FDA Public Workshop Summary: Advancing Animal Models for Antibacterial Drug Development

James M Byrne^{1

2}, Ursula Waack^{3

2}, Edward A Weinstein³, Abhay Joshi⁴, Simone M Shurland³, Dmitri Iarikov³, Jürgen B Bulitta⁵, Binh An Diep⁶, Tina Guina⁷, William W Hope⁸, Matthew B Lawrenz⁹, Alexander J Lepak¹⁰, Brian M Luna¹¹, Lynn Miesel¹², Andrew J Phipps¹³, Thomas J Walsh¹⁴, William Weiss¹⁵, Thushi Amini³, John J Farley³

Affiliations

¹ Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA James.Byrne@fda.hhs.gov.
² Oak Ridge Institute of Science and Education, Oak Ridge, Tennessee, USA.
³ Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁴ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁵ Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Orlando, Florida, USA.
⁶ Division of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
⁷ Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
⁸ Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
⁹ Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases, Department of Microbiology and Immunology, University of Louisville School of Medicine, Louisville, Kentucky, USA.
¹⁰ Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
¹¹ Department of Molecular Microbiology and Immunology, Keck School of Medicine of USC, Los Angeles, California, USA.
¹² Pharmacology Discovery Services, Ltd., New Taipei City, Taiwan.
¹³ Tunnell Government Services, Biomedical Advanced Research and Development Authority, Washington, DC, USA.
¹⁴ Transplantation-Oncology Infectious Diseases Program, Departments of Medicine, Pediatrics, and Microbiology & Immunology, Weill Cornell Medicine of Cornell University, New York, New York, USA.
¹⁵ PreClinical Services, UNT System College of Pharmacy, Fort Worth, Texas, USA.

PMID: 33106262
PMCID: PMC7927847
DOI: 10.1128/AAC.01983-20

Review

FDA Public Workshop Summary: Advancing Animal Models for Antibacterial Drug Development

James M Byrne et al. Antimicrob Agents Chemother. 2020.

. 2020 Dec 16;65(1):e01983-20.

doi: 10.1128/AAC.01983-20. Print 2020 Dec 16.

Authors

Affiliations

¹ Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA James.Byrne@fda.hhs.gov.
² Oak Ridge Institute of Science and Education, Oak Ridge, Tennessee, USA.
³ Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁴ Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
⁵ Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Orlando, Florida, USA.
⁶ Division of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.
⁷ Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.
⁸ Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom.
⁹ Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases, Department of Microbiology and Immunology, University of Louisville School of Medicine, Louisville, Kentucky, USA.
¹⁰ Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
¹¹ Department of Molecular Microbiology and Immunology, Keck School of Medicine of USC, Los Angeles, California, USA.
¹² Pharmacology Discovery Services, Ltd., New Taipei City, Taiwan.
¹³ Tunnell Government Services, Biomedical Advanced Research and Development Authority, Washington, DC, USA.
¹⁴ Transplantation-Oncology Infectious Diseases Program, Departments of Medicine, Pediatrics, and Microbiology & Immunology, Weill Cornell Medicine of Cornell University, New York, New York, USA.
¹⁵ PreClinical Services, UNT System College of Pharmacy, Fort Worth, Texas, USA.

PMID: 33106262
PMCID: PMC7927847
DOI: 10.1128/AAC.01983-20

Abstract

The U.S. Food and Drug Administration (FDA) hosted a public workshop entitled "Advancing Animal Models for Antibacterial Drug Development" on 5 March 2020. The workshop mainly focused on models of pneumonia caused by Pseudomonas aeruginosa and Acinetobacter baumannii The program included discussions from academic investigators, industry, and U.S. government scientists. The potential use of mouse, rabbit, and pig models for antibacterial drug development was presented and discussed.

Keywords: FDA; animal models; antibacterial; antibiotics; drug development; humanized dose; pneumonia; regulatory; workshop.

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References

1. Centers for Disease Control and Prevention. 2019. Antibiotic resistance threats in the United States, 2019. Centers for Disease Control and Prevention, Atlanta, GA. https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-re....
1. Waack U, Weinstein EA, Farley JJ. 2020. Assessing animal models of bacterial pneumonia used in investigational new drug applications for the treatment of bacterial pneumonia. Antimicrob Agents Chemother 64:e02242-19. doi: 10.1128/AAC.02242-19. - DOI - PMC - PubMed
1. Nielsen TB, Yan J, Luna B, Spellberg B. 2018. Murine oropharyngeal aspiration model of ventilator-associated and hospital-acquired bacterial pneumonia. J Vis Exp doi: 10.3791/57672. - DOI - PMC - PubMed
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1. Lawrenz MB, Biller AE, Cramer DE, Kraenzle JL, Sotsky JB, Vanover CD, Yoder-Himes DR, Pollard A, Warawa JM. 2015. Development and evaluation of murine lung-specific disease models for Pseudomonas aeruginosa applicable to therapeutic testing. Pathog Dis 73:ftv025. doi: 10.1093/femspd/ftv025. - DOI - PMC - PubMed

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FDA Public Workshop Summary: Advancing Animal Models for Antibacterial Drug Development

Affiliations

FDA Public Workshop Summary: Advancing Animal Models for Antibacterial Drug Development

Authors

Affiliations

Abstract

References

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LinkOut - more resources

Full Text Sources

Medical