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Lowering Drug Development Costs with Genetically Modified Swine
The US pharmaceutical industry spends approximately $ billion annually to develop new pharmaceutical drugs and medical devices. Today, a new drug takes approximately years and over $ billion to bring to market.
Then, only one in every to drugs is approved by the Food and Drug Administration (FDA). On average, pre-clinical testing for one drug candidate alone costs $ to $ million. These high costs and long drug development intervals are due, in part, to the use of animal models that are not predictive of how the drugs will perform during subsequent human clinical trials. The use of genetically-modified swine for pre-clinical efficacy and toxicity studies will improve the predictive nature of pre-clinical testing and inevitably lower drug and medical device development costs. As a result, patients will receive needed medications faster and more affordably.
Pre-clinical tests involve translational research in which medical devices and/or pharmaceutical products are tested on animals. In these studies, animals are used that express symptoms similar to those found in humans and the results are extrapolated to predict the probability of success when tested in humans. Yet, the predictive ability of animal trials is limited. In many cases, the animals do not have the exact same diseases as those found in humans, but instead are induced to express physiological symptoms similar to those found in humans.
Product development costs could be greatly reduced by using animal models that more closely resemble humans in their disease states and their physiological responses to treatment. Swine have been increasingly used as the animal model of choice because their anatomy, genetics, and physiology are more similar to humans than traditional animal models such as mice (Bendixen et al., 2010).
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