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TB Alliance (formallyThe Global Alliance for TB Drug Development) is a not-for-profit product development partnership (PDP) dedicated to the discovery and development of new, faster-acting and affordable
tuberculosis Tuberculosis (TB) is an infectious disease usually caused by ''Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in w ...
(TB) medicines. Since its inception in 2000, TB Alliance has worked to grow the field of available treatments for TB and now manages the largest
pipeline Pipeline may refer to: Electronics, computers and computing * Pipeline (computing), a chain of data-processing stages or a CPU optimization found on ** Instruction pipelining, a technique for implementing instruction-level parallelism within a s ...
of new TB drugs in history. It was founded in
Cape Town Cape Town ( af, Kaapstad; , xh, iKapa) is one of South Africa's three capital cities, serving as the seat of the Parliament of South Africa. It is the legislative capital of the country, the oldest city in the country, and the second larges ...
, South Africa, and has since expanded. It is headquartered in
New York City New York, often called New York City or NYC, is the List of United States cities by population, most populous city in the United States. With a 2020 population of 8,804,190 distributed over , New York City is also the L ...
and has a regional office in
Pretoria Pretoria () is South Africa's administrative capital, serving as the seat of the executive branch of government, and as the host to all foreign embassies to South Africa. Pretoria straddles the Apies River and extends eastward into the foot ...
.


Background

Tuberculosis Tuberculosis (TB) is an infectious disease usually caused by ''Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in w ...
is the leading cause of infectious death worldwide,  killing approximately 1.6 million people each year. However, research and development for new TB drugs came to a virtual standstill after the 1960s. Today, a four-drug combination therapy exists, but it takes six months or more to be effective. This requires a degree of monitoring (See Direct Observational Therapy, Short-course) beyond the capacity of the health infrastructure in many countries, and adequate TB treatment is not available to more than half of the most infectious cases. This can inhibit control of the disease and fuel the rise of
drug resistance Drug resistance is the reduction in effectiveness of a medication such as an antimicrobial or an antineoplastic in treating a disease or condition. The term is used in the context of resistance that pathogens or cancers have "acquired", that is ...
(See
antimicrobial resistance Antimicrobial resistance (AMR) occurs when microbes evolve mechanisms that protect them from the effects of antimicrobials. All classes of microbes can evolve resistance. Fungi evolve antifungal resistance. Viruses evolve antiviral resistance ...
). About 29% of deaths caused by antimicrobial infections today are due to drug-resistant TB. When infections become resistant to first-line drugs, more expensive therapies must be used to treat them. Lengthier treatment, often in hospitals, substantially increases health care costs as well as the economic burden on families and societies. The cost of treating a single case of multidrug-resistant TB (MDR-TB) or extensively drug-resistant TB (XDR-TB) can be thousands of times more expensive than treating drug-sensitive TB. TB is also the number one killer of people with
AIDS Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV), a retrovirus. Following initial infection an individual ...
, but it is generally agreed that current TB treatments do not work well with the antiretroviral drugs used to treat HIV. New, improved TB treatments are urgently needed. However, the TB drug market lacks sufficient financial incentives to stimulate broad-based investment from
pharmaceutical companies The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate sympto ...
to invest in the new research required to sustain a treatment pipeline. The TB
epidemic An epidemic (from Greek ἐπί ''epi'' "upon or above" and δῆμος ''demos'' "people") is the rapid spread of disease to a large number of patients among a given population within an area in a short period of time. Epidemics of infectious ...
is concentrated in developing countries where drugs must be low in cost to remain accessible. It does not generate the kind of revenue streams that private companies usually deem necessary to justify the research costs and strategic risks involved in pharmaceuticals. TB Alliance was designed to be the primary instrument to fill this vacuum and to ensure that new anti-TB drugs are affordable and accessible in endemic countries.


History

TB Alliance was conceived at a February 2000 meeting in
Cape Town Cape Town ( af, Kaapstad; , xh, iKapa) is one of South Africa's three capital cities, serving as the seat of the Parliament of South Africa. It is the legislative capital of the country, the oldest city in the country, and the second larges ...
,
South Africa South Africa, officially the Republic of South Africa (RSA), is the southernmost country in Africa. It is bounded to the south by of coastline that stretch along the South Atlantic and Indian Oceans; to the north by the neighbouring coun ...
, where 120 representatives from academia, industry, major government agencies, non-governmental organizations and donors gathered to discuss the problems of tuberculosis treatment. Participants stressed the need for faster-acting, novel TB drugs and highlighted the scientific opportunities involved. The resulting "Declaration of Cape Town" provided a road map for TB drug development and outlined the need for creation of the TB Alliance. Maria Freire was appointed as the first Chief Executive Officer and President in 2001 and served in that capacity until 2008, when she left the TB Alliance to become President of the Lasker Foundation. The current CEO and President is Melvin Spigelman.


Program

TB Alliance is a
non-profit A nonprofit organization (NPO) or non-profit organisation, also known as a non-business entity, not-for-profit organization, or nonprofit institution, is a legal entity organized and operated for a collective, public or social benefit, in co ...
product development partnership (See public-private partnership). A PDP builds partnerships between the public, private, academic and philanthropic sectors to drive the development of new products for underserved markets. PDPs retain direct management oversight of their projects, though much of the laboratory and clinical work is done though external research facilities and contractors. This model minimizes costs, including overhead and investments in infrastructure, while optimizing scientific capability to speed new TB drug development. TB Alliance has the largest pipeline of TB drugs in history and part of TB Alliance’s stated mission is to ensure that any new treatments are affordable and accessible in the
developing world A developing country is a sovereign state with a lesser developed industrial base and a lower Human Development Index (HDI) relative to other countries. However, this definition is not universally agreed upon. There is also no clear agreem ...
, and that they are adopted as soon as they become available. Pricing terms are included in all licensing contracts and end products are designed to be easy for patients to take. TB Alliance also collaborates with national and international partners, working to ensure that new therapies are adopted and accessible to
healthcare provider A health care provider is an individual health professional or a health facility organization licensed to provide health care diagnosis and treatment services including medication, surgery and medical devices. Health care providers often rece ...
s and patients via local channels. In February 2019, TB Alliance’s application for the novel tuberculosis (TB) medicine pretomanid was accepted for review by the U.S. FDA. In August 2019, TB Alliance's tuberculosis (TB) medicine pretomanid was approved by the U.S. FDA, to be used in combination with two other antibiotics, bedaquiline and
linezolid Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics. Linezolid is active against most Gram-positive bacteria that cause disease, including streptococci, vanc ...
, for the treatment of extensively drug-resistant (XDR) TB as well as treatment-intolerant or nonresponsive multidrug-resistant (MDR) TB.


Treating Drug-Resistant TB

Combination therapies are essential for treating active tuberculosis infections. Currently, there are four first-line tuberculosis drugs given as a combination therapy over an extended period of time. Some strains of the tuberculosis pathogen are resistant to two (called MDR-TB) or at least four (called XDR-TB) first-line tuberculosis drugs. Due to the contagious nature of tuberculosis, drug resistance is considered to be a serious public health issue, particularly among people with an already weakened immune system, for example people living with HIV.


Donors

The TB Alliance has a diverse set of global partnerships with both public and private sector donors that fund the company’s work. The organization operates with the support of: * Australia Department of Foreign Affairs and Trade *
Bill & Melinda Gates Foundation The Bill & Melinda Gates Foundation (BMGF), a merging of the William H. Gates Foundation and the Gates Learning Foundation, is an American private foundation founded by Bill Gates and Melinda French Gates. Based in Seattle, Washington, it was ...
* Germany's Federal Ministry of Education and Research through KfW * Global Health Innovative Technology (GHIT) Fund * Indonesia Health Fund * Irish Aid * Medical Research Council (United Kingdom) *
National Institute of Allergy and Infectious Disease The National Institute of Allergy and Infectious Diseases (NIAID, ) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID' ...
* Netherlands Ministry of Foreign Affairs * UK Department of International Development (DFID) *
UK Department of Health The Department of Health and Social Care (DHSC) is a department of His Majesty's Government responsible for government policy on health and adult social care matters in England, along with a few elements of the same matters which are not otherwi ...
*
United States Agency for International Development The United States Agency for International Development (USAID) is an independent agency of the U.S. federal government that is primarily responsible for administering civilian foreign aid and development assistance. With a budget of over $27 ...
(USAID)


References

{{Reflist


External links


TB Alliancet

The Stop TB Partnership
Tuberculosis organizations International medical and health organizations