The TransCelerate BioPharma industry group has launched its clinical trial comparator network to establish a reliable means for sourcing quality drugs for clinical trials.
Sponsors’ current means of acquiring clinical trial comparator drugs and co-therapy drugs are inefficient and unpredictable, according to TransCelerate, which is made up of 10 of the largest biopharma companies, including Pfizer, Roche and Sanofi. When comparators and co-therapies are purchased on the open market, it can lead to supply disruptions and timeline delays.
Terry Walsh, RPh, MBA, head of the comparator network initiative for TransCelerate, told Outsourcing-Pharma.com, “The network will allow us to take the process of accessing comparators (standard of care, rescue, and comparator medicines) off the critical path of study start up. Accessing the medicines through the network, when the sponsor company needs them will allow the sponsor to plan accordingly and focus on other activities needed to start a study.”
The comparator network may be similar to agreements made between two companies before a study starts.
“Prior to the creation of the network, some companies created study-specific bilateral agreements, which provided similar benefits and impact as the network,” Walsh told us. “However, the agreements were customized each time two companies worked together and could take up to nine months to negotiate,” where as this will all be set up prior to any new study start.
How it Will Work
Although the network is set up for all member companies, only the manufacturers and sponsors will share the necessary information for each trial.
“The network will not share one member company’s demand data with the entire network,” Walsh explained.
“As the members receive the forecasts from the other members who need their products, this will be better enable the member companies’ commercial units to develop supply chain forecasts, which will decrease the incidences of supply disruption (e.g., it decreases the risk of a vendor going into a region and buying up all the product to use in a clinical trial).”
Sponsors will also now know they can access the medication when it is needed, “as opposed to buying product whenever it is available and no guarantee of future access,” Walsh said.
Benefit to CROs
The creation of the comparator network will also be a boon for CROs (contract research organizations) because of the possibility of sponsors using their supply chain savings to conduct more trials.
Walsh noted, “CROs will benefit as the industry benefits. If we reduce inefficiency and hence save cost, we can develop more drugs – and as a result – conduct more clinical trials. The vast majority of these industry trials are conducted by CROs.”