ClinicalTrials.gov currently lists 301,104 studies with locations in all 50 States and in 208 countries. According to the Tufts Center for the Study of Drug Development (CSDD), there are around 40,000 unique investigators worldwide conducting at least one FDA-regulated clinical trial.
As the number of trials grows, so too does the need for supplies, which has spawned a diverse array of vendors producing them. The global clinical trial supply and logistics market size was recently valued at nearly $15 billion in 2017 and is expected to witness a compound annual growth rate (CAGR) of 7% through 2026. Contract Pharma called on several experts to discuss key trends and challenges in the clinical supply market for this issue.
In “Clinical Manufacturing on Time and within Budget,” Vetter’s David Brett says the key to successfully developing and guiding a drug to the approval stage is early planning as well as compliance with good and high-quality manufacturing practices. “Making the right decisions early will also provide a competitive advantage,” he says. In the article, Mr. Brett offers a checklist for the different phases and actions that need to be taken to help avoid unnecessary costs and delay during the clinical manufacturing process.
At the same time, Torkel Gren from Recipharm emphasizes speed and efficiency in the early phases of development and manufacture to help keep costs low. In “Clinical Trial Supply: The Pathway to Success,” he explains why moving a drug candidate from the lab to first in human trials is a complex, multistage challenge that requires expertise not just in formulation development, but also clinical trial management. “An integrated, structured approach is critical to successfully navigating a pathway from the laboratory to the clinic,” he says, and “experienced contractors are ideally positioned to help drug companies avoid the early phase development pitfalls that can see projects fail at a later stage.”
CRF Bracket’s Bart Nicholson talks about “Optimizing Clinical Supply Management” with the help of Interactive Response Technology (IRT), a new tool de-signed to help life science companies cut drug wastage across clinical programs. He says the pressure to improve efficiency in the supply chain increases as the cost of inventory rises and that IRT solutions have two main functions: to randomize patients onto proper treatment arms and, crucially, to manage clinical supply logistics.
Tim Wright, Editor