The firm offers an all-in-one approach to outsourced manufacturing through its Translational Pharmaceutics platform, which uses clinical feedback to optimize drug formulations as trials are run.
Mark Egerton, CEO of Quotient Clinical Ltd., told us part of the reason the firm decided to acquire two manufacturing facilities in the US is because of the upcoming regulatory changes in the European outsourcing industry.
“With all the potential instability with Brexit and other things in Europe, the US is now absolutely the priority [for Quotient],” Egerton told us.
Although the US acquisitions were to address increasing customer demand, Egerton added that it was also because of how all this uncertainty could potentially impact business.
“The issues with Europe, from my perspective, is that we have quite significant regulatory change coming into play sometime in the next 12 to 24 months,” he explained.
“There will inevitably be some customers that are concerned with some timelines,” he added, and “it would cause significant changes to overseas clients especially.”
The contract development and manufacturing organisation (CDMO) bought Charles Rivers Laboratories small-molecule CDMO business QS Pharma LLC made at the beginning of February.
A second acquisition of SeaView Research in Florida was also made last month.
Egerton said, “We have no special privilege insight into how Trump will impact [this move]. We actually made all the assessments before the change in president.”
Despite this, “although it's all guess work, I doubt we will see any changes to enhance regulations [in the US],” he added.
The issue with Europe
Egerton told us the European clinical trial regulatory change was intended to make it easier for clients to do clinical trials in all phases of development.
However, “In our particular space, we thought the impact on the outsourcing industry would be neutral (i.e. no detrimental impact), but you never know how it's really going to shake out.”
Egerton explained, “I think philosophically, the intent [of the new regulations] was absolutely spot on. But inevitably, when you're trying to get alignment and harmonization between so many stakeholders and agendas, you end up in a situation full of compromises.”
FDA help and Trump
So, over the past 18 months Quotient has been working with customers and former consultants – some of which Egerton said are ex-US FDA – to understand how the firm might implement its Translational Pharmaceutics platform in the US.
“We've really gained confidence over this period of time. Clearly, we need to have more dialogue with the administration over there, but we don't perceive there being any major hurdles,” Egerton added.
“However, I think with the current US administration [Trump] is pro-business, and actually anti-regulation,” he concluded.