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Editor's Pick Meeting Review

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

James M. Byrne, Ursula Waack, Edward A. Weinstein, Abhay Joshi, Simone M. Shurland, Dmitri Iarikov, Jürgen B. Bulitta, Binh An Diep, Tina Guina, William W. Hope, Matthew B. Lawrenz, Alexander J. Lepak, Brian M. Luna, Lynn Miesel, Andrew J. Phipps, Thomas J. Walsh, William Weiss, Thushi Amini, John J. Farley
James M. Byrne
aOffice of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
bOak Ridge Institute of Science and Education, Oak Ridge, Tennessee, USA
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Ursula Waack
aOffice of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
bOak Ridge Institute of Science and Education, Oak Ridge, Tennessee, USA
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Edward A. Weinstein
aOffice of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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Abhay Joshi
cOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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Simone M. Shurland
aOffice of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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Dmitri Iarikov
aOffice of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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Jürgen B. Bulitta
dDepartment of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Orlando, Florida, USA
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Binh An Diep
eDivision of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA
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Tina Guina
fBiomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, Washington, DC, USA
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William W. Hope
gDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom
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Matthew B. Lawrenz
hCenter for Predictive Medicine for Biodefense and Emerging Infectious Diseases, Department of Microbiology and Immunology, University of Louisville School of Medicine, Louisville, Kentucky, USA
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Alexander J. Lepak
iDepartment of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA
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Brian M. Luna
jDepartment of Molecular Microbiology and Immunology, Keck School of Medicine of USC, Los Angeles, California, USA
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Lynn Miesel
kPharmacology Discovery Services, Ltd., New Taipei City, Taiwan
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Andrew J. Phipps
lTunnell Government Services, Biomedical Advanced Research and Development Authority, Washington, DC, USA
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Thomas J. Walsh
mTransplantation-Oncology Infectious Diseases Program, Departments of Medicine, Pediatrics, and Microbiology & Immunology, Weill Cornell Medicine of Cornell University, New York, New York, USA
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William Weiss
nPreClinical Services, UNT System College of Pharmacy, Fort Worth, Texas, USA
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Thushi Amini
aOffice of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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John J. Farley
aOffice of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
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DOI: 10.1128/AAC.01983-20
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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.

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FDA Public Workshop Summary: Advancing Animal Models for Antibacterial Drug Development
James M. Byrne, Ursula Waack, Edward A. Weinstein, Abhay Joshi, Simone M. Shurland, Dmitri Iarikov, Jürgen B. Bulitta, Binh An Diep, Tina Guina, William W. Hope, Matthew B. Lawrenz, Alexander J. Lepak, Brian M. Luna, Lynn Miesel, Andrew J. Phipps, Thomas J. Walsh, William Weiss, Thushi Amini, John J. Farley
Antimicrobial Agents and Chemotherapy Dec 2020, 65 (1) e01983-20; DOI: 10.1128/AAC.01983-20

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FDA Public Workshop Summary: Advancing Animal Models for Antibacterial Drug Development
James M. Byrne, Ursula Waack, Edward A. Weinstein, Abhay Joshi, Simone M. Shurland, Dmitri Iarikov, Jürgen B. Bulitta, Binh An Diep, Tina Guina, William W. Hope, Matthew B. Lawrenz, Alexander J. Lepak, Brian M. Luna, Lynn Miesel, Andrew J. Phipps, Thomas J. Walsh, William Weiss, Thushi Amini, John J. Farley
Antimicrobial Agents and Chemotherapy Dec 2020, 65 (1) e01983-20; DOI: 10.1128/AAC.01983-20
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  • Top
  • Article
    • ABSTRACT
    • INTRODUCTION
    • SCIENTIFIC LANDSCAPE, CLINICAL PHARMACOLOGY, AND DEVELOPMENT RESOURCES
    • MURINE MODELS OF PNEUMONIA
    • NONMURINE ANIMAL MODEL DEVELOPMENT
    • PANEL DISCUSSION
    • POTENTIAL REGULATORY IMPACTS
    • CONCLUSION
    • ACKNOWLEDGMENTS
    • REFERENCES
  • Info & Metrics
  • PDF

KEYWORDS

FDA
animal models
antibacterial
antibiotics
drug development
humanized dose
pneumonia
regulatory
workshop

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