PRA to lead Takeda’s clinical development as staffers ‘transition’ to the CRO

Japanese pharma Takeda has announced a major shake-up of its clinical and drug development as it looks to move hundreds of its staff over to PRA Health with the CRO set to take over control of much of its operations in the U.S. and Europe.

The deal, which also sees the Raleigh, NC-based CRO take the lead on Takeda’s “marketed products, clinical development and post-approval needs,” according to its statement, has been hailed as “transformational” by the pair, and a first for the CRO sector.

In a nutshell, this pact sees PRA manage an entire pipeline of studies for Takeda, across all phases of human development and after approval, while also providing regulatory, drug safety and other operational services for both development and marketed product portfolios--i.e., most of its development operations.

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This will mean that around 300 Takeda employees who are currently supporting drug development and marketed products for the company will “be given the opportunity to transition to PRA” in the U.S. and Europe, Takeda said. Talks over its native Japan employees is “ongoing” between the two companies, and will likely be a trickier transition.

There has been no direct talk of cuts from the pair’s statement, but Takeda said that this new model is aimed “to improve operating efficiencies” as well as to “reduce fixed infrastructure costs.”

It went on: “This flexible approach will facilitate the development of new medicines by focusing resources, teams and activities where needed, an important requirement for an industry-leading, highly agile R&D organization focused on meeting patient needs.”

Takeda is already in the middle of retooling its R&D, announcing back in the summer that it would accelerate its reorganization for its R&D units in the U.S. and Japan to focus on the three therapy areas: oncology, gastroenterology and central nervous system, while also shutting down or de-emphasizing other overseas R&D centers.

“This partnership is an exciting opportunity for PRA and represents a significant milestone and transformational business opportunity for us,” said PRA CEO Colin Shannon.

“This is the first time that a pharmaceutical company and a clinical research organization have come together to create such a comprehensive business and operational strategy. This partnership model redefines collaboration and is the first of its kind in the CRO industry.”

PRA was up 2% on the news while Takeda was down by nearly 1%. Financial terms of the deal were not released.