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Medelis: What would you look for in an outside preclinical team?
Dr. McGarry: Make sure the group understands your project and has the necessary facilities and expertise to meet your needs including the husbandry needs of various animal models, which can differ greatly. The group should have a deep understanding of the complexities of how strains and model characteristics affect the utility of certain animal tumor models. Special technical skills may be necessary that aren’t available at all units, such as gavage or infusion. And finally, they should demonstrate a thorough knowledge of protocol demands and the appropriate degree of compliance and documentation required to fulfill the FDA’s Good Laboratory Practices.
Medelis: Can you discuss GLPs for preclinical work - are they always required?
Dr. McGarry: GLP criteria are animal-specific directives addressing good record-keeping, husbandry, mixing of animals with other animals, and so on. During the regulatory approval process, yes, you must adhere to GLPs.
However, if you’re very early stage and are only assessing general compound parameters, you don’t need the costs associated with GLP-level studies. You obviously need good records, but you don’t need the same level of detail as a GLP study. This scenario is much less expensive and will still give a CMO or principal investigator enough information to determine whether a compound has potential.
Medelis: Many groups have pushed for the elimination of animal-based studies. Is that a likely scenario down the road?
Dr. McGarry: A variety of circles are advocating the elimination of animal-based studies, but the likelihood that permission to initiate clinical trials based on something other than animal-based data seems remote.
However, with genetic engineering, it’s possible to develop targeted knockouts and other genetic alterations that will answer almost any question. That’s a powerful scientific advance that helps us demonstrate efficacy as well as the appropriate hosts for pharmacokinetic and pharmacodynamic studies.
Medelis: Can computational toxicology diminish the reliance on animal models in the future?
Dr. McGarry: Computational toxicology is based on mathematical and computer models derived from historical information, predictive models and in vitro data like expression array analysis of cell cultures. It holds promise. However, it still hasn’t achieved a level of acceptance such that it could satisfy regulatory needs now met with animal data. Database information on families of molecular structures and their associated potential adverse reactions and efficacy still aren’t sufficient to exclude animal studies.
Medelis: How might personalized medicine affect preclinical work?
Dr. McGarry: Personalized medicine started in the early eighties with profiling a tumor for responsiveness to various chemotherapeutic agents. So what does this mean for using animal models? It remains to be seen. Gene profiling is going to make a big difference, but given the legal implications, we’re probably quite far away.
Medelis: So the animal model is here to stay?
Dr. McGarry: Since replacing the bacterium model of the 20th century, mouse models have become the gold standard for mammalian genomics and proteomics and, in turn, the development of therapeutics. It’s a very sophisticated system; given its wide utility and scientific power, I can’t see it being replaced anytime soon.
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