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

Author:

Byrne James M.12ORCID,Waack Ursula12ORCID,Weinstein Edward A.1,Joshi Abhay3ORCID,Shurland Simone M.1,Iarikov Dmitri1,Bulitta Jürgen B.4ORCID,Diep Binh An5,Guina Tina6,Hope William W.7ORCID,Lawrenz Matthew B.8ORCID,Lepak Alexander J.9,Luna Brian M.10ORCID,Miesel Lynn11,Phipps Andrew J.12,Walsh Thomas J.13,Weiss William14,Amini Thushi1,Farley John J.1

Affiliation:

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

2. Oak Ridge Institute of Science and Education, Oak Ridge, Tennessee, USA

3. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

4. Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Orlando, Florida, USA

5. Division of HIV, Infectious Diseases and Global Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA

6. Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, Washington, DC, USA

7. Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, United Kingdom

8. Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases, Department of Microbiology and Immunology, University of Louisville School of Medicine, Louisville, Kentucky, USA

9. Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA

10. Department of Molecular Microbiology and Immunology, Keck School of Medicine of USC, Los Angeles, California, USA

11. Pharmacology Discovery Services, Ltd., New Taipei City, Taiwan

12. Tunnell Government Services, Biomedical Advanced Research and Development Authority, Washington, DC, USA

13. Transplantation-Oncology Infectious Diseases Program, Departments of Medicine, Pediatrics, and Microbiology & Immunology, Weill Cornell Medicine of Cornell University, New York, New York, USA

14. PreClinical Services, UNT System College of Pharmacy, Fort Worth, Texas, USA

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.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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