In Vitro Activity
In the early stages of antimicrobial drug development, you need answers as to whether the agent you are developing has sufficient in vitro activity or you need to confirm and expand the initial data with results from an independent laboratory to determine whether to continue to invest in your asset. JMI Laboratories has the experience and knowledge to perform the initial screens and a variety of studies to characterize the spectrum of activity and potency of your compound compared to other existing therapeutic agents.
How are the studies organized?
Besides designing initial screening and spectrum of activity studies, which can involve small (20-50) or large numbers of organisms (hundreds), there should be a number of other very important studies to consider that will eventually be needed as part of your regulatory submission portfolio. A partial listing of these studies are represented below:
- Evaluations of the bacteriostatic or bactericidal activity by MBC and kill-curve methods
- Determination of resistance selection rates by passaging and mutational single-step analysis
- Postantibiotic-effect studies of target species
- Effects of varying in vitro susceptibility testing conditions
- Development of in vitro testing methods, including appropriate disk mass content and quality control organism range determinations
- Assessment of commercial diagnostics, including MIC, disk and Etest® correlations and regression analyses
- Synergy studies to determine the in vitro effect of drug combinations
What is the end goal?
Advisory Boards – Your company’s leadership group may need to be provided with sufficient microbiology testing data to make a decision as to whether to continue to invest in the drug. These studies can be performed by your own scientists but should also be verified or ultimately performed by an independent laboratory.
Regulatory Applications – An investigational new drug application will need to have sufficient in vitro microbiology data to warrant approval to advance into the clinical phases of development by the evaluating agency.
Clinical Phases of Development – During the clinical trial phases of development, you will need access to the appropriate diagnostics for referred clinical isolates and will want to consider a microbiology laboratory that has experience with your drug. JMI Laboratories can carry that experience from the early stages of antimicrobial in vitro activity development into the clinical phases of support.
The JMI Laboratories Difference
One of the most important factors in designing an in vitro antimicrobial drug development activity study is to have access to the appropriate organisms to be utilized in the testing program and the experience behind the studies. The clinical isolates should be from recent sources, relevant specimen sources and contain both susceptible and resistant populations to challenge the effectiveness of the study drug. Through our antimicrobial surveillance programs, we collect tens of thousands of isolates each year and catalog them in our bacteria and fungal collection libraries and these isolates are carefully selected to meet your experiment design requirements. We also have an extensive library of isolates with defined genetic characteristics that have been evaluated in our Molecular Studies and these can also be incorporated into protocol designs.
Further, our team of experts has vast industry and scientific experience and can assist and collaborate in the design of a program to meet your scientific needs and fiscal requirements.
Our data has been included in numerous antimicrobial regulatory drug applications including many recently approved drugs, thus you can be assured that JMI Laboratories has the experience and will develop the program to complement your regulatory submission.