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Global Antibiotic Research and Development Partnership

From EverybodyWiki Bios & Wiki




Global Antibiotic Research and Development Partnership (GARDP) is a non-profit drug research and development organization developing new and improved antibiotics for infections caused by antibiotic-resistant bacteria and working to ensure sustainable access to these treatments. The research and development work of GARDP is guided by global public health needs and the World Health Organization (WHO) priority pathogens list, which identifies the antibiotic-resistant bacteria that pose the greatest threat to human health.[1] The programme areas of GARDP are sexually transmitted infections (gonorrhoea), infections in children and newborns (neonatal sepsis), hospital-associated infections and discovery and exploratory research.[2]

Led by Executive Director Manica Balasegaram, GARDP is headquartered in Geneva, Switzerland, with affiliate offices through the Drugs for Neglected Diseases initiative (DNDi) in India, Japan, Kenya, Malaysia, South Africa and the United States.

Origins

Antibiotic resistance occurs when bacteria change in response to the use of antibiotics used to treat bacterial infections, making the treatments ineffective.[3] Antibiotic resistance occurs naturally but is accelerated by the overuse and inappropriate use of antibiotics.[4]

The WHO has identified antimicrobial resistance (drug resistance), which includes antibiotic resistance, as one of the greatest threats to global health and development[5] and as an urgent health priority[6]. At least 700,000 people die every year as a result of antimicrobial-resistant infections.[7] Antimicrobial resistance has an annual economic impact of US$55 billion in the United States[8] and €1.1 billion in the European Union and European Economic Area.[9] The World Bank estimates that by 2050 antimicrobial resistance could result in global gross domestic product falling by 3.8% and push up to 28 million people, mostly in low- and middle-income countries, into poverty.[10]

At the 68th World Health Assembly in May 2015, member states endorsed a global action plan to address antimicrobial resistance, which included a proposal for a global antibiotic research and development initiative.[11] A working group was created by WHO and DNDi to determine the design of this new organization.[12] In 2016 GARDP was established by WHO and DNDi, with DNDi agreeing to incubate the organization for a three-year period. In 2019, GARDP became an independent organization.[13]

Non-profit antibiotic development model

Most pharmaceutical companies are no longer working on antibiotic research and development;[14] only four of 15 largest pharmaceutical companies have active antibiotic programmes.[15] Approximately half of antibiotics used today were discovered between the 1950s and 1970s.[16] Since that time, discovery and development of antibiotics has become more complex, time-consuming, and expensive.[17][18] New antibiotics that are approved for use have short treatment durations and controls on their sale and use to slow the emergence and spread of resistance, limiting their return on investment.[19][20]  

Even when new antibiotics are approved for use, they have rarely targeted gram-negative bacteria, which, due to their distinctive structure, are more resistant and cause significant morbidity and mortality worldwide.[21] Of the 25 new antibiotics that entered the market between 1999 and 2014, none targeted gram-negative bacteria.[22]  

To address the market failure of antibiotic research and development,[23] GARDP builds on the non-profit model developed by DNDi.[24] This product development partnership model (also called global public-private partnerships model) enables collaborations in which partners’ resources, assets, capacities, and expertise are leveraged for antibiotic research and development, including from industry, research institutions, academia, governments, and civil society.[25]

This model of antibiotic research and development allows for de-linkage approaches that separate the cost of research and development from profitability and volumes of antibiotics.[26]  

Access and stewardship

It is estimated that 5.7 million people die annually due to a lack of antibiotics, mostly in low- and middle-income countries.[27] One study found that of 25 new antibiotics that entered the market between 1999 and 2014, only 12 were registered for use in more than ten countries.[28] GARDP is addressing the lack of access through activities to enable sustainable access and stewardship of new antibiotics, including in low- and middle-income countries.[29]

GARDP’s access and stewardship framework includes a focus on licensing, regulatory, and procurement approaches, as well as equitable reimbursement models.[30]

Research and development portfolio  

GARDP’s research and development portfolio[31] is informed by global public health needs, focusing on the WHO priority pathogens list, and incorporating the needs of priority populations and addressing critically underfunded and unfilled gaps in the development of treatments.[32][33] The portfolio includes a phase 3 trial of zoliflodacin as a first-in-class treatment for Neisseria gonorrhoeae (gonorrhoea); a phase 3 trial of cefepime-taniborbactam, an investigational combination of the antibiotic cefepime with taniborbactam, a novel, broad-spectrum β-lactamase inhibitor that restores the activity of cefepime against hospital-associated infections, including carbapenem-resistant Enterobacteriaceae (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA); and pre-clinical activities and clinical trials of treatments for neonatal sepsis, including the antibiotic fosfomycin in combination with other candidate antibiotics.

Long-term objective

GARDP plans to develop five new and improved treatments by 2025.[34]

See also

Antimicrobial resistance

Antibiotic-resistant bacteria

References

  1. ↑ "WHO | Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug resistant bacterial infections, including tuberculosis". WHO. Retrieved 2020-06-03.
  2. ↑ Balasegaram, Manica; Piddock, Laura J. V. (2020-05-14). "The Global Antibiotic Research and Development Partnership (GARDP) Not-for-Profit Model of Antibiotic Development". ACS Infectious Diseases. 6 (6): 1295–1298. doi:10.1021/acsinfecdis.0c00101. PMID 32406675 Check |pmid= value (help). Unknown parameter |s2cid= ignored (help)
  3. ↑ "WHO | What is antimicrobial resistance?". WHO. Retrieved 2020-06-03.
  4. ↑ "WHO | What is antimicrobial resistance?". WHO. Retrieved 2020-06-03.
  5. ↑ "Antibiotic resistance". www.who.int. Retrieved 2020-06-03.
  6. ↑ "Urgent health challenges for the next decade". www.who.int. Retrieved 2020-06-03.
  7. ↑ Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations The Review on Antimicrobial Resistance Chaired by Jim O’Neill December 2014
  8. ↑ ANTIBIOTIC RESISTANCE THREATS in the United States, 2013 U.S Department of Health and Human Services, Centers for Disease Control and Prevention
  9. ↑ Antimicrobial Resistance Tackling the Burden in the European Union Organisation for Economic Co-operation and Development
  10. ↑ "By 2050, drug-resistant infections could cause global economic damage on par with 2008 financial crisis". World Bank. Retrieved 2020-06-03.
  11. ↑ "WHO | Global action plan on AMR". WHO. Retrieved 2020-06-03.
  12. ↑ "WHO | Investing in the development of new antibiotics and their conservation". WHO. Retrieved 2020-06-03.
  13. ↑ "GARDP set up as independent legal entity – DNDi". www.dndi.org. 2019-04-02. Retrieved 2020-06-03.
  14. ↑ "Big pharma failing to invest in new antibiotics, says WHO". the Guardian. 2020-01-17. Retrieved 2020-06-03.
  15. ↑ "Wanted: a reward for antibiotic development". Nature Biotechnology. 36 (7): 555. August 2018. doi:10.1038/nbt.4193. ISSN 1546-1696. PMID 29979651. Unknown parameter |s2cid= ignored (help)
  16. ↑ Paharik, Alexandra E.; Schreiber, Henry L.; Spaulding, Caitlin N.; Dodson, Karen W.; Hultgren, Scott J. (2017-12-14). "Narrowing the spectrum: the new frontier of precision antimicrobials". Genome Medicine. 9 (1): 110. doi:10.1186/s13073-017-0504-3. ISSN 1756-994X. PMC 5729598. PMID 29241446.
  17. ↑ "Why is it so hard to develop new antibiotics? | Wellcome". wellcome.ac.uk. Retrieved 2020-06-03.
  18. ↑ "Why Can't We Find New Antibiotics?". pew.org. Retrieved 2020-06-03.
  19. ↑ Fair, Richard J; Tor, Yitzhak (2014-08-28). "Antibiotics and Bacterial Resistance in the 21st Century". Perspectives in Medicinal Chemistry. 6: 25–64. doi:10.4137/PMC.S14459. ISSN 1177-391X. PMC 4159373. PMID 25232278.
  20. ↑ Fair, Richard J; Tor, Yitzhak (2014-08-28). "Antibiotics and Bacterial Resistance in the 21st Century". Perspectives in Medicinal Chemistry. 6: 25–64. doi:10.4137/PMC.S14459. ISSN 1177-391X. PMC 4159373. PMID 25232278.
  21. ↑ Breijyeh, Zeinab; Jubeh, Buthaina; Karaman, Rafik (2020-03-16). "Resistance of Gram-Negative Bacteria to Current Antibacterial Agents and Approaches to Resolve It". Molecules. 25 (6): 1340. doi:10.3390/molecules25061340. ISSN 1420-3049. PMC 7144564 Check |pmc= value (help). PMID 32187986 Check |pmid= value (help).
  22. ↑ Kållberg, Cecilia; Årdal, Christine; Blix, Hege Salvesen; Klein, Eili; Martinez, Elena M.; Lindbæk, Morten; Outterson, Kevin; Røttingen, John-Arne; Laxminarayan, Ramanan (2018-10-16). "Introduction and geographic availability of new antibiotics approved between 1999 and 2014". PLOS ONE. 13 (10): e0205166. Bibcode:2018PLoSO..1305166K. doi:10.1371/journal.pone.0205166. ISSN 1932-6203. PMC 6191083. PMID 30325963.
  23. ↑ Spellberg, Brad (2014-06-27). "The future of antibiotics". Critical Care. 18 (3): 228. doi:10.1186/cc13948. ISSN 1364-8535. PMC 4075146. PMID 25043962.
  24. ↑ Jean-Robert Ioset; Chatelain (March 2011). "Drug discovery and development for neglected diseases: the DNDi model". Drug Design, Development and Therapy. 5: 175–81. doi:10.2147/dddt.s16381. ISSN 1177-8881. PMC 3084299. PMID 21552487.
  25. ↑ Piddock, Laura JV (2018-12-01). "The Global Antibiotic Research and Development Partnership (GARDP): a not-for-profit antibiotic development organisation". The Lancet Infectious Diseases. 18 (12): 1304–1305. doi:10.1016/S1473-3099(18)30661-3. ISSN 1473-3099. PMID 30420229.
  26. ↑ Piddock, Laura JV (2018-12-01). "The Global Antibiotic Research and Development Partnership (GARDP): a not-for-profit antibiotic development organisation". The Lancet Infectious Diseases. 18 (12): 1304–1305. doi:10.1016/S1473-3099(18)30661-3. ISSN 1473-3099. PMID 30420229.
  27. ↑ Access Barriers to Antibiotics Center for Disease Dynamics, Economics & Policy
  28. ↑ Kållberg, Cecilia; Årdal, Christine; Blix, Hege Salvesen; Klein, Eili; Martinez, Elena M.; Lindbæk, Morten; Outterson, Kevin; Røttingen, John-Arne; Laxminarayan, Ramanan (2018-10-16). "Introduction and geographic availability of new antibiotics approved between 1999 and 2014". PLOS ONE. 13 (10): e0205166. Bibcode:2018PLoSO..1305166K. doi:10.1371/journal.pone.0205166. ISSN 1932-6203. PMC 6191083. PMID 30325963.
  29. ↑ Balasegaram, Manica; Piddock, Laura J. V. (2020-05-14). "The Global Antibiotic Research and Development Partnership (GARDP) Not-for-Profit Model of Antibiotic Development". ACS Infectious Diseases. 6 (6): 1295–1298. doi:10.1021/acsinfecdis.0c00101. PMID 32406675 Check |pmid= value (help). Unknown parameter |s2cid= ignored (help)
  30. ↑ Access Workshop Report 2019 Global Antibiotic Research and Development Partnership
  31. ↑ GARDP Pipeline
  32. ↑ L, Folgori; SJ, Ellis; JA, Bielicki; PT, Heath; M, Sharland; M, Balasegaram (November 2017). "Tackling Antimicrobial Resistance in Neonatal Sepsis". The Lancet. Global Health. 5 (11): e1066–e1068. doi:10.1016/S2214-109X(17)30362-5. PMID 29025624. Retrieved 2020-06-03. Unknown parameter |url-status= ignored (help)
  33. ↑ M, Balasegaram; B, Pécoul; G, Gray; M, Sharland; S, Swaminathan (June 2019). "Hard to Study, Hard to Treat: Putting Children at the Centre of Antibiotic Research and Development". The Lancet. Infectious Diseases. 19 (6): 573–574. doi:10.1016/S1473-3099(19)30214-2. PMID 31122767. Retrieved 2020-06-03. Unknown parameter |url-status= ignored (help)
  34. ↑ GARDP Strategy 5BY25


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