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John J S Cadwell

John J S Cadwell

FiberCell Systems Inc., USA

Title: The hollow fi ber infection model: Principles and practice

Biography

Biography: John J S Cadwell

Abstract

Emerging antibiotic resistance presents a serious global health threat. Two million people in the United States were infected with antibiotic resistant bacteria in 2014 and more than 20,000 died as a direct result of these infections, many more from complications. Antimicrobial resistance has been identifi ed as one of the three greatest threats to human health. Antibiotic discovery and development require static susceptibility testing to screen compounds, in vitro pharmacodynamics/ pharmacokinetic (PK/PD) studies to model drug dynamics and effi cacy, and testing in animal models to provide critical information prior to the clinical evaluation of new antibiotics. Th e one compartment PK/PD model typically consists of an open central reservoir containing the organism of interest, a source of diluent and a waste reservoir. Th e disadvantage of this system includes: 1) Open system, not bio safe; 2) Bacteria numbers change over time; 3) Large volume requires large
amount of drug and diluent; 4) Rapid changes in drug concentration not possible and cannot model short half-lives. Anima models have many shortcomings though they have served as a primary development tool for many years: It includes: 1) PK/ PD may not match human values; 2) Cannot sample same animal over time; 3)Diffi cult to study large numbers of bacteria to reveal resistance; 4) Many infections cannot be modeled in a mouse or other animal. To address these shortcomings, the two-compartment in vitro pharmacokinetic model utilizing hollow fi ber bioreactors was developed, the Hollow fi ber infection model (HFIM). Th e advantages of the HFIM are as follows: 1) Closed, bio-safe system; 2) Large number of organism can be tested, revealing resistance; 3) Precisely simulates human PK/PD; 4) Repetitive sampling over time, both drug and organism; 5) Total kill can be determined; 6) Single use, disposable, reproducible; 7) Two drug models can be tested; 8) Can model both dosing curve and elimination curve; 9) Can look at bacteria in diff erent growth phases and in combination with cells. Th e clinical utility of the HFIM has been demonstrated and is now endorsed by the EMA. An overview of historic PK/PD models is presented and the utility of the system as it relates to antibiotics and other drugs are discussed.