Written by Industry Expert: Graig Daley, Business Development Manager
Advances in technology over the past decade have catapulted the world forward in every aspect of our economies. The network of shared knowledge is growing exponentially and with it, new breakthroughs in drug development are constantly evolving. What has not changed however, is the 20 year patent life on new drug discoveries. As a new drug developer, you face daunting odds to bring your drug to market in a safe and just as importantly, timely manner in the eyes of the stakeholders.
The lifespan of clinical trials to FDA approval is typically 11 to 14 years. During that time period there are four main stages of trial progression. The Preclinical and application process can take anywhere from 1 to 6 years, and once completed only 30% of these formulations reach a phase I trial. The average Phase I trial lasts around 2 years, which upon completion has weeded out 86% of the original studies that passed the application process. The remaining 14% of Phase I trial studies progress to Phase II, which will take an average 2 years as well. Furthermore, only 9% of these studies will reach a larger Phase III trial that will on average last another 3 years, of which only 9 to 11% of those will achieve an approval status from the FDA. These figures have recently trended in a positive direction with the total number of approvals estimated at 14%.
Time is often associated with value, the average drug company will spend between $125 and $350 million to reach FDA approval. This number increases substantially when dealing with new larger and more complex molecules that require Cryogenic storage and extreme cold chain logistics for distribution. This poses a major risk to bringing new drug to market since the life of the patent often ends in a few years after approval, at which point any other manufacturer can create a generic version and participate in the monetary success of the original formulation and expenditure.
Citation has watched for over 55 years as the Clinical Trial Industry has evolved, and we have evolved right alongside it. With the launch of our new Citation Critical platform, our labeling solutions will allow the industry to package their product faster and ultimately get the drug into the patients’ hands quicker. Reach out to us to find out more information on Citation Critical and our new 5 day label procurement program.