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).
never start treatment—risking the escalation of disease/amplification of drug-resistance, enhanced infectivity and transmission of disease to others, 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 pharmacy), or no treatment at all. The involvement of both the public and private 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 consideration of bottlenecks.
What are the advantages and disadvantages of centralization in the management of the global drug supply chain, and potential decentralized approaches to improve operations of the supply chain.
What can be learned from case studies and examples from 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
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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).
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 structure 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
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
PRASHANT YADAV
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
11:25 a.m. Speaker/Panel Discussion: Challenges and Barriers from the Perspective of Suppliers and Manufacturers
Panel Moderator:
• Peter Cegielski, CDC
Panelists:
• Iain Richardson, Senior Director, Global Supply Chain and Logistics, Eli Lilly & Co.
• Robert Sebbag, Vice President, Access to Medicine, 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:
• Michael Kimerling, Bill & Melinda Gates Foundation
Panelists:
• Anne Goldfeld, Harvard Medical School/Global Health Committee
• Myriam Henkens, International Medical Coordinator, Médecins Sans Frontières
• Andy Gray, Senior Lecturer, Pharmaceutical Sciences, University of KwaZulu-Natal
• Norbert Ndjeka, MDR TB Director, National Department of Health, South Africa
1:45 p.m. Discussion Session with Panelists and Audience
SESSION II: DEFINING AND ASURING QUALITY
Session Objectives:
• Discuss definitions of “quality” in determinations about quality of SLDs.
• Examine the benefits and limitations of the existing SLD prequalification requirement and process.
• 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:
• Lisa Hedman, Project Manager, Essential Medicines and Health Products: Access and Rational Use, WHO
• Andreas Seiter, Senior Health Specialist, Pharmaceuticals, Health, Nutrition, & Population, World Bank
• Joël Keravec, MSH Brazil Country Program Director
• Patrick Lukulay, Vice President, Global Health Impact 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
3:55 p.m. Perspective from the Funders
CHERI VINCENT
TB Team Leader
USAID
MICHAEL KIMERLING
Senior Program Officer, Tuberculosis Global Health Program
Bill & Melinda Gates Foundation
4:25 p.m. Series of Presentations: Innovative Approaches to Financing
Speakers:
• Brenda Waning, Coordinator, Market Dynamics, UNITAID
• Andre Zagorski, Principal Technical Advisor for TB, Center for Pharmaceutical Management, MSH
• David Ferreira, Managing Director, Innovative Financing, GAVI Alliance
5:00 p.m. Discussion with Speakers and Audience
Issues for Discussion:
• What is lacking in the MDR TB drug supply system? Why do so few firms enter the SLD market?
• How can signaling be improved? What can the private sector do to encourage competition?
• What are imaginative new ways to raise funds for SLDs? To create healthy market expectations that make it possible to reduce prices?
Discussion Moderator:
• Rifat Atun, Imperial College London
5:30 p.m. Adjourn
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
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)
GAIL CASSELL, Workshop Co-Chair
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.
8:30 a.m. Background and Session Objectives
OWEN ROBINSON, Session Chair
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:
• Owen Robinson, Partners In Health
Supply—Drug Shortages
9:50 a.m. Presentation: Drug Supply Shortages at the Global/National Level
CHRISTOPHE PERRIN
QA Pharmacist
IUATLD
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:
• Peter Cegielski, U.S. CDC
Discussion Moderator:
• Owen Robinson, Partners In Health
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
PRASHANT YADAV, Session Chair
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
11:30 a.m. Series of Presentations: Learning from Other Models: Experience with Other Diseases
Speakers:
• Gordon Comstock, Director, Global Supply Chain, Partnership for Supply Chain Management
• David Ripin, Executive Vice President, Access, and Chief Scientific Officer, CHAI
• Nina Schwalbe, Managing Director, Policy and Performance, GAVI Alliance
12:15 p.m. Discussion with Speakers and Audience
Discussion Moderator:
• Prashant Yadav, University of Michigan
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.
BARRY BLOOM, Session Chair
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
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:
• A workshop session chair will first provide a 5-minute report of key issues discussed at the workshop relating to the theme.
• Then, during a 30-minute discussion period, audience 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
PETER CEGIELSKI, Session I Chair
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
3:05 p.m. Segment Three: Logistics, Supply, and Demand
Report from Session Chair
OWEN ROBINSON, Session IV Chair
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
PRASHANT YADAV, Session V Chair
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
BRAD HERBERT
Managing Director
Brad Herbert Associates
SOJI ADEYI
Coordinator, Public Health Programs
World Bank
JOSE GOMEZ-MARQUEZ
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
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)
GAIL CASSELL, Workshop Co-Chair
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
