Priority Medicines For Europe and the...

Chapter 8.1 CS3: Public-Private Partnerships for Neglected DiseasesOpportunities to address pharmaceutical gaps for neglected diseases

Priority Medicines For Europe and the World"A Public Health Approach to Innovation"

Background Paper for Review

Public-Private Partnerships for Neglected Diseases:

Opportunities to address pharmaceutical gaps for neglected diseases

CASE STUDY 3

Global Alliance for TB Drug Development (TB Alliance)

By Elizabeth Ziemba, JD, MPH

7 October 2004

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Case Studies and Needs Assessment of Four Public-Private Partnerships

Global Alliance for TB Drug Development (TB Alliance)

Introduction:

The Global Alliance for TB Drug Development (TB Alliance or GATB) is a nonprofit, public-private partnership organization dedicated to the discovery and development of new, faster-acting and affordable drugs to fight tuberculosis (TB). Established in 2000, the TB Alliance catalyzes global TB drug development and develops a portfolio of promising anti-TB drugs through innovative partnerships involving public, private and academic research worldwide.1

History of TB Alliance:

The TB Alliance was conceived at a February 2000 meeting in Cape Town, South Africa, hosted by the Rockefeller Foundation and the Stop TB Partnership, where 120 representatives from public health, development aid, research, academia, industry and non-governmental organizations gathered to discuss the problems of tuberculosis treatment. Participants stressed the need for new TB drugs and highlighted the unprecedented scientific opportunities, public health imperative and economic rationale for developing new TB treatments. The resulting "Declaration of Cape Town" provided a road map for TB drug development and led to the creation of the Global Alliance for TB Drug Development (TB Alliance), now headquartered in New York City, with offices in Brussels, Belgium and Capte Town, South Africa.2

The formation of the TB Alliance was driven by the need to halt the increasing spread of TB whose control efforts were hindered by the lengthy and cumbersome regimen imposed by old drugs. Research and development in this field had come to a virtual standstill as the last novel anti-TB compound was introduced in 1970 and anti-TB programs winded down even before antimicrobial research at large TB does not get the attention it deserves because its victims are often poor, with the highest disease burden in developing countries, so there is a lack of financial incentive for pharmaceutical companies to invest in the development of new medicines to treat this disease.

The rapid spread of the disease, the growing the lack of effectiveness of existing old medicines, and the increasing resistance to the current treatment regimens are contributing to this global health crisis that the Global Alliance for TB Drug Development is working to solve.

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Mission:

The mission of the TB Alliance is to accelerate the discovery and/or development of cost-effective new drugs that shorten or simplify treatment of TB, provide effective treatment of multi-drug-resistant TB, improve the treatment of latent TB infection, and can be made affordable and accessible in TB endemic countries. Error:Reference source not found

According to its website3:“We are building a portfolio of promising drug candidates and forging innovative partnerships in order to deliver a new anti-tuberculosis drug in a decade.

As a not-for-profit enterprise, we enlist the best practices, science and resources of the private and public sectors the world over to meet this urgent health need.

Our mission is to ensure equitable access to a new, faster tuberculosis cure that will advance global health and prosperity. “In support of its mission the TB Alliance joins forces with other organizations to catalyze science and industry; rallies governments and policymakers; and mobilizes health and advocacy communities.4

Notably, this endeavor is supported by the World Health Organisation: the Stop TB Partnership appointed the TB Alliance as the lead agency of its Working Group for TB drug Development and integrated the search for such new tools as a cornerstone of its Global Plan to Stop TB.

“Now that we have the Global Plan, the world must invest in better treatment today and tomorrow. If we fail to back such a simple roadmap, future generations will remember us, not for stemming the tide, but for choosing to permit an airborne contagion to team up with HIV and sweep the globe.”Dr. LEE Jong-Wook, Director-General, World Health Organization, 2003

Disease Rationale:

The worldwide resurgence of tuberculosis (TB) is extensively documented: Every fifteen seconds, a person dies from TB; one third of the world’s population is already infected with TB; every second someone in the world becomes newly infected with TB.5

The top ten endemic countries are: India, China, Indonesia, Nigeria, Bangladesh, Pakistan, Philippines, Ethiopia, South Africa, and the Russian Federation.Error: Reference source not found With increases in travel, mass transportation and population displacement, TB is everywhere including Europe and North America.Error: Reference source not found

Tuberculosis is a disease caused by bacteria called Mycobacterium tuberculosis. The bacteria usually attack the lungs and are easily spread through the air when a person with an active case of TB coughs or sneezes.6 Individuals with weak immune systems such as

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individuals with AIDS are particularly susceptible to TB. HIV infection is the most potent risk factor for converting latent TB into active transmissible TB.7 – accelerating the spread of the disease - while TB bacteria help accelerate the progress of the AIDS infection in the patient. Today TB is the leading cause of death in persons who are HIV positive. Treatment consists of a six to nine month course of medicines. Daily oral doses of multiple drugs that may include combinations of rifampin, isoniazid, pyrazinamide, ethambutol, or occasionally others, are continued until the patient is cured.8

The expense or availability of the medicines as well as the lengthy course of treatment impacts this regimen. Once patients feel better, they may stop taking the medicines. Unfortunately, more than two- thirds of TB patients do not receive full and proper treatment, further fueling the spread of deadly multi-drug resistant strains (MDR-TB) have emerged.

MDR-TB cannot be adequately treated through the standard short-course therapy, so treatment requires up to 2 years of "second-line" drugs. These drugs are often toxic, expensive and ineffective, since no new drug has been introduced in thirty years. The costs can be staggering - up to 1,400 times the cost of regular treatment. Many MDR-TB cases defy a cure.

Areas where MDR-TB is a serious problem include Estonia, Latvia, and China’s Henan Province. MDR-TB strains also are appearing in significant numbers in Mexico; cases also appear to be increasing in Denmark and Germany

According to the World Health Organization, Global Tuberculosis Control Report, 20019, the number of cases by region has grown and is projected to grow as follows:

Table 8.1. Estimated Number of Tuberculosis Cases by Geographic Region

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Global Tuberculosis Control WHO Report, 2001, WHO/CDS/TB2001.287, page 42, http://www.who.int/gtb/publications/globrep01/PDF/GTBR2001woannexes.pdfaccessed 5 May 2004.

As discussed in other sections of this report, tuberculosis and multiple drug-resistant tuberculosis is a growing health problem in the European Union, particularly the expanded European Union.

Impact of New Drugs

With the new drugs targeted by the TB Alliance, the improved treatment regimen will become the cornerstone of future TB control and accelerate the path to reversing the epidemic, because it will:o Improve DOTS. By shortening or simplifying therapy, a new

regimen will enhance the effectiveness of DOTS programs, improve patient compliance, and thereby increase cure rates.

o Accelerate access to TB treatment and TB control. A shorter TB treatment will dramatically facilitate DOTS implementation and will offer a cost-effective mechanism to expand DOTS in resource-scarce settings. Currently, only one third of patients worldwide are treated under DOTS yet TB control rests on effective treatment of active cases.

o Control MDR-TB. By effectively treating resistant strains, a new drug will have a profound impact on the life of MDR-TB patients. A more effective MDR-TB drug will reduce the length of treatment, thereby increasing compliance among MDR patients and decreasing the emergence of super MDR organisms--those resistant to virtually all known anti-TB drugs.

o Combat HIV. HIV and TB have become twin-epidemics and TB is now the single largest cause of death in AIDS patients. With carefully tested new drugs, the simultaneous administration of anti-TB (ATB) and antiretroviral (ARV) drugs will no longer be hindered by incompatible regimens. Furthermore, a short-acting drug regimen will play a critical role in effective HIV care and prevention.

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http://www.who.int/gtb/publications/globrep01/PDF/GTBR2001woannexes.pdf


Current Organizational Composition, Partners, and Funding:

Organization

The TB Alliance’s business model of a public-private partnership is predicated on lean, efficient operations of a small biotech, with a social mission. In addition to a Chief Executive Officer, who leads the organization and is a member of the Board, the TB Alliance management structure includes Directors of R&D, Advocacy and Public Affairs, and Finance and Administration supported by a small staff and developing activities worldwide through a network of partners. A Stakeholders Association and a Scientific Advisory Committee provide guidance and support to its activities.10

The Board of Directors

A Chief Executive Officer leads the organization and is a member of the Board. The Board of Directors assumes fiduciary responsibility for the TB Alliance and guides the business strategy, reviewing its strategies, actions, and budgets. The Board consists of seven to thirteen directors, elected for staggered three-year terms. Currently, the TB Alliance’s Board has eleven members, representing international and national government agencies, pharmaceutical and biotechnology companies, private foundations and non-governmental organizations.Error: Reference source notfound

Please refer to Annex 8.1.3, Section C for a list of members of the Board of Directors.

Stakeholders Association

The TB Alliance also includes in its governance framework a group of institutions that join in a "Stakeholders Association" and have certain roles and responsibilities of advising, guiding and supporting the organization. Provisions were made for close coordination between the TB Alliance, its Board of Directors, and its Stakeholders; including the election of a member of a Stakeholders representative to sit ex-officio on the Board of Directors. Stakeholders represent the breadth of institutions worldwide that share a clear interest and, a significant stake, in ensuring the development of new TB drugs through the Alliance. They include representatives from developing nations, governments, NGOs, foundations, industry, and other significant contributors to the fight against tuberculosis.11

Please refer to Annex 8.1.3, Section C for a list of members of the Stakeholders Association.

Scientific Advisory Committee

The TB Alliance established a Scientific Advisory Committee to assist in evaluating proposals and projects under consideration for

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investment as part of its TB drugs portfolio. Members of the Scientific Advisory Committee are selected for three-year terms. To address myriad scientific and technical needs, the Chair has the flexibility to invite scientists to serve as ad hoc members for limited periods of time or on a project-by-project basis. The Scientific Advisory Committee provides technical expertise on drug research, development, manufacturing, and distribution, as well as other medical and scientific issues, and consists of 15 scientific experts from a wide range of relevant disciplines, including, basic science, clinical expertise, drug development and ethics, among many others.12

Please refer to Annex 8.1.3, Section C for a list of members of the Scientific Advisory Committee.

Management Team and Staff

While operating on several continents, the TB Alliance maintains a lean organizational structure, adding resources as needed. This model allows it to be nimble and proactive, allowing it to continuously survey possible novel TB drug candidates and selectively intervene to move a drug candidate through development and ultimately to regulatory approval and registration.13

Please refer to Annex 8.1.3, Section C for more information about the Chief Executive Officer, Dr. Maria Freire and the staff of the TB Alliance.

Partners

TB Alliance has mobilized numerous partners in the drug development and funding process. By entering into public-private partnerships, the organization stimulates and leverages the basic research, discovery and development work carried out in industry, universities, and public and private research and clinical laboratories worldwide to ensure that promising drug candidates will move rapidly along the development "pipeline" to the patients in need. Detailed descriptions of specific partnerships and pipelines projects are provided below.

TB Alliance has received support including funding and in-kind donations such as expertise from the Bill & Melinda Gates Foundation, Rockefeller Foundation, Netherlands Ministry for Development Cooperation, U.S. Agency for International Development, World Health Organization, National Institute of Allergy and Infectious Diseases (National Institutes of Health), Centers for Disease Control and Prevention, GlaxoSmithKline, Bristol Myers Squibb Foundation , Medical Research Council of South Africa, and Research Triangle Institute.

Funding

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The TB Global Alliance has succeeded in raising more than $ 42 million from various public and private sources as of August 2004, and is finalizing and additional $8 million grant from USAID.

These funders and amounts are as follows:

DONORS TOTAL (USD)

Bill & Melinda Gates Foundation 25,000,000

Rockefeller Foundation 15,000,000

USAID 8,000,000

Dutch Government and World Health Organization (WHO)

2,000,000

Bristol Myers Squibb Foundation 150,000

TOTAL in grants 50,150,000

Additional in- kind contributions (US National Institutes of Health) 2,100,000

Initiative on Public-Private Partnerships for Health websitehttp://www.ippph.org/index.cfm?fund=add&passyr=1999&page=/ippph/partnerships/name&thechoice=show&id=10&typobj=0&id_chapter=funding, accessed 5 May 2004. Revised by TB ALLIANCE AUG 2004

No funds in support of this partnership have been received from the European Union.

Strategy and Pipeline Overview

Strategy

In order to address the market failures that produced a dearth of research and development to support new tuberculosis medicines, the TB Alliance is working towards solutions as a public-private partnership ensuring that anti-TB candidates are identified in public and private laboratories worldwide and move quickly through all stages of development.

The TB Alliance takes a two-pronged approach to its research and development strategy: (1) Building and managing a portfolio of promising anti-TB compounds whose development is outsourced to public and private collaborators worldwide and (2) Identifying and supporting projects that address critical infrastructure gaps and help to streamline the process for the successful registration of anti-TB medicines.14

The TB Alliance is building a solid portfolio of projects at the lead identification, lead optimization, preclinical and clinical development stages. Through competitive requests for proposals and active scouting, the TB Alliance identifies the most promising drug development projects. After scientific and technical due

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http://www.ippph.org/index.cfm?fund=add&passyr=1999&page=/ippph/partnerships/name&thechoice=show&id=10&typobj=0&id_chapter=funding

http://www.ippph.org/index.cfm?fund=add&passyr=1999&page=/ippph/partnerships/name&thechoice=show&id=10&typobj=0&id_chapter=funding


diligence, it selects project investments to enhance and strengthen its pipeline, thereby increasing the chances of success. It also actively engages with industry to advance TB drug development beyond its own portfolio.

A specific, technical development plan with clear timelines is established for each compound/project selected for the portfolio. The development plan includes a series of milestones, each designed to prompt a go/no-go decision that determines whether development continues. In a model already proven in industry, the TB Alliance outsources these activities, or engages in collaborative development with pharmaceutical research and development partners, but retains control of the management oversight, closely monitoring and evaluating progress at every stage.

To expedite registration of new medicines and to keep costs down, investments are leveraged by:15

Outsourcing to cost-effective contract research organizations, companies and/or other highly qualified technical/scientific institutions worldwide;

Obtaining in-kind contributions from public and private sector collaborators and partners;

Actively monitoring each stage of the R&D pipeline through dedicated project management;

Creating synergies between and among critical partners in drug development, particularly in the pharmaceutical industry;

Capitalizing on new scientific advances, such as the sequencing of M. tuberculosis, combinatorial chemistry, and other developments;

Pursuing creative licensing and intellectual property agreements;

Reducing the cost and length of clinical trials by obtaining regulatory fast- track status, conducting clinical trials where the necessary volume of patients already resides, and an efficient and proactive management process.

By combining public resources, both technical and financial, with private sector expertise and know-how16, the TB Alliance leads the drive to develop a solid portfolio of therapeutic alternatives and bring a new TB drug to the market by 2010.

Pipeline

Since 2000, the TB Alliance has catalyzed the expansion of the TB drug pipeline, now encompassing 20 drug R&D projects, by taking the lead or partnering on the development of seven projects at discovery, development and clinical stages, and actively negotiating for an additional nine.

The following chart represents the global drug development pipeline as of mid 2004:

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[The following section is an excerpt from the website, http://66.216.124.114/7_1_1GenericNewsArticles.asp?itemId=384, accessed 5 May 2004]

The TB Alliance has assembled a portfolio of promising anti-TB compounds and is overseeing their development. The compounds, which were carefully selected through TB Alliance business development initiatives including requests for proposals (RFPs), span the lead identification, lead optimization, and preclinical development phases. The portfolio reflects the TB Alliance strategy to engage expertise and resources in every discipline worldwide from academia, industry and public laboratories.

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http://66.216.124.114/7_1_1GenericNewsArticles.asp?itemId=384


Table 8.1.5 TB Alliance Product PortfolioError: Reference source not found

PA-824 & Analogs. PA-824, a nitroimidazole licensed by the TB Alliance from Chiron Corporation in 2002, has now successfully passed major preclinical milestones. The TB Alliance is on track to hold a pre-IND meeting with the FDA in early October 2004 with the goal of initiating a Phase I clinical study of PA-824 in the first quarter of 2005. .17The TB Alliance has also initiated a back-up program for analogs of PA-824 at the lead optimization stages and is finalizing a related collaborative research program with Novartis Institute for Tropical Diseases (NITD) in Singapore.

MJH-98-I-81 is an analog of isoniazid and a lead compound from the research project at Dr. Michael Hearn’s laboratory at Wellesley College. Through a two-year research project with the TB Alliance, Dr. Hearn has synthesized hundreds of distinct molecules. Emphasizing diversity, the goal is to find a path to a new drug using a wealth of existing and novel chemistry. MJH-98-1-81, an analog of isoniazid (INH), the cornerstone of current therapy, has good activity in vitro against M. tuberculosis and a high selectivity index.18

KRQ-10018. KRQ-10018, a novel quinolizine compound, is at the lead optimization stage at the Korea Research Institute of Chemical Technology (KRICT) in Taejon, South Korea. Acquired by the TB Alliance in April 2003, KRQ-10018 has demonstrated activity and specificity for tuberculosis. The compound is to be further evaluated for preclinical efficacy.Error: Reference source not found

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Quinolzines and Pyridones. Under the same agreement, the Korea Research Institute of Chemical Technology (KRICT) is synthesizing hundreds of quinolizines, quinolone and pyridone compounds. Quinolones, which are structurally similar to the quinolizines, are already on the market for other indications and have great potential for the treatment of TB. Compounds will be further tested in vitro and in vivo for specific activity against TB by KRICT’s partner, the Yonsei University in Seoul.Error: Referencesource not found

Moxifloxacin. Moxifloxacin, a quinolone with worldwide regulatory approval and developed by Bayer AG for treatment of skin and upper respiratory tract infections and pneumonia, has shown high levels of activity against TB in in vitro models. Research funded by the TB Alliance has affirmed moxifloxacin’s early promise for shorter therapy through in vivo experiments in a mouse model developed by Dr. Jacques Grosset of the Johns Hopkins University. Through a collaboration facilitated by the TB Alliance, the CDC TB Trials Consortium has undertaken a Phase II clinical trial to determine the acceptability and short-term efficacy of a moxifloxacin-containing regimen.Error: Reference source not found As of this writing, the TB Alliance is finalizing an agreement with Bayer and will take the lead of further developments of moxifloxacin for a TB indication.

Macrolides. On June 1, 2004, the TB Alliance entered into a two-year Sponsored Research and Collaborative Agreement with the University of Illinois at Chicago under which Dr. Scott G. Franzblau, Professor and Director, Institute for Tuberculosis Research, College of Pharmacy will undertake the synthesis and biological testing of macrolide antibiotics for the treatment of tuberculosis (TB).Among those classes of antimicrobial agents that do not include TB as an indication, the macrolides stand out as one of the most likely to yield a clinically useful TB drug based on the following properties: oral bioavailability and distribution to the lungs, low toxicity, infrequent adverse reactions, extensive intracellular concentration and activity, anti-inflammatory activity and, perhaps most importantly, demonstrated clinical utility and bactericidal activity in infections caused by several pathogenic and opportunistic mycobacteria. The primary goal of this project is to optimize the anti-TB activity of the macrolide antibiotics through the synthesis of additional chemically modified derivatives of erythromycin.

Other Projects under Negotiation. In addition to the compounds listed above, the TB Alliance is currently in discussion with public, private and academic facilities about partnering on the development of other compounds.

Catalyzing R&D Worldwide

While simultaneously building its own portfolio through the partnerships with public and private partners described above,

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including Bayer, Chiron and Novartis, the TB Alliance has helped catalyze the global TB drug pipeline by engaging all relevant industry players and by enhancing technologies to support drug development in general.

In this vein, the TB Alliance has taken both advisory and advocacy roles to support ongoing corporate efforts for TB, such as those currently underway at Novartis, Anacor, AstraZeneca, Lupin, Glaxo SmithKline (GSK) and other companies. Moreover, the TB Alliance Scientific Advisory Committee includes drug discovery and TB experts from GSK, Pfizer and Johnson &Johnson. Additionally, to enhance the scope and depth of the global pipeline, the TB Alliance has also invested in platform technologies that expedite, support and lower hurdles in TB drug development.

One essential platform technology is the mouse model for preclinical testing, which was instrumental in affirming preclinical efficacy of lead compounds, discussed above. Dr. Jacques Grosset, a researcher at the Johns Hopkins University, is widely recognized for his mouse model of tuberculosis which closely mimics human disease, allowing drug candidates to be tested prior to clinical trials. In research funded by the TB Alliance, Dr. Grosset’s mouse model affirmed the in vitro activity of moxifloxacin against M. tuberculosis. Moxifloxacin, a quinolone developed by Bayer AG, is now being tested in a Phase II clinical trial organized by CDC TB Trials Consortium and in a collaboration facilitated by the TB Alliance. The support of the TB Alliance also helps ensure that the murine model, a platform technology, will continue to be available for other TB drug development studies.Error: Reference source notfound

Others include the establishment of a worldwide inventory of preclinical and clinical capacity/expertise and clinical trial site standardization in selected countries in order to ensue the necessary clinical infrastructure as portfolio compounds advance to clinical trials. The TB Alliance is supporting the standardization of a network of 15 global sites in Africa, Asia and South America. The network is managed by Dr. Amina Jindani, a leading authority on TB clinical trials, based at the International Union Against Tuberculosis and Lung Disease (IUATLD). Dr. Jindani is evaluating the efficacy of TB therapy using WHO-recommended fixed dose combinations (FDCs), where four drugs are combined in a single pill. By training staff and upgrading laboratories, Dr. Jindani’s project can also provide the TB community with a set of potential clinical trial sites and establish guidelines for clinical trials to be used with potentially new anti-TB drugs.Error: Reference sourcenot found

Challenges in TB Drug Development:

The TB Alliance has identified three major gaps in TB drug development:19

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Product/compound Gap - Contrary to earlier assumptions that novel and effective anti-tuberculosis agents readily existed, the TB Alliance found that few lead compounds existed at late-stage development than originally thought requiring more work on innovative investigations of promising compounds at much earlier stages of development.

Knowledge Gap - In response to the lack of new validated molecular targets for TB research and the incomplete understanding of TB latency and persistence, the TB Alliance has made significant strategic investments in identifying new leads, negotiating agreements for access to existing compound databases, and forming expert groups to examine crucial areas in novel anti-tuberculosis drug development, among others.

Expertise Gap - Because TB requires more sophisticated handling during clinical trial testing unlike other diseases of the poor, such as malaria, the TB Alliance has invested in assessing and improving clinical trial capacity worldwide in preparation for the need to effectively evaluate upcoming novel compounds.

Outlook and Critical Constraints

The TB Alliance makes a forceful case for investments into TB drug development. It argues that developing a new pipeline of therapeutic alternatives for TB will cost an annual $40 million, only a fraction of the $4 billion spent yearly on diagnosis and treatment, primarily underwritten by the public sector. Furthermore, this $40 million cost would be a modest investment to reverse the trend of a disease whose global economic toll reaches already an annual $16 billion.

Unlike public-private partnerships developing novel prevention tools who often lack distribution mechanisms, the TB Alliance will be able to rely on a decade of investments into DOTS programs and their drug procurement and distribution mechanisms such as the Global Drug Facility. While further improvements in access to DOTS are imperative, the mechanisms are in place for the TB Alliance to rely on for the distribution of the new drugs in combination therapy.

On the other hand, as described above, the dearth of TB drug R&D in the last decades generated a series of gaps in the pipeline and in the global expertise, issues that the TB Alliance has had to address since one of the elements of success for this enterprise is the capacity to expand the portfolio of promising drug candidates to its optimal size.

To respond to this challenge, the TB Alliance has engaged multiple strategies, such as: scouting worldwide; investing selectively in earlier stages of research and development to prime the pump for new leads and active moieties; negotiating agreements for access to existing company libraries; forming expert groups to examine

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crucial areas in novel anti-tuberculosis drug development; and engaging the scientific community as well as leading funders of science to address TB. Within 3 years, it was able to significantly expand the portfolio of TB drug projects and the network of players involved.

As the TB Alliance enters the next crucial phase of drug development, the support of additional donors will be key to its success. In particular, the initiation of clinical trials, including the establishment of both infrastructure and a network of facilities, will require the rapid ramp-up of financial support and expanded endorsements.

Today, the major obstacle to the development of therapeutic alternatives for TB remains the lack of global investment into drug R&D for a disease providing little market incentive for industry investments.

Contact information

Office locations:

New York80 Broad Street31st FloorNew York, NY 10004USAPhone: +1 (212) 227-7540Fax: +1 (212) 227-7541

BrusselsAvenue Louise 1791050 BrusselsBelgiumPhone: +32 2 210 02 20Fax: + 32 2 223 6928

South Africac/o Medical Research CouncilP.O. Box 19070Tygerberg, Cape Town 7505South AfricaEmail: [email protected]

1 Global Alliance for TB website, http://www.tballiance.org, accessed 5 May 2004.2 Global TB Alliance website, http://www.tballiance.org/7_5_X_Fact_Sheet.asp, accessed 5 May 2004.5 Global Alliance for TB website, http://www.tballiance.org/2_1_C_AGlobalThreat.asp, accessed 5 May 2004.

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mailto:[email protected]

http://www.tballiance.org/2_1_C_AGlobalThreat.asp

http://www.tballiance.org/7_5_X_Fact_Sheet.asp

http://www.tballiance.org/


References and key documents consulted:Specific references are located at the end of the paper in the endnotes section.

Key documents consulted:

2002-2003 Annual Report, One Goal: A New TB Drug, Global Alliance for TB Development

The Economics of TB Drug Development, The Global Alliance for Tuberculosis Drug Development, October 2001, http://www.tballiance.org/pdf/Economics%20Report%20Full%20(final).pdf

Scientific Blueprint for TB Drug Development, Global Alliance for TB Drug Development, October 2000, http://www.tballiance.org/pdf/TB%20Scientific%20Blueprint%20Sum.pdfaccessed 5 May 2004.

Global Tuberculosis Control WHO Report 2001, WHO/CDS/TB2001.287.

3 Website for Global Alliance for TB Research, http://www.tballiance.org/1_1_C_MissionandVision.asp, accessed 5 May 2004.4 2002-2203 Annual Report, One Goal: A new TB Drug; Global Alliance for TB Drug Development.6 Website for the Centers for Disease Control, http://www.cdc.gov/nchstp/tb/faqs/qa_introduction.htm#Intro1, accessed 5 May 2004.7 Website for Global Alliance for TB Research, http://www.tballiance.org/2_1_1_TBandHIV.asp, accessed 5 May 2004.8 AllRefer website, http://health.allrefer.com/health/pulmonary-tuberculosis-treatment.html, accessed 5 May 2004.9 Global Tuberculosis Control WHO Report, 2001, WHO/CDS/TB2001.287, page 42, http://www.who.int/gtb/publications/globrep01/PDF/GTBR2001woannexes.pdfaccessed 5 May 2004.10 Global TB Alliance website, http://www.tballiance.org/1_2_1_Governance.asp, accessed 12 May 2004.11 Global TB Alliance website, http://www.tballiance.org/1_2_2_stakeholders.asp, accessed 12 May 2004.12 Global TB Alliance website, http://www.tballiance.org/1_2_3_scientific.asp, accessed 12 May 2004.13 Global TB Alliance website, http://www.tballiance.org/1_4_TBAlliance_Team.asp, accessed 12 May 2004.14 Global TB Alliance website, http://www.tballiance.org/3_1_C_CatalyzingRandD.asp, accessed 12 May 2004.15 Global TB Alliance website, http://www.tballiance.org/3_1_C_CatalyzingRandD.asp, accessed 5 May 2004.16 Initiative on Public-Private Partnerships for Health website, http://www.ippph.org/?page=/ippph/partnerships/name&thechoice=show&id=10&typobj=0&id_chapter=impact, accessed 5 May 2004.17 Global TB Alliance website, http://66.216.124.114/3_1_2_AportfolioofDrugCandidates.asp, accessed 12 May 2004.18 Global TB Alliance website, http://66.216.124.114/7_1_1GenericNewsArticles.asp?itemId=384, accessed 12 May 2004.19 IPPPH website, http://www.ippph.org/?page=/ippph/partnerships/name&thechoice=show&id=10&typobj=0&id_chapter=impact, accessed 2 June 2004.

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http://www.tballiance.org/pdf/TB%20Scientific%20Blueprint%20Sum.pdf

http://www.tballiance.org/pdf/TB%20Scientific%20Blueprint%20Sum.pdf

http://www.tballiance.org/pdf/Economics%20Report%20Full%20(final).pdf

http://www.tballiance.org/pdf/Economics%20Report%20Full%20(final).pdf

http://www.ippph.org/?page=/ippph/partnerships/name&thechoice=show&id=10&typobj=0&id_chapter=impact




http://66.216.124.114/3_1_2_AportfolioofDrugCandidates.asp




http://www.tballiance.org/3_1_C_CatalyzingRandD.asp

http://www.tballiance.org/3_1_C_CatalyzingRandD.asp

http://www.tballiance.org/1_4_TBAlliance_Team.asp

http://www.tballiance.org/1_2_3_scientific.asp

http://www.tballiance.org/1_2_2_stakeholders.asp

http://www.tballiance.org/1_2_1_Governance.asp

http://www.who.int/gtb/publications/globrep01/PDF/GTBR2001woannexes.pdf

http://health.allrefer.com/health/pulmonary-tuberculosis-treatment.html

http://health.allrefer.com/health/pulmonary-tuberculosis-treatment.html

http://www.tballiance.org/2_1_1_TBandHIV.asp

http://www.cdc.gov/nchstp/tb/faqs/qa_introduction.htm#Intro1

http://www.tballiance.org/1_1_C_MissionandVision.asp


References to Case Study 3

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