ABSTRACT

The development of new pharmaceuticals is expensive; constantly at risk due to scientific, regulatory, and market forces; and driven by the willingness of companies and/or investors to invest in a given program, whether the target market is for humans or animals. Historically, large pharmaceutical companies have not developed a new compound for both humans and animals in parallel. This chapter compares and contrasts human and veterinary drug development requirements. It explores changing business models in the pharmaceutical industry and how that is likely to impact future investment in veterinary drugs. Biotech or “specialty pharma” is increasingly becoming the research arm of the industry. To the extent that the smaller biotech or specialty pharma companies are more efficient at keeping expenses low, the net present value calculation is positive for smaller opportunities. Studies designed to establish the safety of the new compound, expressed as a consideration of risk and benefit, are an essential component that drives the execution of drug development activities.