Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex therapies not only increase risk in drug development but also drive costs even higher. A recent analysis of the investment needed to develop a new prescription medicine shows the total cost can be as high as $2.6 billion.1 That number becomes even more staggering when you consider the fact that only about 12 percent of drug candidates that make it to Phase I testing are eventually approved by the FDA.2 The investment companies lose as a result may be too devastating to their bottom line to ever recover.
That is why it is important to have a clinical packaging strategy that can successfully manage the supply of your expensive drug product throughout the duration of clinical testing. To do this, sponsor companies must balance control of the drug supply with control of shipping costs. Achieving this requires maximizing the amount of drug available for distribution while minimizing overages across clinical trial sites.
The following six strategies can be used to find balance; nevertheless, they all require the support of a trusted clinical packager. Without this valuable insight, a company could experience a costly interruption or extended delay and, as a result, a devastating impact on its timeline to commercialization.