Posted 29 June 2016
By Zachary Brennan
The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients.
The group is working to leverage the data and best practices of its members, such as Pfizer, Amgen, AstraZeneca, Merck and Roche, across a wide swath of trial-related initiatives, including clinical data standards, trial diversity, a comparator network and placebo and standard of care data sharing.
Dalvir Gill, CEO of TransCelerate, told Focus in an exclusive interview on Wednesday at the DIA annual conference that the group is not focused on changing regulations or the policies of regulators, though much of what TransCelerate does has regulatory implications.
For instance, Gill pointed to the group’s electronic label initiative, which is looking to create a more updateable label that’s easier and more beneficial to patients and sponsors, though Gill acknowledged that the feasibility of the project “is limited because of the regulations.”
“If we truly want to get to more user-friendly e-label,” Gill said, then the paper booklets stuck to pill bottles should be reformed and technology experts, regulators and sponsors “have to be at the table.”
He also noted that TransCelerate has worked on its own common protocol template for clinical trials alongside the US Food and Drug Administration (FDA), though FDA is also developing its own template with the National Institutes of Health.
And although Gill acknowledged that the regulators are slow to adopt change, he said TransCelerate has engaged extensively with FDA, European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
“Today’s regulatory environment is tougher,” Gill said. “You can only take a certain leap,” but TransCelerate “haven’t had anyone say ‘you can’t do that.’ In fact, I think they unanimously think it’s time to strip out inconsistencies and inefficiencies…we have all this data sitting with companies, why aren’t we sharing it?”
“Regulators have said to us: It’s much easier to collaborate with us than with individual companies,” he added. “My message to them is to continue to work and support and guide us so we know where they’re going.”
As far as progress on TransCelerate’s various initiatives, Gill said the sharing of about 30 databases has already helped to cancel one large study (he could not specify which due to proprietary information) and cut the number of patients in another in half.
“Once you open the collaboration door, there’s a head-long rush through it,” Gill said, particularly for the TransCelerate members, where the legal issues of such data sharing are taken out of the picture.
He also noted that TransCelerate subsidiary BioCelerate is beginning work in the preclinical area, with a toxicology data sharing project.
“Most of what we’re doing is tackling R&D [research and development], and in particular D inefficiencies,” Gill added, noting that soon the benefits of his group's members will extend to other pharmaceutical and biotech companies that are not members.