008, he launched Mali’s first national drug resistance survey, to be conducted throughout the country in 2009.


Gail H. Cassell, Ph.D., is currently Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, Indiana. She is former Charles H. McCauley Professor and Chair of the Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a department that ranked first in research funding from the National Institutes of Health (NIH) during

1

 At the time of printing, biographies were not available for Caroline Ryan and Alexander Sloutsky.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 117
Appendix B Participant Biographies1 yanis ben Amor, Ph.D., is an Associate Research Scientist at the Earth Insti- tute and the Tuberculosis Coordinator for the Millennium Villages Project (MVP). The TB initiative at MVP focuses on delivering a comprehensive package of TB interventions in remote health centers in rural settings across 10 African countries. By promoting community-based directly observed treatment, short course (DOTS), the TB initiative aims to decrease death rates by improving case detection and treatment success rates. Dr. Ben Amor’s TB-related research is focused on finding ways to improve TB diag- nosis in developing countries. He analyzes new, rapid diagnostic tools being investigated, and develops ways to allow their implementation in resource- poor settings, where electricity and clean water can be limiting factors. In 2006, Dr. Ben Amor validated the use of line probe assays in Rwanda for the detection of multidrug-resistant TB in that country. In October 2008, he launched Mali’s first national drug resistance survey, to be conducted throughout the country in 2009. Gail H. Cassell, Ph.D., is currently Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, Indiana. She is former Charles H. McCauley Profes- sor and Chair of the Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a department that ranked first in research funding from the National Institutes of Health (NIH) during 1 At the time of printing, biographies were not available for Caroline Ryan and Alexander Sloutsky. 

OCR for page 117
 THREAT OF DRug-RESISTANT TubERCulOSIS the decade of her leadership. She obtained her B.S. from the University of Alabama in Tuscaloosa and in 1993 was selected as one of the top 31 female graduates of the twentieth century. She obtained her Ph.D. in microbiology from the University of Alabama at Birmingham and was selected as its 2003 Distinguished Alumnus. Dr. Cassell is past President of the American Society for Microbiology (the oldest and largest life sciences organization, with a membership of more than 42,000). She was a member of the NIH Director’s Advisory Committee and of the Advisory Council of the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Cassell was named to the original Board of Scientific Councilors of the Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), and served as chair of the board. She recently served a 3-year term on the advisory board of the Direc- tor of CDC and as a member of the Secretary of Health and Human Services’ Advisory Council of Public Health Preparedness. Currently she is a member of the Science Board of the U.S. Food and Drug Administration (FDA). Since 1996 she has been a member of the U.S.–Japan Cooperative Medical Science Program, responsible for advising the respective governments (U.S. State Department/Japanese Ministry of Foreign Affairs) on joint research agen- das. She has served on several editorial boards of scientific journals and has authored more than 250 articles and book chapters. Dr. Cassell has received national and international awards and an honorary degree for her research in infectious diseases. She is a member of the Institute of Medicine (IOM) and is currently serving a 3-year term on the IOM Council, the institution’s governing board. Dr. Cassell has been intimately involved in the formulation of science policy and legislation related to biomedical research and public health. For 9 years she was chair of the Public and Scientific Affairs Board of the American Society for Microbiology; she has served as an advisor on infectious diseases and indirect costs of research to the White House Office of Science and Technology Policy, and has been an invited participant in numerous congressional hearings and briefings related to infectious diseases, antimicrobial resistance, and biomedical research. She has served two terms on the Liaison Committee on Medical Education (LCME), the accrediting body for U.S. medical schools, as well as other national committees involved in establishing policies on training in the biomedical sciences. She recently completed a term on the Leadership Council of the School of Public Health of Harvard University. Currently she is a member of the Executive Commit- tee of the Board of Visitors of Columbia University School of Medicine, the Executive Committee of the Board of Directors of the Burroughs Wellcome Fund, Research!America, and the Advisory Council of the Johns Hopkins School of Nursing. kenneth G. Castro, M.D., is Assistant Surgeon General, U.S. Public Health Service, and Director of CDC’s Division of Tuberculosis Elimination (Sep-

OCR for page 117
 APPENDIx b tember 2008). Since January 1993, he has served as Director of the Divi- sion of Tuberculosis Elimination in CDC’s National Center for HIV, STD, and TB Prevention (NCHSTP). In this role, Dr. Castro leads the team of technical experts devoted to TB elimination efforts in the United States: his division sponsors TB prevention, control, and research activities through- out the nation and other parts of the world. Since 1995, he has served as Co-chair of the U.S. Federal Tuberculosis Task Force. Recognizing the importance and magnitude of global TB, Dr. Castro has advanced U.S. involvement in global TB control efforts, serving as an expert advisor to the World Health Organization (WHO) and the International Union Against Tuberculosis and Lung Diseases (IUATLD). He is a founding member of the global Stop TB Partnership and member of its Coordinat- ing and Executive Boards. In an unusual distinction afforded to a division director, Dr. Castro, who is a Commissioned Corps Officer in the U.S. Public Health Service, was promoted to the flag rank of Assistant Surgeon General (RADM, 0-7) in May 2000. Since the 2006 description of exten- sively drug-resistant (XDR) TB, he has provided national and global lead- ership in the development of a coordinated response to this urgent health problem. Prior to serving as director of CDC’s Division of TB Elimination, Dr. Castro worked as the Assistant Director for TB and HIV, Office of HIV/AIDS at CDC, from May to December 1992. In May 1992, he was appointed to the office of Associate Director of HIV/AIDS to coordinate CDC-wide HIV-associated TB activities, after serving for almost 2 years as the Assistant Chief of the Epidemiology Branch in the Division of HIV/ AIDS in the National Center for Infectious Diseases. From July 1989 until August 1990, he served as Special Assistant to the Director for Science in the Division of HIV/AIDS. Dr. Castro began his career with CDC in 1983 as an Epidemic Intelligence Service (EIS) officer with the AIDS Program, where he became a staff medical epidemiologist after completing the EIS training in 1985. A physician-scientist trained in epidemiology, he has a specialty in internal medicine and subspecialty in infectious diseases. He received his bachelor’s degree in 1974 from the University of Puerto Rico; completed postgraduate biology studies at Northeastern University in Bos- ton in 1976; and received his medical doctorate from the State University of New York at Stony Brook School of Medicine in 1980. Dr. Castro went on to complete his internal medicine postgraduate training in 1983 in the residency program in social medicine at the Montefiore Medical Center, Albert Einstein College of Medicine in New York. From 1988 until 1989, he continued his education, completing a fellowship in infectious diseases at the Emory University School of Medicine, where his work focused on describing the increase in the number of people with TB and its associa- tion with the HIV/AIDS epidemic. Since 1988, Dr. Castro has served as an adjunct clinical faculty member of the Division of Infectious Diseases,

OCR for page 117
0 THREAT OF DRug-RESISTANT TubERCulOSIS Emory University School of Medicine, and at the infectious diseases clinic at Grady Memorial Hospital in Atlanta. Peter Cegielski, M.D., M.P.H., received his bachelor’s degree with honors from Harvard University in 1978. He received his medical degree in 1984 from the University of California at San Diego School of Medicine. He completed a residency in internal medicine in 1987 and a fellowship in infectious diseases/international health in 1990, both at Duke University Medical Center. For 2 years of the fellowship he was posted to Muhimbili Medical Center, University of Dar es Salaam, Tanzania, where he was a Lecturer and Consultant Physician. From 1991 to 1994, Dr. Cegielski was an Assistant Professor in the Division of Infectious Diseases/International Health at Duke, and in 1995 he received a master’s degree in epidemiol- ogy from the University of North Carolina at Chapel Hill School of Public Health. From 1994 to 1996, he held a joint appointment as Chief of Medi- cal Services and Research, Center for Pulmonary Infectious Disease Con- trol, and as an Assistant Professor in the Department of Medicine, both at the University of Texas Health Center at Tyler, Texas. At the end of 1996, he took a faculty position in the Department of Epidemiology at the Johns Hopkins University School of Public Health. In this capacity, he moved to Chiang Mai, Thailand, where he served as field director of the Johns Hopkins HIV/AIDS research program at Chiang Mai University. Then in 1998, he joined the International Activity of the Division of TB Elimina- tion at CDC. In 2001, the International Activity became the International Research and Programs Branch, and Dr. Cegielski was promoted to Team Leader for Drug-Resistant TB. His work focuses on the epidemiology, prevention, diagnosis, and treatment of TB, especially drug-resistant TB. Richard E. Chaisson, M.D., is Professor of Medicine, Epidemiology and International Health and Director of the Center for Tuberculosis Research at The Johns Hopkins University. He received his B.S. and M.D. degrees from the University of Massachusetts, and trained in internal medicine and infectious diseases and epidemiology at the University of California, San Francisco, where he conducted research on the HIV epidemic in injection drug users and initiated early studies on the interaction of TB and HIV. He then served as Director of the Johns Hopkins AIDS Service from 1988 to 1998, where he pioneered the use of observational cohort studies for under- standing the natural history, treatment, and outcomes of HIV disease. Dr. Chaisson became Director of TB Preventive and Treatment Services for the Baltimore City Health Department in 1992, and built a productive clinical research program focusing on molecular epidemiology and TB clinical trials. In 1998 he founded the Johns Hopkins Center for Tuberculosis Research, a multidisciplinary research and training center with more than $120 mil-

OCR for page 117
 APPENDIx b lion in grants for the study of TB from bench to bedside. Dr. Chaisson’s research interests focus on TB and HIV infection, including global epide- miology and control, prevention, clinical trials, and public health interven- tions. He is currently principal investigator for multiple research grants for studies of the treatment, prevention, and control of TB and HIV. He is also principal investigator of the Consortium to Respond Effectively to the AIDS/TB Epidemic (CREATE), an international research consortium funded by the Bill and Melinda Gates Foundation to assess the impact of novel strategies for controlling HIV-related TB. Dr. Chaisson has published more than 350 scientific papers and book chapters. He was awarded the World Lung Health Award in 2006 by the American Thoracic Society for his scientific contributions to global control of pulmonary infections. Charles Daitch, Ph.D., is CEO of Akonni Biosystems Inc., which he founded in 2003. Dr. Daitch has diagnostic product development and R&D experi- ence from NIH, the U.S. Department of Agriculture, and Sandia National Laboratories. He has held senior-level management positions at Verid- ian Corporation and at HandyLab Inc. Since 1987, Dr. Daitch’s career has focused on automated and miniaturized biological detection systems. Jeffrey M. Drazen, M.D., attended Tufts University with a major in phys- ics and Harvard Medical School, and served his medical internship at Peter Bent Brigham Hospital in Boston. Thereafter, he joined the Pulmo- nary Divisions of the Harvard hospitals. He served as Chief of Pulmonary Medicine at the Beth Israel Hospital, Chief of the combined Pulmonary Divisions of the Beth Israel and Brigham and Women’s Hospitals, and finally as Chief of Pulmonary Medicine at Brigham and Women’s Hospital. Through his research, he defined the role of novel endogenous chemical agents in asthma. This work led to four new licensed pharmaceuticals for asthma, with more than 5 million people treated worldwide. In 2000, Dr. Drazen assumed the post of Editor-in-Chief of the New England Jour- nal of Medicine. During his tenure, the journal has published major papers advancing the science of medicine, including the first descriptions of severe acute respiratory syndrome (SARS) and papers modifying the treatment of cancer, heart disease, and lung disease. The journal, which has more than a million readers each week, has the highest impact factor of any journal publishing original research. Paul Farmer, M.D., Ph.D., is a Founding Director of Partners In Health, an international charity organization that provides direct health care services and undertakes research and advocacy activities on behalf of those who are sick and living in poverty. Dr. Farmer’s work draws primarily on active clin- ical practice (he is an attending physician in infectious diseases and Chief

OCR for page 117
 THREAT OF DRug-RESISTANT TubERCulOSIS of the Division of Social Medicine and Health Inequalities at Brigham and Women’s Hospital in Boston, and Medical Director of a charity hospital, the Clinique Bon Sauveur, in rural Haiti) and focuses on diseases that dis- proportionately afflict the poor. Along with his colleagues at Brigham and Women’s Hospital, in the Program in Infectious Disease and Social Change at Harvard Medical School, and in Haiti, Peru, and Russia, Dr. Farmer has pioneered novel, community-based treatment strategies for AIDS and TB (including multidrug-resistant TB). Dr. Farmer and his colleagues have successfully challenged the policy makers and critics who claim that quality health care is impossible to deliver in resource-poor settings. Dr. Farmer has written extensively about health and human rights, and about the role of social inequalities in the distribution and outcome of infectious diseases. He is the author of Pathologies of Power (2003), Infections and Inequalities (1998), The uses of Haiti (1994), and AIDS and Accusa- tion (1992). In addition, he is co-editor of Women, Poerty, and AIDS (1996) and of The global Impact of Drug-Resistant Tuberculosis (1999). Dr. Farmer is the recipient of the Duke University Humanitarian Award, the Margaret Mead Award from the American Anthropological Association, the American Medical Association’s Outstanding International Physician (Nathan Davis) Award, and the Heinz Humanitarian Award. In 1993, he was awarded a John D. and Catherine T. MacArthur Foundation “genius award” in recognition of his work. Dr. Farmer is the subject of Pulitzer Prizewinner Tracy Kidder’s Mountains beyond Mountains: The Quest of Dr. Paul Farmer, a Man Who Would Cure the World (2003). He received his bachelor’s degree from Duke University and his M.D. and Ph.D. from Harvard University. He is Presley Professor of Medical Anthropology in the Department of Social Medicine at Harvard Medical School. Anthony S. Fauci, M.D., is Director of NIAID at NIH. Since his appoint- ment to that position in 1984, he has overseen an extensive research portfolio devoted to preventing, diagnosing, and treating infectious and immune-mediated diseases. Dr. Fauci also is Chief of the NIAID Laboratory of Immunoregulation, where he has made numerous important discoveries related to HIV/AIDS; he is one of the most-cited scientists in the field. In addition, he has served as a key advisor to the White House and the Depart- ment of Health and Human Services on global AIDS issues, and on initia- tives to bolster medical and public health preparedness against emerging infectious disease threats such as pandemic influenza. Dr. Fauci, a member of the National Academy of Sciences, has received numerous awards for his scientific accomplishments, including the National Medal of Science, the George M. Kober Medal of the Association of American Physicians, the Mary Woodard Lasker Award for Public Service, and the 2008 Presidential Medal of Freedom. He has been awarded 32 honorary doctorate degrees

OCR for page 117
 APPENDIx b and is the author, coauthor, or editor of more than 1,100 scientific publica- tions, including several major textbooks. Hamish S. F. Fraser, MbChb, MRCP MSc, is an Assistant Professor of Medi- cine at Harvard Medical School and Associate Physician at the Brigham and Women’s Hospital. As Director of Informatics and Telemedicine at Partners In Health (PIH), he directs the development of web-based electronic medi- cal record (EMR) systems and data analysis tools to support the treatment of drug-resistant TB and HIV in Peru, Haiti, Rwanda, Lesotho, Malawi, and the Philippines. The first system developed, the PIH-EMR, currently supports the management and monitoring of more than 6,500 patients in treatment for MDR TB in Peru and 1,000 patients in the Philippines. Dr. Fraser also led the development of the HIV-EMR, which is used to support the treatment of HIV patients in rural Haiti. Both of these systems include data analysis tools, as well as components that track the current use of medication and predict future medication needs. The EMR systems used by Partners In Health were designed as part of an international collabora- tion to develop flexible, open-source medical record systems in developing countries. The first version of this OpenMRS system, of which Dr. Fraser is a co-founder, went live in February 2006 in Kenya and in August 2006 in Rwanda. OpenMRS is now also used to support the Partners In Health projects in Lesotho and Malawi and will soon be used to support MDR TB care in Haiti. Gerald Friedland, M.D., is Director of the AIDS Program at Yale New Haven Hospital and Professor of Medicine and Epidemiology and Public Health at Yale School of Medicine. He is a former member of the Govern- ing Council of the International AIDS Society, National Advisory Council, National Institute on Drug Abuse, and Advisory Council, Office of AIDS Research, and currently serves on the WHO HIV/TB Working Group and as Chairman of the Board of Directors of the Aaron Diamond AIDS Research Center in New York City. Dr. Friedland has been directly involved in the development of comprehensive HIV care programs since the begin- ning of the HIV epidemic in 1981. His work was initially in the Bronx, New York, and has continued since 1991 in New Haven, Connecticut. He has developed and directed large-scale clinical and epidemiologic studies among vulnerable populations with and at risk for HIV disease. His group presented the first convincing evidence of lack of transmission of HIV by close personal contact, and defined the predictors of HIV transmission and natural history of HIV disease among injection drug users and the risk of reactivation of TB among those coinfected with HIV. More recently, Dr. Friedland has worked on clinical trials of antiretroviral therapies. He is currently Principal Investigator of New England ProACT, a regional

OCR for page 117
 THREAT OF DRug-RESISTANT TubERCulOSIS AIDS clinical trials network specializing in antiretroviral therapy trials. In this work he has focused on recruitment, enrollment, retention, and special issues with respect to HIV therapeutics among injection drug users and other marginalized populations, including the definition of pharma- cokinetic drug interactions between HIV and substance abuse therapies. Dr. Friedland’s research also has focused on studies at the interface of biology, clinical care, and behavior, including adherence to HIV therapies and the inte- gration of prevention strategies and clinical care, notably in the development and testing of interventions to reduce the risk of HIV transmission among HIV-positive persons in clinical care. Dr. Friedland is also actively involved in HIV/AIDS international research aimed at providing access to antiretroviral therapy in resource-limited settings. The major focus of this work is the inte- gration of HIV and TB care and treatment in coinfected patients, with the aim of improving diagnosis, treatment, and outcomes for both diseases. This work has led to the discovery of XDR TB as a major cause of death among HIV/TB coinfected patients in South Africa and now focuses on the diagno- sis, treatment, and reduction of transmission of MDR and XDR TB in HIV coinfected patients. Dr. Friedland directs and participates in several research projects addressing these issues in rural and urban South Africa, supported by charitable research foundations and NIH. He is a Visiting Professor at the Nelson R. Mandela School of Medicine of the University of KwaZulu- Natal in Durban, South Africa, and the Mailman School of Public Health of Columbia University. Neel Gandhi, M.D., is Assistant Professor of Medicine and Epidemiology at Albert Einstein College of Medicine and Montefiore Medical Center. He graduated from Brown Medical School and received training in primary care internal medicine at Columbia-Presbyterian Medical Center, clinical epidemiology in the Robert Wood Johnson Clinical Scholars Program at Yale University, and infectious diseases at Emory University. Dr. Gandhi has been engaged in clinical research in TB/HIV coinfection since 1998, when he performed his first research study in India. Since 2002, he has been performing epidemiology and operational research in rural South Africa in an effort to address the converging epidemics of HIV and TB. In November 2006, he was the lead author on a study describing high rates of mortality in patients with XDR TB and HIV coinfection. This study has been credited with uncovering a rapidly expanding MDR TB and XDR TB epidemic in South Africa. Dr. Gandhi is currently funded through a Clinical Scientist Development Award and an Operations Research on AIDS Care and Treat- ment in Africa Award (ORACTA) from the Doris Duke Charitable Founda- tion. These grants provide support to elucidate risk factors for developing MDR and XDR TB, to test the MODS assay (a rapid TB drug-resistance assay) in a high HIV-prevalence setting, to create a community-based treat-

OCR for page 117
 APPENDIx b ment program for MDR TB in HIV coinfected patients, and to develop a comprehensive airborne infection control program in a rural district hospital. Additionally, Dr. Gandhi is a co-investigator on grants to expand TB/HIV integration efforts in rural South Africa (President’s Emergency Plan for AIDS Relief [PEPFAR], CDC), to examine the risk of household transmission of MDR and XDR TB in rural South Africa (NIH Fogarty Institute), and to elucidate the molecular epidemiology of drug-resistant TB in rural South Africa (Einstein Center for AIDS Research). Qian Gao, Ph.D., is Professor at Fudan University, Shanghai Medical College. He received his Ph.D. in 2000 from the University of South- ern California, and was a postdoctoral fellow at the School of Medicine, Stanford University, in 2003. His research interests are in the identification and characterization of new virulence genes of M. tuberculosis, the molecu- lar epidemiology of TB, and anti-TB drug discovery. Ann Ginsberg, M.D., Ph.D., is Head of Clinical Development for the TB Alliance. Prior to joining the TB Alliance in June 2004, she was Director, Project Management at Merck & Co., Inc. for 2 years. Dr. Ginsberg also brings 15 years of experience at NIH to this position. She began her NIH career in the National Cancer Institute as a Medical Staff Fellow and Resi- dent in Anatomic Pathology. She subsequently joined the National Institute of Diabetes, Digestive and Kidney Diseases as a Senior Staff Fellow in the Laboratory of Cellular and Developmental Biology. In 1995 she joined NIAID as Program Officer for Tuberculosis, Leprosy and Other Mycobacte- rial Diseases; she was appointed Chief of the Respiratory Diseases Branch in 2000. Trained as a molecular biologist, Dr. Ginsberg is a board-certified anatomic pathologist. She holds a B.A. from Harvard University, an M.D. from Columbia University, and a Ph.D. from Washington University. She is the author of numerous scientific publications and recipient of several prominent awards, including the Department of Health and Human Ser- vices Secretary’s Award for Distinguished Service in 2000. She has served on multiple global health committees and is currently a member of the Board of Directors of the Aeras Global TB Vaccine Foundation. Anne Goldfeld, M.D., is Associate Professor of Medicine at Harvard Medi- cal School, Senior Investigator at the Immune Disease Institute, Associate Professor of Immunology and Infectious Disease at the Harvard School of Public Health, and a member of the Infectious Disease Division at Brigham and Women’s Hospital in Boston. Work in her laboratory focuses on basic gene regulation and on new understanding of how the immune system responds to TB and AIDS. Her laboratory has discovered basic mechanisms of cell type and inducer-specific gene regulation using the TNF gene and

OCR for page 117
 THREAT OF DRug-RESISTANT TubERCulOSIS HIV as model systems and genes and described new T cell responses associ- ated with TB susceptibility and latency. As co-founder of the Cambodian Health Committee and the Global Health Committee, she has helped pio- neer new models of TB and AIDS care and treatment while integrating basic research methods to improve care and to discover new approaches to and therapies for these diseases in Cambodia and globally. Mark Harrington is Executive Director of the Treatment Action Group (TAG) in New York City. He graduated from Harvard with a B.A. in 1983, and organized many demonstrations as a member of ACT UP/New York (AIDS Coalition to Unleash Power), 1988–1992, including “Seize Control of the FDA” in 1988 and “Storm the NIH” in 1990. In 1992 he co-founded TAG. In 1997 he won a MacArthur Foundation “genius award” for his AIDS activism. He is a member of the WHO Strategic and Technical Advisory Committee for HIV, the WHO Strategic and Technical Advisory Group for Tuberculosis, and the writing group on WHO Guidelines for Antiretroviral Therapy for HIV Infection in Resource-Limited Settings, and he served for 12 years on the Department of Health and Human Ser- vices’ Panel on Clinical Practices for Treatment of HIV Infection in Adults and Adolescents. Mr. Harrington has been an ad hoc member of the FDA Antiviral Drugs Advisory Committee three times and served on the NIH AIDS Clinical Trials Group (ACTG) Opportunistic Infections and Primary Infection Committees and Community Constituency Group (CCG) between 1989 and 1993. He has presented four plenary talks at International AIDS Conferences in Amsterdam (“Pathogenesis and Activism,” 1992), Geneva (“Cure: Myth or Reality?,” 1998), Durban (“Epidemiology and Activism,” 2000), and Mexico City (“Moving from Universal Access to Comprehensive and Universal Primary Health Care for All,” 2008). He published a chapter on AIDS activism in Tactical biopolitics: Art, Actiism, and Technoscience (2008) and co-authored recent articles in PloS Medicine and The lancet on the need for better drugs and diagnostics to treat and diagnose TB (2007). He has also written many articles and reports for ACT UP and TAG. Salmaan keshavjee, M.D., Ph.D., is Assistant Professor of Social Medicine and Medicine at Harvard Medical School and at Brigham and Women’s Hospital. Since 2001, he has been working with the Boston-based non- profit Partners In Health, treating drug-resistant TB in Tomsk, Russian Federation. In Tomsk, he has worked extensively on expanding MDR TB treatment from the penitentiary to the civilian sector and from urban to rural areas. Since 2004, he has also led the Harvard/Partners In Health research efforts in Tomsk and has been a driving force behind Partners In Health’s Russia-wide MDR TB training programs. In addition to his work in Russia, Dr. Keshavjee was central to the 2006 launch of Partners

OCR for page 117
 APPENDIx b In Health’s HIV and TB work in Lesotho. These efforts led to the devel- opment of a community-based treatment program for patients coinfected with HIV and MDR TB, aimed not only at dramatically improving care throughout Lesotho but also at extending this coordinated treatment model to coinfected patients throughout sub-Saharan Africa and other regions with high levels of HIV/TB coinfection. In September 2007, Dr. Keshavjee was appointed Chairman of the Green Light Committee (GLC) for MDR TB. The GLC is a mechanism of WHO and the Stop TB Partnership that assists countries faced with MDR TB in accessing concessionally priced, quality-assured second-line anti-TB drugs for use in projects providing care in accordance with WHO and international guidelines. Jim yong kim, M.D., Ph.D., holds appointments as François Xavier Bagnoud Professor of Health and Human Rights at the Harvard School of Public Health and Professor of Medicine and Social Medicine at Harvard Medical School. He is Chief of the Division of Global Health Equity at Brigham and Women’s Hospital, a major Harvard teaching hospital; direc- tor of the François Xavier Bagnoud Center for Health and Human Rights; and Chair of the Department of Global Health and Social Medicine at Harvard Medical School. Dr. Kim is currently leading a new Harvard University–based initiative in global health delivery, which is designed to discover and widely share knowledge about the effective implementation of health programs in resource-poor countries. Dr. Kim returned to Harvard in December 2005 after a 3-year leave of absence at WHO. While on leave, he was Director of WHO’s HIV/AIDS Department, a post to which he was appointed in March 2004 after serving as advisor to the WHO Director- General. He oversaw all of WHO’s work related to HIV/AIDS, focusing on initiatives to help developing countries scale up their treatment, prevention, and care programs, including the “3×5” initiative, designed to put 3 million people in developing countries on AIDS treatment by the end of 2005. Dr. Kim has 20 years of experience in improving health in developing countries. He is a founding trustee and the former Executive Director of Partners In Health, a not-for-profit organization that supports a range of health pro- grams in poor communities in Haiti, Peru, Russia, Rwanda, Lesotho, and the United States. An expert in TB, Dr. Kim has chaired or served on a num- ber of committees on international TB policy. He has conducted extensive research into effective and affordable strategies for treating strains of TB that are resistant to standard drugs. While at WHO, he was responsible for coordinating HIV efforts with the TB department. Dr. Kim trained dually as a physician and medical anthropologist and received his M.D. and Ph.D. from Harvard University. He has been recognized on numerous occasions as a global leader and distinguished professional. He received a MacArthur “genius award” in 2003, was named one of America’s 25 best leaders by

OCR for page 117
 THREAT OF DRug-RESISTANT TubERCulOSIS u.S. News & World Report in 2005, and was named one of the 100 most influential people in the world by Time magazine in 2006. He was a con- tributing editor to the 2003 and 2004 World Health Report, and his edited volume Dying for growth: global Inequity and the Health of the Poor analyzes the effects of economic and political change on health outcomes in developing countries. Michael E. kimerling, M.D., M.P.H., serves as a Senior Program Offi- cer for TB in the Global Health Program at the Bill and Melinda Gates Foundation, working closely with established grantees and new partners on translational and operational research, and technology delivery issues urgently required to intervene in the global TB and MDR/XDR epidemics. Trained as an internist, he started his medical career working with non- governmental organizations in refugee medicine and rebuilding primary health services in chronic conflict zones. He comes to the foundation from the University of Alabama at Birmingham, where he was a Professor of Medicine in the Division of Infectious Diseases and in the Department of Epidemiology, School of Public Health. He is an expert in MDR-TB pro- grammatic management and global TB control, TB-HIV program integra- tion, TB in prisons, and issues regarding public-private mix, particularly around the inclusion of hospitals. He is a member of the Core Group of the WHO Stop TB Partnership’s MDR-TB Working Group and also a member of the Technical Review Panel of the Global Fund. Michael has extensive field, program, and operational research experience in Asia, Africa, Latin America, Russia, and other former Soviet Republics. Ruth Levine, Ph.D., is an internationally recognized expert on global health and health policy. She is a health economist with more than 15 years of experience in designing and assessing the effects of social-sector programs in Latin America, eastern Africa, the Middle East, and South Asia. In addition to serving as the Center for Global Development’s (CGD’s) Vice President for Programs and Operations, she leads the center’s work on global health policy, including chairing a series of working groups on key policy and finance constraints on the effective use of donor funding for health programs in low-income countries. Before joining CGD, Dr. Levine designed, supervised, and evaluated loans at The World Bank and the Inter-American Development Bank. Between 1997 and 1999, she served as Advisor on the Social Sectors in the Office of the Executive Vice President of the Inter-American Development Bank. Dr. Levine holds a doctoral degree in economic demography from The Johns Hopkins University. She is co-author of the books The Health of Women in latin America and the Caribbean (2001) and Millions Saed: Proen Successes in global Health (2004, updated as Cases in global Health: Millions Saed [2007]), as well

OCR for page 117
 APPENDIx b as the major reports Making Markets for Vaccines: Ideas to Action (2005), When Will We Eer learn: Improing lies Through Impact Ealuation (2006), and A Risky business: Saing Money and Improing global Health Through better Demand Forecasting (2007). Jeffrey L. Moe, Ph.D., Executive in Residence, joined the Health Sector Management program, Fuqua School of Business, in 2001. His research interests include new incentives for innovation in neglected tropical and infectious disease research, private-sector responses to the global health care worker shortage, and the use of business intelligence as a basis for competitive advantage among life sciences firms. Dr. Moe is co-author of “Developing Drugs for Developing Countries” (Health Affairs, March/ April 2006), which led to the Sec. 524 amendment in the Food and Drug Administration Amendments Act of 2007. The article recommended, and the legislation now establishes in law, a new incentive for neglected tropical disease medicines: the priority review voucher (PRV). A PRV is awarded for U.S. registration of a new medicine (new chemical, biologic, or diagnos- tic) for a tropical disease (one of 16 diseases, including TB and malaria), termed the “tropical drug.” The holder exercises the voucher by receiving priority review of a second drug, the “voucher drug,” for FDA approval to market to U.S. patients. The FDA issued its guidance in October 2008 to administer the new voucher program, and the first tropical drug appli- cations for the program were submitted beginning September 28, 2008. Dr. Moe is Chief Executive Officer of the Institute for Global Disease Medicines, Inc. (IGDM). IGDM utilizes a proprietary proteome capture discovery technology that combines focused chemical libraries with parallel affinity capture screens. The drug discovery engine enables new drug can- didates to be identified in large combinatorial chemical libraries en masse and rapidly progressed to Phase I clinical trials through directed iterative chemistry. The platform first identifies the use of drug candidates that are preselected based on such criteria as solubility profile, likely pharmacoki- netic profile, ability to be derivated, and distinctiveness relative to known compounds. IGDM is structured as a not-for-profit/for-profit hybrid busi- ness model and will become a self-sustaining biotechnology organization that is funded by philanthropic donations and grants. Its initial research program will focus on malaria and cancer. Dr. Moe is Director, Private Sector Task Force (TF), which operates under the aegis of the Global Health Workforce Alliance (managed by WHO). The TF identifies and promotes the expansion of private-sector initiatives that are increasing the supply, effectiveness, and retention of health care workers. Dr. Moe leads the research and administration of the Technical Working Group, which carries out analysis, interventions, and evaluation for the TF. The TF is using an innovative social/business “incubator” approach to increase the

OCR for page 117
0 THREAT OF DRug-RESISTANT TubERCulOSIS scaling and cross-border movement of effective private-sector responses to the worker shortage. Before coming to Duke, Dr. Moe was an executive at GlaxoSmithKline. During a 15-year career he held positions in busi- ness development, corporate strategy, marketing, market economics, and human resources. He received his Ph.D. in organization development and behavior in 1981 from the University of North Carolina at Chapel Hill. He graduated from the Kellogg School, Northwestern University, Executive Development Program, in 1997. Megan Murray, M.D., Ph.D., is an Assistant Professor of Epidemiology at the Harvard School of Public Health and an Assistant Professor of Medicine at Harvard Medical School. She is an Instructor with both the DGHE and the Infectious Disease unit at Massachusetts General Hospital. Dr. Murray’s research group has the following major areas of interest: within-species comparative genomics of M. tuberculosis strains, modeling the transmission dynamics of emerging infectious diseases, including MDR TB, West Nile virus, SARS, and various sexually transmitted diseases, human iron metabo- lism and tuberculosis susceptibility, identifying risk factors for the transmis- sion of drug-sensitive and drug-resistant tuberculosis transmission using molecular and conventional epidemiologic methods, outcomes research in tuberculosis treatment and control programs, pedagogy in interdisciplinary research and emerging infectious disease, and exhaled particles and their relationship to infectivity of infectious agents. Carol A. Nacy, Ph.D., is currently Founder and Chief Executive Officer of Sequella, Inc., a 10-year-old privately held biopharmaceutical company that commercializes new and more effective products for diagnosis and treatment of TB and other infectious diseases. Sequella has a late-stage diagnostic product completing its clinical evaluation in 2008 and a new TB drug completing Phase I clinical trials. The company has secured sev- eral large pharma commercial partners that will market and sell its lead diagnostic, and recently in-licensed a promising new TB drug from Sanko, Ltd. It has raised nearly $38 million to date from institutional and quali- fied investors and peer-reviewed grants. Prior to joining Sequella, Dr. Nacy was Executive Vice President and Chief Scientific Officer at EntreMed, Inc., from 1993 through the company’s successful public offering in June 1996. She left EntreMed in November 1996 to establish Sequella, and was part- time Chief Scientific Officer (1997–1998) for Anergen, Inc., a California company focused on autoimmune diseases. There she reorganized the sci- entific staff and approach and positioned the company for acquisition by Corixa Corporation in December 1998. Dr. Nacy became full-time CEO and Chair of the Board of Sequella in January 1999. She is a member of the Board of Directors of both companies (ASM Resources, Social and

OCR for page 117
 APPENDIx b Scientific Systems) and nonprofit agencies (Sequella Foundation, Women in Bio, Sloan Biotechnology Industry Organization), and serves on a number of committees in global health organizations. Prior to her business experi- ence, Dr. Nacy was career Scientist and Science Manager at the Walter Reed Army Institute of Research, Washington, DC, where she studied tropical infectious diseases and published more than 140 scientific papers. She was elected to the American Academy of Microbiology in 1985. She maintains strong ties to the scientific research community, and was President of the American Society for Microbiology (1996) and the Society for Leukocyte Biology (1993) and served on the Board of the National Academy of Sci- ences, National Research Council (1996–2001). She is an adjunct faculty member of the Department of Biology, Catholic University of America, and Department of Tropical Diseases, The George Washington University. She earned her A.B., M.S., and Ph.D. degrees from the Catholic University of America, and in 2002 was awarded the Lifetime Achievement Award in Sci- ence from that institution. Dr. Nacy was singled out as a Top 50 Innovator in the United States by Inc. Magazine in 2002, named Entrepreneur of the Year by Women in BIO in 2004, named by the state of Maryland among its Top 100 Business Women in 2005, and named by the Washington business Journal as a top 25 female executive in the Washington, DC, metropolitan area in 2005. In 2006, she received a National Leadership Award in Health- care from the National Urban Technology Center in New York City, and in 2007 she was honored with a Special Outstanding Achievement Award for Clinical Trials by Women in BIO. Edward Anthony Nardell, M.D., is a pulmonologist with a special inter- est in TB. He trained in pulmonary medicine at Massachusetts General Hospital, with additional research training at Boston University School of Medicine. While at Boston City Hospital, he became director of TB control for the city of Boston. In 1981 he became Chief of Pulmonary Medicine and Director of Tuberculosis Control for the city of Cambridge, positions he held until 2005. His principal academic appointment is as Associate Professor of Medicine, Harvard Medical School, with secondary parallel appointments in the Department of Social Medicine and Harvard School of Public Health. In the early 1980s, Dr. Nardell became Medical Director of Tuberculosis Control for the Massachusetts Department of Public Health, a position he held for 18 years. In 2002 he joined Partners In Health as Director of Tuberculosis Research. In 2005 he left Cambridge Hospital to assume a full-time research position in the Department of Social Medicine and Health Inequalities, Brigham and Women’s Hospital, the hospital arm of Partners In Health. He is also a member of the Pulmonary Division at the hospital, where he serves on the pulmonary consult service. Dr. Nardell’s research interests include the control of MDR TB in Peru, Russia, and

OCR for page 117
 THREAT OF DRug-RESISTANT TubERCulOSIS other high-burden countries. His special research interest is airborne TB transmission and control. He currently has a project in South Africa, funded by the National Institute for Occupational Safety and Health (NIOSH), studying the transmission of MDR TB using large numbers of guinea pigs to quantify the infectiousness of MDR TB patients and the effectiveness of various control interventions, including ultraviolet germicidal irradiation. Dr. Nardell is past President of the Massachusetts Thoracic Society and the North American Region, IUATLD. He was the 2005 recipient of the Chadwick Medal of the Massachusetts Thoracic Society. Dale Nordenberg, M.D., is a health care consultant currently working as the Senior Scientist supporting the National Biosurveillance Advisory Sub- committee (NBAS) Task Force on Diagnostic and Laboratory Information Exchange. In this role, his focus is on leveraging the regulatory process to accelerate the development of data exchange standards for diagnostic tests and the governance for the National Biosurveillance Enterprise for Human Health. From 2001 through 2007, Dr. Nordenberg held various positions at CDC, including Associate Director and Chief Information Officer (CIO), National Center for Infectious Diseases (NCID), and Senior Advisor for Strategic Planning, Office of the CIO, CDC. During this time, he led the development of CDC’s agency-wide information technology (IT) strategic plan (2008–2012) and was responsible for informatics for NCID. At NCID, he initiated the implementation of a single laboratory platform for the center’s laboratories and launched the Public Health Laboratory Interop- erability Project (PHLIP) in collaboration with the Association of Public Health Labs to create a standards-based national laboratory data shar- ing network. Dr. Nordenberg was involved in many disease surveillance, outbreak response, and bioterrorism preparedness and response activities and informatics programs. Prior to joining CDC, he was a founding execu- tive of a company that launched VeriSign affiliates in Latin America and Asia. Before that he was a member of the faculty in the Emory School of Medicine, where founded and directed the Office of Medical Informatics for the Emory University Children’s Center. Dr. Nordenberg has served on the boards of numerous companies. Most recently he was a member of the board for Coventry Health Care of Georgia. Dr. Nordenberg is a board-certified pediatrician. He received a B.S. in microbiology from the University of Michigan and his medical degree from Northwestern Univer- sity; he completed his training in pediatrics at McGill University, Montreal Children’s Hospital, and a fellowship in epidemiology and public health in the Epidemic Intelligence Service program at CDC. Paul Nunn, M.D., is Coordinator of the WHO team in the Stop TB Depart- ment that is concerned with TB and HIV, anti-TB drug resistance, infection

OCR for page 117
 APPENDIx b control, and laboratory strengthening. He led the team that prepared the WHO policy on collaborative TB/HIV activities, as well as a number of guidelines on how to address the problem of the impact of HIV on TB. Since September 2006, his responsibilities have included coordinating the global response to XDR TB. Previously, Dr. Nunn was Chief of TB research and surveillance in WHO’s Global TB Program, in which he set up the Global TB Research Initiative and established the WHO/IUATLD anti-TB drug resistance surveillance project. Before joining WHO, he was with the London School of Hygiene and Tropical Medicine in Kenya. He researched the impact of HIV on TB in Nairobi; was a visiting scholar at the University of California, Berkeley; and was Coordinator of the Diploma in Tropical Medicine and Hygiene course. He trained as a respiratory physician at the Royal Postgraduate Medical School, London, following clinical studies at University College, London, and received a degree in physiological sciences from Oxford. He has published more than 50 peer-reviewed papers. David Persing, M.D., Ph.D., is Executive Vice President and Chief Medical and Technology Officer at Cepheid in Sunnyvale, California. He obtained a B.A. degree in biochemistry from San Jose State University in 1979, and an M.D.–Ph.D. from the University of California, San Francisco, in 1988. His doctoral research was conducted in the Department of Biochemistry and Biophysics. He completed his residency in laboratory medicine at the Yale University School of Medicine and then joined the Laboratory Medicine and Pathology Staff at the Mayo Clinic, where he developed extramurally funded research programs on hepatitis viruses and tick-borne infections. In 1992 Dr. Persing established and directed the Molecular Microbiol- ogy Laboratory at the Mayo Rochester campus, which became one of the preeminent molecular diagnostic laboratories of its type in the country. In 1999, he joined Corixa Corporation in Seattle, where eventually as Chief Scientific Officer he headed research groups focused on innate immunity, vaccine development, and molecular diagnostics. From 2001 to 2005 he was principal investigator for two grants totaling $18 million in the area of Toll-like receptor agonists and antagonists. He is currently supported by $11 million in grants from NIAID and the Bill and Melinda Gates Foun- dation via the Foundation for Innovative New Diagnostics (FIND) for the development of MDR TB diagnostics. Dr. Persing has authored more than 260 peer-reviewed articles, book chapters, and reviews; served as editor-in- chief for 3 books on molecular diagnostics; and is an inventor on 16 issued or pending U.S. patents. Iain Richardson is Director, Global Supply Chain and Logistics at Eli Lilly and Company. A graduate in chemical engineering from the University of Edinburgh with a masters in biochemical engineering from University

OCR for page 117
 THREAT OF DRug-RESISTANT TubERCulOSIS College London, he has worked for Eli Lilly for more than 20 years in the Manufacturing Division. A native of Scotland, he joined the company at its Liverpool facility in Technical Services before relocating to the United States in 1991. During 9 years in the United States, he held leadership positions in the company’s Animal Health division before becoming Director of Manu- facturing Strategy in 1998. In 2000, Mr. Richardson moved to Geneva, Switzerland, where he had manufacturing responsibility for Contract Man- ufacturing operations in Europe, the Middle East, and Africa, and Lilly and Contract Manufacturing operations in the Asia-Pacific area. It was in this assignment that he first began working on Lilly’s MDR TB philanthropic initiative, with particular responsibility for the transfer of technology for Cycloserine and Capreomycin to the identified manufacturing partners. He relocated back to the United States in 2006. Since that time he has been responsible for Lilly’s contract manufacturing processes globally, and he is now responsible for global supply chain and logistics operations for the company. He continues to lead Lilly’s transfer of technology and product supply initiatives for the MDR TB program. John Ridderhof, Ph.D., is Associate Director of Laboratory Science, National Center for Preparedness Detection and Control of Infectious Diseases (NCPDCID/CCID), CDC. He began his career as a microbiologist from 1979 to 1984 in the Virginia State Mycobacteriology and Mycology Laboratory. After attending graduate school at the University of North Carolina, Chapel Hill School of Public Health (UNC-SPH), he held an American Society of Microbiology–sponsored postdoctoral fellowship in clinical and public health microbiology from 1987 to 1988 at the Medical College of Virginia/Virginia Commonwealth University. He then served from 1988 to 1992 as Deputy Director of the Delaware State Public Health Laboratory. Dr. Ridderhof came to CDC in 1992 as Chief of the Laboratory Standards Branch, with responsibility for developing and supporting labo- ratory regulations (Clinical Laboratory Improvement Amendments [CLIA]). From 1994 to 2000, he served as Assistant Director, DLS, responsible for coordinating and conducting all mycobacteriology laboratory training, performance evaluation, and research activities in addition to coordinating the Clinical Laboratory Improvement Advisory Committee. In his recent position as Chief of the Laboratory Systems Development Branch (LSDB), he coordinated various international activities, including those focused on international TB laboratory strengthening, and the National Laboratory Systems initiative. The LSDB activities also included international and domestic laboratory training activities and research and guidelines in labo- ratory quality assurance in resource-limited countries. DLS has developed many of the international guidelines and training materials for TB and HIV in collaboration with many organizations. A DLS priority is to promote a

OCR for page 117
 APPENDIx b quality management systems framework and approach to strengthening laboratory systems. DLS/LSDB activities and responsibilities involve close partnerships with the Association of Public Health Laboratories (APHL), WHO, IUATLD, and other organizations to facilitate consensus and develop programs, training products, and guidelines that promote quality labora- tory testing standards in support of public health in the United States and globally. Dr. Ridderhof is currently serving as Chair of the WHO/Stop TB Partnership Global Laboratory Initiative for 2006–2008. In August 2007 he was appointed Associate Director for Laboratory Science for NCPDCID. Dr. Ridderhof received a B.S. degree in biology at Virginia Commonwealth University. He holds master’s and doctorate degrees in public health labora- tory practice from UNC-SPH and certification as High Complexity Labora- tory Director (HCLD/ABB). Leonard Sacks, M.D., was born in Johannesburg, South Africa, where he received his medical education at the University of the Witwatersrand, grad- uating MBBCh in 1979. He completed his medical residency at Baragwanath Hospital in Johannesburg, becoming a Fellow of the College of Physicians (South Africa) in 1984. In 1988 he moved to the United States, completing a fellowship in immunopathology at Upstate Medical Center in Syracuse, New York, followed by a fellowship in infectious diseases at the Veterans Administration Medical Center in Washington, DC. Since that time he has worked as an attending physician in infectious diseases both in Washington, DC, and in South Africa, with particular interests in antimicrobial therapy, TB, and tropical diseases. Since joining the FDA in 1998, Dr. Sacks has served as a medical reviewer and team leader in the Division of Special Pathogens and Immunological Drug Products, Center for Drug Evaluation and Research; he is currently Deputy Director of the FDA’s Office of Critical Path Programs. Dr. Sacks holds an academic position as Associate Clinical Professor of Medicine at The George Washington University. Sarita Shah, M.D., M.P.H., is Assistant Professor of Medicine and Epidemi- ology/Population Health at Albert Einstein College of Medicine, New York. She completed her internal medicine residency at Columbia-Presbyterian Hospital, New York, and earned her M.D. degree from the Johns Hopkins School of Medicine, Maryland. She completed an M.P.H. degree at Colum- bia Mailman School of Public Health, New York. Dr. Shah spent 2 years in the Division of Tuberculosis Elimination at CDC, where she served as an Epidemic Intelligence Service (EIS) officer from 2004 to 2006. She was proj- ect officer for a variety of TB epidemiologic and program-building efforts in Ethiopia, Venezuela, and Southeast Asia. Dr. Shah served as lead investiga- tor for the first survey that described the global emergence of XDR TB, a collaboration that involved CDC, WHO, and the international network of

OCR for page 117
 THREAT OF DRug-RESISTANT TubERCulOSIS TB reference laboratories. Since completing the EIS program at CDC, she has been working in Tugela Ferry, South Africa, where her research focuses on improving diagnosis and treatment of drug-resistant TB. In 2007, she received a 3-year Clinical Scientist Development Award from the Doris Duke Charitable Foundation to support this work. Additional funding from the Howard Hughes Medical Institute is supporting a study to improve TB diagnosis in children. Dr. Shah has also received funding from the Einstein Center for AIDS Research for research in the molecular epidemiology of MDR and XDR TB in Tugela Ferry. She complements her research with providing care for HIV/AIDS patients in the Bronx, New York, and teach- ing residents on the inpatient wards. Martie van der Walt, Ph.D., Interim Director for the TB Epidemiology and Intervention Research Unit, joined TB research at the Medical Research Council South Africa in 1998. Her basic training is in microbiology (MScAgric); she obtained a Ph.D. in biotechnology (vaccine development for livestock) and also holds an M.B.A. Dr. Van der Walt has been responsible for the unit’s operational research program and for projects in such areas as program implementation, DOTS evaluation, and drug-resistant TB and epidemiology. The unit was tasked with implementing the programmatic management of MDR TB under DOTS-Plus, and oversaw this effort until it became a control program activity. Through the unit’s operations research activities, Dr. Van der Walt has a network of TB control programs on both the national and provincial levels, thereby having access to all types of TB patients at all levels of the control program. She has worked extensively in all nine provinces of South Africa. She has worked in close collaboration with the Ministry of Health in research translation, policy development, and policy implementation, especially for drug-resistant TB and uptake of new diagnostics for the program. She has been responsible for the large- scale rapid MDR TB diagnosis project, providing evidence to WHO leading to new policy for the diagnosis of drug-resistant TB. Dr. Van der Walt has also been overseeing the 5-year Cooperative Agreement between CDC and the unit. She has performed program review in Swaziland. She is a mem- ber of the Stop TB New Diagnostics Working Group, the Drug-Resistance Working Group, and the WHO Global XDR-TB Task Force; served on the Green Light Committee from 2005 to 2007; and is a member of the Global Alliance Shareholders Association. Charles D. Wells, M.D., currently serves as Medical Director for the Tuber- culosis Products Unit at Otsuka Pharmaceutical Development and Com- mercialization (OPDC), having joined the company in May 2007 to support efforts to develop the compound OPC-67683 for TB treatment. Prior to joining OPDC, he served as Chief of the International Research and Pro-

OCR for page 117
 APPENDIx b grams Branch within the Division of Tuberculosis Elimination at CDC, 2001–2007, which has been a leading technical group for epidemiologic, clinical, and diagnostics research on TB and provided direct technical assis- tance internationally for the implementation and scale-up of programs for TB, TB/HIV (within PEPFAR), and MDR TB. Dr. Wells attended North Carolina State University, where he received a B.S. in chemical engineering in 1987. He then completed his medical studies at the University of North Carolina, Chapel Hill in 1992. After medical school, he completed a resi- dency in internal medicine at Emory University in 1995; an EIS fellowship at CDC in 1997; and a clinical fellowship in infectious diseases, also at Emory University, in 1998. He is board certified in both internal medicine and infectious diseases. Dr. Wells began his research in TB in 1995 upon joining EIS and has remained in the field since that time. In addition to his previous work at CDC, he spent nearly 2 years working on new drug devel- opment for TB at PathoGenesis Corporation, 1998–1999. Additionally, while he was at CDC, his group successfully launched a 2,000-patient clini- cal trial in Botswana in November 2004, evaluating the optimal duration for isoniazid preventive therapy for persons living with HIV in TB-endemic settings. During his 13 years working in TB, TB/HIV, and MDR TB, he has worked in many countries, including Vietnam, Cambodia, Thailand, the Philippines, India, Russia, the Baltic countries, South Africa, Botswana, Ethiopia, Brazil, and Mexico, among others. Raymond L. Woosley, Ph.D., earned his Ph.D. in pharmacology from the University of Louisville and an M.D. from the University of Miami. He specialized in internal medicine and clinical pharmacology at Vanderbilt University, where he rose to the rank of Professor of Medicine. At George- town University, he served as Chairman of the Department of Pharmacol- ogy and in 2000 was appointed Associate Dean for Clinical Research. In 2001 he became Vice President for Health Sciences at the University of Arizona and Dean of the College of Medicine. In January 2005 he assumed the position of President of The Critical Path Institute (C-Path), a nonprofit corporation formed by the FDA and the University of Arizona to accelerate the development of safe, innovative medicines. Since 1999, Dr. Woosley has directed 1 of 14 federally funded Centers of Education and Research on Therapeutics (CERTs). His research has been published in more than 260 publications and has investigated the basic and clinical pharmacology of drugs for the treatment of arrhythmias and the cardiac toxicity of drugs. His research revealed the mechanism of the toxicity of the antihistamine Seldane, which contributed to its subsequent removal from the market. For his contributions to medicine, he received the Rawls-Palmer Award from the American Society of Clinical Pharmacology and Therapeutics and the FDA Commissioner’s Special Citation for his work to advise the

OCR for page 117
 THREAT OF DRug-RESISTANT TubERCulOSIS agency on the toxicity of dietary supplements containing ephedra. In addi- tion, Dr. Woosley is a past President of the Association for Medical School Pharmacology and the American Society for Clinical Pharmacology and Therapeutics. He holds faculty appointments at the BIO5 Institute of the University of Arizona and the Biodesign Institute at Arizona State Univer- sity. His research investigates the mechanisms responsible for adverse drug interactions and means of prevention. Paul Zintl, M.P.A., is Chief Operating Officer for Partners In Health and Senior Advisor for Planning and Finance for the Program in Infectious Disease and Social Change (PIDSC) at Harvard Medical School. He joined Partners In Health and Harvard Medical School in January 2002. Previ- ously, he was Managing Director of J.P. Morgan & Co. in New York, where he worked for 18 years until 1995. In this capacity, his responsibilities included management, control, analysis, and evaluation of the firm’s trad- ing businesses. After leaving J.P. Morgan, he studied state criminal justice systems and worked as a private consultant for 2 years. In 1998 he received an M.P.A. degree from the John F. Kennedy School of Government at Har- vard. From 2000 to 2007, Mr. Zintl served as Chairman of the Board of Directors of Federated Dorchester Neighborhood Houses, Inc. He served as a trustee of St. Luke’s-Roosevelt Hospital in New York City from 1988 to 2000 and on the Board of the Neighborhood House Charter School in Dorchester, Massachusetts, from 1996 to 2004. Mr. Zintl earned an under- graduate degree from the University of Virginia and a master of divinity degree from Harvard University.