TransCelerate BioPharma, the non-profit organisation set up by leading pharmaceutical companies last September to advance innovation and tackle inefficiencies in R&D, has put into operation a Comparator Network to ensure rapid, reliable sourcing of quality medicines for clinical trials.
Last month several TransCelerate member companies executed a master service agreement affirming their mutual commitment to supply comparator drugs for trials promptly and securely.
The Clinical Trial Comparator Network is now active and the first network-based transaction has been initiated.
The network will shorten timelines for clinical studies while enhancing patient safety, TransCelerate says. It expects more companies to join the initiative, as well as further network transactions.
Inefficient and unpredictable
As things stand, the mechanisms for acquiring comparator and co-therapy drugs in clinical trials are “inefficient and unpredictable”, Transcelerate notes.
Unless there is a specific agreement in place, sponsor companies are often unable to secure comparators and co-therapies directly from each other, leaving them to buy the drugs on the open market.
This not only creates uncertainties about adequate and timely supplies of the necessary comparators but can also result in supply disruptions, TransCelerate points out.
“As newer and more sophisticated therapies enter the market, the current situation is likely to deteriorate,” it warns.
Right drugs at right time
Locating and accessing the right comparators at the right time, in the right quantities and “with the accompanying drug stability and regulatory information we need, doesn’t always happen efficiently”, commented Dalvir Gill, chief executive officer of TransCelerate.
“This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs,” Gill added.
By activating the Comparator Network, participating TransCelerate companies will be able to source comparator drugs directly from one other, secure supplies when needed and in the quantities needed, access drug data, and “totally mitigate the risk of counterfeit drugs in that clinical trial”, Gill said.
Improved access to comparator drug stability and regulatory data will enable member companies to reduce waste by allowing for better management of temperature excursions, while facilitating global clinical trials, observed Terry Walsh, head of the Comparator Network.
Companies will also be able to tap into detailed demand data, facilitating supply-chain planning and reducing the risk of any supply issues for crucial products, Walsh noted.