Appendix A

Workshop Agenda

DEVELOPING AND STRENGTHENING THE GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MULTIDRUG-RESISTANT TB:
A WORKSHOP

July 31-August 1, 2012

IOM Keck Center
Room 100
500 Fifth Street, NW
Washington, DC 20001

Background and Meeting Objectives:

 

To effectively treat patients diagnosed with multidrug-resistant (MDR) tuberculosis (TB) (in 2010, WHO estimated that there were approximately 650,000 cases of MDR TB,1 and there were 150,000 deaths in 2008), and protect the population from further transmission of this disease, an uninterrupted supply of quality-assured second-line anti-TB drugs (SLDs) is necessary. The IOM Forum on Drug Discovery, Development, and Translation has convened a multi-year international initiative on MDR TB, which began with a foundational workshop in Washington, DC, in 2008, and when completed will have included international workshops in the high-burden countries of South Africa (2010), Russia (2010), India (2011), and China (forthcoming 2013). The four workshops that have been held to date have each identified issues related to the global drug supply chain for quality-assured second-line drugs for MDR TB as major barriers to access to treatment.

When SLDs are unavailable to the national TB control programme (NTP) and medical providers, patients miss critical doses of medicine or

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1 WHO 2011/2012 Tuberculosis Global Facts, http://www.who.int/tb/publications/2011/factsheet_tb_2011.pdf (accessed October 18, 2012).



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Appendix A Workshop Agenda DEVELOPING AND STRENGTHENING THE GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MULTIDRUG-RESISTANT TB: A WORKSHOP July 31–August 1, 2012 IOM Keck Center Room 100 500 Fifth Street, NW Washington, DC 20001 Background and Meeting Objectives: To effectively treat patients diagnosed with multidrug-resistant (MDR) tuberculosis (TB) (in 2010, WHO estimated that there were approximately 650,000 cases of MDR TB,1 and there were 150,000 deaths in 2008), and protect the population from further transmission of this disease, an unin- terrupted supply of quality-assured second-line anti-TB drugs (SLDs) is necessary. The IOM Forum on Drug Discovery, Development, and Transla- tion has convened a multi-year international initiative on MDR TB, which began with a foundational workshop in Washington, DC, in 2008, and when completed will have included international workshops in the high- burden countries of South Africa (2010), Russia (2010), India (2011), and China (forthcoming 2013). The four workshops that have been held to date have each identified issues related to the global drug supply chain for quality-assured second-line drugs for MDR TB as major barriers to access to treatment. When SLDs are unavailable to the national TB control programme (NTP) and medical providers, patients miss critical doses of medicine or 1  WHO 2011/2012 Tuberculosis Global Facts, http://www.who.int/tb/publications/2011/ factsheet_tb_2011.pdf (accessed October 18, 2012). 115

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116 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB never start treatment—risking the escalation of disease/amplification of drug-resistance, enhanced infectivity and transmission of disease to oth- ers, and death. Also, compared to the 6–9 month treatment course for drug-susceptible TB, treatment of DR TB requires a daily regimen of less potent, more expensive and more toxic drugs over the course of 2 years or more. Ensuring a reliable and affordable supply of high-quality SLDs is a complex public health intervention that, thus far, has not been organized or implemented in a way that allows all providers and patients access to second-line anti-TB drugs when they are needed. In 2010, the Green Light Committee (GLC)-approved (and thus quality-assured) 42,033 SLD patient treatments,2 reaching only about 6.47 percent of the estimated cases of MDR TB. Although some MDR TB patients not having access to SLDs through a GLC-approved program receive appropriate treatment through a government-run or other quality assurance program, it is estimated that 90 percent of patients with drug-resistant TB are not receiving treatment through a government-run or quality-assured program; thus they are likely receiving treatment from sources of unknown quality (e.g., the local phar- macy), or no treatment at all. The involvement of both the public and pri- vate sectors is important to ensure that patients receive effective second-line drugs in a timely and cost-efficient manner. This public workshop will explore innovative solutions to the problem of how to get the right SLDs for MDR TB to people who critically need them. More specifically, the workshop will examine current problems and potential opportunities for coordinated international efforts to ensure that a reliable and affordable supply of high-quality SLDs is available. The workshop objectives are to consider: • To what extent and in what ways current mechanisms are or are not effectively accomplishing what is needed, including consider- ation of bottlenecks. o  are the advantages and disadvantages of centraliza- What tion in the management of the global drug supply chain, and potential decentralized approaches to improve operations of the supply chain. o  can be learned from case studies and examples from What other diseases (e.g., malaria/Affordable Medicines Facility and HIV/AIDS/PEPFAR). • The current allocation of responsibilities and roles of the private (including industry and nonprofit public health organizations) and 2 GDF Annual Report, 2010, available at http://www.stoptb.org/assets/documents/gdf/ whatis/GDF%20Anuual%20Report%202010.pdf, p. 10 (accessed October 18, 2012).

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APPENDIX A 117 public sectors, and examination of opportunities for enhancing and optimizing collaboration. • Identification of potential innovative solutions to the problem. Day One 8:00 a.m. Continental Breakfast Available 8:30 a.m. Opening Remarks Gail Cassell, Workshop Co-Chair Visiting Professor, Department of Global Health and Social Medicine, Harvard Medical School Vice President, TB Drug Discovery, Infectious Disease Research Institute Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company (retired) Barry Bloom, Workshop Co-Chair Distinguished Service Professor, Department of Immunology and Infectious Diseases, Harvard University Dean of the Harvard School of Public Health (former) SESSION I: OVERVIEW OF THE BARRIERS IN THE SUPPLY CHAIN FOR MDR TB DRUGS Session Objectives: • Provide an overview of the history and current operational struc- ture of the supply chain for SLDs for MDR TB. • Examine barriers preventing the optimal operation of the current supply chain. • Discuss implications for access to SLDs as they are approved and become available as new drugs on the market. 9:00 a.m. Overview, Background, and Session Objectives Peter Cegielski, Session Chair Team Leader for Drug-Resistant TB International Research and Programs Branch, Division of Tuberculosis Elimination U.S. Centers for Disease Control and Prevention

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118 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB 9:15 a.m. Background on the Green Light Committee and the SLD Supply Chain for MDR TB Salmaan Keshavjee Assistant Professor, Department of Medicine & Director, Program in Infectious Disease and Social Change, Department of Global Health and Social Medicine, Harvard Medical School Associate Physician, Brigham and Women’s Hospital, Division of Global Health Equity Senior Tuberculosis Specialist, Partners In Health 9:35 a.m. GDF Vision for the SLD Supply Chain for MDR TB Lucica Ditiu Executive Secretary  Stop TB Partnership 9:50 a.m. Series of Presentations: Challenges and Barriers to Efficient Operation of Existing Supply Chain  rashant Yadav P Senior Research Fellow and Director, Health Care Research William Davidson Institute University of Michigan Sana Mostaghim MDR-TB Drug Access Project Manager Clinton Health Access Initiative Rifat Atun Professor, International Health Management Head, Healthcare Management Group Imperial College London 10:35 a.m. Discussion Session with Speakers and Audience Discussion Moderator: • Peter Cegielski, CDC 11:05 a.m. BREAK

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APPENDIX A 119 11:25 a.m. Speaker/Panel Discussion: Challenges and Barriers from the Perspective of Suppliers and Manufacturers Panel Moderator: • Peter Cegielski, CDC Panelists: •  ain Richardson, Senior Director, Global Supply Chain I and Logistics, Eli Lilly & Co. •  obert Sebbag, Vice President, Access to Medicine, R Sanofi 11:55 a.m. Discussion Session with Panelists and Audience 12:15 p.m. LUNCH 12:45 p.m. Speaker/Panel Discussion: Challenges and Barriers from the Perspective of Countries and Providers/Collaborating Organizations Panel Moderator: •  ichael Kimerling, Bill & Melinda Gates Foundation M Panelists: •  nne Goldfeld, Harvard Medical School/Global Health A Committee •  yriam Henkens, International Medical Coordinator, M Médecins Sans Frontières •  ndy Gray, Senior Lecturer, Pharmaceutical Sciences, A University of KwaZulu-Natal •  orbert Ndjeka, MDR TB Director, National N Department of Health, South Africa 1:45 p.m. Discussion Session with Panelists and Audience SESSION II: DEFINING AND ASSURING QUALITY Session Objectives: • Discuss definitions of “quality” in determinations about quality of SLDs. • Examine the benefits and limitations of the existing SLD prequali- fication requirement and process.

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120 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB • Discuss applications and lessons learned from other programs and sectors. 2:15 p.m. Background and Session Objectives Amy Bloom, Session Chair Acting Chief, Infectious Diseases Division USAID 2:20 p.m. Series of Presentations: Setting Quality Standards Speakers: •  isa Hedman, Project Manager, Essential Medicines and L Health Products: Access and Rational Use, WHO •  ndreas Seiter, Senior Health Specialist, Pharmaceuticals, A Health, Nutrition, & Population, World Bank •  oël Keravec, MSH Brazil Country Program Director J •  atrick Lukulay, Vice President, Global Health Impact P Programs, USP 3:00 p.m. Discussion with Speakers and Audience Discussion Moderator: • Amy Bloom, USAID 3:30 p.m. BREAK SESSION III: SLD FINANCING ISSUES Session Objectives: • Discuss issues relating to financing. Who will support the supply and delivery of SLDs? • Discuss potential innovative approaches and mechanisms that could be used for financing of SLDs. 3:50 p.m. Background and Session Objectives Rifat Atun, Session Chair Professor, International Health Management Head, Healthcare Management Group Imperial College London

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APPENDIX A 121 3:55 p.m. Perspective from the Funders Cheri Vincent  Team Leader TB USAID Michael Kimerling Senior Program Officer, Tuberculosis Global Health Program  & Melinda Gates Foundation Bill 4:25 p.m. Series of Presentations: Innovative Approaches to Financing Speakers: •  renda Waning, Coordinator, Market Dynamics, B UNITAID •  ndre Zagorski, Principal Technical Advisor for TB, A Center for Pharmaceutical Management, MSH •  avid Ferreira, Managing Director, Innovative Financing, D GAVI Alliance 5:00 p.m. Discussion with Speakers and Audience Issues for Discussion: •  hat is lacking in the MDR TB drug supply system? W Why do so few firms enter the SLD market? •  ow can signaling be improved? What can the private H sector do to encourage competition? •  hat are imaginative new ways to raise funds for SLDs? W To create healthy market expectations that make it possible to reduce prices? Discussion Moderator: •  ifat Atun, Imperial College London R 5:30 p.m. Adjourn

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122 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB DEVELOPING AND STRENGTHENING THE GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MULTIDRUG-RESISTANT TB: A WORKSHOP July 31–August 1, 2012 IOM Keck Center Room 100 500 Fifth Street, NW Washington, DC 20001 Day Two 8:00 a.m. Continental Breakfast Available 8:25 a.m. Day 2 Welcoming Remarks , Workshop Co-Chair Barry Bloom Distinguished Service Professor, Department of Immunology and Infectious Diseases, Harvard University Dean of the Harvard School of Public Health (former)  Workshop Co-Chair Gail Cassell, Visiting Professor, Department of Social Medicine, Harvard Medical School Vice President, TB Drug Discovery, Infectious Disease Research Institute Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company (retired) SESSION IV: SELECTED ISSUES OF DEMAND AND SUPPLY Session Objectives: • Identify and discuss key issues affecting and impeding the entry of SLDs into countries. • Discuss drug supply shortage issues.

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APPENDIX A 123 8:30 a.m. Background and Session Objectives  , Session Chair Owen Robinson Program Manager Partners In Health Demand—Entry of SLDs into Countries 8:35 a.m. Presentation: Country-Specific Regulations Vincent Ahonkhai Senior Regulatory Affairs Officer Gates Foundation 8:50 a.m. Presentation: Demand Forecasting Meg O’Brien Director Global Access to Pain Relief Initiative 9:05 a.m. Presentation: Information Management Issues Hamish Fraser Assistant Professor of Medicine, Harvard Medical School Director of Informatics and Telemedicine, Partners In Health 9:20 a.m. Discussion with Speakers and Audience Discussion Moderator: •  wen Robinson, Partners In Health O Supply—Drug Shortages 9:50 a.m. Presentation: Drug Supply Shortages at the Global/National Level Christophe Perrin QA Pharmacist IUATLD

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124 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB 10:05 a.m. Presentation: Drug Supply Shortages at the Facility Level Jim Barrington Global Program Director Novartis 10:20 a.m. Discussion with Speakers and Audience Discussant: •  eter Cegielski, U.S. CDC P Discussion Moderator: •  wen Robinson, Partners In Health O 10:50 a.m. BREAK SESSION V: LEARNING FROM OTHER MODELS Session Objectives: • Examine models and experiences from efforts addressing other diseases and supply chains. • Explore how the supply chain for SLDs for MDR TB is different from and/or similar to other supply chains. 11:10 a.m. Background and Session Objectives  , Session Chair Prashant Yadav Senior Research Fellow and Director, Health Care Research William Davidson Institute University of Michigan 11:15 a.m. Innovation in Practice: Lessons from the AMFm Soji Adeyi Coordinator, Public Health Programs World Bank

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APPENDIX A 125 11:30 a.m. Series of Presentations: Learning from Other Models: Experience with Other Diseases Speakers: •  ordon Comstock, Director, Global Supply Chain, G Partnership for Supply Chain Management •  avid Ripin, Executive Vice President, Access, and Chief D Scientific Officer, CHAI •  ina Schwalbe, Managing Director, Policy and N Performance, GAVI Alliance 12:15 p.m. Discussion with Speakers and Audience Discussion Moderator: •  rashant Yadav, University of Michigan P 12:45 p.m. LUNCH SESSION VI: CONCLUDING SESSION Session Objectives: • Identify and discuss key themes from the workshop. • Consider promising and innovative suggestions and potential solutions. , Session Chair Barry Bloom Distinguished Service Professor, Department of Immunology and Infectious Diseases, Harvard University Dean of the Harvard School of Public Health (former) 1:15 p.m. Presentation of Findings from the MDR TB Innovation Summit Tracy Sims Vice President Lilly Foundation

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126 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB 1:35 p.m. Group Brainstorming Session: Innovative Suggestions and Options for a Way Forward The group brainstorming session will be broken down into four segments, grouped according to themes that roughly correspond to the workshop sessions. For each segment: •  workshop session chair will first provide a 5-minute A report of key issues discussed at the workshop relating to the theme. •  hen, during a 30-minute discussion period, audience T members are invited to provide comments, innovative suggestions, and options for a way forward on key questions related to the theme. 1:35 p.m. Segment One: Mechanisms to Purchase and Supply Drugs: Who Will Get It Done? Report from Session Chair  , Session I Chair Peter Cegielski Team Leader for Drug-Resistant TB International Research and Programs Branch, Division of Tuberculosis Elimination U.S. Centers for Disease Control and Prevention 1:40 p.m. Discussion with Session Chair and Audience 2:10 p.m. Segment Two: Drug Quality Assurance Report from Session Chair Amy Bloom, Session II Chair Acting Chief, Infectious Diseases Division USAID 2:15 p.m. Discussion with Session Chair and Audience 2:45 p.m. BREAK

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APPENDIX A 127 3:05 p.m. Segment Three: Logistics, Supply, and Demand Report from Session Chair  , Session IV Chair Owen Robinson Program Manager Partners In Health 3:10 p.m. Discussion with Session Chair and Audience 3:40 p.m. Segment Four: Innovative Financing Report from Session Chair  , Session V Chair Prashant Yadav Senior Research Fellow and Director, Health Care Research William Davidson Institute University of Michigan 3:45 p.m. Discussion with Session Chair and Audience 4:15 p.m. Reflecting on the Way Forward/Next Steps Discussants Salmaan Keshavjee Assistant Professor, Department of Medicine and Director, Program in Infectious Disease and Social Change, Department of Global Health and Social Medicine, Harvard Medical School Associate Physician, Brigham and Women’s Hospital, Division of Global Health Equity Senior Tuberculosis Specialist, Partners In Health  rad Herbert B Managing Director Brad Herbert Associates Soji Adeyi Coordinator, Public Health Programs World Bank

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128 GLOBAL SUPPLY CHAIN FOR SECOND-LINE DRUGS FOR MDR TB  arquez Jose Gomez-M Director, Little Devices Lab Massachusetts Institute of Technology Trish Stroman Principal Boston Consulting Group Amy Bloom Acting Chief, Infectious Diseases Division USAID 5:15 p.m. Key Themes and Closing Remarks , Workshop Co-Chair Barry Bloom Distinguished Service Professor, Department of Immunology and Infectious Diseases, Harvard University Dean of the Harvard School of Public Health (former)  Workshop Co-Chair Gail Cassell, Visiting Professor, Department of Social Medicine, Harvard Medical School Vice President, TB Drug Discovery, Infectious Disease Research Institute Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company (retired) 5:30 p.m. Adjourn