The expansion includes a new office in Utrecht, NL, which will for the first time focus primarily on product registration trials in the area.
The team will work on start-up, site management, project management and monitoring services to for sponsors ranging from biotechs, pharma and medical device companies. There is also a new UK office, also focused largely on product registration.
VP and general partner Frank van de Wijngaert told Outsourcing-Pharma the move reflects PRA’s efforts to appease an industry that is trending towards late phase development.
“Since the economic meltdown, pharma companies have rationalised their pipelines,” he told us. “They realised they cannot develop all of the compounds in all of the therapy areas that they want to, and the first phase to be hit by that is early development.”
He said that pharma and biotechs survive by raising capital to develop pipelines adding: “If it isn’t already in development, it’s now difficult because the cash is not there.
“It’s not as much of an issue at PRA because we have some good pipelines, but you’ll notice that the bigger firms like Paraxel and Covance’s annual reports show that early phase is not as much of a focus as PIII and IV.”
The late phase boom
However, Wijngaert said the slump in early phase pharmaceutical development is not all bad news for CROs (contract research organisations) like PRA.
He told us the sector is not only seeing increased business because of a shift in focus to late phase programs, but also because of added regulations which require a greater focus on drugs after they leave the lab.
“Late phase is doing well because there are stricter requirements for safety from the authorisations, so you have to expand your programme with late phase and post marketing studies,” he said.
Wijngaert also said that a rise in the generics field has been a contributing factor to the need for services.
“The pharma industry has become quite smart when they know they are going to lose patent on a certain drug, because they have now started to release a new formulation so that they get longer from the drug,” he said.