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The nonprofit industry R&D consortium addresses one of the difficulties of clinical trial administration
It is common, in clinical trials, to require so-called comparator drugs, which need to be safely and verifiably obtained samples of an existing drug product, to which the tested drug will be compared in a trial. But without patients, prescriptions and the other machinery of conventionally prescribing drugs, this is not as easy as might be expected. Generally, there needs to be an agreement in place between biopharmaceutical companies; lacking that, the drugs must be purchased on the open market, which in turn creates complications in trial design and the assurance that an adequate quantity will be on hand when needed.
"The current process to source and manage comparator drugs and co-therapies can be challenging," said Dalvir Gill, PhD, CEO of
TransCelerate BioPharma Inc. (Philadelphia). "Locating and accessing these 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.”
To address this, TranCelerate has set up the Comparator Network initiative, which entails a master service agreement among participants, and dedicated resources for tracking shipments, anticipating demand, and ensuring safe delivery. But most of all, it will save time and effort. “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,” said Terry Walsh, RPh, MBA, head of the Initiative. “Member companies will also have the ability to receive detailed demand data, which will facilitate improved supply chain planning.”
Collaborations like these are exactly why TransCelerate was set up last year. The organization has nearly 20 members, including many of the biggest pharma companies, to address common issues in conducting biopharma R&D. New members are invited to join.