TransCelerate CEO, leaders offer update on industry group’s activities

The group is now more regularly engaging with regulators as well, including the FDA, EMA, Japan’s PMDA and Health Canada. Future meetings will also include the Ministry of Health of Mexico in the second quarter of this year.

“It makes sense to engage these regulators so we don’t stray from their guidance,”​ Gill said, also noting the creation of a CRO forum​ to engage further with experts in clinical trials.

Reb Tayyabkhan, head of central clinical services at Bristol-Myers Squibb, who also is the liaison to the CRO forum, noted that the group felt the need to engage with CROs on a more upfront basis because for the last two and a half years, when it went to implement solutions, “we’d then reach out to CROs on how best to implement some of the new technlogy and tools, which is kind of inefficient​.”

The group is also continuing to facilitate the sharing of “massive amounts of data​,” as well as saving time with GCP (Good Clinical Practice) training efforts, qualifying investigator sites and helping companies solve temperature excursions on drug shipments.

In terms of the excursions, he said companies are now sharing stability data, which is helping to save time and money.

A future roadmap is also in development to further discuss patient centricity and other topics, though he warned, “There are more problems than TransCelerate can take on​.”

Most recently, the group launched two new initiatives​ around electronic labeling and placebo and standard of care data sharing.

Craig Lipset, head of clinical innovation at Pfizer, said that from an efficiency standpoint the electronic labeling initiative could save companies a lot of time and cost because they would no longer need to print and re-print labels for many of the studies.

“More importantly is the downstream utilization of the labels​,” Lipset said, noting that e-labels offer a “great opportunity to leverage technology and help patients access”​ more content on their medicines, and analytics information will allow companies to ensure the information is useful and timely.

Andy Lee, SVP of global clinical trial operations at Merck, who’s also working on the quality management workstream for TransCelerate, noted that the group has looked at quality defects from regulatory inspections and found that they’ve been nearly identical for the past 10 years. The finding has the led to a more focused approach. He also said the recent interactions with the regulators has been “fruitful and positive​.”