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The inclusion of companion species with naturally occurring tumors provides significant opportunities for optimizing drug development pathways that other model systems cannot provide. Over the past decade, tremendous growth in the field of comparative oncology has occurred, including significant increases in organized consortium infrastructure, availability of investigational reagents and regulatory standardization. These advances are currently being applied to the development of novel cytotoxic, immunologic and biology-based anticancer therapies, innovative drug delivery systems, identification and validation of biological endpoints, noninvasive imaging techniques and surrogate markers critical to the design of Phase I and Phase II human clinical trials. The biotechnology and pharmaceutical industries recognize the utility of the model΄s inclusion and several examples exist where they have initiated studies in companion species to assist in drug development. We are clearly at a period in time where the microscope is turned on this model and while currently a theory, the next 5 or 10 years should determine the degree to which information generated through the inclusion of companion animals with cancer is applicable to human cancer drug development. [ABSTRACT FROM AUTHOR]