Appendix A

Workshop Agenda

THE GLOBAL CRISIS OF DRUG-RESISTANT TUBERCULOSIS AND THE LEADERSHIP OF THE BRICS COUNTRIES: CHALLENGES AND OPPORTUNITIES

Wednesday–Friday, January 16–18, 2013 Beijing, China

The increasing burden of drug-resistant tuberculosis introduces new challenges to traditional TB control and treatment programs and calls upon the global health community to collaborate and share scientific information in new and different ways. This 3-day workshop is sponsored by the Forum on Drug Discovery, Development, and Translation of the U.S. National Academy of Sciences, the Institute of Medicine (IOM), and the Institute of Microbiology of the Chinese Academy of Sciences (CAS). Following an inaugural meeting in Washington, DC, in 2008, this workshop in Beijing is the fourth in a series of international workshops convened by the U.S. IOM. The objective of the workshop series is to realistically assess the impact of and challenges resulting from drug-resistant TB globally and in the four countries with the most people affected (China, India, Russia, and South Africa). A public workshop was also convened in July/August 2012 in Washington, DC, to identify opportunities to improve the global supply chain for second-line TB drugs. Specifically, the goals of the workshop series include

•   Consider a wide spectrum of issues pertaining to the science and policy around drug-resistant tuberculosis—from biology, epide-



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Appendix A Workshop Agenda the global crisis of drug-resistant tuberculosis and the leadership of the brics countries: challenges and opportunities Wednesday–Friday, January 16–18, 2013 Beijing, China The increasing burden of drug-resistant tuberculosis introduces new challenges to traditional TB control and treatment programs and calls upon the global health community to collaborate and share scientific information in new and different ways. This 3-day workshop is sponsored by the Forum on Drug Discovery, Development, and Translation of the U.S. National Academy of Sciences, the Institute of Medicine (IOM), and the Institute of Microbiology of the Chinese Academy of Sciences (CAS). Follow­ng an i inaugural meeting in Washington, DC, in 2008, this workshop in Beijing is the fourth in a series of international workshops convened by the U.S. IOM. The objective of the workshop series is to realistically assess the impact of and challenges resulting from drug-resistant TB globally and in the four countries with the most people affected (China, India, Russia, and South Africa). A public workshop was also convened in July/August 2012 in Washington, DC, to identify opportunities to improve the global supply ­ chain for second-line TB drugs. Specifically, the goals of the workshop series include • Consider a wide spectrum of issues pertaining to the science and policy around drug-resistant tuberculosis—from biology, epide- 151

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152 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS miology, and surveillance; to diagnosis, treatment, and infection control; to issues pertaining to the drug supply chain, laboratory capacity, and needs of vulnerable populations. Each workshop will address some or all of these multiple disciplines and facilitate discussion about a global “blueprint for action.” • Present promising new research, and also to identify specific gaps in knowledge and consider potential needs for additional research, funding, and international attention. The workshop series has been hosted over a period of several years, cre- ating a venue and body of knowledge that explicitly considers and addresses developments over a period of time, thus permitting relatively quick adjust- ments in knowledge and strategy. The workshop series convenes interna- tional experts, permitting exchange of information among experts from each of the participating countries and globally. Each workshop in the series results in a U.S. National Academies publication summarizing the work- shop presentations and discussions. This workshop in Beijing will address the current status of drug-resis- tant tuberculosis globally, and in China, and consider lessons learned from the other three high burden countries; highlight global challenges to control- ling the spread of drug-resistant strains; and discuss innovative strategies to advance and harmonize local and international efforts to prevent and treat drug-resistant TB. The workshop will consider urgent themes relating to the problem of multidrug-resistant (MDR) TB, extensively drug resistant (XDR) TB, and emergent TB strains that are potentially untreatable with drugs available and will consider the critical leadership role of the BRICS countries in addressing the threats and opportunities in drug-resistant TB. the global crisis of drug-resistant tuberculosis and the leadership of the brics countries: challenges and opportunities Wednesday, January 16, 2013 Beijing, China DAY 1 7:00 a.m. Registration 8:30 a.m. Welcome and Introductory Remarks (Moderator: Lixin Zhang)

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APPENDIX A 153 Yaping Zhang Vice President Chinese Academy of Sciences 9:00 a.m. Group Photo 9:15 a.m. Global Burden, Themes from Institute of Medicine Workshops in Other BRICS Countries, and Workshop Goals Gail Cassell Chair, IOM Planning Committee Harvard Medical School Infectious Disease Research Institute George Fu Gao Vice Director General Chinese Center for Disease Control and Prevention Beijing Institute of Biological Sciences, CAS 9:45 a.m. Opening Keynote Address Twenty-Five Years After the First Major MDR TB Outbreak: Is It Time for a New Strategy? Paul Farmer Chair, Department of Global Health and Social Medicine Harvard Medical School 10:15 a.m. BREAK 10:45 a.m. Panel Discussion: Challenges and Opportunities for the BRICS Country Leadership The BRICS countries, represented by the Ministers of Health of the Federative Republic of Brazil, the Russian Federation, India, People’s Republic of China, and Republic of South Africa, met in New Delhi on 11 January 2013 at the Second BRICS Health Ministers’ Meeting. The Ministers recognized that multidrug-resistant tuberculosis is a major public health problem for the BRICS countries due to its high prevalence and incidence mostly on the marginalized and vulnerable sec- tions of society. They resolved to

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154 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS •  ollaborate and cooperate for development of capacity and c infrastructure to reduce the prevalence and incidence of tuberculosis through innovation for new drugs/vaccines, diagnostics; and •  romotion of consortia of tuberculosis researchers to col- p laborate on clinical trials of drugs and vaccines; •  trengthening access to affordable medicines and delivery s of quality care. The Ministers also recognized the need to cooperate for adopting and improving systems for notification of tuberculo- sis patients, availability of anti-tuberculosis drugs at facilities by improving supplier performance, and procurement systems and logistics and management of HIV-associated tuberculosis in the primary health care system. The Ministers also recognized the importance and need of technology transfer as a means to empower developing coun- tries. In this context, they underlined the important role of generic medicines in the realization of the right to health. The Ministers renewed their commitment to strengthening international cooperation in health, in particular south–south cooperation, with a view to supporting efforts in developing countries to promote health for all and resolve to estab- lish the BRICS network of technological cooperation. (Delhi Communiqué, January 12, 2013, http://pib.nic.in/newsite/ erelease.aspx?relid=91533) Rifat Atun Professor of International Health Management Imperial College London Kristina Wallengren Clinical Advisor KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH) Salmaan Keshavjee Associate Professor, Department of Global Health and Social Medicine Harvard Medical School

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APPENDIX A 155 Grigory Volchenkov Head Doctor Vladimir Oblast TB Dispensary Center of Excellence for TB Infection Control Yanlin Zhao Vice Director, National Center for Disease Control and Prevention Director, National Tuberculosis Reference Laboratory Chinese Center for Disease Control and Prevention 11:30 a.m. Discussion with speakers and audience Moderators: Gail Cassell Harvard Medical School Infectious Disease Research Institute Yanlin Zhao Vice Director, National Center for Disease Control and Prevention Director, National Tuberculosis Reference Laboratory Chinese Center for Disease Control and Prevention 12:00 p.m. LUNCH Session I: Drug-Resistant TB in China Session Objectives: • Describe the health care delivery system in China and recent sur- veillance results of drug-resistant TB in China. Identify where data are missing and are most needed. • Discuss the burden of drug-resistant TB in China from the perspec- tive of clinicians and health care providers. • Present data on the burden of drug-resistant TB in vulnerable populations such as domestic migrant workers and individuals with comorbidities, including HIV and diabetes. • Present international perspectives on the impact of health delivery systems on DR TB control and care.

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156 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS Session Chairs: • China co-chair: Fabio Scano, World Health Organization • U.S. co-chair: Paul Farmer, Harvard Medical School 1:30 p.m. Overview of the Health Care Delivery System and Programmatic Management of MDR TB in China Mingting Chen Vice Director/Researcher National Center for Tuberculosis Control and Prevention Chinese Center for Disease Control and Prevention 2:00 p.m. 2007 National Survey of Drug Resistance in China Yanlin Zhao Vice Director, National Center for Disease Control and Prevention Director, National Tuberculosis Reference Laboratory Chinese Center for Disease Control and Prevention 2:30 p.m. Panel Discussion: Perspectives from Public Health and Hospital Systems in China [20 min. each speaker] Clinical Diagnosis and Treatment of Drug-Resistant TB Wenhong Zhang Huashan Hospital of Fudan University, Shanghai, China M/XDR TB Chemotherapy in China Shou-yong Tan Guangzhou Chest Hospital 3:10 p.m. BREAK 3:30 p.m. Panel Discussion: Treating Drug-Resistant TB in Vulnerable Populations in China [20 min. each speaker] Drug-Resistant TB and HIV in China Liu Feiying Guangxi Center for Disease Control and Prevention, China

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APPENDIX A 157 Drug-Resistant TB and Diabetes in China Chu Naihui (Oral presentation by Duan Hongfei) Beijing Chest Hospital 4:10 p.m. Discussion with speakers and audience 4:30 p.m. Panel Discussion: Impact of Health Care Delivery Systems on DR TB [20 min. each speaker] Peru, Russia, and Lesotho Salmaan Keshavjee Associate Professor Department of Global Health and Social Medicine Harvard Medical School Community-Based Care in South Africa Kristina Wallengren Clinical Advisor KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH) Direct Collaboration and “South-to-South Transfer” in Cambodia and Ethiopia Anne Goldfeld Harvard Medical School/Global Health Committee 5:30 p.m. Discussion with speakers and audience 6:00 p.m. Closing remarks and adjourn day 1

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158 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS the global crisis of drug-resistant tuberculosis and the leadership of the brics countries: challenges and opportunities Thursday, January 17, 2013 Beijing, China DAY 2 Session II: Transmission and infection control: Epidemiological and GEnotypic evidence and consequences Session Objectives: • Provide an overview of the epidemiological, phenotypic, and geno- typic evidence for primary transmission of drug-resistant TB. • Discuss the consequences of transmission of drug-resistant TB in communities and hospitals. • Consider the scientific evidence for active case finding, rapid diag- nosis, and treatment based on drug-susceptibility testing (DST) to stop transmission. • Discuss the role of infection control in China today and consider infection control policies and practices in other countries with a high prevalence of drug-resistant TB. • Describe drug-resistant TB risk factors (e.g., inadequate treat- ment, losing patients during follow-up, drug shortages, exposure to drug-resistant TB due to inadequate infection control) and pro- vide in-country perspectives of the issues and current strategies for prevention and control. Session Chairs: • China co-chair: Wenhong Zhang, Huashan Hospital of Fudan University • U.S. co-chair: Edward Nardell, Harvard School of Public Health 8:00 a.m. Global Perspective on Transmission: Value in Genotype Mapping of Disease Transmission Dynamics Neel Gandhi Associate Professor Department of Epidemiology Rollins School of Public Health Emory University

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APPENDIX A 159 8:30 a.m. Current Status of Infection Control in China: Different Perspectives [20 min. each speaker] Hospital System Perspective Liang Li Clinical Center for Tuberculosis, China CDC Public Health Systems Guangxue He Chinese Center for Disease Control and Prevention Infection Control Challenges Carol Rao U.S. Centers for Disease Control and Prevention 9:30 a.m. Discussion with speakers, panelists and audience 10:00 a.m. BREAK 10:20 a.m. Perspectives on Infection Control in Other Countries [20 min. each speaker] South Africa Carrie Tudor Fogarty Global Health Postdoctoral Fellow Johns Hopkins School of Nursing Institutional Infection Control in Russia Grigory Volchenkov Head Doctor Vladimir Oblast TB Dispensary Center of Excellence for TB Infection Control 11:00 a.m. Redesign of Health Care Facilities, Active Case Finding, Rapid Diagnosis, and Effective Treatment Based on DST to Stop Transmission in Institutional and Community Settings Edward Nardell Associate Professor Departments of Environmental Health and Immunology and Infectious Diseases, Harvard School of Public Health

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160 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS 11:30 a.m. Discussion with speakers and audience 11:45 a.m. LUNCH Session III: RApid Diagnostic technology: Current Status and Limitations Session Objectives: • Provide an overview of the methods of DST used globally and the advantages and disadvantages of different tests. • Discuss the current use of diagnostic tests for drug-susceptible and drug-resistant TB in China and identify the barriers to rapid diagnosis and management of patients. Consider challenges in diag- nosing TB and drug-resistant TB vs. nontuberculous mycobacteria (NTM). Provide a laboratory- and hospital-based perspective on DST. • Discuss work from other countries in implementing programs for rapid diagnosis of drug-resistant TB and consider the populations in which various DSTs work best. Session Chairs: • China co-chair: Jack Zhang, PATH • U.S. co-chair: Jean-Luc Berland, Fondation Mérieux 1:00 p.m. DST in Detecting DR TB, Overview of Other Technologies, and Rollout of GeneXpert in South Africa: What Are the Gaps? Mark Nicol Division of Medical Microbiology and Institute for Infectious Diseases and Molecular Medicine University of Cape Town and National Health Laboratory Service South Africa 1:30 p.m. Panel Discussion: Perspectives on Drug-Resistant TB Diagnostic Technologies in Use in China [15 min. each speaker] SAT-TB Assay Jin Chen Shanghai Pulmonary Disease Hospital

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APPENDIX A 161 GeneXpert Yao-ju Tan Guangzhou Chest Hospital GenoType MTBDRplus Wei Ge Shandong Chest Hospital Line Probe Assay (LPA) Hairong Huang Beijing Chest Hospital Cross Priming Amplification (CPA) Pang Yu Chinese Center for Disease Control and Prevention 2:45 p.m. Genetic Diversity of DR TB: Implication for Future Diagnostics Megan Murray Professor Department of Global Health and Social Medicine Harvard Medical School 3:15 p.m. Discussion with speakers and audience 3:30 p.m. BREAK Session IV: ADDRESSING diagnosis and treatment across the spectrum of drug resistance Session Objectives: • Describe the prevalence of MDR, pre-XDR, XDR, and untreatable TB in key countries. • Consider the diagnosis and treatment challenges associated with MDR, pre-XDR, and XDR TB. How can a TB program effectively meet the needs of patients? Session Chairs: • China co-chair: Jin Liang Ju, Shanghai Pulmonary Disease Hospital • U.S. co-chair: Neel Gandhi, Emory University

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162 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS 3:45 p.m. MDR and XDR TB Clinical Perspective Richard Chaisson Johns Hopkins University 4:05 p.m. Panel Discussion: Treating the Spectrum of Drug Resistance in China [20 min. each speaker] New Diagnostic Marker Screening in TB Meningitis Xiaoyou Chen Tuberculosis Department, Beijing Chest Hospital Beijing Tuberculosis & Thoracic Tumor Research Institute Surgical Treatment of M/XDR TB Xiao Ning Beijing Chest Hospital, Capital Medical University 4:45 p.m. The Need for a Paradigm Shift in Treatment of the Spectrum of Drug Resistant TB Markus Maeurer Professor and Head, Therapeutic Immunology Division Karolinska Institute 5:15 p.m. MDR, XDR, and Untreatable TB from a Laboratory Perspective [20 min. each speaker] Martie van der Walt Interim Director, TB Epidemiology and Intervention Research Unit South African Medical Research Council Sven Hoffner Director, WHO Supranational TB Reference Laboratory Associate Professor, Department for Preparedness Swedish Institute for Communicable Disease Control

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APPENDIX A 163 5:55 p.m. Totally Drug-Resistant TB in India: Lessons and Opportunities from a Clinical Perspective Zarir Udwadia Consultant Chest Physician Hinduja Hospital Mumbai, India 6:25 p.m. Discussion with speakers, panelists, and audience 7:15 p.m. Closing remarks and adjourn day 2 the global crisis of drug-resistant tuberculosis and the leadership of the brics countries: challenges and opportunities Friday, January 18, 2013 Beijing, China DAY 3 Session V: Drug-Resistant TB in PEDIATRIC populations Session Objectives: • Review the global burden and transmission of pediatric DR TB. • Discuss challenges in diagnosis and treatment of DR TB in children. Session Chairs: • China co-chair: Qian Gao, Fudan University, China • U.S. co-chair: Mercedes Becerra, Harvard Medical School 8:00 a.m. Children as Sentinels for Transmission and Policy Response Mercedes Becerra Associate Professor Department of Global Health and Social Medicine Harvard Medical School 8:30 a.m. Pediatric Drug-Resistant TB in China Tao Li Shanghai Public Health Clinical Center

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164 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS 8:50 a.m. Drug-Resistant TB in Meningitis Shunying Zhao (Oral presentation by Huimin Li) Beijing Children’s Hospital 9:10 a.m. Status of Pediatric MDR/XDR TB in the Russian Federation and Other Former Soviet Union Countries: Managing Pediatric Drug-Resistant TB in a Setting with Separate Medical Structures for Adults and Children Valentina Aksenova (Oral presentation by Rita Guenther) Head, Childhood and Adolescent Tuberculosis Department Research Institute of Phthisiopulmonology First Moscow Sechenov State Medical University  Chief Pediatric Phthisiologist, Ministry of Health, Russian Federation 9:30 a.m. Discussion with speakers and audience 9:45 a.m. BREAK Session VI: Looking Forward: Developing and strengthening the drug supply chain for drug-resistant TB Session Objectives: • Consider to what extent and in what ways current supply chain mechanisms are or are not effectively accomplishing what is needed, in China and beyond, including consideration of bottlenecks. • Consider the current allocation of responsibilities and roles of the private (including industry and not-for-profit public health organi- zations) and public sectors, and examination of opportunities for enhancing and optimizing collaboration. • Identify potential innovative solutions to the supply chain problem. Session Chairs: • China co-chair: Wenhong Zhang, Huashan Hospital, Fudan University • U.S. co-chair: Barry Bloom, Harvard School of Public Health

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APPENDIX A 165 10:00 a.m. Barriers, Challenges, Needs, and Potential Solutions for the SLD Supply Chain Barry Bloom Co-chair, IOM workshop, Developing and Strengthening the Global Supply Chain for Second-Line Drugs for MDR TB Distinguished Service Professor Department of Immunology and Infectious Diseases Harvard University Dean of the Harvard School of Public Health (former) 10:20 a.m. Panel: Different Perspectives on the Global Supply Chain Rifat Atun Professor of International Health Management Imperial College London Dan Collins Corporate Affairs Eli Lilly and Company Mingting Chen Chinese Center for Disease Control and Prevention Dale Nordenberg Chief Executive Officer Novasano Health and Science Oskar Slotboom Head, Vaccine and Infectious Diseases Xian Janssen Pharmaceutical Ltd., Johnson & Johnson 11:30 a.m. Discussion with speakers and audience 11:45 a.m. LUNCH Session VII: Looking Forward: embracing a new vision for researcH Session Objective: • Review the state of the art in TB research and identify opportuni- ties to apply new research tools to the problem of DR TB.

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166 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS Session Chairs: • China co-chair: Min Fang, Institute of Microbiology, Chinese Academy of Sciences • U.S. co-chair: Anne Goldfeld, Harvard Medical School/Global Health Committee 1:00 p.m. The Need for a Paradigm Shift in TB Research: Synergy of Discovery and Delivery of Care Anne Goldfeld Harvard Medical School/Global Health Committee 1:30 p.m. New Tools to Facilitate TB Research [10 min. each speaker] NIH Global TB Research Resources Maria Giovanni Director, Office of Genomics and Advanced Technologies Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases U.S. National Institutes of Health TBResist: A Global Consortium for Whole Genome Sequencing of Drug-Resistant TB Gail Cassell Harvard Medical School Infectious Disease Research Institute Chemogenomics Patrick Tao Li BGI (formerly Beijing Genomics Institute) Meta-Analysis Kathryn DeRiemer University of California, Davis 2:10 p.m. Discussion with speakers, panelists, and audience

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APPENDIX A 167 Session VIII: Creating an evidence-based blueprint for action: Identification of Four steps Session Objective: • Present highlights from the workshop and identify a blueprint for action based on discussions from the previous 2.5 days. Session Chairs: • China co-chair: Yanlin Zhao, Chinese Center for Disease Control and Prevention • U.S. co-chair: Gail Cassell, Harvard Medical School and Infectious Disease Research Institute 2:30 p.m. Action #1: Expose and Address the Silent Epidemic of DR TB in Children: Evidence Challenges and Mobilization of a Global Network Mercedes Becerra Associate Professor Department of Global Health and Social Medicine Harvard Medical School Qian Gao Fudan University, Shanghai 2:45 p.m. Action #2: Adopt Genomic Tools to Map the Epidemic of Drug-Resistant TB and Address Diagnostic Challenges Sven Hoffner Director, WHO Supranational TB Reference Laboratory Associate Professor, Department for Preparedness Swedish Institute for Communicable Disease Control Yanlin Zhao Vice Director, National Center for Disease Control and Prevention Director, National Tuberculosis Reference Laboratory Chinese Center for Disease Control and Prevention

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168 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS 3:00 p.m. Action #3: Block Transmission of Drug-Resistant TB Edward Nardell Associate Professor Departments of Environmental Health and Immunology and Infectious Diseases Harvard School of Public Health Lixin Zhang Deputy Director, CAS Key Laboratory of Pathogenic Microbiology & Immunology Inaugural Director of Drug Discovery Center for Tuberculosis Institute of Microbiology, Chinese Academy of Sciences 3:15 p.m. Action #4: Revolutionize Drug Distribution, Guarantee Drug Quality, and Reform Regulatory Approval and Registration Policies Barry Bloom Distinguished Service Professor Department of Immunology and Infectious Diseases Harvard University Dean of the Harvard School of Public Health (former) 3:30 p.m. BREAK Session IX: A biosocial approach: Science and economic intervention for DR TB control—BRICS at the Forefront Session Objective: • Discuss the leading role of BRICS countries in the effort to com- bine science and evidence-based policies with economic interven- tions to combat DR TB. Session Chairs: • China co-chair: Yanlin Zhao, Chinese Center for Disease Control and Prevention • U.S. co-chair: Rifat Atun, Professor of International Health Management, Imperial College London

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APPENDIX A 169 3:45 p.m. What Will Be Required for Zero Deaths from Drug-­ Resistant TB? Salmaan Keshavjee Associate Professor Department of Global Health and Social Medicine Harvard Medical School 4:15 p.m. Reflections from BRICS Countries: What Are the Next Steps? Rifat Atun Professor of International Health Management Imperial College London Paul Farmer Chair, Department of Global Health and Social Medicine Harvard Medical School Kristina Wallengren Clinical Advisor KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH) Grigory Volchenkov Head Doctor Vladimir Oblast TB Dispensary Center of Excellence for TB Infection Control Yanlin Zhao Vice Director, National Center for Disease Control and Prevention Director, National Tuberculosis Reference Laboratory Chinese Center for Disease Control and Prevention 5:15 p.m. Discussion with speakers and audience 6:00 p.m. Reflections on the New Delhi Communiqué Jarbas Barbosa (by teleconference) Vice-Minister of Health Federative Republic of Brazil

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170 DRUG-RESISTANT TUBERCULOSIS IN CHINA AND THE BRICS 6:15 p.m. Adjourn day 3 and workshop 7:00 p.m. BANQUET