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

doi:10.1128/AAC.01983-20

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

Antimicrob Agents Chemother. 2020 Dec 16;65(1):e01983-20. doi: 10.1128/AAC.01983-20. Print 2020 Dec 16.

Authors

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 [email protected].
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.

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.

Publication types

Research Support, U.S. Gov't, Non-P.H.S.
Review

MeSH terms

Acinetobacter baumannii*
Animals
Anti-Bacterial Agents* / therapeutic use
Drug Development
Mice
Models, Animal
Rabbits
Swine
United States
United States Food and Drug Administration

Substances

Anti-Bacterial Agents