Ensuring Sustainability of Needed Antibiotics: Aiming for the DART Board

doi:10.7326/M19-1893

. 2019 Oct 15;171(8):580-582.

doi: 10.7326/M19-1893. Epub 2019 Oct 8.

Ensuring Sustainability of Needed Antibiotics: Aiming for the DART Board

Brad Spellberg¹, Travis B Nielsen², David N Gilbert³, Andrew F Shorr⁴, Eric P Brass⁵

Affiliations

¹ Los Angeles County and University of Southern California Medical Center, Los Angeles, California (B.S.).
² Stritch School of Medicine and Parkinson School of Health Sciences and Public Health, Loyola University Chicago, Maywood, Illinois (T.B.N.).
³ Providence Portland Medical Center and University of Oregon Health Sciences School of Medicine, Portland, Oregon (D.N.G.).
⁴ Pulmonary and Critical Care Medicine Service, MedStar Washington Hospital Center, Washington, DC (A.F.S.).
⁵ David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California (E.P.B.).

PMID: 31590184
PMCID: PMC7296826
DOI: 10.7326/M19-1893

Ensuring Sustainability of Needed Antibiotics: Aiming for the DART Board

Brad Spellberg et al. Ann Intern Med. 2019.

. 2019 Oct 15;171(8):580-582.

doi: 10.7326/M19-1893. Epub 2019 Oct 8.

Authors

Brad Spellberg¹, Travis B Nielsen², David N Gilbert³, Andrew F Shorr⁴, Eric P Brass⁵

Affiliations

¹ Los Angeles County and University of Southern California Medical Center, Los Angeles, California (B.S.).
² Stritch School of Medicine and Parkinson School of Health Sciences and Public Health, Loyola University Chicago, Maywood, Illinois (T.B.N.).
³ Providence Portland Medical Center and University of Oregon Health Sciences School of Medicine, Portland, Oregon (D.N.G.).
⁴ Pulmonary and Critical Care Medicine Service, MedStar Washington Hospital Center, Washington, DC (A.F.S.).
⁵ David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California (E.P.B.).

PMID: 31590184
PMCID: PMC7296826
DOI: 10.7326/M19-1893

No abstract available

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Figures

**Figure.1. Schematic of a sustainable model for targeted discovery and development of new antibiotics.**
Stages include Discovery (basic science work and lead-candidate identification), Early Development (lead optimization, manufacturing, preclinical toxicity, pharmacology, IND preparation, and phase I clinical trials), Late Development (phase II/III clinical trials and NDA filing), and Commercialization (postmarketing). Prioritization of funding to target clinical unmet needs would be set by the DART Board list from Early Development through Commercialization, with the ability to influence the Discovery phase. Academia will continue to conduct early disovery work using existing funding mechanisms. Nonprofits would participate at all stages. For-profit companies could continue to participate at all stages, particularly via outlicensing arrangements with academia and nonprofits. Revenue from commercial sales and licensing fees from for-profit companies would be fed back into nonprofits and/or government funding agencies whose mission is to discover and develop new antibiotics. BARDA = Biomedical Advanced Research and Development Authority; DART = Developing Antibiotics for Resistant Targets; IND = Investigational New Drug; NDA = New Drug Application; NIH = National Institutes of Health; PPPs = public private partnerships.

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References

1. Johnson AS. Medicine’s responsibility in the propagation of poor protoplasm. N Engl J Med. 1948;238:755–8. [PMID: 18860758] - PubMed
1. Finland M, Kirby WM, Chabbert YA, et al. Round table: are new antibiotics needed? Antimicrob Agents Chemother (Bethesda). 1965;5:1107–14. [PMID: 5883409] - PubMed
1. Nielsen TB, Brass EP, Gilbert DN, et al. Sustainable discovery and development of antibiotics—is a nonprofit approach the future? N Engl J Med. 2019;381:503–5. [PMID: 31216396] doi:10.1056/NEJMp1905589 - DOI - PMC - PubMed
1. Infectious Diseases Society of America. White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens. Clin Infect Dis. 2012;55:1031–46. [PMID: 22891041] - PMC - PubMed
1. U.S. Food and Drug Administration. Generating Antibiotic Incentives Now. Accessed at www.fda.gov/media/110982/download on 1 August 2019.

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[1] Johnson AS. Medicine’s responsibility in the propagation of poor protoplasm. N Engl J Med. 1948;238:755–8. [PMID: 18860758] - PubMed

[2] Johnson AS. Medicine’s responsibility in the propagation of poor protoplasm. N Engl J Med. 1948;238:755–8. [PMID: 18860758] - PubMed

[3] Finland M, Kirby WM, Chabbert YA, et al. Round table: are new antibiotics needed? Antimicrob Agents Chemother (Bethesda). 1965;5:1107–14. [PMID: 5883409] - PubMed

[4] Finland M, Kirby WM, Chabbert YA, et al. Round table: are new antibiotics needed? Antimicrob Agents Chemother (Bethesda). 1965;5:1107–14. [PMID: 5883409] - PubMed

[5] Nielsen TB, Brass EP, Gilbert DN, et al. Sustainable discovery and development of antibiotics—is a nonprofit approach the future? N Engl J Med. 2019;381:503–5. [PMID: 31216396] doi:10.1056/NEJMp1905589 - DOI - PMC - PubMed

[6] Nielsen TB, Brass EP, Gilbert DN, et al. Sustainable discovery and development of antibiotics—is a nonprofit approach the future? N Engl J Med. 2019;381:503–5. [PMID: 31216396] doi:10.1056/NEJMp1905589 - DOI - PMC - PubMed

[7] Infectious Diseases Society of America. White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens. Clin Infect Dis. 2012;55:1031–46. [PMID: 22891041] - PMC - PubMed

[8] Infectious Diseases Society of America. White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens. Clin Infect Dis. 2012;55:1031–46. [PMID: 22891041] - PMC - PubMed

[9] U.S. Food and Drug Administration. Generating Antibiotic Incentives Now. Accessed at www.fda.gov/media/110982/download on 1 August 2019.

[10] U.S. Food and Drug Administration. Generating Antibiotic Incentives Now. Accessed at www.fda.gov/media/110982/download on 1 August 2019.

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Ensuring Sustainability of Needed Antibiotics: Aiming for the DART Board

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Ensuring Sustainability of Needed Antibiotics: Aiming for the DART Board

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