We are investing in the development and regulatory approval of more effective TB vaccines. Our goal is to have one vaccine candidate in Phase III clinical trials by 2016, as well as to increase the number of other TB vaccine candidates.
At the same time, we are working to address the barriers to the discovery and development of TB vaccines. The mechanisms of vaccine-induced protection against TB are poorly understood, and there are no known biomarkers that can predict the efficacy of a TB vaccine candidate. This means vaccine development currently involves lengthy and costly trials.
To address these challenges, we created the TB Vaccine Accelerator program, which works to identify promising vaccine concepts that are alternatives to those currently in the pipeline and have a high potential of improving our understanding of TB and leading to more effective vaccine development.
More Effective Drug Regimens
TB can rapidly develop resistance to a single drug, so treatment will always require a combination of drugs. However, conventional drug development requires that new TB drugs be evaluated separately in clinical trials, so new drugs can be tested in combination only after they have been approved individually. This means that developing more effective TB regimens could take decades. To address this obstacle, we have joined with partners to create the Critical
Path to TB Drug Regimens (CPTR) initiative, which brings together leading international pharmaceutical companies, public health experts, nongovernmental organizations, and U.S. and other regulatory authorities to expedite testing of promising TB drug candidates in combination and to identify new regulatory pathways and other means of accelerating the drug development process.
We also need new drugs that can radically shorten the course of treatment. We are funding the TB Drug Accelerator program, which aims to identify new ways to target bacteria that are resistant to current drug regimens, develop new tools for drug discovery, and discover new drugs that can lead to accelerated treatment regimens.
New Diagnostic Tools
The microscopy room at a hospital specializing in tuberculosis and respiratory diseases in New Delhi, India.
We are developing less expensive, more effective diagnostic tools that can reach more of the TB patient population and can be used at the point of care rather than requiring processing by a distant lab. Part of this effort involves research into new biomarkers of TB infection and treatment responses that will improve detection and clinical management of TB. One new technology we have funded, GeneXpert, has the potential to significantly increase the speed and accuracy of TB diagnosis. We need to find ways to expand access to this tool because fast, accurate diagnosis is essential to enabling patients to begin appropriate treatment quickly and preventing further transmission.
Disseminating Innovations in TB Control
We are conducting pilot studies of innovative TB control tools and delivery approaches in India, China, and South Africa and using the findings to disseminate the most effective approaches globally. One of our projects focuses on finding cost-effective ways to deploy a more rapid and accurate diagnostic tool in South Africa. In India, we have supported efforts to bring together the Indian government, the World Health Organization (WHO), USAID, and the World Bank to support innovative TB control efforts. We are also engaging the private sector in India to promote TB diagnosis and treatment research and development. Through our advocacy work in China, MDR-TB has been classified as a “highly reimbursable disease” under the country’s health insurance schemes, which means that Chinese patients with this condition will be more likely to receive financial assistance in paying for their treatment.
Access, Efficiency, and Cost Reductions
We collaborate with global health partners such as the Global Fund to Fight AIDS, Tuberculosis and Malaria; WHO; and UNITAID to make the most of their resources and investments and thereby reduce the cost of innovative technologies, attract enough manufacturers to ensure stable and affordable prices for new TB technologies, and accelerate adoption of effective new approaches to fighting TB.
Staff members at the Coptic Mission Hospital in Lusaka, Zambia, which has special programs to treat TB and HIV.
We advocate for greater political commitment and funding for fighting TB, particularly for research and development in the later phases of clinical trials. We believe that strengthening partnerships with donor governments and multinational institutions, the pharmaceutical and biotechnology industries, and governments of TB-endemic countries is critical to fighting the disease. These partnerships can lead to greater investment in research and development as well as in the delivery of existing and new tools.