Speaking at the 50
“We made a decision pretty early on to limit this TransCelerate organization to biopharma companies because if we open it up to suppliers it could become pretty large, but that doesn’t mean we don’t want to collaborate with suppliers, we have to,” John Hubbard, TransCelerate board member and Pfizer SVP, said.
Gill added that CROs often have “far more efficient processes” than sponsors and the collaborative absolutely wants to engage the CRO industry, but it has to be in the right way. “What we don’t want to do is to work with 15 CROs individually on every project – it would just not be practical,” Gill said.
TransCelerate’s risk-based monitoring pilot is running through two CROs and Hubbard added that TransCelerate will probably work with CROs through subcommittees, forums, or through ACRO (Association of Clinical Research Organizations).
GCP Training, Other Progress
One area of particular progress for the group has been in GCP (good clinical practice) training where the group has been able to help its members avoid duplicative training requirements.
“Just to give a sense of where we are, we’ve issued 41,000 GCP certifications; that means 41,000 training efforts will now not be repeated by 19 companies – and that’s just a fraction of what that number will look like as more companies report their certifications. In addition to that we’ve trained 70 external vendors that can do the same training,” Gill said.
TransCelerate is also undertaking initiatives around risk-based monitoring, a shared investigator portal, comparators and data standards.
Sometime in the middle of next year, the first release of the portal will occur, followed by a second and third release, which will “hopefully stop driving investigators crazy” with all of the different portals used by sponsors, Gill said.
The comparators project aims to share stability data on comparator drugs between member companies. “Thirty seven transactions have already occurred within TransCelerate member companies – sharing comparator drugs directly with each other…to avoid wasting drugs and delayed clinical trials,” Gill added.
The data standards project will leverage the work of CDISC (Clinical Data Interchange Standards Consortium) to accelerate the goal of 35 standards over five years, he said. “Here’s another example of where we’re looking to collaborate again,” Gill said.
He added that the collaborative eventually wants to get the industry to a point in the future where companies are Big Pharma is only competing on molecules.