Appendix B

Participant Biographies

Barry R. Bloom, Ph.D. (Workshop Co-Chair), is Harvard University Distinguished Service Professor and Joan L. and Julius H. Jacobson Professor of Public Health, Department of Immunology and Infectious Diseases, Harvard School of Public Health (HSPH). Dr. Bloom served as dean of HSPH from 1998 through 2008 and is a leading scientist in the areas of infectious diseases, vaccines, and global health. After more than 35 years as the Principal Investigator in the laboratory researching the immune response to TB, he recently shut down his Harvard lab to concentrate on teaching and lecturing. He is a member of the National Academy of Sciences, IOM, American Association for the Advancement of Science, and American Philosophical Society. While dean of HSPH, Dr. Bloom served as secretary/treasurer for the Association of Schools of Public Health. Prior to coming to Harvard, he served as Chair of the Department of Microbiology and Immunology at the Albert Einstein College of Medicine and as an Investigator of the Howard Hughes Medical Institute, where he also served on the National Advisory Board. In 1978, he was a consultant to the White House on international health policy. He is a past president of the American Association of Immunologists and the Federation of American Societies for Experimental Biology. He received the first Bristol-Myers Squibb Award for Distinguished Research in Infectious Diseases, shared the Novartis Award in Immunology in 1998, and was the recipient of the Robert Koch Gold Medal for lifetime research in infectious diseases in 1999. Dr. Bloom has been extensively involved with WHO for more than 40 years. He is currently chair of the Technical and Research Advisory Committee to the Global Programme on Malaria at WHO, has been a member of the WHO



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Appendix B Participant Biographies Barry R. Bloom, Ph.D. (Workshop Co-Chair), is Harvard University Dis- tinguished Service Professor and Joan L. and Julius H. Jacobson Professor of Public Health, Department of Immunology and Infectious Diseases, Harvard School of Public Health (HSPH). Dr. Bloom served as dean of HSPH from 1998 through 2008 and is a leading scientist in the areas of infectious diseases, vaccines, and global health. After more than 35 years as the Principal Investigator in the laboratory researching the immune response to TB, he recently shut down his Harvard lab to concentrate on teaching and lecturing. He is a member of the National Academy of Sci- ences, IOM, American Association for the Advancement of Science, and American Philosophical Society. While dean of HSPH, Dr. Bloom served as secretary/treasurer for the Association of Schools of Public Health. Prior to coming to Harvard, he served as Chair of the Department of Microbiol- ogy and Immunology at the Albert Einstein College of Medicine and as an Investigator of the Howard Hughes Medical Institute, where he also served on the National Advisory Board. In 1978, he was a consultant to the White House on international health policy. He is a past president of the American Association of Immunologists and the Federation of American Societies for Experimental Biology. He received the first Bristol-Myers Squibb Award for Distinguished Research in Infectious Diseases, shared the Novartis Award in Immunology in 1998, and was the recipient of the Robert Koch Gold Medal for lifetime research in infectious diseases in 1999. Dr. Bloom has been extensively involved with WHO for more than 40 years. He is currently chair of the Technical and Research Advisory Committee to the Global Programme on Malaria at WHO, has been a member of the WHO 129

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130 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB Advisory Committee on Health Research, chaired the WHO Committees on Leprosy Research and Tuberculosis Research, and chaired the Scientific and Technical Advisory Committee of the United Nations Development Programme (UNDP)/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. He is also a member of the Innovation Working Group under the U.N. Secretary General’s Joint Effort to Improve the Health of Women and Children. Dr. Bloom also serves on the Scientific Advisory Boards of the Earth Institute at Columbia University, the Doris Duke Charitable Foundation, the City University of New York School of Public Health at Hunter College, and the Howard Hughes Medical Institute–KwaZulu-Natal Research Institute for TB and HIV. In addition, he is an Expert Advisory Group member of the Global Fund–AMFm and Scientific Oversight Group member of the Institute for Health Metrics and Evaluation at the University of Washington, Seattle. He is a member of the Board of Trustees for the Tuberculosis Vaccine Institute (TBVI) and the first Chair of the Board of Trustees and now Chair Emeritus of the International Vaccine Institute (IVI). Most recently, he joined the Advisory Board of the Fogarty International Center at the National Institutes of Health (NIH). He is a graduate of Amherst College (B.S. 1958 and honorary D.Sc. 1990) and Rockefeller University (Ph.D. 1963). Gail H. Cassell, Ph.D. (Workshop Co-Chair), is a Visiting Professor in the Department of Global Health and Social Medicine, Harvard Medi- cal School, and Vice President of TB Drug Discovery of the nonprofit Infectious Disease Research Institute in Seattle. Dr. Cassell has recently retired as Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company in Indianapolis, Indiana. In this capacity, among other things, she was responsible for initiating and leading the nonprofit Lilly TB Drug Discovery Initiative launched in 2007. In 2003, she was one of two individuals at Eli Lilly who initiated and developed the Lilly Multidrug Resistant Tuberculosis Partnership. The partnership has resulted in company support to date of $135 million and is the largest philanthropic effort in Eli Lilly’s 125-year history. The partnership now involves more than 20 partners, including WHO and CDC. She is the former Vice President of Infectious Diseases Drug Discovery and Clinical Development of Eli Lilly, where she led the programs of a hepatitis C protease inhibitor from the discovery phase to clinical candidate (the compound is now in Phase III clinical trials) and the development of a new antibiotic from clinical development to product decision. Prior to moving to Eli Lilly in 1997, Dr. Cassell was the former Charles H. McCauley Professor and Chair of the Department of Micro- biology at the University of Alabama Schools of Medicine and Dentistry at Birmingham, a department that ranked first in research funding from

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APPENDIX B 131 NIH during the decade of her leadership. She obtained her B.S. from the University of Alabama in Tuscaloosa and in 1993 was selected by that institution as one of the top 31 female graduates of the 20th century. She obtained her Ph.D. in Microbiology from the University of Alabama at Birmingham and was selected as its 2003 Distinguished Alumnus. She is a past President of the American Society for Microbiology (the oldest and single largest life sciences organization with a membership of more than 42,000). She was named to the original Board of Scientific Councilors of the Center for Infectious Diseases, CDC, and served as Chair of the Board. She has served on the Advisory Board of the Director of NIH, the Director of CDC, the Secretary of Health and Human Services Advisory Council of Public Health Preparedness, and the FDA Science Board: Advisory to the Commissioner. Currently she is a member of the NIH Science Management Board, the newly appointed NIH Board of Trustees, and the Advisory Council of the Fogarty International Center of NIH. Since 1996 she has been a member of the U.S.–Japan Cooperative Medical Science Program responsible for advising the respective governments on joint research agen- das (U.S. State Department/Japan Ministry of Foreign Affairs). She has served on several editorial boards of scientific journals and has authored over 350 articles and book chapters. Dr. Cassell has received national and international awards for her research in infectious diseases, including two honorary degrees; the CDC Honor Award in Public Health for exceptional leadership and contributions in the development and implementation of the CDC’s Emerging Infectious Disease Plan 1997; a Citation from the FDA Commissioner for her role as Chair of the review of science and tech- nology at FDA and the report FDA: Science and Mission at Risk in 2008; and the Emmy Klineberger-Nobel Award in 2008 by the International Organization for Mycoplasmology for outstanding and sustained research contributions to the field of mycoplasmology. She is a member of the IOM of the National Academy of Sciences and has recently completed a second 3-year term on the IOM Council, the governing board. She was elected in 2011 to membership on the U.S. Council of Foreign Relations. Dr. Cassell has been intimately involved in establishment of science policy and legisla- tion 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; has served as an adviser 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 resis- tance, 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 estab- lishing policies in training in the biomedical sciences. She is an Emeritus

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132 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB Member of the Board of Research!America and a former member and Chair of the Board of Directors of the Burroughs Wellcome Fund. She has recently completed terms on the Leadership Council of the School of Public Health of Harvard University, the Executive Committee of Colum- bia University Medical Center Board of Visitors, and the Johns Hopkins School of Nursing. Currently she is a member of the Morehouse School of Medicine Board of Trustees, and the Advisory Council of the University of North Carolina Gillings School of Global Public Health. Olusoji Adeyi, M.D., M.B.A., Dr.P.H., is the Sector Manager for Health, Nutrition, and Population (Eastern and Southern Africa) at the World Bank in Washington, DC. He is responsible for the World Bank’s support for country-led policies, strategies, operations, and partnerships in the subregion. World Bank’s work in Africa emphasizes improved governance, improved competitiveness of human capital, and reduction of vulnerabilities from short- and long-term effects of poor health. Dr. Adeyi was founding Director of AMFm at the Global Fund. An innovation in the architecture of financing medicines for malaria through the commercial private sector, NGOs, and the public sector, AMFm combines a global buyer subsidy with support for implementation at the country level. He was formerly Coordi- nator of Public Health Programs at World Bank, where he led a number of initiatives on global public health policies, strategies, and analyses of the integration of health systems and health interventions. Dr. Adeyi has exten- sive experience in policies, strategies, and programs for health systems, service delivery, and disease control at the global, regional, and country levels in Africa, Eastern Europe, and Central Asia. He has had responsibili- ties with the Federal Ministry of Health in Nigeria, WHO, UNAIDS (Joint United Nations Programme on HIV and AIDS), and the Harvard School of Public Health. He has authored research papers and books on service delivery, quality of care, maternal health, health financing, HIV/AIDS, TB, malaria, and chronic noncommunicable diseases. Dr. Adeyi specializes in global health policies, strategies, and financing. He speaks English, Yoruba, and French (working knowledge). Vincent Ahonkhai, M.D., FAAP, is the Senior Regulatory Affairs Officer for Global Health at BMGF. His role is to provide strategic regulatory oversight for on-time development and registration of foundation health technologies, including vaccines, drugs, diagnostics, and public health pesti- cide products. His background is in biopharmaceutical global health R&D, including Clinical Development, Medical Affairs, Regulatory Affairs, and Product Safety and Pharmacovigilance. His specialty is Infectious Disease medicine.

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APPENDIX B 133 Rifat Atun, M.B.B.S., M.B.A., FRCGP, FFPH, FRCP, is Professor of Inter- national Health Management at the Business School and the Faculty of Medicine at Imperial College London. He is Head of The Health Man- agement Group at Imperial College Business School. His research focuses on health systems reform, innovation in the life sciences, and diffusion of innovations in health systems. He has published widely in these areas. Between 2008 and 2012, he was a member of the Executive Management Team of the Global Fund in Switzerland as the Director of the Strategy, Per- formance, and Evaluation Cluster. He is Chair of the Stop TB Partnership Coordinating Board. Dr. Atun has worked at the UK Department for Inter- national Development Health Systems Resource Centre and has acted as a consultant for World Bank, WHO, and a number of international agencies on the design, implementation, and evaluation of health systems reforms. Dr. Atun has served as a member of the Advisory Committee for the WHO Research Centre for Health Development in Japan. He is a member of the PEPFAR Scientific Advisory Board and the UK Medical Research Council’s Global Health Group. He is also a member of the Global Task Force on Expanded Access to Cancer Care and Control in Developing Countries. Dr. Atun studied medicine at the University of London as a Commonwealth Scholar and subsequently completed his postgraduate medical studies and M.B.A. at the University of London and Imperial College London. He is a Fellow of the Faculty of Public Health of the Royal College of Physicians (UK), a Fellow of the Royal College of General Practitioners (UK), and a Fellow of the Royal College of Physicians (UK). Jim Barrington, M.B.A., is the Global Program Director of “SMS for Life,” Novartis, a public–private partnership and a Roll Back Malaria Partnership Initiative, directly aimed at making sure every child contracting malaria has access to malaria medicines, when and where they need it. Previously, Mr. Barrington was the Corporate CIO of Novartis, where he was accountable for all Novartis information systems, IT, and infrastructure worldwide, with an annual IT budget of $1.6 billion. Prior to joining Novartis, he worked with ABB in Zurich, Switzerland, where he was Senior Vice President and Group CIO. Before this, he spent 5 years in Italy as Vice President of IT with the Whirlpool Corporation with accountability for all IT in Europe, the Middle East, Africa, Asia Pacific, India, and China. He also worked with Gillette for 10 years in the United Kingdom and Germany, and spent 4 years with Eli Lilly in Ireland. Mr. Barrington was born in Ireland and holds an M.B.A. from Kingston University. Amy S. Bloom, M.D., graduated from Smith College with a major in American Studies/Government-Labor History and received her M.D. from Albany Medical College of Union University. After completing her residency

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134 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB in medicine at the University of Rochester, she worked at the University as an intensivist and Emergency Department attending. After several years in practice, she joined CDC as an Epidemic Intelligence Service (EIS) officer assigned to the Virginia Department of Health, continuing as a Preventive Medicine Resident in the Respiratory and Childhood Diseases Branch, Divi- sion of Bacterial and Mycotic Diseases. Following her training, she served as a medical epidemiologist in the HIV section of the Women’s Health and Fertility Branch, Division of Reproductive Health, where she worked on HIV shedding and mucosal immunity as well as the development of HIV preventive technologies. She also participated in CDC’s response to the Ebola outbreak in Kikwit, Democratic Republic of the Congo, heading the epidemiology team. The following year she became an American Associa- tion for the Advancement of Science, Science, Engineering, and Diplomacy Fellow assigned to USAID. Since that time she has worked for CDC and USAID on a broad range of HIV and TB care issues in more than 20 coun- tries and provided technical assistance to many international, national, and local agencies, governments, and NGOs. She is currently serving as Acting Chief, Division of Infectious Diseases, USAID, covering TB, malaria, and Neglected Tropical Diseases (NTDs). Peter Cegielski, M.D., M.P.H., received his B.A. in Biochemistry from Har- vard University in 1978 and his M.D. from the University of California, San Diego in 1984. He completed a residency in Internal Medicine in 1987 and a fellowship in Infectious Diseases and International Health in 1990, both at Duke University Medical Center. After his fellowship, he joined Duke’s faculty, simultaneously earning an M.P.H. in Epidemiology from the Uni- versity of North Carolina at Chapel Hill. After Duke, he held faculty posi- tions at Muhimbili University Medical Center, Dar es Salaam, Tanzania; the University of Texas Health Sciences Center in Tyler; and Johns Hopkins School of Public Health, including 2 years as Field Director of Hopkins’ HIV/AIDS research unit at Chiang Mai University, Thailand. In 1998, he joined the Division of TB Elimination at CDC, becoming the Team Leader for DR TB in 2001. Dr. Cegielski was a founding member of the Stop TB “Green Light Committee” (GLC) in 2000 and its chair from 2004–2006. He was the first person to recognize the global emergence of XDR TB and led the team that first defined, documented, and described it. Gordon Comstock, M.B.A., serves as the Director, Global Supply Chain, for the Partnership for Supply Chain Management, Inc. He directs the global supply chain activities supporting both the PEPFAR/USAID SCMS project and the Global Fund’s Voluntary Pooled Procurement initiative. He also serves as a Principal Program Associate in the Center for Pharma- ceutical Management of MSH. Previously, he was Director of Intellectual

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APPENDIX B 135 Property for the College of Medicine, University of Illinois. Mr. Comstock served as a managing partner for LifeScience Partners, developing business models and strategies for start-up companies, and was a senior consul- tant with Deloitte & Touche and Opinion Research Corporation. As vice president of MAP International, his managerial experience includes leading international health education and pharmaceutical distribution programs with operations in the United States, Europe, Africa, Caribbean, and South America. Mr. Comstock earned his M.B.A. at Northwestern University, Kellogg Graduate School of Management. Lucica Ditiu, M.D., has been appointed Executive Secretary of the Stop TB Partnership, WHO. A native of Romania, Dr. Ditiu is a physician and researcher who has devoted her career to improving the lives of people liv- ing in communities heavily burdened by TB. Dr. Ditiu began a career with WHO in 2000 as a medical officer for TB in Albania, Kosovo, and Mace- donia within the disaster and preparedness unit of the WHO European Regional Office. In this role she worked with all institutions involved in TB care, including ministers of health and justice. She also directly supported civil society and communities, funding their efforts through a grant from the European Commission for Humanitarian Assistance. In 2006, she was selected to be a medical officer in the TB unit of the European Regional Office in Copenhagen. In 2010, Dr. Ditiu joined the Stop TB Partnership Secretariat in Geneva to lead the TB REACH initiative, whose goal is to improve access to TB treatment. The program awards grants of up to $1 million USD to applicants demonstrating that their organizations can reach poor and vulnerable populations and provide them with TB care. A 1992 graduate of the University of Medicine and Pharmacy in Bucharest, Dr. Ditiu completed specialty training in pulmonology through a joint program with the Romanian National Institute of Lung Diseases (Marius Nasta). In 1999, she received a certificate in International Public Health from the George Washington University in Washington, DC, which she completed as a Fellow in epidemiology of lung diseases, TB control, program manage- ment, and evaluation. In 2004, she received the National Order of Merit medal for medicine in recognition of her fundraising efforts on behalf of the Romanian TB Control Program and Ministry of Health. David Ferreira, M.Sc., M.A., is Managing Director for Innovative Finance, and Head of the Washington, DC, Office, GAVI Alliance. Mr. Ferreira joined GAVI in 2010, following his tenure as founding Investment Manager of Soul City Broad-Based Empowerment Company, an investment firm owned by a health communications nonprofit in South Africa. He continues to serve as a non-executive director there. Mr. Ferreira has also served as a non-executive director at the listed education company ADvTECH and,

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136 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB through appointment by the government of President Nelson Mandela, at the MIIU Company, which assisted South African municipalities in creat- ing public–private partnerships. Mr. Ferreira, whose career has focused on finance and on public–private partnerships, was a founding shareholder and director of Praxis Capital, a private equity firm that invested in South Africa’s health care and education sectors. He also established and man- aged the Private Sector Investments Unit of the Development Bank of Southern Africa. At World Bank, he helped design financial instruments for governments in Asia and Latin America to attract private financing to infrastructure projects. Mr. Ferreira began his career as a human rights and labor lawyer in South Africa and later practiced at the U.S. law firm Davis Polk & Wardwell. He is a Rhodes Scholar, with an M.Sc. from the London School of Economics, an M.A. from Oxford University, and B.A. and L.L.B. degrees from the University of the Witwatersrand in Johannesburg. Hamish Fraser, M.B.Ch.B., is an Assistant Professor of Medicine at Har- vard Medical School, a Research Associate at Brigham and Women’s Hos- pital, and Former Director of Informatics and Telemedicine, Partners In Health. He trained in General Medicine, Cardiology, and Knowledge Based Systems in the United Kingdom and completed a fellowship in Clinical Decision Making and Cardiology at the Massachusetts Institute of Tech- nology (MIT) and the New England Medical Center. His work has led to the migration of medical informatics tools and expertise from developed countries to some of the most challenging environments in the developing world. For 11 years Dr. Fraser has been the Director of Informatics and Telemedicine at Partners In Health, where he leads the development of Web- based medical record systems, data analysis tools, and pharmacy systems. These systems support the treatment of DR TB and HIV, primary care, and heart disease in Haiti, Malawi, Peru, the Philippines, and Rwanda. Along with colleagues from the Regenstrief Institute at the University of Indiana and the South African Medical Research Council, Dr. Fraser is a co-founder of the OpenMRS collaborative, a broad international collaboration to develop a flexible, open-source medical record system platform for use in developing countries. He also cofounded a training program in Rwanda to train local computer scientists to build medical information systems like OpenMRS, and co-leads a course at Harvard and MIT on the role of information systems in improving quality of care in developing countries. Dr. Fraser has a strong interest in the evaluation of medical information systems in developing countries and is currently working with WHO to develop a framework for such evaluation worldwide. Anne Goldfeld, M.D., is a Professor of Medicine at Harvard Medical School, Professor of Immunology and Infectious Diseases at the Harvard

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APPENDIX B 137 School of Public Health, Senior Investigator at the Immune Disease Institute and Program in Cellular and Molecular Biology at Children’s Hospital, Boston, and a Physician at Brigham and Women’s Hospital in the Depart- ment of Medicine and the Infectious Disease Division. She is also the co- founder and President of the Cambodian and Global Health Committees. A major focus of her laboratory is the understanding of the mechanisms of transcriptional activation of the tumor necrosis factor (TNF) gene and of HIV-1. Through studies of TNF gene expression in a range of cell types, including T cells, B cells, macrophages, and fibroblasts, the laboratory developed the paradigm of cell type- and stimulus-specific inducible eukary- otic gene regulation through the formation of distinct enhanceosomes and higher-order chromatin structure. The characterization of the molecular mechanisms of the regulation of transcription and replication of HIV by M.tb. is another main research focus in the Goldfeld laboratory in model systems of HIV and TB co-infection. A third area of focus of the Goldfeld laboratory is the study of host susceptibility and resistance genes and their variants that influence the pathogenesis of TB and AIDS, including the first identification and description of a gene linked to TB susceptibility and the discovery of IL-10-producing T regulatory cells in TB and an infectious disease in general. In parallel work she has developed delivery-of-care net- works and access to treatment for TB and HIV in Cambodia and treatment of MDR TB in Ethiopia. The Cambodian and Global Health Committees, respectively, have initiated and are scaling up MDR care in partnership with the Ministry of Health of each country. Recently, Dr. Goldfeld was the senior Principal Investigator of a trial to determine optimal timing of ARV therapy in immunosuppressed TB patients with HIV. This trial, the CAMELIA (CAMbodian Early vs. Late Introduction of Antiretrovirals), has resulted in improved timing of drug regimens that could reduce mortality globally from co-infection and provides a model for HIV/TB care that will be transferred and adapted to resource-poor settings elsewhere in Asia and Africa. By nesting scientific studies within this clinical trial, the laboratory is elucidating immunological mechanisms and genetic associations with dif- ferent disease outcomes in TB, AIDS, and TB/HIV co-infection. Jose Gomez-Marquez is Director, and Principal Medical Device Designer, Little Devices Lab, MIT, and creator of MIT’s first course on affordable medical device hardware, D-Lab Health. He is co-inventor of the MEDIKit platform, a series of design building blocks that empower doctors and nurses in developing countries to invent their own medical technologies. The lab’s work in TB includes the Adhere.IO platform of interactive diag- nostics to enhance medication adherence. Other research projects include crowd-sourced diagnostics, paper microfluidics, and affordable diagnostics for extreme environments. Mr. Gomez-Marquez serves on the European

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138 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB Union’s Science Against Poverty Taskforce and has participated as an expert advisor on the President’s Council of Advisors on Science and Technology. In 2009, Mr. Gomez-Marquez was selected to Technology Review’s T35, which also named him Humanitarian of the Year. In 2011, he was named a TED (Technology, Entertainment, Design) Fellow and is a co-founder of LDTC+Labs. Andrew L. Gray, M.Sc. (Pharm.), FPS, is a pharmacist whose research interests include policy analysis (in particular, the development and imple- mentation of National Drug Policies), rational medicines use, and the application of Highly Active Antiretroviral Therapy in resource-constrained settings. He is a Senior Lecturer in the Discipline of Pharmaceutical Sci- ences, School of Health Sciences, University of KwaZulu-Natal, Durban, South Africa. He is also a consultant pharmacist for the Centre for the AIDS Programme of Research in South Africa (CAPRISA) and non-executive chair of JEMBI Health Systems, a nonprofit company focused on develop- ing computer/information technology-based health care solutions for the developing world. Mr. Gray is a Fellow and Honorary Life Member of the Pharmaceutical Society of South Africa, a past President of the South African Association of Hospital and Institutional Pharmacists, a past Presi- dent of the Hospital Pharmacy Section, and currently Chair of the Board of Pharmaceutical Practice of the International Pharmaceutical Federation. He is a member of WHO’s Expert Panel on Drug Policies and Management and has served on the Expert Committee on the Selection and Use of Essential Medicines. He also serves on the WHO Guideline Review Committee. Lisa Hedman, M.S., is with the Essential Medicines and Health Products unit at WHO headquarters in Geneva, Switzerland. She manages a broad ranges of issues with a view of promoting access to medicines, especially essential medicines that may not be sufficiently available to people who need them. Ms. Hedman first joined WHO as project manager for the WHO Pandemic Influenza A (H1N1) Vaccine Deployment Initiative. Prior to joining WHO, she held several positions with the Program for Appropri- ate Technology in Health and supported other NGOs. She was the team leader for capacity development in procurement and supply chain with the Program for Appropriate Technology in Health, developing strategies for international donors and working onsite in low- and middle-income countries to implement activities related to access and quality of medicines. Myriam Henkens, M.D., M.P.H., is the International Medical Coordinator for MSF. For more than 6 years, Dr. Henkens worked in field positions with MSF in several countries in Africa and Asia. After completing an M.P.H. at the Johns Hopkins University, she became the director of the medical

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APPENDIX B 139 department at MSF in Brussels and is now in charge of MSF’s international medical coordination. Besides coordinating the medical departments of all MSF sections, Dr. Henkens continues to be involved in several medical topics, such as drug and medical devices QA, TB, meningitis, cholera, vac- cination, etc. Dr. Henkens represents MSF at several interagency platforms, such as the International Coordination Group for meningitis and yellow fever, among others. She participated in GLC. She has also been invited as an expert to several platforms on cholera vaccines, the WHO Essential Medicines List, etc. Brad Herbert, M.B.A., is founder and Managing Director of Brad Herbert Associates. Mr. Herbert has more than 30 years of experience in interna- tional development, with a focus in the social sectors, including health and education. For 27 years, Mr. Herbert was with World Bank, where he spent the majority of his tenure based in developing countries. In 2002, he left World Bank to join and help establish the Global Fund. At the Global Fund, he was the Chief of Operations, with the equivalent rank of Assistant Sec- retary General at WHO, and was responsible for their multibillion-dollar grant program in over 130 countries. As a result of years of development experience and leadership roles, Mr. Herbert brings a practical, results- oriented approach to program policy, development, and accelerated imple- mentation of health and education projects. He holds a B.A. in Business Administration from the University of Maryland and an M.B.A. from the George Washington University. He is currently a board member of Mothers 2 Mothers, an international NGO based in Cape Town, South Africa. He is working on the prevention of HIV transmission from mother to child. He is also a member of the Dalberg Global Development Advisor’s Technical Advisory Committee and a member of a Technical Committee at the Global Fund for pricing options under AMFm. Joël Keravec, D.V.M., Ph.D., M.B.A., is the Brazil Country Program Direc- tor for MSH. Dr. Keravec has 20 years of experience as a public health consultant and project manager in Latin America, Africa, and Europe for the United Nations Development Programme; United Nations Educational, Scientific and Cultural Organization; MSH; French Ministry of Foreign Affairs; Pan American Health Organization; and Brazilian Ministry of Health. As MSH Senior Technical Advisor/Country Director for Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program activities in Brazil, he managed an 8-year technical assistance and capacity building program for strengthening DOTS implementation and MDR TB control, for which the e-TB Manager system (www.etbmanager.org) was developed. He also provides technical assistance to the NTPs in Europe, Asia, and Africa to strengthen MDR TB Programs, SLD management, and

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140 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB information systems. He has been appointed by WHO Geneva as a GDF Technical Review Committee member and Global GLC member. From 1999 until 2004, Dr. Keravec served as Deputy Director of Brazil’s National Institute of Quality Control in Health (Brazil NRA Lab), where he managed reorganization of all aspects of the national drug reference laboratory. His areas of technical expertise include pharmaceutical management of product QA and international quality standards for medicine quality testing labo- ratories, selection of essential medicines for standardized TB treatment, improved policy and regulatory environment for essential medicines, and improved product management information systems. Salmaan Keshavjee, M.D., Ph.D., Sc.M., is the Director of the Program in Infectious Disease and Social Change at the Department of Global Health and Social Medicine at Harvard Medical School. Trained as a physician and social anthropologist, Dr. Keshavjee is an Assistant Professor of Medi- cine and Social Medicine at Harvard Medical School and in the Division of Global Health Equity at Brigham and Women’s Hospital. He is also an attending in Internal Medicine at Brigham and Women’s Hospital. Dr. Keshavjee completed his thesis work in Harvard’s Department of Anthro- pology and Center for Middle Eastern Studies on health policies in post- Soviet Tajikistan. His clinical research has focused on the implementation of DR TB treatment projects run by Partners In Health and associated treatment outcomes. He has worked extensively with Partners In Health’s DR TB program in Russia since 2000. From 2006 to 2008, he was Deputy Country Director for the Partners In Health Lesotho Initiative, launching one of the first community-based treatment programs for MDR TB/HIV co- infection in sub-Saharan Africa. Since 2008 he has led Partners In Health’s Russia research initiative, coordinating a multidisciplinary team studying treatment outcomes in DR TB. This work is informing efforts to treat DR TB in the region, including Central Asia, and has resulted in several manuscripts of global clinical and policy significance. Starting in 2005, Dr. Keshavjee represented Partners In Health/Harvard on GLC for MDR TB, the principal global mechanism for MDR TB treatment expansion, housed at the Stop TB Partnership and WHO. From 2007 until September 2010, he served as the Committee’s Chair. Through his roles at Harvard, Partners In Health, and GLC, he has advised numerous national programs on the clinical and programmatic management of MDR-TB. Michael Kimerling, M.D., M.P.H., is a Senior Program Officer on the Tuberculosis Global Health Program, BMGF. Dr. Kimerling joined BMGF in 2008 from the University of Alabama at Birmingham (UAB), where he was a tenured Professor of Medicine. Trained as an internist, he started

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APPENDIX B 141 his medical career working with NGOs in refugee medicine and rebuild- ing primary health care services in chronic conflict zones, including several years with Doctors Without Borders in Cambodia and as a consultant to MSF on TB in Russia. He also worked as a TB consultant to WHO in Myanmar. At UAB, Dr. Kimerling was funded by USAID for more than 10 years to do capacity building and operations research on various aspects of TB control, building programs in multiple settings within Asia, Africa, Latin America, and the former Soviet Union. At BMGF, he works closely with established grantees (CREATE and FIND) and new country partners (Brazil and South Africa) on translational and operational research and on delivery issues relevant to the uptake of existing and new technologies. He has been a member of the Technical Review Panel of the Global Fund for 3 years and also serves on the coordinating board of the Stop TB Partner- ship. Besides his M.D., Dr. Kimerling has an M.P.H. in Epidemiology and an undergraduate degree in Medical Anthropology (with highest honors). Patrick Lukulay, Ph.D., is currently the Vice President of Global Health Impact Programs for the U.S. Pharmacopeial Convention (USP), overseeing all grant-funded programs that provide technical assistance to developing countries. He is also Director of the Promoting the Quality of Medicines program, a 5-year, $35 million cooperative agreement supported by USAID and implemented by USP. In that capacity, Dr. Lukulay oversees the work of about 20 staff, providing technical assistance to 35 countries to help strengthen their QA and quality systems for pharmaceuticals. Dr. Lukulay holds a Ph.D. in Analytical Chemistry from Michigan State University and worked in the pharmaceutical industry for Wyeth and Pfizer for a combined 12 years as Senior Principal Scientist. He has authored several articles in separation science, spectroscopy, and medicines quality. He serves on the IOM committee on counterfeit drugs and frequently speaks at national and international conferences. Sana Mostaghim works for CHAI as the MDR TB Drug Access Project Manager. He is based in New Delhi and focuses on CHAI’s work to improve access to second-line anti-TB medicines in the global public mar- ket. Prior to this, he worked on a project to support the Indian government develop its scale-up strategy for MDR TB treatment. Before CHAI, he worked for 3 years in management consulting in Canada, where he focused on the utilities and retail industries. His role as a researcher for UNDP’s “Growing Inclusive Business Models” initiative in 2007 fostered his over- arching passion for the alignment of private-sector and human development interests. Mr. Mostaghim holds a B.A. with Distinction from the Richard Ivey School of Business in Canada.

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142 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB Norbert Ndjeka, M.D., is a Specialist Family Physician with interests in TB and HIV. Dr. Ndjeka is the Director of MDR TB, TB and HIV, Department of Health, South Africa. He served as WHO Temporary MDR TB Advisor. He is a member of the TB TEAM Experts Roster as an Experienced Expert in M/XDR TB under the STOP TB Department of WHO, and a member of the Board of Directors for Bela Bela HIV/AIDS Prevention Group. Dr. Ndjeka previously worked as Clinical Head, Limpopo MDR TB Unit; Senior Specialist and Senior Lecturer in Family Medicine, University of Limpopo; MDR TB and Infection Control Advisor, University Research Corporation; Senior Medical Superintendent, Warmbaths Hospital, Lim- popo Province; Medical Superintendent, St. Rita’s Hospital, Limpopo Province; and Medical Officer at Botlokwa, Kgapane, and St. Rita’s Hos- pital. Dr. Ndjeka’s qualifications include an M.D. from the University of Kinshasa, Democratic Republic of the Congo; a Diploma in Health Service Management from the University of Witswatersrand; a Diploma in HIV Management from the College of Medicine of South Africa; and a Master of Medicine from Medunsa. Meg O’Brien, Ph.D., is the Director of the Global Access to Pain Relief Initiative, a program of the Union for International Cancer Control and the American Cancer Society to improve access to essential pain medicines. Previously, Dr. O’Brien was the research director of the Center for Strate- gic HIV Operations Research at CHAI and worked on the establishment of HIV treatment clinics for the U.S. government’s PEPFAR program in Tanzania as a Postdoctoral Fellow at the Harvard School of Public Health. She also worked as the Chief Epidemiologist of the HIV Outpatient Clinic in New Orleans while completing her Doctorate in Epidemiology at the Tulane School of Public Health and Tropical Medicine. Dr. O’Brien started her career as a biostatistician at Statistics Collaborative, Inc., while earning a master’s degree in International Health from the George Washington Uni- versity School of Public Health and Health Services. She also has a degree in Biology and a certificate in African Studies from Georgetown University. Christophe Perrin, M.Sc., is a French QA pharmacist with The Union. Mr. Perrin earned an M.Sc. in Public Health at the Institute of Tropical Medi- cine in Antwerp. He worked in clinical research for oncology and diabetes medicines before doing several missions for humanitarian organizations. Since 2005, his activities have been concentrated on challenges affecting supply of QA medicines in low-resource countries, as well as access to treatment and innovation for neglected infectious diseases such as TB. Since joining The Union, his activities have also involved non-communicable diseases, such as asthma and diabetes.

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APPENDIX B 143 Iain Richardson, M.S., is currently Senior Director of Global Supply Chain and Logistics for Eli Lilly and Company, responsible for global demand management, supply chain planning, risk management programs, and logis- tics. He is also responsible for Eli Lilly’s Legacy Product portfolio and Transfer of Technology as part of Eli Lilly’s philanthropic MDR TB pro- gram. Mr. Richardson has been involved in the MDR TB program since its beginning in 2003. He has a bachelor’s degree in Chemical Engineering from the University of Edinburgh and a master’s in Biochemical Engineering from University College London. He has been with Eli Lilly for 25 years since joining the company’s Liverpool facility as a Technical Services Asso- ciate. Prior to his current role, he was Director of Contract Manufacturing for Eli Lilly’s external manufacturing operations in Europe, Asia, and North America. David H. Ripin, Ph.D., is the Executive Vice President of Access Programs and Chief Scientific Officer at CHAI, where he oversees CHAI’s work on increasing access to medicines and diagnostics for HIV, malaria, and TB through the use of sustainable market interventions. CHAI’s Access Programs have successfully implemented agreements with pharmaceutical companies to lower the price of key drugs and diagnostics for HIV/AIDS, malaria, and TB by up to 80 percent, among other achievements. Dr. Ripin joined CHAI in 2007. Prior to assuming his current role, he led CHAI’s Pharmaceutical Sciences Team, which conducts research and development work. These efforts focus on reducing the cost of key drugs through recom- mending formulation, manufacturing process, and sourcing improvements, as well as conducting the transfer of these processes to manufacturing part- ners. Dr. Ripin is actively involved in setting international priorities for HIV drug optimization work, including organizing the Conference on Antiretro- viral Drug Optimization in 2009. Before joining CHAI, he worked at Pfizer Inc. for 10 years as part of the research and development group, focusing on the commercialization and manufacture of drug candidates. Dr. Ripin received a B.S. in Chemistry and Asian Studies from Washington University in St. Louis and obtained his Ph.D. in Chemistry at Harvard University. Owen Robinson, M.P.P., is a Program Manager at Partners In Health. Mr. Robinson has been at Partners In Health since 2010, where he has been involved in managing the development of a new national teaching and refer- ral hospital in Haiti, and is now in a cross-site management role. Previously, he worked at CHAI addressing market-related challenges that prevent patient access to key health commodities, including medicines to treat MDR TB. Earlier, he advised clients in the health care sector as a consultant and project manager at The Boston Consulting Group.

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144 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB Nina Schwalbe, M.P.H., is Managing Director of Policy and Performance at GAVI Alliance. Prior to joining GAVI in 2008, Ms. Schwalbe directed the policy department at the Global Alliance for TB Drug Development, a prod- uct development partnership focused on the development of medicines for TB. In this capacity, she led the TB Alliances efforts to promote adoption and introduction of new TB drugs, co-chaired the Stop TB Partnership’s task force on retooling, and was a member of the Center for Global Devel- opment’s working group on demand forecasting. She has spent more than 20 years in international health. For 7 years she directed the Soros Founda- tions’ global public health program, which focused on a range of critical issues including strengthening health systems, TB, HIV/AIDS, and programs aimed at vulnerable populations. She also worked in maternal/child health, first with the Population Council and then with AVSC International (now Engender Health), focusing on the introduction of new programs and technologies. Ms. Schwalbe holds degrees from Harvard and Columbia Universities and is a member of the Council on Foreign Relations and of the faculty of the Department of Population and Family Health at Columbia’s Mailman School of Public Health. She has served on the program com- mittees for Doctors of the World USA, Treatment Action Groups’ TB/HIV project, and the Open Society Institute’s Public Health Watch program, as well as on the boards of the Stop TB Partnership, European Observatory for Health Care Reform, AIDS Foundation East/West, Open Health Institute in Moscow, and International Gay and Lesbian Human Rights Commission. Robert Sebbag, M.D., is currently Vice President, Access to Medicines at Sanofi. In his role, Dr. Sebbag participates in the company’s access to medicines strategy development for the Southern hemisphere. Prior to join- ing Sanofi, Dr. Sebbag worked in Brussels for the European Federation of Pharmaceutical Industries and Associations on creating a communications platform for the pharmaceutical companies operating in Europe. In his prior role, he was Senior Vice President of Communications for the vaccine company, Aventis Pasteur (today known as Sanofi Pasteur). In addition to his activities within the pharmaceutical industry, Dr. Sebbag is also teach- ing public health courses within the Paris hospital system, focusing on tropical parasitic diseases. He is active within the French Red Cross and has participated in numerous health missions in the Southern hemisphere. Dr. Sebbag is an M.D. with a specialty in tropical parasitic diseases and training in psychiatry. Andreas Seiter, M.D., is a Senior Health Specialist and Expert for Pharma- ceutical Policy and Management at the World Bank’s Health, Nutrition, and Population Anchor. He joined World Bank in 2004 and is responsible for analytical and advisory work in all areas of pharmaceutical policy, such

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APPENDIX B 145 as regulation, governance, QA, financing, purchasing, supply chain, and rational use. He has been working with World Bank teams, policy makers, and experts on the client side in several countries in Africa, Eastern Europe, the Middle East, Latin America, and South Asia. In 2010, he published the book A Practical Approach to Pharmaceutical Policy. Dr. Seiter, a German national, is a physician by training and practiced medicine before joining the pharmaceutical private sector in 1984. He held various positions in medical operations, product management, communications, and stake- holder relations in the industry prior to joining World Bank. Tracy J. Sims is Vice President, Eli Lilly & Co. Foundation. Mr. Sims is responsible for leading strategy development and tactical implementation of Eli Lilly’s global corporate responsibility programs. Eli Lilly’s corporate responsibility vision for global health programs is to “catalyze sustainable access to improved health care outcomes for underserved populations.” Mr. Sims oversees staff who are deployed globally in support of the global health strategy. Mr. Sims joined Eli Lilly in 1995 and has since held several sales, marketing, corporate affairs, and strategy leadership roles. Prior to joining Eli Lilly, Mr. Sims held positions with the American Diabetes Asso- ciation as Regional Director and with a U.S. Senator as Assistant Director. Mr. Sims had also been responsible for leading the U.S. Public Policy Plan- ning and Development team with a focus on both state and federal issues. He has acted as spokesperson for Eli Lilly with major media, international and domestic officials, trade, and advocacy organizations on a range of complex issues, including business administration, access to health care, and corporate responsibility. Mr. Sims holds a B.A. in Communications and History from Whitworth University in Washington State, where he graduated with honors. Trish Stroman, M.S.P.H., M.B.A., is a Principal in the Washington, DC, office of The Boston Consulting Group (BCG). She is a core member of BCG’s Health Care practice with a focus in Global Health. The majority of Ms. Stroman’s work has been in HIV, malaria, and TB with clients includ- ing BMGF, WHO, and several of the product development partnerships. She received an M.B.A. and M.S. in Public Health from The University of North Carolina at Chapel Hill, as well as a bachelor’s in Human Biology from Stanford University. Cheri Vincent, M.S.P.H., is TB Team Leader, USAID, Global Health Bureau. Ms. Vincent is the TB Team Leader with USAID’s infectious disease divi- sion, focusing on TB prevention and care. She provides the policy, strategic direction, and oversight for USAID’s TB program. She also is a member of the Stop TB Partnership Coordinating Board as well as the core technical

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146 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB groups on TB Infection Control and TB Public Private Mix. She is a mem- ber of the U.S. government’s delegation on the Global Fund Board. She has more than 16 years of experience in international public health and has worked in the field and in Washington, DC, with USAID for 14 years. She has experience working in Eastern Europe, Asia, and Africa, living 6 years in the Central Asian Republics. Ms. Vincent received an M.P.H. with a concentration in Environmental Sciences from Tulane University and an undergraduate degree in Biochemistry. Brenda Waning, Ph.D., M.P.H., serves as Coordinator of Market Dynamics at UNITAID, a WHO partnership based in Geneva. She leads UNITAID’s technical team responsible for monitoring trends in HIV/AIDS, TB, and malaria markets; identifying strategic opportunities to intervene in these markets; and assessing the public health and market impact of UNITAID’s interventions. Prior to joining UNITAID, Dr. Waning served as Director of Pharmaceutical Policy at Boston University School of Medicine, where she authored numerous peer-reviewed studies on pharmaceutical policy at local, national, and global levels. Dr. Waning serves on many expert advi- sory groups, including the Market Dynamics Advisory Group of the Global Fund and the Access and Delivery Advisory Committee of the Medicines for Malaria Venture. Prashant Yadav, Ph.D., M.B.A., B.Chem.Eng., is Director of the Health- care Research Initiative at the William Davidson Institute at the University of Michigan. He also holds faculty appointments at the Ross School of Business and the School of Public Health at the University of Michigan. A leading expert on pharmaceutical and health care supply chains in develop- ing countries, Dr. Yadav’s research explores the functioning of health care supply chains using a combination of empirical, analytical, and qualitative approaches. He currently serves as Chair of the Market Dynamics Advisory Group of the Global Fund. Andre Zagorski, M.A., is Principal Technical Advisor for TB for the MSH Systems for Improved Access to Pharmaceuticals and Services Program based in Arlington, Virginia. He has more than 18 years of global TB and essential medicines project management experience in regions includ- ing Europe, Asia, and Africa. He oversees the SIAPS core TB portfolio of activities, including collaborative efforts with WHO, the Global Fund, GDF, GLC, Stop TB partners, and field programs aimed at strengthening pharmaceutical management systems for TB control programs. His techni- cal areas of expertise include project management, implementation, and evaluation; health systems strengthening and policy; SCM; development

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APPENDIX B 147 of pharmaceutical management tools and use of tools developed by MSH; management information systems; monitoring and evaluation; and devel- opment of training courses and capacity building programs. He holds a master’s degree in Training and has completed Fellowships in Psychology.

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