Barry Lake, CEO and Executive Chairman at Devana Solutions, LLC, told us, in order to address pharmaceutical drug prices, change must take place in historically ignored parts of the supply chain. Namely, at the clinical trial or investigational site level.
According to Lake, these challenges can be overcome if we start putting the focus of attention and information where the “rubber meets the road.”
So, what is the leading factor driving up the cost of getting a new investigational drug to market?
Lake said the answer is long cycle times and increasing costs associated with the clinical trial process.
“Current estimates put the costs of lengthy clinical trials at up to 90% of the total development cost of a new drug,” he told us.
“Unless clinical trial cycle time (and therefore costs) can be reduced, it’s fair to say that it is all but impossible to reduce drug development costs and, therefore, prescription drug prices,” Lake explained.
However, Lake stressed that lower drug costs cannot be realized without cutting drug development costs – which ring in around $2.87bn per approved drug.
“It’s easy for the American public and our political leadership on both sides of the aisle to think that pharmaceutical company headquarters can merely flip a switch to make change take place,” Lake added.
“The general public, the current Administration and our Congressional leadership is largely unaware that the leading factor behind high prices is the escalating costs of drug development.”
Identifying clinical trial site challenges
Patient recruitment and retention challenges are well documented and according to Devana, about 25% of the entire clinical trial spend is deployed on zero-enrolling or under-enrolling sites.
“That’s real money being tossed out the window,” said Lake. “What’s more, with half of every dollar spent by a sponsor to develop a new drug being paid to trial sites, identification of the top-performing research sites is critical intelligence.”
Lake said the key to success is selecting trial sites that deliver and manage effective trials. Consequently, the industry has turned to data in order to help it identify these sites.
“In a data-driven industry, now there is data to back up site performance and selection,” added Lake.
Ultimately, Lake told us funneling the right information to the right channels, at all stages of the drug development process, “will aid in the implementation of the new standards that the Trump Administration and Congress seeks,” and, “over the long haul, will reshape the pricing structures for many prescription drugs.”