TransCelerate BioPharma has reached its primary milestone in its Clinical Trial Comparator Network initiative. Formed to establish reliable, rapid sourcing of quality drug products for use in clinical trials, the Comparator Network will enable accelerated clinical trial timelines and enhanced patient safety.
In July, a master service agreement (MSA), affirming a mutual commitment to offer secure and rapid supply of comparator drug products for clinical trials, was executed by several TransCelerate member companies. The network is now active and the first network-based transaction has been initiated.
Currently, the mechanisms to acquire clinical trial comparator drugs and co-therapy drugs are inefficient and unpredictable. Unless a specific agreement is in place between biopharmaceutical companies, trial sponsors frequently are unable to secure comparators and co-therapies directly from each other, and therefore must purchase on the open market. This leads to uncertainties regarding the ability to obtain an adequate and timely supply of necessary comparators and can result in supply disruptions. As newer and more sophisticated therapies enter the market, the situation may deteriorate. Difficulty in the sourcing of comparator drugs can result in delays for a clinical study and delay availability of the drug to patients.
"The current process to source and manage comparator drugs and co-therapies can be challenging," said Dalvir Gill, Ph.D., chief executive officer of TransCelerate. "Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information doesn't always happen efficiently. This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs. With the activation of our Comparator Network, participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and mitigate the risk of counterfeit drugs in that clinical trial."
Terry Walsh, R.Ph., MBA, head of the Comparator Network initiative for TransCelerate, said, "We believe the Comparator Network will provide an infrastructure that improves the primary operating model for the comparator supply chain. Improved access to comparator drug stability and regulatory data will enable member companies to reduce waste by allowing for better management of temperature excursions and facilitate global trials. Member companies also will have the ability to receive detailed demand data, which will facilitate improved supply chain planning and reduce the chance of supply issues for crucial products."
"For the first time, this TransCelerate initiative will allow industry-wide alignment and improved supply chain around comparator drugs for clinical trials that is so critical to enhancing patient safety and improving the efficiency of clinical trials," said Paul Stoffels, M.D., chief scientific officer and worldwide chairman, pharmaceuticals at Johnson & Johnson.
TransCelerate expects more companies to join the Comparator Network.