CARB-X

{{Short description|Nonprofit partnership}}

Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global nonprofit partnership focused on supporting the development of new antibacterial products. Its mission is to strengthen the pipeline of vaccines, rapid diagnostics, antibiotics and non-traditional products to prevent, diagnose and treat life-threatening bacterial infections.{{Cite web|title=Overview|url=https://carb-x.org/about/overview/|access-date=2022-01-14|website=Carb-X|language=en-US}}

CARB-X was launched in summer of 2016 at the Boston University School of Law, where Kevin Outterson, CARB-X Executive Director and Professor of Law, teaches health law, corporate law, and co-directs the Health Law Program.{{Cite web|title=CARB-X Global Partnership|url=https://www.bu.edu/law/faculty-scholarship/carb-x/|url-status=live|access-date=2021-06-18|website=Boston University|archive-url=https://web.archive.org/web/20160802054526/http://www.bu.edu:80/law/faculty-scholarship/carb-x/ |archive-date=2016-08-02 }}

Antimicrobial resistance background

Bacteria are constantly evolving to evade death. Even the most powerful "last resort" drugs are becoming less effective due to resistance.{{Cite web|last=CDC|date=2021-11-22|title=How do germs become resistant?|url=https://www.cdc.gov/drugresistance/about/how-resistance-happens.html|access-date=2022-01-14|website=Centers for Disease Control and Prevention|language=en-us}} Without an arsenal of effective antibiotics to treat infections, modern medical procedures – such as chemotherapy and surgeries – are more risky and put patients' lives at risk.{{Cite web|title=Wellcome Trust Report: "How is modern medicine being affected by drug-resistant infections?"|url=https://cms.wellcome.org/sites/default/files/2021-09/AMR-Rand-Report-How-is-modern-medicine-being-affected-by-drug-resistant-infections.pdf|url-status=live|archive-url=https://web.archive.org/web/20211029164109/https://cms.wellcome.org/sites/default/files/2021-09/AMR-Rand-Report-How-is-modern-medicine-being-affected-by-drug-resistant-infections.pdf |archive-date=2021-10-29 }} Approximately 1.27 million people died {{Cite web |title=Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis |url=https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext}} globally in 2019 due to drug-resistant bacterial infections. CARB-X supports projects that are focused on the most dangerous bacteria{{Cite web|title=Overview|url=https://carb-x.org/about/overview/|access-date=2022-01-14|website=Carb-X|language=en-US}} identified by the World Health Organization (WHO){{Cite web|title=WHO Priority List of Antibiotic Resistant Bacteria|url=https://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf|url-status=live|archive-url=https://web.archive.org/web/20170227180238/http://who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf |archive-date=2017-02-27 }} and Centers for Disease Control and Prevention (CDC) priority lists.{{Cite web|last=CDC|date=2021-11-23|title=The biggest antibiotic-resistant threats in the U.S.|url=https://www.cdc.gov/drugresistance/biggest-threats.html|access-date=2022-01-14|website=Centers for Disease Control and Prevention|language=en-us}}

On average, it costs more than $1 billion and takes 1–15 years to develop a new antibiotic for use in patients. {{Cite web|title=Why is it so hard to develop new antibiotics?|url=https://wellcome.org/news/why-is-it-so-hard-develop-new-antibiotics|access-date=2022-01-14|website=Wellcome|language=en}} A strong economic model to incentivize a steady supply of new antibiotics does not exist. Without enough revenue to recover research and development expenses, small antibiotic companies have been filing for bankruptcy, and large pharmaceutical companies are shuttering their antibiotics divisions.{{Cite news|last=Jacobs|first=Andrew|date=2019-12-25|title=Crisis Looms in Antibiotics as Drug Makers Go Bankrupt|language=en-US|work=The New York Times|url=https://www.nytimes.com/2019/12/25/health/antibiotics-new-resistance.html|access-date=2022-01-14|issn=0362-4331}} New economic models, support from organizations like CARB-X, and increased investment are needed to drive innovation.

Funding

CARB-X receives funding from four governments and two nonprofit organizations. These include the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), part of the [https://aspr.hhs.gov/Pages/Home.aspx Administration for Strategic Preparedness and Response] (ASPR); Wellcome Trust, a global charitable foundation; [https://fundit.fr/en/institutions/german-federal-ministry-education-and-research-bmbf Germany's Federal Ministry of Education and Research (BMBF)]; the [https://www.gov.uk/government/groups/the-global-amr-innovation-fund UK Government's Global Antimicrobial Resistance Innovation Fund (UK GAMRIF)]; the Bill & Melinda Gates Foundation; the [https://www.canada.ca/en/public-health.html government of Canada]; and the [https://novonordiskfonden.dk/en/ Novo Nordisk Foundation]. CARB-X also receives in-kind support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH).{{Cite web|title=Overview|url=https://carb-x.org/about/overview/|access-date=2022-01-14|website=Carb-X|language=en-US}}

In its first five years, from 2016 to 2021, CARB-X awarded $361 million to 92 projects.{{Cite web |title=2020-2021 CARB-X Annual Report |url=https://carb-x.org/wp-content/uploads/2021/10/CarbX_AR_20-21.pdf |url-status=live |archive-url=https://web.archive.org/web/20211012103935/https://carb-x.org/wp-content/uploads/2021/10/CarbX_AR_20-21.pdf |archive-date=2021-10-12}} In 2022, BARDA and Wellcome renewed committed renewed funding up to an additional $370 million to CARB-X.{{Cite web |title=U.S. government and Wellcome commit up to an additional US$370 million to CARB-X |url=https://carb-x.org/carb-x-news/u-s-government-and-wellcome-commit-an-additional-us370-million-to-carb-x/ |access-date=2022-08-24 |website=Carb-X |language=en-US}} In 2023, the German and UK governments renewed funding to CARB-X, committing an additional €41 million{{Cite web |title=GERMAN GOVERNMENT RENEWS COMMITMENT TO CARB-X |url=https://carb-x.org/carb-x-news/german-government-renews-commitment-to-carb-x/}} and £24 million;{{Cite web |title=UK GOVERNMENT BOLSTERS PARTNERSHIP WITH CARB-X |url=https://carb-x.org/carb-x-news/uk-government-bolsters-partnership-with-carb-x/}} the government of Canada committed CAD$6.3 million over two years; and The Novo Nordisk Foundation committed USD$25 million over three years.

In addition to awarding non-dilutive funding, CARB-X partners with a Global Accelerator Network (GAN) of experts who offer product developers advice on a range of issues, including drug development, business strategy, policy and regulatory affairs.{{Cite web |title=Accelerators / Other Partners |url=https://carb-x.org/partners/global-accelerator-network/ |access-date=2022-01-14 |website=Carb-X |language=en-US}}

At the 2024 G7 Joint Finance and Health Ministers’ Meeting, Italy announced a $21 million investment in CARB-X, a partnership that funds early-stage antibiotic research.{{Cite web |title=Documents of the Health Ministers' Meeting in Ancona {{!}} G7 Italia |url=https://www.g7italy.it/en/documents-of-the-health-ministers-meeting-in-ancona/?utm_campaign=pharmalittle&utm_medium=email&_hsenc=p2ANqtz-8PbEdhI1CLTvLHww-e_0Oj3Hd_M_-zGoUzaRBEnRx5VYFy_cIVTZCxwYh2zsFNUKI2eiynEmAUCggo4Qvr7-Owjyzk8w&_hsmi=329758226&utm_content=329758226 |access-date=2024-10-18 |website=G7 Italia 2024 |language=en}} This funding aims to accelerate the development of new products for preventing, diagnosing, and treating drug-resistant infections. Italy joins five other G7 governments and major global health foundations, and CARB-X has already supported 104 R&D projects globally, with 18 advancing to clinical trials and some reaching the market.

Global Recognition

The G7 Health Ministers have cited CARB-X{{Cite web |date=May 20, 2022 |title=G7 Health Ministers' Communiqué |url=https://www.g7germany.de/resource/blob/974430/2042058/5651daa321517b089cdccfaffd1e37a1/2022-05-20-g7-health-ministers-communique-data.pdf |website=G7 Germany}} among the critical initiatives to support as the G7 governments renew their 2021 commitment to address the most dangerous drug-resistant infections. In May 2023, the global threat of Antimicrobial Resistance and the importance of supporting CARB-X as a global push incentive that coordinates and accelerates much-needed antibacterial innovation was featured in G7 Hiroshima Leaders’ Communiqué[https://www.mofa.go.jp/files/100506878.pdf G7 Hiroshima Leaders’ Communiqué] (PDF). G7 Japan. May 20, 2023 and the G7 Nagasaki Health Ministers’ Communiqué.[https://www.mhlw.go.jp/content/10500000/001096403.pdf G7 Nagasaki Health Ministers’ Communiqué] (PDF). G7 Japan. May 13, 2023. The same year, G20 Health Ministers cited CARB-X as playing a critical role in accelerating antimicrobial R&D and access.[https://www.g20.in/content/dam/gtwenty/gtwenty_new/document/G20_HMM_Outcome_Document_and_Chair_Summary.pdf G20 Health Ministers' Outcome Document] (PDF). G20 India. August 19, 2023. In October 2024, the importance of supporting CARB-X as a global push incentive that accelerates the research and development of antibacterial products was featured in G7 Health Ministers' Communiqué.<{{cite web |title=G7 Health Ministers' Communiqué |url=https://www.salute.gov.it/imgs/C_17_pubblicazioni_3482_allegato.pdf |website=G7 Italy |access-date=18 October 2024}}

In May 2024, the Antimicrobial Resistance (AMR) Multi-Stakeholder Partnership Platform issued a call for actionable steps to address the rising threat of AMR ahead of the United Nations General Assembly High-Level Meeting on AMR in September 2024. The call recommended increasing public investment in push incentives to catalyze global antimicrobial R&D efforts and cited CARB-X as a push mechanism that should be mobilized due to CARB-X’s critical role in supporting the discovery and development or new antimicrobials.[https://openknowledge.fao.org/server/api/core/bitstreams/f252d9e2-91f2-48d7-a20c-50da25539234/content Call for actionable steps in response to the rising threat of antimicrobial resistance (AMR)] Antimicrobial Resistance (AMR) Multi-Stakeholder Partnership Platform. May 2024.  

CARB-X also was named in the Political Declaration on antimicrobial resistance (AMR) approved by United Nations Member States during the High-Level Meeting on September 26, 2024 at the 79th Session of the UN General Assembly. “The research and development pipeline for vaccines, diagnostics, therapeutics, especially antimicrobials and alternatives to the use of antimicrobials, to prevent and address antimicrobial resistance, especially antibiotics, are insufficient,” UN Member States note with concern in the declaration. As a consequence, they openly “recognize the benefits of public-private partnerships in the development of and access to antimicrobials, vaccines, diagnostics and alternatives to antimicrobials and in contributing to supply chain sustainability, and take note of the work of the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research and Development Partnership (GARDP).” [https://www.un.org/pga/wp-content/uploads/sites/108/2024/09/FINAL-Text-AMR-to-PGA.pdf Political Declaration of the High-level Meeting on Antimicrobial Resistance.] September 2024

See also

References

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