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Appendix A Agenda THE NEW PROFILE OF DRUG RESISTANT TUBERCULOSIS: A GLOBAL AND LOCAL PERSPECTIVE Sponsored by the U.S. National Academy of Sciences, Institute of Medicine, Forum on Drug Discovery, Development, and Translation, and the Russian Academy of Medical Sciences, this 2-day workshop will address the spread of multidrug-resistant (MDR) tuberculosis in Russia and across the globe, as well as the rapid emergence and spread of extensively drug resistant (XDR) tuberculosis. The implications of totally drug resistant (TDR) tuberculosis will also be discussed, as well as the newly emerging profile of MDR TB. Objectives: The primary goals of this workshop are: • t o increase awareness and create a renewed sense of urgency of the growing global burden of multidrug- and extensively drug-resistant tuberculosis (MD/XDR TB) and its profile in Russia; • t o consider the magnitude of transmission of drug-resistant strains and options for transmission and infection control; • t o address the MDR TB burden in vulnerable populations, includ- ing pediatric cases, those co-infected with HIV, and substance abusers; • t o assess current treatment options and approaches to patient care, taking into account the unique needs of the population being treated; 113

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114 DRUG-RESISTANT TUBERCULOSIS IN RUSSIA • t o discuss the supply of quality-assured second-line TB drugs and the pipeline for a new “cocktail” of TB drugs; • t o assess the current state of the art for rapid detection of drug resistance—and its implication for patient management; and • t o suggest policies to accelerate improvements in drug-resistant TB treatment and infection control. Wednesday, May 26 Conference Venue: International Science & Technology Centre (ISTC) Krasnoproletarskaya ulitsa, 32-34 127473 Moscow, Russia 09:00–09:30 Welcoming Remarks and Overview of Conference Objectives Dmitry Orlov, Russian Academy of Medical Sciences Mikhail Perelman, Moscow Medical Academy Gail Cassell, Eli Lilly and Company 09:30–12:30 Roundtable #1: Magnitude of the Burden of Drug Resistant Tuberculosis—Local and Global Perspectives Co-Chairs: Marina Yakimova, Central TB Research Institute Jeffrey Drazen, New England Journal of Medicine Global Status of MDR/XTR Tuberculosis, 30 min Salmaan Keshavjee, Chair, Green Light Committee (GLC) Harvard Medical School Epidemiology of TB in the Russian Federation, 30 min Marina Yakimova, Central TB Research Institute Prevalence of Drug Resistance at the Initiation of Second- Line Drugs in Eight Countries, 30 min Peter Cegielski, U.S. Centers for Disease Control and Prevention Profile of MDR/XDR in South Africa Based Upon Laboratory Data, 30 min Gerrit Coetzee, National Health Laboratory Service, South Africa

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115 APPENDIX A Current Status of Disease Burden and Programmatic Management of MDR/XDR TB in China, 30 min Mingting Chen, Center for Disease Control and Pre- vention, China Roundtable Discussion, 30 min 12:30–13:30 Lunch 13:30–15:30 Roundtable #2: The Capability of Health Care Systems to Keep Up with the Spread of MDR TB Co-Chairs: Elena Skachkova, Central Research Institute for the Organization and Informatization of Health Care, Moscow Dale Nordenberg, Novasano Health and Science Monitoring System of MDR TB, 30 min Elena Skachkova, Central Research Institute for the Organization and Informatization of Health Care, Moscow Surveillance Systems for TB Drug Resistance in China, 30 min Renzhong Li, Center for Disease Control and Prevention, China Laboratory lnformation Barriers to MDR TB Control, 30 min Dale Nordenberg, Novasano Health and Science Roundtable Discussion, 30 min 15:30 – 15:45 Break 15:45 – 17:45 Roundtable #3: Treatment of Drug-Resistant TB in Vulnerable Patient Populations Co-Chairs: Irina Vasilyeva, Central TB Research Institute Janet Tobias, Ikana Media Treatment of MDR TB, the CTRI Experience, 15 min Irina Vasilyeva, Central TB Research Institute

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116 DRUG-RESISTANT TUBERCULOSIS IN RUSSIA Approach to the Treatment of Children Infected with Multidrug-Resistant TB, 15 min Elena Ovsiankina,1 Central TB Research Institute HIV and MDR TB Co-Infection, 15 min Olga Frolova, Federal Center of TB/AIDS Treatment MDR TB in Cases of Substance Abuse, 15 min Piotr Golubchikov, Regional Anti-Tuberculosis Dispensary, Tomsk Epidemiology of TB in the Prison System of the Russian Federation, 15 min Svetlana Safonova, Federal Correction System, Russian Federation Response Panel and Roundtable Discussion, 45 min Sonya Shin, Harvard Medical School Carlos Pérez-Vélez, National Jewish Hospital, Denver Gary Reubenson, Rahima Moosa Mother & Child Hospital, South Africa 17:45–18:30 Gaps in TB Research: Meeting Report from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) Barbara Laughon, NIAID/NIH Alexandr Apt, Central Institute for Tuberculosis, Moscow Opportunities for International Cooperation Stuart Politi, Civilian Research and Development Foundation 1 Unable to attend the workshop due to an emergency.

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117 APPENDIX A Thursday, May 27 Conference Venue: International Science & Technology Centre (ISTC) Krasnoproletarskaya ulitsa, 32-34 127473 Moscow, Russia 08:30–10:10 Roundtable #4: Rapid Methods for Determining Drug Resistance in Tuberculosis and Implications for Patient Management Co-Chairs: Elena Larionova, Central TB Research Institute Jerrold Ellner, Division of Infectious Diseases, Boston University Molecular and Genetic Methods of Mycobacteria Identification in Russia, 20 min Tatiana Smirnova, Central TB Research Institute Overview of Rapid Methods for Determining Drug Resistance in Mycobacterium tuberculosis, 20 min Elena Larionova, Central TB Research Institute Implication of Rapid Detection of Resistance in Patient Management, 20 min Danila Zimenkov, Engelhardt lnstitute of Molecular Biology, Moscow Response Panel and Roundtable Discussion, 40 min Maria Giovanni, National Institute of Allergy and Infectious Diseases, National Institutes of Health Nico Gey van Pittius, Stellenbosch University, South Africa Qian Gao, Shanghai Medical College, China 10:10–12:00 Roundtable #5: MDR TB Transmission and Infection Control Co-Chairs: Rostislav Mitrofanov, Novosibirsk Tuberculosis Research Institute Edward Nardell, Harvard Medical School Infection Control in Anti-Tuberculosis Institutions, 20 min Elina Sevastyanova, Central TB Research Institute

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118 DRUG-RESISTANT TUBERCULOSIS IN RUSSIA Transmission of MDR/XDR in Shanghai, 20 min Qian Gao, Shanghai Medical College, China Transmission-Based Genetic Analysis in South Africa, 20 min Nico Gey van Pittius, Stellenbosch University, South Africa Turning off the Spigot: Reducing Nosocomial Drug- Resistant TB Transmission, 20 min Edward Nardell, Harvard Medical School Roundtable Discussion, 30 min 12:00–13:00 Lunch 13:00 – 13:50 Roundtable #6: lnnovative Efforts to Advance MDR TB Control and Treatment Co-chairs: Vladislav Gergert, Central SRI of TB, RAMS Jeffrey Drazen, New England Journal of Medicine Stem Cell TB Therapy Application in Experiment, 20 min Vladislav Gergert, Central SRI of TB, RAMS Stem Cell Therapy in MDR TB Patients: A Promising Approach? 20 min [via online presentation] Mark Maeurer, Karolinska Institute Roundtable Discussion, 10 min 13:50–14:35 Roundtable #7: Addressing Challenges in MDR TB Drug Procurement Co-chairs: Nikita Afanasiev, USAID, Moscow Paul Zintl, Partners In Health The World Health Assembly Resolution on MDR/XDR TB: Is It Important for Russia’s Second-Line TB Drug Supply? 15 min Paul Zintl, Partners In Health

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119 APPENDIX A Response Panel and Roundtable Discussion, 30 min Dmitry Goliaev, Russian Health Care Foundation Alex Golubkov, Partners In Health Benjamin Potashnikov, Biocom, Russia 14:35–15:00 Break 15:00–18:15 Roundtable #8: Closing Plenary Lectures: A Blueprint for Action Chair: Gail Cassell, Eli Lilly and Company Remarks from Academician Mikhail Perelman, Moscow Medical Academy The Realities of Global MDR TB Control and the Growing Number of Totally Resistant Cases (XDR TB): An Argument for Quantifying the Threat in Tangible Ways Paul Farmer, Partners In Health The Critical Role of Regulatory Science and Innovation in Making Existing Drugs Matter and in Development of New TB Drugs and Diagnostics Margaret Hamburg, Commissioner, U.S. Food and Drug Administration Former Public Health Commissioner, New York City Summary of Meeting Highlights and a Blueprint for Action Salmaan Keshavjee, Green Light Committee (GLC) Initiative Response Panel and Roundtable Discussion Peter Cegielski, U.S. Centers for Disease Control and Prevention Mingting Chen, Center for Disease Control and Prevention, China Gerrit Coetzee, National Health Laboratory Service, South Africa Janet Tobias, Ikana Media 18:15–18:30 Closing Remarks Gail Cassell, Eli Lilly and Company

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