The COMBINE project is part of the IMI AMR Accelerator. One of the scientific aims of COMBINE is to improve and standardize the pneumonia animal model used in AMR research and to develop improved tools to reliably translate results in animals into results in humans.
This workshop addressed the need for standard protocols to ease harmonization of non-clinical efficacy data and facilitate the establishment of standardized high-quality infection models. We focused on preclinical lung infection models for the most relevant Gram-negative AMR pathogens (K. pneumoniae, P. aeruginosa and A. baumannii). Our speakers and panelists from industry, academia and regulatory agencies discussed previously identified factors of variability and control parameters in murine pneumonia infection model protocols and addressed the challenges and strategies for in vivo PK/PD, identifying the critical factors affecting the predictive value for translation to clinic.. Moreover, this webinar provided an open discussion forum aimed at reaching a consensus to establish a standardized high-quality preclinical murine pneumonia model for PK/PD analysis of small-molecule antibiotics. Further, we explored protocol adjustments for efficacy studies beyond PK/PD.
Speakers & Panelists: Experts on murine lung infection models from academia, industry and regulatory agencies presented and discussed parameters for PK/PD of small-molecule antibiotics and special considerations for additional readouts or alternative applications of these models.
Participation: This free online workshop was of particular interest to investigators applying preclinical murine models for efficacy and PK/PD assessment.
|Day 1, Tuesday April 27th 2021 (15:00-19:00 CEST)
Developing a standardized murine pneumonia model to characterize PK/PD of antibiotics
|Day 2, Wednesday, April 28th 2021 (15:00-19:00 CEST)
Standard protocols for murine pneumonia models – beyond PK/PD
|15:00 – 15:20 Welcome and introduction
15:20 – 15:45 Parameters that are important for murine pneumonia model used for PK/PD characterization and recommendations for a standard protocol
15:45 – 16:10 Impact of murine pneumonia infection model and treatment regimen in antibiotics efficacy
16:25 – 18:45 Panel Discussion: murine pneumonia model variables to standardize PK/PD analysis of small-molecule antibiotics
18:45 – 19:00 Wrap-up & Survey
|15:00 – 15:10 Welcome/Introduction
15:10 – 15:40 Murine pneumonia model special considerations for bacteriophages efficacy testing
15:40 – 16:10 Murine pneumonia model special considerations for monoclonal antibodies efficacy testing
16:10 – 16:30 Murine pneumonia model special considerations for Iron sequestering anti-infectives efficacy testing
16:55 – 17:25 Importance of Epithelial Lining Fluid (ILF) in PK/PD characterization for pneumonia and procedures for collecting and analyzing ELF from mice
17:25 – 17:55 Murine pneumonia model special considerations for ß-lactam/ß-lactamase inhibitor (BL/BLI) testing
17:55 – 18:25 Murine pneumonia model special considerations for A. baumannii infection
18:25 – 18:50 Survey results presentation
18:50 – 19:00 Wrap-up
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