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Nineteenth programme report | TDR 2007-2008

TDR/GEN/09.1

Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2009

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Compiled and edited by Julie N RezaDesign and layout by Lisa SchwarbCover Photo: WHO/TDR/Craggs

This report represents the combined efforts of many TDR staff, all of whom are thanked for their invaluable input, comments and support.

3Nineteenth programme report | TDR 2007-2008

Contents

Foreword by Dr Margaret Chan, Director-General, World Health Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Message from Professor Rolf Korte, Chair of the TDR Joint Coordinating Board (JCB) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

About TDR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Key achievements during 2007-2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

TDR in a changing global health landscape, Introduction by TDR Director Dr Robert Ridley . . . . . . . . . . 13

Research for delivery and access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Discovery and development of tools and products for neglected diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Empowerment – fostering research leadership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Stewardship – harmonizing support and aligning research to country needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Key publications and resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

TDR governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

TDR partnerships 2007-2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

TDR financial information 2007-2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

PART I

PART II

PART III

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“ TDR has decades of experience in building national research capacity and promoting local ownership and community engagement. ”


PART IPART I

We are at a critical time in our efforts to meet interna-tional health commitments made by United Nations member states. Health is the explicit focus of 3 of the 8 Millennium Development Goals, and is implicitly present in the remaining 5. On current trends, goals set for reducing maternal and childhood mortality are the least likely to be met in virtually all regions of the world. In welcome contrast, we see positive signs that malaria and tuberculosis could be controlled by 2015. For both diseases, however, problems of drug resistance need to be monitored as an urgent priority. Globally, numbers of new HIV infections have been gradually declining and numbers of people receiving AIDS treatment have risen, although the unmet need for treatment remains unac-ceptably large. Clearly, attainment of the health-related goals requires more effort on multiple fronts.

TDR is a source of innovation for new products and approaches. Since its inception, this special programme has given highest priority to the neglected tropical diseases, which currently affect around 1.2 billion of the world’s poorest people. TDR has consistently brought the power of rigorous scientific investigation to bear on these largely ancient diseases, which continue to anchor so many people in poverty.

We know from our experiences with primary health care that demand-led initiatives have the greatest chance of sustainable success. This is firmly acknowledged in the new TDR strategy – health leaders in endemic countries know best what works and what they need most in their countries.

As the Commission on Social Determinants of Health concluded in its 2008 report, efforts to reduce inequities in health outcomes depend on improvements in the conditions of daily life and fundamental changes in the inequitable distribution of power, money and resources. TDR looks at the impact of gender and cultural issues as part of the overall investigation of what works and what does not, and is identifying new strategies that can, for example, increase women’s status and role within the health system.

TDR has also made vital contributions to the develop-ment of WHO’s health research strategy and the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, which promotes innovation as a way to improve the range and affordability of medical interventions for diseases that disproportionately affect developing countries (approved as WHA resolution 61.21).

The new strategy that TDR has begun to implement will increase our ability to attack, on multiple fronts, some very long-standing and seemingly intractable problems. I mean here our ability to scale up show-case pilot projects to reach large populations, to improve access to existing interventions, and to reach the poor on an adequate scale. I also mean our ability to address multiple health needs in a cost-effective, integrated way. The new ambitions fixed for this programme greatly expand the portfolio of strategies being pursued in our collective efforts to improve health and alleviate poverty.

TDR is performing a more strategic role and providing a more holistic approach. These are very welcome attributes in the complex landscape of public health. We greatly need coordination, cohesion and coherence. TDR is using its convening power to catalyze concrete and strategic action. It is empowering disease endemic countries to take leadership roles, building on its decades of experience building national research capacity.

These tasks are not easy, but they are absolutely vital to our goals and our prospects for long-term success. These new functions, if performed well, will greatly increase our chances of making life better for the world’s huge population of neglected people with neglected health needs. I look forward to supporting and utilizing the range of broadened outcomes as TDR moves forward in this strengthened strategic role.

Foreword by Dr Margaret ChanDirector-General, World Health OrganizationExecuting agency for TDR

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“ TDR has never been an organization that rests on its laurels. Its future success will be measured by its ability to act as a catalyst for disease endemic countries to initiate and lead sustainable research initiatives. ”


PART I

The past two years have been both an exciting and challenging period for TDR’s Joint Coordinating Board (JCB). Health research has risen as a priority on global health agendas, and is seen as critical to reducing poverty and achieving the UN Millennium Develop-ment Goals (MDGs).

New challenges have emerged with the epidemiology of infectious diseases constantly evolving. Fresh health initiatives are providing new momentum. At the same time the multiplicity of actors contribute to a more complex institutional environment in which disease endemic countries (DECs) continue to risk being left behind in planning, and priority setting in the global research enterprise as a whole.

In response to these developments and challenges, TDR embarked on an extensive review of its operations and series of stakeholder consultations culminating in the adoption of a new Ten-Year Strategy in 2007, endorsed at the JCB’s 30th anniversary session in Geneva in June 2007.

In line with the strategy, the JCB also approved a new six-year business plan, which started to be imple-mented at the beginning of 2008. This plan positions TDR to play a global ‘stewardship’ role as facilitator and knowledge manager in the global research effort on infectious diseases of poverty. Similarly, TDR is stimulating efforts to empower researchers from DECs to build and exercise leadership at individual, institutional and national levels. The JCB itself has been an active contributor to this effort by striving to bring more DECs into the circle of TDR’s governance and to facilitate their strengthened contribution.

The JCB has also welcomed the reshaping of TDR’s research activities in the context of this new strategy. Research has been refocused to fill targeted, neglected needs in the research continuum. These include both the discovery of new drugs and tools at the upstream end of research and, at the other end of the spectrum, improving better use and access among poor popula-tions to the tools already available.

TDR’s research activities are increasingly underpinned by a trans-disciplinary view of health as defined not only by biomedical determinants but also social factors, such as gender and socio-economic status.

I commend to the global health community the output and impact of TDR historically, and particularly over the last two years. Its achievements continue to outweigh its limited budget. Despite this time of financial crisis, I believe that TDR deserves increased, not merely maintained, financial support from the many stakeholders that benefit from its activities.

TDR has never been an organization that rests on its laurels. Its future success will be measured by its ability to act as a catalyst for disease endemic countries to initiate and lead sustainable research initiatives that produce the innovative solutions of the future, develop a stronger presence in international health research, and effectively use research to inform and influence policy and practice.

Message from Professor Rolf KorteChair of the TDR Joint Coordinating Board (JCB)*

* The Joint Coordinating Board, TDR’s top level governing body which meets annually and counts 34 members (for more details, see chapter on governance).

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“ TDR – three simple letters that stand for the Special Programme for Research and Training in Tropical Diseases, the leading UN-based organization dedicated to research on infectious diseases of poverty. ”


PART I

TDR – three simple letters that stand for the Special Programme for Research and Training in Tropical Diseases, the leading UN-based organization dedicated to research on infectious diseases of poverty.

Since its establishment at the World Health Organization (WHO) in 1975, TDR has stimulated research and development of new drugs and diagnos-tics and implementation strategies that contributed to global elimination campaigns for four major diseases – Chagas disease, leprosy, lymphatic filariasis, and onchocerciasis – and a regional elimination campaign against visceral leishmaniasis. TDR field research has been critical in generating evidence that led to the adoption of major new health strategies, such as the use of bednets, artemisinin-based combination therapies (ACTs), pre-packaged antimalarial drugs in malaria prevention and treatment, community-directed interventions (CDIs) against onchocerciasis and malaria, and multidrug therapy for leprosy. TDR has also fostered the training of thousands of developing country researchers and has strengthened hundreds of developing country research institutions while playing a critical role in the birth of organizations such as the Global Forum for Health Research (GFHR), the Medicines for Malaria Venture (MMV) and the Founda-tion for Innovative New Diagnostics (FIND).

TDR operates within a broad framework of inter-governmental and interagency cooperation and participation. It has a budget of approximately US$ 50 million and a staff of 100; its unique position derives not from this budget or its relatively small size, but from the breadth of the consensus through which it operates in partnership with hundreds of scientists, institutions and networks all over the world, and by the manner in which it is governed, with its 4 co-sponsoring organizations as well as an indepen-dent governing board comprising equal representation of developed and developing countries.

Building on a successful past, TDR embarked on a new 10 year-strategy in 2007 in response to changes in the global health and research landscape. This strategy aims to foster ‘an effective global research effort on infectious diseases of poverty, in which disease endemic countries play a pivotal role’ and has three strategic arms: research on neglected priority needs, empowerment and stewardship.

In this report we provide an overview of our progress and achievements in the first phase of implementing this strategy during 2007-2008.

About TDR

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Within research for delivery and access, four studies led to significant outcomes that particularly deserve highlighting. These demonstrated that:

• Communities can effectively manage the collec-tion, distribution and administration of multiple complex interventions, including the diagnosis and treatment of malaria. This has major implications for community engagement in strengthening primary health care in Africa.

• Delivery of a malaria drug rectally (rectal artesunate) in the community close to the home to children seriously ill with malaria can ‘buy them time’ to get to health centres far away from their rural villages, preventing death and neurological damage.

• Tuberculosis (TB) detection by microscopy can be simplified in resource-poor settings, relieving pressure on over-stretched laboratories and limiting the number of long trips, often on foot, that patients need to make to clinics.

• Several dengue diagnostic tests meet appropriate standards and can now be offered at reduced cost to public health programmes through a WHO procure-ment scheme.

Similarly, under research for discovery and development of new tools and products there were several advances that could have a major impact in the future:

• A new, simplified skin patch test has been developed for the diagnosis of onchocerciasis. Approval from the ministries of health of endemic countries will now be sought for its use during large surveillance in onchocerciasis endemic areas which have undergone numerous rounds of ivermectin treatment.

• Lymphatic filariasis lesions of young children in India can be reversed by appropriate treatment, with implications for control strategies.

• Two new fixed-dose artemisinin combination drugs for the treatment of malaria have been developed, led by the Drugs for Neglected Diseases initiative (DNDi) with support from TDR. Mefloquine-arte-sunate was registered in Brazil by Farmanguinhos. Amodiaquine-artesunate was registered in Morocco by Sanofi-Aventis.

• TDR drug discovery networks have continued to generate lead compounds that have been transitioned into drug discovery projects with other partners.

Key achievements during 2007-2008

TDR achievements fall into four broad categories:

• Research for delivery and access

• Discovery and development of tools and products for neglected diseases

• Empowerment to foster capacity and research leadership

• Stewardship to harmonize and align research to country needs


PART I

At TDR we believe that how we do our work is just as important as what we do. Our new vision puts the focus on researchers and policy makers living in disease endemic countries. They should increasingly be setting the priorities, leading the research and making the decisions on how to use research evidence that affects the lives of people in their countries. Developing country scientists either led, or were significantly engaged in the research highlights mentioned on page 10.

Working with partners, TDR has supported the initiatives listed below that we believe will lay a sound basis for the empowerment of developing country researchers and the stewardship of research on infectious diseases of poverty.

Empowerment to foster capacity and research leadership in developing countries has been facilitated by supporting (in partnership with others):

• The creation of ANDI, the African Network for Drugs and Diagnostics Innovation, to bring together researchers, research organizations, policy makers and manufacturers in a coordinated manner that promotes and sustains African-led product R&D innovation and capacity building. This network is generating a lot of interest and support.

• Establishment of a new initiative, Enhancing Support for Strengthening the Effectiveness of National Capacity Efforts (ESSENCE), to help increase coordi-nation among donors in aligning their support of research in developing countries with the country needs.

• The building of new clinical trial research centres in Liberia and the Democratic Republic of Congo (DRC), enabling African scientists to lead the phase III trial of a new drug for onchocerciasis.

• Biosafety courses, and establishment of the first training programme for countries to address the social and ethical issues associated with the potential release of genetically modified mosquitoes.

Stewardship through broad stakeholder engagement in the provision of platforms for sharing knowledge and agreeing on priority strategies and agendas has been facilitated by:

• Development and launch of a new web-based portal – TropIKA.net – to allow more equitable access to information that can support evidence-based decision making and provide collaborative workspaces for key discussion groups and meetings.

• Support for the development of the Global Strategy and Plan of Action (GSPA) on Public Health, Innova-tion and Intellectual Property that was adopted by the World Health Assembly (WHA) in 2008, creating new momentum and more equal opportu-nities for health-related research and development (R&D) in developing countries.

• Support for the Global Ministerial Forum for Research on Health in Bamako, Mali in 2008.

• Laying the groundwork for the TDR Global Report on Research on Infectious Diseases of Poverty for early 2011 through the establishment of several expert disease and thematic reference groups.

• Development of guidelines and research strategies around specific issues in tropical disease research.

• Publication of over 400 peer reviewed TDR-supported research articles. More than 60% had a lead author with affiliation to a disease endemic country.

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“ TDR is in a unique position to ‘steward’ and promote newperspectives, and new research and capacity building initiatives to address global neglected disease priorities.”


PART I

The institutions and policies driving international health have undergone enormous change in recent years. World attention on diseases of poverty has been driven by civil society, governments, philanthropic organizations, health workers and researchers, and has led to a focus on the UN Millennium Development Goals (MDGs). Health research is a key component of this change. It should be better appreciated as a wise investment that can reap huge returns for human development, saving money and lives and enriching individuals and communities.

An expansion of product development partnerships (PDPs) is among the recent developments, helping to find novel ways of fighting disease through the devel-opment of new and improved treatments, diagnostics and other interventions. Continued investment and advances in basic science improve our knowledge and understanding of the interplay between infectious disease agents, the humans they infect and the vectors (often insects such as mosquitoes) that aid their transmission. The global armoury against diseases goes on expanding, and steps continue to be made towards the further elimination of several diseases, with talk by some of even globally eliminating malaria. If such elimination is to occur, however, increased attention will need to be paid to research that not only produces innovative tools, but that better informs how interven-tions are best administered and made accessible within resource poor communities.

The scope of health research has thus expanded, so that basic and clinical health research is beginning to be better complemented by much-needed research in social science, operations, implementation and health systems. This is exemplified by the release of the 2008 report of the WHO Commission on the Social Determinants of Health. Sectors such as agriculture, education and the environment are now included as part of a broader ‘research for health’ approach, with the need to link the organization of health research within the broader structures promoting science and technology in countries increasingly well recognised. This holistic approach should lead to better, more sustainable research and interventions that are directed towards country and community needs. Success will only come, however, if it is recognized that developing countries now have enhanced abilities to undertake, manage, initiate and lead research. Sustainable advances require strengthening these capabilities and enabling developing country ownership, responsibility and leadership within the many national and global research initiatives being launched to address infectious diseases of poverty.

TDR has played a major role in many of the advances referred to above, and in many cases, laid the foundation for new models and approaches that were taken forward by other organizations. As the leading UN-based organization dedicated to research on infec-tious diseases of poverty, TDR is in a unique position to ‘steward’ and promote new perspectives, and new research and capacity building initiatives to address global neglected disease priorities. A historical review of TDR’s contributions to tropical disease research and capacity building since its inception was published in 2007 to celebrate the 30th anniversary of TDR’s unique co-sponsored and intergovernmental governing body, its Joint Coordinating Board (JCB). It is available online at www.who.int/tdr.

TDR in a changing global health landscapeIntroduction by TDR Director Dr Robert Ridley

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Our new vision

Our new vision, launched in 2007, focuses on the fundamentals – to ensure that those who live in low and middle-income countries, where diseases kill and maim, can pivotally engage within global partnerships to find solutions to their problems and take control of their health-care needs.

We are committed to fostering an effective global research effort on infectious diseases of poverty in which disease endemic countries (DECs) play a pivotal role, focusing on three areas of work to achieve this:

• Stewardship: to improve coherence of global research efforts to meet country needs and priorities.

• Empowerment: to help enhance and improve DEC capacity and leadership in research.

• Research on neglected priority needs: to improve access to new and improved interventions.

Using a two-pronged effort, we are fostering:

1) discovery research directly relevant to neglected diseases and the targeted development of new products and treatment regimens that are not adequately addressed by other partners

2) implementation and operational research assessing new health interventions for real-life settings and developing and assessing strategies for improving and scaling up access and delivery.

A new way of working and communicating

In accordance with our new vision and strategy, TDR’s programme has been reorganized with new functions, staff and committees. To improve our communications about these issues, we have launched a new website, expanded our regular newsletter TDRnews, published three times per year, and are reporting research results in a variety of formats designed to meet the needs of varied audiences.

This biennial report on TDR’s activities is presented in a different format to that of previous years. It provides a general overview of TDR’s key activities, complementing a full series of 11 more detailed reports on different lines of TDR activity which are available in print and online at the TDR website (www.who.int/tdr) along with scientific publications and other documentation. Beginning next year, this progress report will be published annually to provide timely information on our latest activities and developments. We welcome feedback on these new communications approaches and on our work in general.

“ Our vision: To foster aneffective global research effort on infectious diseases of poverty in which disease endemic countries play a pivotal role. ”


Research Empowerment

Stewardship

Discovery

“ Infectious diseases continueto place an immense burden on the overstretched resources of disease endemic countries, and add to the suffering of those already battling with poverty. ”

“ The landscape in internationalhealth has changed enormously in recent years... and ‘research for health’ is currently high on the international health agenda. ”

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Research for delivery and access

TDR research is helping evaluate, assess and scale up health interventions, enhancing

their access in the countries and regions (often remote and rural) where they are most

needed. Multi-site and multi-country studies are carried out to common protocols

wherever possible so that findings have general applicability. TDR is also actively

engaged at the forefront of research that is embedded in national control programmes

– so that evidence-based interventions are integrated into use within health systems.

This results in strengthening systems and minimizing the disruption and distortion

that can often arise from scaling up of specific interventions.

Research


PART II

Key delivery and access highlights

• Studies funded and coordinated by TDR, working with the African Programme for Onchocerciasis Control (APOC), have demonstrated that a community-led approach in Africa can be utilized to deliver multiple interventions, including doubling access to malaria treatment within 24 hours and increasing delivery of bednets. This strategy has the potential to improve primary health care and strengthen health systems at their periphery.

• A large, randomized-controlled study funded and coordinated by TDR demonstrated that the use of rectal artesunate by trained volun-teers in remote areas prior to hospital referral could substantially reduce the risk of death or disability among children with severe malaria.

• TDR-sponsored studies and systematic reviews led to a significant change in WHO’s tuberculosis (TB) diagnostic policy, reducing the number of smears required for a labora-tory diagnosis of TB in resource-constrained settings – thus making diagnosis more cost-effective and easier for patients by reducing their number of visits to clinics.

• Three of nine dengue serological (IgM) tests evaluated by a laboratory network, jointly sponsored by TDR and the Paediatric Dengue Vaccine Initiative (PDVI), were found to be adequately accurate and sensitive for recom-mended use, leading to their placement on the WHO procurement list at reduced in cost to countries.Research

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Achievement detailsIntegrated community-directed interventions – improving access to drugs and preventive measures

Many simple and effective interventions are available to prevent and treat infectious diseases of poverty, but often these do not reach those that need them most – particu-larly in Africa. A TDR-coordinated study1 addressed this issue by showing how community-directed delivery of health interventions (CDI) in an integrated manner could dramatically improve access to vital drugs and preventive measures, particularly for malaria, in remote African communities. The strategy was based on the successful model developed by APOC for distribution of ivermectin for onchocerciasis (river blindness) in remote communities, only in this case there was a broader package of interventions (vitamin A, insecticide-treated bednets, antimalarial medications, and tuberculosis treatment). Carried out among 2 million people in Cameroon, Nigeria and Uganda, the study conducted by African researchers showed that bednet coverage, for example, was two times higher in CDI areas compared to other control districts, and showed how community volunteers, when empowered, could implement multiple interventions at various levels of complexity and across different diseases. These findings could have important implications both for improving health care at the primary level and for strengthening health systems. A number of African countries are using these results to implement such a CDI approach.

Rectal artesunate for malaria – saving lives in rural areas

A huge problem faced by rural communities is lack of access to malaria treatment at the first signs of illness, resulting in treatment delays that often lead to death or disability. A large randomized-controlled trial of 18 000 patients, 12 000 with malaria, coordinated by TDR and undertaken by lead investigators from malaria-endemic areas of Bangladesh, Ghana and the United Republic of Tanzania, found that one rectal artesunate suppository, administered before referral to the hospital, substantially reduced the risk of death or disability in patients in rural villages with severe malaria (who could not be given oral treatment and who were unable to get to a facility for injections for several hours). The Lancet published the study2 and in a commentary wrote, “If there are a handful of important papers every decade that will influence the way malaria is treated, this study is one of them.” These results provide additional evidence for the Malaria Treatment Guidelines Committee to make treatment recommendations. The potential to save lives is huge.

A new protocol for diagnosis of tuberculosis – making diagnosis easier for the patient

TDR-sponsored systematic reviews3 led to a WHO policy recommendation that the number of patient sputum specimens to be examined for smear microscopy diagnosis of TB be reduced from three to two, and for these samples to be taken within one day rather than two days, in areas where workload is high and resources limited. Not only does this allow for a substantial increase in the numbers of patients that can be assessed over a given time period, it also makes diagnosis a much easier process for patients (as they to


PART II

make fewer trips to the diagnosis facility). This policy change has important implications for women in the developing world who are often only diagnosed in advanced stages of the disease as they are unable to take 2 days off from their household and childcare duties to go to a clinic.

Evaluation of diagnostic tests – improving detection of dengue

Three of nine dengue serological (IgM) tests evaluated by the PDVI-TDR dengue laboratory network were shown to meet pre-determined levels of specificity and sensitivity.4 The results led WHO to include them in its Bulk Procurement Scheme at negotiated prices. This allows health-care institutions and programmes to purchase quality-assured diagnostic tests, which in turn will improve case management and also allow more effective detection and monitoring of dengue outbreaks.

Tuberculosis – many serological tests shown to have poor performance

TDR coordinated and funded researchers to carry out an evaluation of 19 TB serology tests widely used in disease endemic countries (DECs), finding none that showed acceptable performance characteristics.5 This evidence highlights the need for stricter regulatory control of diagnostics.

Home Management of Malaria – feasible and effective

TDR-supported research has continued to demonstrate that the delivery of the artemisinin-combination treatment (ACT) Coartem® via community volunteers, as part of home-based management of malaria, is feasible and effective.6-8 Another study – an evaluation of a pilot – showed that Child, Family and Wellness (CFW) shops were also capable of providing ACTs complying with national treatment guidelines. These shops are run by trained nurses or shop operators to dispense and sell essential drugs under a franchise arrangement with a Kenyan-based nongovernmental organization (NGO) called Sustainable Healthcare Foundation (SHEF). The evidence suggests that extensions to the health-care system like these, where there are no nearby doctors or health-care centres, provide important avenues for increased access to care close to home.

Schistosomiasis – studies on praziquantel dosage

A series of multi-country clinical trials were sponsored by TDR to compare the efficacy and safety of the most common single dosages of praziquantel (40 and 60 mg/kg) in patients with the different parasite species in Asia, Africa and the Americas. Results of those trials are now informing schistosomiasis treatment policies.9 In the Philippines, for instance, where the parasite Schistosoma japonicum is predominant, the 40 mg/kg dose was shown to be as effective as and better tolerated than the higher 60 mg/kg dose. In Brazil, however, results support the use of the 60 mg/kg dose for S. mansoni (which is the only species in Brazil). Data from studies in the United Republic of Tanzania and Mauritania are under analysis. Such findings underline the fact that different drug treatments may be required for different environments in light of variations in species, infection rates and social interactions.

“ This evidence highlightsthe need for stricter regulatory control of diagnostics. ”

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Ongoing workBearing in mind the importance of adapting inter-ventions to ensure their effectiveness in real-life settings, TDR continues to evaluate interventions to support disease elimination, community-level strategies, diagnostic and drug-based interven-tions, and vector control measures in the field. Some of our ongoing work is outlined below, and will be updated in future reports.

Research to support disease eliminationVisceral leishmaniasis – improving case-finding and treatment strategies

TDR is the main research arm of the campaign to eliminate visceral leishmaniasis (VL) in Bangladesh, India and Nepal. Two major multi-centre research studies have begun in the Indian subcontinent on VL case-finding and treatment strategies, and on the cost-effectiveness of VL vector management. These studies are due to be completed in 2011. A key preliminary finding is that house-to-house screening can effectively double the number of VL cases identified in one year. Such work brings researchers, national programme managers and the communities in which they work, together – and this is beginning to have a positive effect overall on the VL elimination campaign for the Indian subcontinent.

Onchocerciasis – studies on breaking disease transmission

Studies assessing the potential for multi-year high coverage preventive treatment with ivermectin to break the transmission of onchocerciasis (river blindness) in certain epidemiological settings are close to completion and will be reported in 2009.

Community level activitiesHome-based management of malaria – evolving the strategy and expanding to improve management of fever

The fact that ACTs can be successfully integrated into the home-based management of malaria (HMM) is now influencing malaria control policy, expanding the care delivery options. TDR is working with United Nations Children’s Fund (UNICEF) and other partners to develop integrated home-based approaches to the management of childhood fevers due to different causes such as pneumonia, diarrhoea and malaria. Initial results are anticipated the end of 2009. Studies are also being done to determine how to include rapid diagnostic tests into HMM and whether HMM can be adapted to urban areas (results are expected in 2010).

Diagnostic methodsSyphilis – evaluation of rapid diagnostic tests leads to elimination campaign

Six effective rapid syphilis tests previously evaluated by TDR are currently listed in WHO’s Bulk Procurement Scheme. TDR is now working with seven countries (Brazil, China, Haiti, Peru, Uganda, United Republic of Tanzania and Zambia) on how to introduce the tests


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into control programmes as part of elimination plans. Work is also underway to complete field assessment of a framework for the introduction of rapid syphilis diagnostic tests in countries in Asia, Africa and the Americas. Results are anticipated in late 2009.

Dengue – making disease classification easier

Since the early 1970s, dengue has been classified into three categories: dengue fever; dengue hemorrhagic fever; and dengue shock syndrome. However, such classification is difficult to apply in many settings, particularly in the context of the changing epidemi-ology of the disease. A TDR and European Union supported 4-year prospective clinical study (DENCO) in seven Asian and Latin American countries has now been completed and has given rise to an alternative classification which is being further assessed with a view to revising the classification and updating clinical guidelines in 2009.

Malaria – evaluation of marketed malaria rapid diagnostic tests

There is a multitude of marketed rapid diagnostic tests for malaria. However, there has been no comparative evaluation of them or assessment of whether they truly meet the standards required for public health use. In collaboration with multiple partners, TDR coordinated the evaluation of over 40 rapid diagnostic tests, with results made public in April 2009.

DrugsOperations research – scaling up antiretroviral treatment in Africa

TDR has supported country-devised and country-developed research associated with the scaled up use of antiretroviral (ARV) drugs. A first phase of operational research projects on ARV treatment scale-up with five HIV/AIDS high-burden countries will be reported in 2009 and a second phase of research is being developed. Findings so far have varied from country to country. Such findings are being incorporated into national policy while phase II plans are being developed. Related to this, TDR and the Global Fund to Fight AIDS, Tuberculosis and Malaria have produced a collaborative framework on implementation/opera-

tions research, which can be viewed or downloaded from the publications area of our website (www.who.int/tdr). Several of the countries involved in TDR studies have leveraged TDR support to obtain additional funds from the Global Fund for operations research.

Determining the safety and efficacy of concomitant and early use of anti-tb chemotherapy and highly active antiretroviral therapy (haart) among hiv-infected tuberculosis patients in sub-saharan africa

Studies are under way to assess the safety and efficacy of concomitant use of HAART and TB treatment, and to determine at what stage of HIV progression it becomes appropriate to start HAART. With four countries and 1800 patients, this represents one of the largest ever clinical studies on how best to treat HIV-infected TB patients. First results are anticipated in 2010.

Vector control measuresDengue – new approaches to control

Work is under way to assess the potential to combine two approaches – building upon a multi-centre cost-effectiveness study on targeted interventions and work on insecticide-treated materials (ITMs) such as bednets.

In collaborations with the International Development Research Centre (IDRC), Canada, studies are also under way that integrate research on environmental, vector-epidemiological (entomological) and social factors to make communities less vulnerable to vector-borne diseases such as dengue and Chagas disease in both Asia and South America.

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Discovery and development of tools and products for neglected diseases

Discovery

Over the last ten years, global efforts to develop new tools and products for neglected

diseases (such as drugs, diagnostics and vaccines) have dramatically increased. The

recent Global Strategy and Plan of Action (GSPA) on Public Health, Innovation and

Intellectual Property,10 adopted at the 2008 World Health Assembly recognizes this

need and calls for building and improving innovative capacity for research (particularly

in developing countries) and for improving, promoting and accelerating transfer and

technology between developed and developing countries as well as among developing

countries. TDR is focusing its activities in this area through innovative networks and

collaborative efforts that complement the role of other initiatives such as public-private

partnerships (PPPs).


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Key tools and products highlights

Discovery

• A transdermal delivery technology based version of a skin patch originally devised by African researchers to detect Onchocerca volvulus infection (in a project funded and coordinated by TDR) has been successfully developed in collaboration with Lohmann Therapie-Systeme AG for the diagnosis of onchocerciasis infection.

• A TDR-funded study in India has shown that albendazole and diethylcarbamazine treatment can reverse lymphatic filariasis lesions in young children at the early stage of the disease.

• Several TDR-supported activities in drug devel-opment have reached crucial milestones:

– A fixed-dose combination of mefloquine and artesunate for the treatment of uncomplicated malaria, initiated by TDR and primarily supported by Drugs for Neglected Diseases Initiative (DNDi) in collaboration with Farmanguinhos, has received regulatory approval in Brazil.

– A collaborative effort between TDR, Medicines for Malaria Venture (MMV) and GlaxoSmithKline (GSK) to develop a fixed-dose combination of chlorproguanil —dapsone—artesunate for the treatment of uncomplicated malaria was stopped following observation of adverse safety events in phase III studies.

– Moxidectin, a new drug in development for onchocerciasis control, has progressed from phase II to phase III under TDR coordination.

• TDR’s novel drug discovery networks and partnerships with both the public and private sectors in developed and developing countries have led to a managed portfolio of new drug leads for malaria and other diseases. These leads are undergoing further optimization, and in some cases helping to kick-start drug innovation in some disease endemic countries.

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Achievement details

DiagnosticsHigh-quality diagnostic tests are often unaffordable or inaccessible to patients in developing countries, while a lack of regulatory approval standards means poor quality diagnostics are widely sold and used. TDR has focused on research that can (i) lead to the development of diagnostic tools and methodologies for diseases such as TB, onchocerciasis and dengue; and (ii) evaluate currently available and marketed diagnos-tics to assess if they meet the standards necessary for public health use.

Onchocerciasis – a new skin patch test

A diethylcarbamazine (DEC)-containing skin patch test has been developed as a non-invasive tool to detect onchocerciasis infection. The DEC in the patch kills Onchocerca microfilaria in the skin giving rise to a rash within 24 hours that allows for easy detection. This method replaces the painful method of ‘snipping’ of pieces of skin and examining it under the microscope for the parasites. The concept of using DEC on the skin in this way arose from African scientists, but there had previously been no technology to allow its standardization and large-scale use. TDR supported the clinical (unpublished data) and field evaluation of the skin patch test, which was developed using transdermal delivery technology developed by LTS Lohmann Therapie-Systeme AG. Based on the review of the data from these evaluations and recom-mendation of the Technical Consultative Committee of the African Programme for Onchocerciasis Control (APOC), APOC will seek approval from onchocerciasis-endemic countries to use the patch as a tool to detect

residual infection in people from areas that have undergone extensive rounds of ivermectin treatment, and potentially for surveillance for re-emergence in areas that have stopped ivermectin treatment.

Drug research and development (R&D)Few drugs are currently available for the management of neglected tropical diseases, mechanisms of action are poorly understood and dosage and regimens are not always based on detailed pharmacokinetic and phar-macodynamic information. In addition, their extended use carries the risk of drug resistance development. We support drug research and development (R&D) at two levels – improving the use of drugs already available and supporting the discovery and development of new drugs.

Lymphatic filariasis – early treatment reverses lesions

A TDR-funded study in India on disease progression in children infected with Brugia malayi and the effect of treatment (albendazole + diethylcarbamazine) showed that lymphatic vessel lesions could be found in children as young as 3 years.11 Prompt treatment of these children resulted in a decline in microfilaremia and improvement of the subclinical pathology. The results highlight the reversibility of early lymphatic lesions and the need for early treatment. These obser-vations have been recognized as extremely important to the Global Programme for Lymphatic Filariasis.

Discovery and development of new drugs for malaria and onchocerciasis

Registration of amodiaquine-artesunate and mefloquine-artesunate

A TDR-initiated project on fixed-dose artemisinin combination therapies (ACTs) for the treatment of malaria was transferred to DNDi leadership six years ago, but with ongoing technical support from TDR. It reached a major achievement within the last two years when the amodiaquine-artesunate fixed-dose combination was registered in Morocco in 2007 by Sanofi-Aventis; it is now WHO pre-qualified. Mefloquine-artesunate fixed-dose combination was registered in Brazil by Farmanguinhos in 2008.


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Development of chlorproguanil-dapsone-artesunate terminated

This treatment for uncomplicated malaria – undertaken in collaboration with GSK and MMV – was stopped after phase III studies demonstrated safety concerns in patients suffering from deficiency in an enzyme called G6PD. This last example clearly demonstrates the ‘high-risk’ nature of drug development.

Onchocerciasis drug moxidectin progresses from phase II to phase III

For the past 20 years, ivermectin has successfully controlled most onchocerciasis symptoms (e.g. blindness and skin rashes) with an annual treatment that kills young worms, but not adult worms. Today, the drug is distributed to more than 60 million Africans through community-directed distribution systems established by APOC. A new drug, moxidectin, owned by Wyeth Pharmaceuticals, is now being tested by TDR in collaboration with Wyeth and APOC as a new treatment that could kill or sterilize adult parasites (which have an estimated lifespan of around 15 years). If proven effective and safe, moxidectin could poten-tially be used to eradicate onchocerciasis using the community-directed distribution mechanisms estab-lished by APOC for ivermectin. The completed phase I studies12-13 and the ongoing phase II proof-of concept study show moxidectin safety and microfilariacidal activity to be comparable to ivermectin. The phase III study was initiated in Liberia (see page 31), and is expected to be initiated in the Democratic Republic of the Congo (DRC) and Ghana by mid-2009. Submis-sion for registration is targeted for 2013 in parallel to large-scale community studies.

Drug discoveryTDR’s approach to drug discovery has been to harness the potential of novel networks and partnerships between the public and private sectors in both developed and developing countries, to help redress the desperate lack of drug leads and candidates to feed the development pipelines.14 At the same time, TDR is able to use this to build the capacity of DEC researchers in drug discovery research and to promote innovation for product R&D in DECs.

New drug discovery networks – leading to new leads

Thousands of compounds have been screened within the TDR screening network and several leads are now being optimized as potential drugs for malaria, Chagas disease and other neglected parasitic diseases. An orally-active lead compound for malaria has been identified based on animal data in a project managed at the University of Cape Town, South Africa, and collaborative discussions are ongoing with MMV as co-funding partner for this project. In another signifi-cant development, Novo Nordisk, in collaboration with the Chinese National Drug Screening Centre in Shanghai, has provided access to its ‘small-molecule compound library’ so that compounds can be screened against all diseases relevant to TDR’s activities. This complements the earlier compound libraries contrib-uted by several other pharmaceutical partners for compound screening within the TDR drug discovery network. It should be emphasized that an open source database of drug targets (www.tdrtargets.org) has been developed through this innovative network.15 In addition to supporting drug discovery, the database is also supporting diagnostics target discovery for neglected diseases and has the potential to support the discovery of new vaccine candidates.

26


Ongoing work

DiagnosticsChagas disease – standardized polymerase chain reaction protocol

TDR has sponsored a multi-country process of standardizing and validating the use of PCR for Chagas disease studies that could have impact both on patients and the conduct of clinical trials. Publication of the results and outcome of these studies are anticipated in 2009.

Drug R&DTB-HIV/AIDS – shortened regimen for gatifloxacin

A new fixed-dose combination therapy containing the fluoroquinolone gatifloxacin is under development as a TB treatment that could shorten treatment for this disease from 6 to 4 months. Recruitment in phase III studies is now completed and a decision on whether or not to apply for regulatory approval will be made in 2010.

Human african trypanosomiasis – improving treatment regimens

There are two ongoing studies on treatments for Human African trypanosomiasis (HAT), both aimed at improving existing treatment regimens. One study is investigating a 3-day regimen of pentamidine against the existing 7-day regimen for early stage HAT, with final results still several years away. The other study is on the use of a combination of nifurtimox and

eflornithine for the treatment of late stage HAT; this regimen has the advantage of shortening both the treatment period (from 14 days down to 10 days) and the interval of daily injections (from four to two daily) – both important factors in the delivery of treatment in resource-poor settings. This study has been developed and managed in conjunction with a related DNDi study. Recruitment was completed in December 2007. The follow up of these patients will continue until June 2009, after which the results will be analysed.

Catalysing vector control interventionsControl of vectors is a key element in the control of vector-borne diseases. Over the years, TDR has played a catalytic role in vector research, supporting the activities of international networks and initiatives and leading a pragmatic response to address the require-ments for potential deployment – including ethical, legal and social issues of using genetically modified vectors (see page 32 for related empowerment activities).

African trypanosomiasis – genomics

Progress continues on sequencing the tsetse fly genome through TDR activities on vector control interventions convened consortium.

Malaria – insecticide resistance

Work supported through the Multilateral Initiative for Malaria (MIM) is contributing to continent-wide data on insecticide resistance in malaria vectors and providing country-specific support on integrated vector management. Work within the network (in Burkina Faso) led to the establishment of a laboratory colony of Anopheles funestus. This is a novel achievement that will provide a valuable resource for understanding insecticide resistance. Further studies are also being conducted to assess insecticide resistance mechanisms and the potential epidemiological impact of this in Africa through TDR activities on innovative vector control interventions.


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28

Empowerment – fostering research leadership

Empower

TDR’s empowerment function builds on the many years of our support for research

capacity building in developing countries through focused research projects, course

development and training and networks. With our new strategy, we underscore the

importance of research quality in disease endemic countries (DECs) and have taken

steps forward by building quality into our services and products at each stage to

ensure cost effectiveness, sustainability and competitiveness of the researchers and

institutions in DECs. TDR is seeking to promote a pivotal role for DECs, not just through

its research but also through its governance structure (see page 43 Governance). Specific

‘empowerment’ support activities in TDR are coordinated by an Empowerment team,

but empowerment principles and activities are carried out across the entire spectrum

of TDR’s programmes.


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Empowerment highlights

Empower

In line with our focus on networks and collaborations, many of the highlights listed below were carried out in collaboration with partners:

• Launch of the African Network for Drug and Diagnostic Discovery and Innovation (ANDI), an initiative that aims to support African-led innovation, capacity and infra-structural development. This is believed to be a promising model for the implementation of the Global Strategy and Plan of Action for Public Health, Innovation and Intellectual Property.

• Launch of Enhancing Support for Strength-ening the Effectiveness of National Capacity Efforts’ (ESSENCE), a new initiative by several funding agencies who requested support by TDR to act as a neutral party to convene them and increase their internal coordination.

• TDR-established three clinical trial research centres in remote, post-conflict

areas in Liberia and the DRC to create research capacity in preparation for phase III trials of moxidectin (a potential drug for the acceleration of the elimination, and possibly for the eradication, of onchocerciasis).

• TDR has established the first programme of its kind for addressing social and ethical issues arising from the release of genetically modified mosquitoes, leading to continent-wide biosafety training in Africa, Asia and South America.

• The percentage of peer-reviewed articles on TDR-supported work with a lead author from a developing country increased to 65% during 2007-2008 (59% and 71% for 2007 and 2008 respectively).

• Refined grant giving and review processes were initiated to ensure quality and excellence of research and stronger linkages between individual training and capacity building with institutional and national capacity strengthening needs.

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Today, there is a need not only to support the development of technical research capacity but also of research leadership in the countries where the diseases of poverty occur. Greater equity and sustainable progress will ensue if researchers in developing countries play enhanced leadership roles at institutional, national and international levels. To undertake this effectively it is vital that the needs of individuals are matched to the needs of their institutions and countries. Quality and excel-lence in research is a core value that permeates everything that we do. In 2008, we introduced changes into our calls for applications, selection, monitoring and evaluation processes of all our capacity building programmes so that we could assure that individual and institutional needs were being met. There is now much closer support and follow up of all TDR grantees funded through the Empowerment unit.

Achievement details

NetworksWe believe that helping networks to establish them-selves in an organized way is one of the surest ways of empowering research communities from developing countries. We have established diagnostics research networks in over 40 countries. During 2007-2008 we also helped establish several networks that focus on research for health, with three of the most important described below.

African Network for Drugs and Diagnostics Innovation (ANDI) – developing country-led capacity

TDR’s successful North-South drug discovery networks and fellowship training programmes provided the impetus for the African Network for Drugs and Diagnos-tics Innovation (ANDI) initiative,16 which is now seen as a promising model for implementation of the Global Strategy and Plan of Action on Public Health, Innova-tion and Intellectual Property. The goal is to develop African-led product R&D innovation to support the discovery, development and delivery of new tools, including those based on traditional medicines, for diseases that are predominant in Africa. ANDI held its inaugural meeting in October 2008 in Abuja with the support of the Nigerian government and the Economic Community of West African States (ECOWAS), where more than 200 delegates from 21 countries endorsed the concept.

“Empowerment’s goal: To develop and sustain leadership

in health research and decision-making so that high-quality

institutional and national systems can identify and manage

research priorities. ”

Summary of research and development landscape in Africa. For more information please

see: www.who.int/tdr/news-events/news/pdf/ANDI-rd-landscape-abstracts.pdf and Mboya-Okeyo et al., 2009.16


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ESSENCE – funders working together to increase research capacity in Africa

Enhancing Support for Strengthening the Effectiveness of National Capacity Efforts (ESSENCE) is a new initiative of development and research funding agencies that TDR is supporting at their request. It was established in 2008 in the spirit of the Paris Declaration on Aid Effectiveness – to harmonize donor efforts and to strengthen research capacity in low-income African countries.17 Members of the initial ESSENCE steering committee include the United Kingdom’s Department for International Development (DFID), Canada’s International Development Research Centre (IDRC), the Ministry of Foreign Affairs of the Netherlands, the Norwegian Agency for Development Cooperation (NORAD), the Swedish International Development Cooperation Agency (Sida), the Bill & Melinda Gates Foundation and the Wellcome Trust. The New Partner-ship for Africa’s Development (NEPAD) is also part of the executive group and the European Developing Countries Clinical Trials Partnership (EDCTP) is also engaged, while TDR hosts the secretariat in Geneva.

Regional network for schistosomiasis in africa

Building on the success of the Regional Network for Asian Schistosomiasis, in 2007 TDR facilitated the establishment of the African network with the Danish Institute for Health Research and Development. The network’s goal is to help develop strong links between research and ministries of health in Africa, as it has in Asia, and provide opportunities for South-South collaboration with the well established Asian Network.

Supporting clinical research in post-conflict areasAlthough TDR does not normally engage in bricks and mortar infrastructure development, we have been busy building physical infrastructure as part of building clinical trial capacity in Liberia18 and the Democratic Republic of Congo – in preparation for the phase III trial of moxidectin, a potential drug for eradication of onchocerciasis (see box 1).

BOX 1 – Building a research centre in Liberia based around renewable resources

With funds provided by the African Programme for Onchocerciasis Control and Wyeth Pharmaceuticals, TDR financed the construction of a modern clinical trial centre in Bolahun in a remote corner of Liberia for researchers to carry out clinical trials starting with the Phase III study for moxidectin. This area was selected because onchocerciasis is endemic there and the 15 years of civil conflict have delayed implementation of annual ivermectin treatments available in most other onchocerciasis-endemic African regions.

During the conflict, much of the area – which is difficult to access by road, particularly in the rainy season – was ravaged, with schools, clinics and houses looted and burned. Generators are the only source of electricity. The first task was to construct a mud brick building to house the study subjects, laboratories and examination rooms, and to obtain and install equipment suitable for conducting clinical trials according to international standards in this environment (with backups in place in case of malfunctioning of a machine). The building was designed with features that keep room temperature relatively low without air-conditioning, which meant a reduction in the ecological footprint.

One of the biggest challenges is to provide a stable electricity source to power the equipment essential to a study. A diesel-based system was implemented for the moment. Keeping in mind the difficulty in delivering fuel by road and the minimal budgets for clinical trials of diseases of poverty, solar power based electricity is vital for the research in this centre to be financially sustainable and to reduce the environmental impact of the centre. At present, a donor is being sought and methods for using local waste as a source of biofuels for a back-up generator are being investigated.

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Training courses – improving researchers’ skillsTDR has continued to promote good research through a variety of short courses – including immunology, functional genomics, good clinical practice (GCP), good clinical laboratory practice (GCLP), Good Labora-tory Practice (GLP) and ethics. Our guidelines for GLP, GCP and ethical review continue to be among the most frequently downloaded documents from our website. A new development in TDR training courses deserves particular mention.

Encouragingly, this proportion has been steadily increasing since 2000 – which suggests progress in our efforts to increase the role played by DEC researchers (see the figures below).

Period time % DEC first authorship

2000-2002 47%

2003-2004 50%

2005-2006 58%

2007-2008 65%

Ongoing work

NetworksNetworks – ensuring research ethics are on the agenda

A long-established network that continues to have major impact is the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). This forum has led to legislative changes in human subject research in the past and has recently established recognition programmes for ethical review commit-tees – helping improve the quality of review for human subject research. Increased effort in 2009 will be placed on supporting the Pan-African Bioethics Initiative (PABIN). Both of these regional institutions and other regional groups form part of a global strategic initiative, The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), to develop capacity for ethical review.

In November 2008, a new course designed to build capacity in assessment of Biosafety for Human Health and the Environment was given by the African Regional Training Centre (in Bamako). This was followed by the Laboratory Biosafety and Biosecurity course given in December 2008 by the Biorisk Reduction for Dangerous Pathogens unit of WHO’s Department of Epidemic and Pandemic Alert and Response. A similar course will be staged at the soon-to-be opened regional biosafety training centres in Asia and Latin American in 2009. Such courses are particularly important for countries where the release of genetically modified (GM) mosquitoes, which could play a role in reducing or interrupting dengue and malaria transmission, may be imminent.

Authorship by developing country scientists – an increasing trendDuring 2007-2008 TDR-supported research led to over 400 papers being published in the peer-reviewed scientific press19 – a high proportion of which have a first author with DEC affiliation – 65% overall, with approximately 59% for 2007 and 71% for 2008.


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Research networks – building capacity while carrying out research

TDR has helped establish networks (involving North and South research institutions) to conduct research on neglected tropical diseases. Several scientists and institutions from DECs are now taking part in our North–South networks and contributing to research efforts while helping to build their research capacity. In collaboration with others, we are supporting research fellows from DECs to receive drug discovery training at pharmaceutical and academic research laboratories, where they benefit from the experience of mentors who support and provide guidance.

Shifting research management to disease endemic countriesTDR is now working to decentralize managerial activi-ties for coordination of research projects and training at the regional and country level. We believe that this will both enhance local ownership of research and help to build sustainable centres that can access resources from other funders. An initial step in this direction was made through a Memorandum of Understanding in 2008 with Thammasat University in Thailand, which will increasingly take on training and research activities relating to clinical studies in the Asia region. Additional regional centres will be identified and established in the future.

TrainingOver the 2007-2008 period, 19 people received their PhDs or Masters degrees with TDR financial support. In the context of leadership, several programmes are being scaled up and developed to promote the career development of post-doctoral and faculty researchers and scientists.

Stewardship34

Stewardship – harmonizing research efforts and aligning priorities to country needs

TDR’s stewardship function is focused on providing the knowledge necessary to make

research policy and priority decisions, and advocating for research needed to reduce the

diseases of poverty. Activities are designed to bring together institutions, investigators,

donors and decision-makers in international health research – helping those in disease

endemic countries play a pivotal role in setting and implementing relevant, national

research agendas. In line with its new strategy, TDR has created a Stewardship team

specifically dedicated to the promotion of neglected diseases knowledge management,

sharing and priority setting in the global health arena. However, stewardship activities

are also carried out throughout TDR, as an element integral to disease-related research,

capacity building and other activities. To enhance the coherence of research, TDR is

increasingly taking into account intersectoral issues that impact on neglected infectious

diseases such as the environment and climate change.

Stewardship35Nineteenth programme report | TDR 2007-2008

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Stewardship highlights

• TDR, with partners, launched TropIKA-net (www.tropika.net), the web-based global knowledge management platform, on inter-national health research.

• Supported WHO and the Intergovern-mental Working Group (IGWG) in the development of the Global Strategy and Plan of Action (GSPA) on Public Health, Innovation and Intellectual Property.10

• Supported the partners responsible for preparation of the programme for the Global Ministerial Forum for Research on Health in Bamako, Mali in 2008, and provided a web-based meeting hub that brought participants and others together during and after this major event.20

• Laid the groundwork for the TDR Global Report on Research on Infectious Diseases of Poverty for early 2011 and for several disease and thematic reference groups that will review research priorities and identify research gaps.

• Developed guidelines and information sources to inform specific activities in tropical disease research.

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Stewardship – harmonizing research efforts…

Infectious diseases of poverty are a formidable stumbling block to human development and realization of the health-related Millennium Development Goals in most low-income countries. Despite increased funding for health research, the impact on human health has been less than optimal – partly because research efforts have been uncoordinated, fragmented, and sometimes not well focused with inequity in input from the developing world. At TDR we are trying to redress this situation.

Achievements

TropIKA.net – a new knowledge management platform improving information accessFor research to be effective, it is essential that researchers can readily access and share information relevant to their work. With this in mind, TropIKA.net was launched in October 2007 as a web-based, global knowledge management platform (www.tropika.net). TropIKA’s special features useful to stakeholders have been widely recognized. It has achieved this success through the efforts of the partners involved in its management such as BIREME/PAHO/WHO (the Latin American and Caribbean Center on Health Sciences Information) in Brazil and its collaboration with major actors in the field of health information: the US National Library of Medicine (NLM/NIH), the WHO sponsored Health Internetwork for Access to Research Initiative (HINARI) and the Public Library of Science (PLoS) journals. During 2009, TropIKA.net aims to become a ‘one-stop shop’ for information on research for infectious diseases of poverty.

Complementing this, TropIKA.net knowledge hubs have invigorated dialogue at meetings and conferences by enhancing preparation, participation, and follow-up. They also allow those unable to attend in person to provide input during and after the meetings and conferences. Such facilities were used for the first time at the Ministerial Conference on Research for Health in the African Region in Algiers, (June 2008) and at the Global Ministerial Forum on Research for Health in Bamako, Mali (November 2008). Coverage of the Third High Level Forum on Aid Effectiveness held in Accra, Ghana

“ Infectious diseases of povertyremain a formidable stumbling block to human development and the attainment of the health-related Millennium Development Goals in most low income countries ”

Stewardship will:

• help identify priority needs/major research gaps

• provide a strategic overview of infectious diseases research

• provide a global knowledge platform on health research

• provide a neutral discussion platform for stakeholders

• advocate for support of health research and the use of its results

• foster research networks and innovative research initiatives


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(September 2008) was also provided through TropIKA, and a self-service version of the knowledge hub was developed and used for the founding meeting of the African Network for Drugs and Diagnostics Innovation (ANDI) in Abuja, Nigeria (October 2008). Numerous collaborative workspaces to support activities carried out by TDR and by partners such as the Global Fund to Fight AIDS, Tuberculosis and Malaria have also been set up on the platform, and TropIKA.net is also providing the framework to facilitate the consultative and collaborative process of the scientific working groups and stakeholders for the Bill & Melinda Gates Foundation R&D initiative on the malaria eradication research agenda (malERA) and the ESSENCE initiative (see page 31).

Support for GSPAWHO’s World Health Assembly approved in 2008 a Global Strategy and Plan of Action (GSPA) on Public Health, Innovation and Intellectual Property.10 This is a major plan covering research priorities for diseases that disproportionately affect developing countries, and promoting equity among countries. TDR played a significant role, working with WHO, to support the Intergovernmental Working Group (IGWG) that led to the GSPA. We are particularly involved in the follow-up of three elements of the GSPA, namely (1) research priority setting; (2) promoting R&D for diseases that disproportionately affect developing countries; and (3) building research capability for innovation in developing countries. With respect to element 1, TDR’s Stewardship function is seen as pivotal within the context of the GSPA to work with stakeholders to help develop priorities for infectious diseases of poverty. The European Commission is currently collaborating with TDR and supporting this work. With respect to element 3, TDR is supporting the development of ANDI with various stakeholders including the African Development Bank (see page 30).

Bamako Global Ministerial Forum for Health Research and TDR

In order to assess health research priorities, we have continued dialogue with a range of stakeholders – both regional and global – through meetings, conferences, workshops and the development of stakeholder networks. This includes working with the Steering Committee of the 2008 Global Ministerial Forum for Health Research in Bamako, regional consultations contributing to the Bamako forum for the Eastern Mediterranean Region (EMR) in Tehran and the African Region (AFR) in Algiers.

The Global Report on Research on Infectious Diseases, Disease Reference Groups (DRGs) and Thematic Reference Groups (TRGs)Our major effort is to inform and update stakeholders on global research efforts through the publication every two to three years of a Global Report on Research on Infectious Diseases of Poverty. The first edition of this report will be published in early 2011, and will be based on input from 10 new international reference groups (see box 2). These groups will comprise internationally-recognized experts with multidisciplinary backgrounds, including representa-tives from national ministries and research bodies, regional economic organizations, philanthropic foundations, civil society, the scientific community and other stakeholders. Through a consultation process in 10 DECs over a period of two years (along with regional consultations organized in all WHO regions to ensure regional input), they will systematically review and evaluate relevance of research evidence; assess

38

Stewardship – harmonizing research efforts…

challenges in control; highlight scientific advances; and provide independent recommendations and guidance on priority areas and critical research gaps. The group on Environment, Agriculture and Infectious Diseases held its first meeting in October 2008 in Beijing, China; the full complement of reference groups is expected to be established in 2009.

Guidance documentation on research prioritiesIn the next section of this report on publications and resources, there will be many references to how TDR has added value to important issues facing infectious diseases of poverty. Many of these have already been referenced in earlier sections of the report, but several deserve highlighting based on their high impact.

BOX 2 – The reference groups

Disease Reference Groups (DRGs)

• DRG 1 Malaria

• DRG 2 Tuberculosis

• DRG 3 Chagas disease, human African trypanosomiasis and leishmaniasis

• DRG 4 Helminth diseases (including onchocerciasis, filariasis, schistosomiasis and soil-transmitted helminths)

• DRG 5 Dengue and other emerging viral diseases of public health importance

• DRG 6 Other infectious diseases, including zoonoses

Thematic Reference Groups (TRGs)

• TRG 1 Social science research and gender

• TRG 2 Innovation and biotechnology platforms for health interventions

• TRG 3 Implementation research and health systems research

• TRG 4 Environment, agriculture and human health

Framework for Operations and Implementation Research in Health and Disease Control Programs Operations/implementation research (OR/IR) typically examines how to improve programmes by overcoming bottlenecks, and investigates how to scale up programmes more effectively. OR/IR is increasingly being recognized as key to the improvement of health systems by health policy-makers. TDR worked with the Global Fund to Fight AIDS, Tuberculosis and Malaria to develop a strategic framework that countries can use to develop implementation research components to their funded projects so that they can identify how best to implement and improve new practices. Endorsed now by several major international aid organizations, the document acts as a source for the Global Fund for all applications relating to operations research.

Guidance on diagnostics evaluationThere is a huge gap in agreed processes for evaluating diagnostics technologies for public health. TDR has thus utilized one of its expert committees and partnered with Nature Reviews Microbiology to produce a series of supplements on diagnostic evaluation guides for specific diseases. In the last two years, supplements have been published on CD4 diagnostics for HIV21 and visceral leishmaniasis.22

Stewarding research activities through new databases for drug researchThe open source database of potential drug targets (www.tdrtargets.org)22 aims to facilitate the identifica-tion and prioritization of candidate drug targets for pathogens.

Neglected diseases: A human rights analysisThis review by Paul Hunt, the Special Rapporteur to the UN, on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, introduces and explores the connections between human rights and neglected diseases. It signals how a human rights approach can contribute to the fight against neglected diseases.


PART II

References

1 Community-directed interventions for major health problems in Africa. Geneva, World Health Organization, 2008. Available from www.who.int/tdr/publications/tdr-research-publications/community-directed-interventions-health-problems/pdf/cdi_report_08.pdf

2 Gomes MF et al. Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial. Lancet, 2009, 373:557-566.

3 Reduction of number of smears for the diagnosis of pulmonary TB. Geneva, World Health Organization, 2007. Available from www.who.int/tb/dots/laboratory/policy/en/index2.html

4 Evaluation of commercially available anti-dengue virus immunoglobulin M tests. Geneva, World Health Organization, 2009. Available from www.who.int/tdr/publications/tdr-research-publications/diagnostics-evaluation-3/pdf/diagnostics-evaluation-3.pdf

5 Laboratory-based evaluation of 19 commercially available rapid diagnostic tests for tuberculosis. Geneva, World Health Organization, 2008. Available from www.who.int/tdr/publications/tdr-researchpublications/diagnostics-evaluation-2/pdf/diagnostic-evaluation-2.pdf

6 Ajayi IO et al. Feasibility and acceptability of artemisinin-based combination therapy for the home management of malaria in four African sites. Malaria Journal, 2008, 7:6.

7 Ajayi IO et al. Effectiveness of artemisinin-based combination therapy used in the context of home management of malaria: A report from three study sites in sub-Saharan Africa. Malaria Journal, 2008, 7:190.

8 Tiono A et al. Implementation of home based management of malaria in children reduces the work load for peripheral health facilities in a rural district of Burkina Faso. Malaria Journal, 2008, 7:201.

9 Belizario Jr VY et al. Efficacy and safety of 40 mg/kg and 60 mg/kg single doses of praziquantel in the treatment of schistosomiasis. Journal of Pediatric Infectious Diseases, 2008, 3:27-34.

10 Resolution WHA61:21. Global strategy and plan of action on public health, innovation and intellectual property. In: Sixty-first World Health Assembly, Geneva, 19-24 May 2008. Resolutions and decisions, annexes. Geneva, World Health Organization, 2008. (WHA61/2008/REC/1). Resolutions and decisions: 31. Available from www.who.int/gb/or/e/e_wha61r1.html

11 Shenoy RK et al. Antifilarial drugs, in the doses employed in mass drug administrations by the Global Programme to Eliminate Lymphatic Filariasis, reverse lymphatic pathology in children with Brugia malayi infection. Annals of Tropical Medicine and Parasitology. 2009, 103:235-247.

12 Cotreau MM et al. The antiparasitic moxidectin: safety, tolerability, and pharmacokinetics in humans. The Journal of Clinical Pharmacology, 2003, 43:1108-1115.

13 Report on an informal meeting assessing the feasibility of initiating the first phase II study of moxidectin tablets in subjects infected with Onchocerca volvulus, Accra, Ghana, 5-6 May 2005. Geneva, World Health Organization, 2008. Available from www.who.int/tdr/svc/publications/tdr-research-publications/moxidectin

14 Nwaka S and Hudson A. Innovative lead discovery strategies for tropical diseases. Nature Reviews Drug Discovery, 2006, 5:941-955.

15 Agüero F et al. Genomic-scale prioritization of drug targets: the TDR Targets database. Nature Reviews Drug Discovery, 2008, 7:900-907.

16 Mboya-Okeyo T et al. The African network for drugs and diagnostics innovation. Lancet, 2009, 373:1507-1508.

17 Whitworth JA et al. Strengthening capacity for health research in Africa. Lancet, 2008, 372:1590-1593.

18 Reviving research in Liberia. TDRnews, 2009, No. 82:19-23. Available from www.who.int/tdr/svc/publications/tdrnews/pdf/TDRnews-issue-82.pdf

19 Giving a voice to health researchers in disease endemic countries. TDRnews, 2007, No. 78:26-29. Available from www.tropika.net/editorial/gv/giving_voice.pdf

20 2008 Global Ministerial Forum on Research for Health. Commentary and analysis: Strengthening Research for Health, Development and Equity, 17-19 November 2008, Bamako, Mali. TropIKA.net website. Available from www.tropika.net/svc/home/bamako2008

21 Evaluating diagnostics: the CD4 guide. Nature Reviews Microbiology, 2008, Nov. Vol 6, issue 11s.

22 Evaluating diagnostics: the VL guide. Nature Reviews Microbiology, 2007, Nov. Vol 5, issue 11s

40

PartnershipsFinancial

GovernanceResources

“ TDR’s unique positionderives... from the breadth of the consensus through which it operates in partnership with hundreds of scientists, institutions and networks all over the world, and by the manner in which it is governed.”

“ TDR is a partnershipprogramme, bringing people and groups together to identify research gaps, advocate for increased research, and work together to support research and build research capacity.”

Key publications and resourcesTDR-funded research has led to 199 articles in peer-reviewed scientific journals in 2007 and 207 in 2008 (a total of 406 for the biennium). These articles are all listed in the publications section on the TDR website. Encouragingly, the percentage of first authors from DECs has been increasing over the years; for 2007 and 2008 this percentage was approximately 59% and 71% respectively.

The 3 times a year TDRnews was redesigned in 2007 to better meet researcher and stakeholder needs.

The TDR website was redesigned in 2008 to reflect the new strategy, and is drawing approximately 1000 visitors a day – 40% of them from disease endemic countries.

TDR also produces scientific and technical reports, guidelines and manuals. These are classified as WHO publications, and have an ISBN number. Below is a list of the major publications for 2007 and 2008; these are freely accessible in the publications section of the TDR website (www.who.int/tdr/svc/publications).

Published in 2008Community-directed interventions for major health problems in AfricaA report outlining the results from a CDI study carried out in seven research sites in three countries (Cameroon, Nigeria and Uganda).

Evaluating diagnostics: the CD4 guide. Nature Reviews Microbiology (Volume 6, issue 11, Suppl)A guide on evaluating CD4 immunodiagnostics published in collaboration with Nature Reviews.

Framework for operations and implementation research in health and disease control programmesA collaborative document with the Global Fund for Malaria, HIV/AIDS and TB, aiming to standardize the practice of operations research (OR) across the international health community and to stimulate the integration of OR into health programs. This document is available in English, French and Spanish.

Genomic-scale prioritization of drug targets: the TDR targets database. Nature Reviews Drug Discovery (Volume 5, pp. 900-907)A review of the development of the TDR Targets database (www.tdrtargets.org), which facilitates the identification and prioritization of candidate drug targets for pathogens.

Laboratory-based evaluation of 19 commercially available rapid diagnostic tests for tuberculosis. Diagnostics evaluation series No. 2A report on a WHO/TDR sponsored evaluation of commercially available rapid TB tests.

Strengthening health-economics capability in AfricaA summary and the outcomes of a regional consultation of experts and policymakers.

The social context of schistosomi-asis and its control: an introduction and annotated bibliographyA book presenting a micro as well as a macro view of schistosomiasis.

The use of visceral leishmaniasis rapid diagnostic testsA user guide to the proper use of rapid diagnostics tests for visceral leishmaniasis.


PART III

PartnershipsFinancial

Resources

Published in 2007Applied social sciences for public health (ASSPH): Higher degree training for implementation research on tropical diseasesA report presenting the background on the training needs in ASSPH in sub-Saharan Africa, with an overview of related courses and programmes available locally and internationally.

Effective project planning and evaluation in biomedical researchA set of three booklets to accompany a course on effective project planning and evaluation in biomedical research, including a step-by-step guide, a training manual and a train-the-trainer guide. The first two are also available in French.

Ethical challenges in study design and informed consent for health research in resource-poor settingsA review by Patricia Marshall (in Social, Economic and Behavioural Research, Special Topics No. 5).

Evaluating diagnostics: the VL Guide. Nature Reviews Microbiology (Volume 5, issue 11, Suppl)A guide on evaluating diagnostics for VL published in collaboration with Nature Reviews.

Lessons learned in Home Manage-ment of Malaria: Implementation research in four African countriesA guide on the home management of malaria, which focuses in particular on Burkina Faso, Ghana, Nigeria and Uganda.

Neglected diseases: A human rights analysisA review by Paul Hunt (in Social, Economic and Behavioural Research, Special Topics No. 6).

Recommendations of the Informal consultation on Issues for clinical product development for Human African TrypanosomiasisWHO report following an informal consultation on the development of clinical products for Human African Trypanosomiasis. Also available in French.

Report of the expert consultation on immunotherapeutic interven-tions for tuberculosis A report following expert consulta-tion on immunotherapeutic interventions for tuberculosis.

Reporte sobre la enfermedad de ChagasReport on Chagas disease. In Spanish.

Scientific working group report on dengueA report from the 2006 meeting of the Dengue Scientific Working Group.

Special issue focusing on the helminth drug initiative in expert opinion on drug discoveryA documentation of the rationale for the TDR Helminth Drug Initiative and reportings coming out of this.

42

Key publications and resources

TDR governance

TDR is governed formally through three bodies:

• The Joint Coordinating Board (JCB)

• The Standing Committee

• The Scientific and Technical Advisory Committee (STAC)

More details about these bodies are given in the next few pages.

TDR operates under the legal auspices of WHO as its executing agency and within a broad framework of intergovernmental and interagency cooperation and participation.

The TDR governing bodies

Joint Coordinating Board (JCB)

Executing Agency (WHO)

TDR Organization

Standing Committee(UNICEF, UNDP, World Bank, WHO)

Scientific & Technical Advisory Committee (STAC)


PART III

The Joint Coordinating Board (JCB)TDR’s top governing body is the Joint Coordinating Board (JCB). The JCB meets annually to review TDR’s strategic direction and activities, evaluate progress and plans, determine the budget and approve arrangements for the Programme’s financing.

12governments (selected by

TDR resource contributors)

6cooperating

parties (selected by JCB)

4co-sponsors

(UNICEF, UNDP, World Bank, WHO)

12governments (selected by

WHO regional committees)

Standing Committee

The new vision, strategy and its six year business plan (2008–2013) were endorsed by the JCB at the 30th anniversary session held in Geneva in June 2007. At the 31st session of the JCB, which took place in June 2008 in Rio de Janeiro, the JCB provided further guidance to TDR on matters related to the implementa-tion of TDR’s new strategy and business plan that started on 1 January 2008. The Board is strongly supporting TDR’s work in strengthening the pivotal role of disease endemic countries’ in leading health research and setting priorities.

Composition of the JCB

44

Governance

The JCB consists of 34 members: TDR’s four co-spon-soring agencies (UNICEF, UNDP, the World Bank and WHO); 12 contributor governments or constituency groupings of contributor governments selected by resource contributors to TDR; 12 governments repre-senting the six regions of WHO and selected by the six regional committees of WHO; and 6 other cooperating parties of TDR selected by the JCB itself. The table below shows the membership of governments in the JCB during the period under report.

12governments

(selected by TDR resource contributors)

2007 2008

Belgium Belgium

Canada Canada

Denmark China

Germany Germany

India India

Japan Japan

Mexico Netherlands

Netherlands Nigeria

Nigeria Norway

Norway Sweden

Switzerland Switzerland United Kingdom of Great Britain and Northern Ireland

United Kingdom of Great Britain and Northern Ireland

12governments

(selected by WHO regional committees)

Bangladesh Bhutan

Brazil Bulgaria

Central African Republic Brazil

Chad Chad

Cuba Comoros

Djibouti Costa Rica

Greece Libyan Arab Jamahiriya

Philippines Papua New Guinea

Syrian Arab Republic Syrian Arab Republic

Thailand Thailand

Uzbekistan Uzbekistan

Viet Nam Viet Nam

6cooperating parties

(selected by JCB)

China Cuba

Ghana Ghana

Iran (Islamic Republic of ) Iran (Islamic Republic of )

Luxembourg Luxembourg

Sweden Panama

United States of America United States of America

Professor Rolf Korte, Senior Health Policy Advisor for the German Agency for Technical Collaboration in Germany acted as JCB chair in 2007 and 2008, while Dr Frank Nyonator, the Director of Policy, Planning, Monitoring and Evaluation for the Ghana Health Service acted as vice-chair in 2007 and Professor Rodrigo Corrêa-Oliveira, Director, René Rachou Research Centre at Fiocruz from Brazil acted as vice-chair in 2008.


PART III

The Standing CommitteeThe Standing Committee oversees the management and financing of TDR and comprises the four co-sponsors – UNICEF, UNDP, the World Bank and WHO. It has met three times each in 2007 and 2008, providing advice and guidance to TDR on issues related to TDR’s managerial oversight mandate.

In order to enhance the coherence and coordination between TDR’s governing bodies, the Chair and Vice-Chair of the JCB as well as the Chair of STAC have also participated in the meetings of the Standing Committee on an ex-officio basis. During the period of the elabora-tion and launch of TDR’s new strategy, participation in the Standing Committee was further extended to two JCB representatives from disease endemic countries and one from an Organisation for Economic Co-operation and Development (OECD) country.

The Scientific and Technical Advisory Committee (STAC)The STAC – consisting of 21 leading health scientists selected on the basis of their professional and scientific expertise in the endemic countries - meets on an annual basis to oversee TDR’s scientific activities in accordance with its three major functions:

• Review, from a scientific and technical standpoint, the content, scope and dimensions of TDR, including the diseases covered and approaches to be adopted;

• Recommend priorities within TDR, including the establishment and disestablishment of Scientific Steering Committees, Task Forces and Working Groups, and all scientific and technical activities related to TDR;

• Independently evaluate the scientific and technical aspects of all activities of TDR.

46

Governance

TDR partnerships 2007-2008

TDR is a partnership programme, bringing people and groups together to identify research gaps, advocate for increased research and work together to support research and build research capacity where it’s needed in low and middle-income countries. We work with governments around the world, multilateral and bilateral donors, and many programmes, services, partnerships and organizations involved in health research and delivery. Here we provide some examples from the last two years of the types of stake-holders and partners that we have worked with, and give a brief overview of their role in TDR activities. This section does not attempt to list all the many groups and organiza-tions that we work with, but instead provides insight into how some of our interactions with partners increase our potency and leverage and help us work toward our goal.

Academic institutions and research institutionsTDR has a long-standing history of working in partnership with academic and research institutions throughout the world, in both developed and developing countries. During 2007-2008 we continued to develop such partnerships. For instance, our research activities on innovative vector control interventions involved partnership with the University of Tokyo (contributing to the sequencing of Glossina morsitans morsitans genome), the Wellcome Trust Sanger Institute (helping sequence the Glossina m. morsitans genome), and partners contributing to the mobilization of research and control communities – including the Kenyan Agricultural Research Institute (KARI), the Tanzanian Trypanosomiasis Research Institute (TTRI), and the Ugandan National Livestock Research Institute (NaLIRI).

National, regional and global health initiatives and programmesIn drug development and evaluation for helminths and other neglected tropical diseases, our main partners were the African Onchocerciasis Control Programme (APOC), the lymphatic filariasis elimination programmes, schisto-somiasis control programmes and national dengue, Chagas disease and African trypanosomiasis control initiatives. These stakeholder groups are well established and can, for instance, highlight research needs and gaps, provide us

with links to key national institutions (such as national drug regulatory agencies) and help us advocate for increased funding.

Pharmaceutical companies and public-private partnershipsTDR is, in many ways, the originator of today’s public-private partnership (PPP). From its early days, it has brought together pharmaceutical companies with governments and research organizations to help develop new drugs for diseases of poverty, and over half of all new drugs in tropical diseases developed since 1975 are a result of TDR partnering with industry. Many PPPs and PDPs (public-private development partnerships) have been launched since then (some initiated by TDR). During 2008 TDR worked closely with several PPPs, including the Medicines for Malaria Venture (MMV), the Drugs for Neglected Diseases initiative (DNDi) and the Global Alliance for TB Drug Development. MMV and TDR, for example, acted as partners and co-funders of two antimalarial drug discovery projects – one at Pharma-copeia and a second project together with University of Cape Town. Meanwhile, pharmaceutical companies such as Pfizer, Bayer, GlaxoSmithKline (GSK), Sanofi-Aventis, Merck-Serono, Chemtura, Wyeth and many others continue to support TDR research efforts.

Nongovernmental organizations, non-profit organizations and fundersPartnership with groups such as the Stop TB Partnership represent an unprecedented opportunity for research to be integrated. Such an alliance provides strong leverage for resources and global consensus for action. Our relationship with donors has also formed at different levels and often involves more than receiving funds for of our activities. For instance, in 2008 a framework and guidance to countries for implementation research in health and disease control programs was developed in association with The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), with the goal of increasing this type of research within the GFATM grants to countries.


PART III

TDR financial information 2007-2008This 2007–08 programme progress report spans twobudgetary bienniums: 2006–2007 and 2008–2009.

At the beginning of 2008 TDR reorganized itsprogramme and adopted a new strategy, incorporatinga business line structure. These factors, together witha move to a new accounting system, mean that it isdifficult to provide detailed information about expendi-ture for the cross-biennium period 2007–2008

RevenueTotal revenue for the period 2007–2008 was US$ 74 million (US$ 36.4 million in 2007 and US$ 37.6 million in 2008). Details are shown in the table on the next page.

ExpenditureFor 2007–2008, actual total expenditure wasUS$ 83.7 million. This was higher than revenue inthis period due to the use of some of the budgetcarryover from the previous period.

For illustrative purposes, budgeted expenditure by the new strategy’s business lines is presented in the diagram below.

For 2008-2009, the JCB approved an expenditure budget of US$ 121 million.

Stewardship 8%

Empowerment 11%

Lead discovery for drugs 8%

Innovation research 1%

Vector Control interventions 8%

Drug development for helminths /NTDs 10%

Evidence for treatment of TB/HIV 9%

Antimalarial policy/access 10%

Visceral leishmaniasis elimination 2%

Community-based interventions 2%

Special research initiatives 8%

Programme related support 16%

Quality assured diagnostics 9%

48

CONTRIBUTOR 2007 2008 TOTAL 2007-2008

Belgium 1,075,263 1,464,129 2,539,392

China 770,995 55,000 825,995

Cuba 4,975 5,000 9,975

Denmark 1,901,141 2,109,705 4,010,846

Finland 192,788 -- 192,788

Germany 1,030,411 1,230,529 2,260,940

Ghana 14,972 -- 14,972

India 25,000 25,000 50,000

Iran (Islamic Republic of ) 20,000 10,719 30,719

Ireland 288,184 314,465 602,649

Italy 66,667 3,573,746 3,640,413

Japan 400,000 400,000 800,000

Luxembourg 1,333,333 1,891,074 3,224,407

Malaysia 24,978 25,000 49,978

Mexico -- 10,000 10,000

Netherlands 1,173,770 1,173,770 2,347,540

Nigeria 95,238 101,865 197,103

Norway 4,413,843 3,565,368 7,979,211

Panama 7,000 7,000 14,000

Spain 73,108 -- 73,108

Sweden 3,338,172 3,140,704 6,478,876

Switzerland 1,500,000 1,962,661 3,462,661

Thailand 21,752 23,607 45,359

Turkey 5,000 5,000 10,000

United Kingdom of Great Britain and Northern Ireland 6,021,275 1,988,072 8,009,347

United States of America 1,640,000 2,481,250 4,121,250

African Programme for Onchocerciasis Control (APOC) 695,610 700,000 1,395,610

Bill & Melinda Gates Foundation (USA) 3,228,410 1,173,209 4,401,619

ExxonMobil Foundation 500,000 500,000 1,000,000

Global Fund to Fight AIDS, Tuberculosis and Malaria 292,000 292,000

International Development Research Centre (CAN) 482,901 765,938 1,248,839International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)

-- 1,000,000 1,000,000

International Vaccine Institute, Republic of Korea (PDVI) 175,000 100,000 275,000

Medicines for Malaria Venture (MMV) 3,731,872 174,434 3,906,306

Miscellaneous 11,841 -- 11,841

Oswaldo Cruz Foundation (Brazil) 149,960 -- 149,960

University of Heidelberg (funds from CEC), Germany 36,400 27,095 63,495

World Bank 2,000,000 1,900,000 3,900,000

World Health Organization -- 1,789,000 1,789,000

Wyeth -- 3,600,000 3,600,000

TOTAL CONTRIBUTIONS FOR TDR 36,449,859 37,585,340 74,035,199

TDR financial contributions 2007-08 in US dollars


PART III

All pics from WHO/TDR/Craggs, except: Page 4: WHO/Chris Black – 8: WHO/TDR –12: WHO/TDR/Craggs – 14: WHO/TDR/Crump – 18: WHO/TDR/Gomes – 19: WHO/TDR/Pagnoni – 20: WHO/TDR/Ghalib – 26: WHO/TDR/Fisher – 28: Olivier Asselin – 30: Simon Fenwick (map) – 31: WHO/TDR/Kuesel – 32: Olivier Asselin and WHO/TDR/Karbwang – 33: WHO/TDR/Remme – 35-37: Olivier Asselin – 46: WHO/TDR/Schwarb.

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For research on diseases of povertyUNICEF • UNDP • World Bank • WHO

The Special Programme for Research and Training in Tropical Diseases (TDR) is a global programme of scientific collaboration established in 1975. Its focus is research into neglected diseases of the poor, with the goal of improving existing approaches and developing new ways to prevent, diagnose, treat and control these diseases. TDR is sponsored by the following organizations:

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