- Takeda Pharmaceutical has created a close strategic partnership with contract research organization PRA Health Sciences, and will rely on PRA to "deliver on the company’s pipeline and marketed products clinical development and post-approval needs."
- Set up as part of Takeda’s significant changes to its R&D structure, the move is meant to provide operational efficiencies and reduce infrastructure costs.
- The Japanese pharma announced in July 2016 that its would spend $725 million over two years to reorganize the company, focusing more on three therapeutic areas—oncology, gastroenterology and CNS —and cutting annual costs by $175 million.
The trend towards outsourcing clinical trials is growing, with analysts predicting that almost 72% of clinical trials will be managed by a contract research organizations (CRO) by 2020. This has resulted in many pharma companies using CROs to manage some of their clinical trials.
Takeda, though, is taking things one step further by creating ties on a strategic level with CRO PRA Health Sciences. This will result in handing over the management of the Phase 1 to Phase 4 clinical trials for its whole pipeline to the CRO, as part of the company’s major global R&D restructuring, which was announced in July 2016.
While the agreement with PRA isn’t a joint venture, it is creating an unusually tight-knit collaboration, which will include the transfer of operational expertise from Takeda to PRA in an attempt to improve efficiency, increase globalization and reduce fixed infrastructure costs. PRA will manage clinical studies across Takeda’s pipeline, covering Phase 1 to Phase 4, as well as regulatory, pharmacovigilance and other support services.
“This partnership is a fundamental part of Takeda’s R&D transformation and represents a truly innovative approach to clinical development, unprecedented in our industry,” said Andy Plump, director, chief medical and scientific officer at Takeda.
This could be the first time that a CRO and a pharma company have come together on such a large scale. But as with all programs that promise efficiency savings, there could be job impacts here, as around 300 employees in drug development and marketed products at Takeda will be given the “opportunity to transition” to PRA’s sites in Europe and the U.S.