TB Alliance: Difference between revisions

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| image = TBA logo rev 2008lg RGB.jpg =

| caption = TB Alliance logo

| type = [[Nonprofit]]

| status = Active

| headquarters = [[New York City]], [[Pretoria]]

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| name = The Global Alliance for TB Drug Development

| abbreviation = TB Alliance

| established = February 2000

| revenue = =

| website = {{URL|https://www.tballiance.org/}}

'''TB Alliance''' (formerlyformally '''The 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]] (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 [[Drug pipeline|pipeline]] of new TB drugs in history.<ref name=":0">{{Cite web|url=https://www.tballiance.org/portfolio|title=Clinical Portfolio {{!}} TB Alliance|website=www.tballiance.org|access-date=2019-04-25}}</ref> It was founded in [[Cape Town]], South Africa, and has since expanded. It is headquartered in [[New York City]] and has a regional office in [[Pretoria]].<ref>{{Cite web|url=http://www.tballiance.org/annualreport2016/index.htm|title=Home|website=TB Alliance 2016 Annual Report|language=en-US|access-date=2019-04-25}}</ref>

[[Tuberculosis]] is the leading cause of infectious death worldwide,<ref>{{Cite web|url=httphttps://www.who.int/gho/tb/en/|title=WHO {{!}} Tuberculosis (TB)|website=WHO|access-date=2019-04-25}}</ref>,  killing approximately 1.6 million people each year.<ref>{{Cite web|url=https://www.who.int/news-room/fact-sheets/detail/tuberculosis|title=Tuberculosis (TB)|website=www.who.int|language=en|access-date=2019-04-25}}</ref> 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 [[Tuberculosis management#Monitoring, DOTS, and DOTS-Plus|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]] (See [[antimicrobial resistance]]).

About 29% of deaths caused by antimicrobial infections today are due to drug-resistant TB.<ref>{{Cite web|url=https://www.who.int/tb/areas-of-work/drug-resistant-tb/global-situation/en/|archive-url=https://web.archive.org/web/20151212050442/http://www.who.int/tb/areas-of-work/drug-resistant-tb/global-situation/en/|url-status=dead|archive-date=December 12, 2015|title=WHO {{!}} Drug-resistant TB: global situation|website=WHO|access-date=2019-04-25}}</ref><ref>{{Cite web|url=https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf|title=Tackling Drug-Resistant Infections Globally: Final Report and Recommendations|last=The Review on Antimicrobial Resistance|first=|date=|website=|archive-url=|archive-date=|dead-url=|access-date=}}</ref> 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.<ref>{{Cite web|url=httphttps://www.who.int/tb/publications/global_report/en/|title=WHO {{!}} Global tuberculosis report 2018|website=WHO|access-date=2019-04-25}}</ref>.

TB is also the number one killer of people with [[AIDS]] , 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 company|pharmaceutical companies]] to invest in the new research required to sustain a treatment pipeline. The TB [[epidemic]] is concentrated in developing countries where drugs must be low in cost to remain accessible.<ref>{{Cite web|url=https://www.who.int/tb/publications/global_report/gtbr2017_annex4.pdf?ua=1|title=TB burden estimates, notifications and treatment outcomes|last=WHO|first=|date=|website=|archive-url=|archive-date=|dead-url=|access-date=}}</ref> 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.

TB Alliance was conceived at a February 2000 meeting in [[Cape Town]], [[South Africa]], 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"<ref>{{cite web|title=The Cape Town Declaration of the Working Alliance for TB Drug Development|url=http://www.tballiance.org/downloads/publications/CapeTownDeclaration.pdf|website=www.tballiance.org|location=Cape Town, South Africa|date=February 8, 2000}}</ref> 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.<ref>{{cite web|title=Global Alliance for TB Drug Development Appoints Respected Scientist and Director of R&D as New Chief Executive|url=http://www.tballiance.org/news/global-alliance-tb-drug-development-appoints-respected-scientist-and-director-rd-new-chief|website=www.tballiance.org|date=9 October 2008 |accessdate=9 October 2008}}</ref>

TB Alliance has the largest pipeline of TB drugs in history<ref name=":0" /> and part of TB Alliance’sAlliance's stated mission is to ensure that any new treatments are affordable and accessible in the [[developing world]], and that they are adopted as soon as they become available.<ref>{{Cite web|url=https://www.tballiance.org/about/mission|title=About TB Alliance|website=TB Alliance|language=en|access-date=2019-04-25}}</ref> 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]]s and patients via local channels.

In February 2019, TB Alliance’sAlliance's application for the novel tuberculosis (TB) medicine [[pretomanid]] was accepted for review by the U.S. FDA.<ref name=":1">{{Cite web|url=https://www.tballiance.org/news/pretomanid-enters-FDA-review|title=TB Medicine Pretomanid Enters Regulatory Review Process in the United States {{!}} TB Alliance|website=www.tballiance.org|date=8 March 2019 |access-date=2019-04-25}}</ref> IfIn approvedAugust 2019, theTB drugAlliance's wouldtuberculosis be(TB) indicatedmedicine forpretomanid usewas asapproved partby ofthe aU.S. new regimenFDA, to be used in combination with two other antibiotics, [[bedaquiline]] and [[linezolid]], for the treatment of extensively drug-resistant (XDR) TB as well as treatment-intolerant or nonresponsive multidrug-resistant (MDR) TB.<ref name=":1" />

==Treating Drugdrug-Resistantresistant TB==

The TB Alliance has a diverse set of global partnerships with both public and private sector donors that fund the company’scompany's work. The organization operates with the support of:<ref>{{Cite web|url=https://www.tballiance.org/about/donors|title=Donors|website=TB Alliance|date=15 July 2015 |language=en|access-date=2017-06-20}}</ref>

* [[Department of Foreign Affairs and Trade (Australia)|Australia Department of Foreign Affairs and Trade]]

* [[Medical Research Council (United Kingdom)|Medical Research Council]] (United Kingdom)

* [[National Institute of Allergy and Infectious Diseases|National Institute of Allergy and Infectious Disease]]

* [[Ministry of Foreign Affairs (Netherlands)|Netherlands Ministry of Foreign Affairs]]

* [[Department for International Development|UK Department of International Development]] (DFID)

* [[United States Agency for International Development]] (USAID)

* [httphttps://www.tballiance.org/ The GlobalTB Alliance] for TB Drug Development]

* [httphttps://www.stoptb.org/ The Stop TB Partnership]