PRA Health Sciences and Takeda Pharmaceutical have entered into a new partnership agreement under which PRA Health Sciences will serve as Takeda’s primary strategic partner to deliver on the company’s pipeline and marketed products clinical development and post-approval needs.

“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, M.D., Ph.D., director, chief medical and scientific officer at Takeda. “PRA has a reputation for providing tailored sourcing solutions. We believe PRA will be an ideal partner as we focus, deliver and advance our current and future pipeline.”

The innovative partnership provides a flexible operating model that combines operational expertise, transferred from Takeda to PRA, with PRA’s wide range of global capabilities. This model is aimed to improve operating efficiencies, drive globalization and reduce fixed infrastructure costs. 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.

“This partnership is an exciting opportunity for PRA and represents a significant milestone and transformational business opportunity for us,” said PRA Chief Executive Officer Colin Shannon. “This is the first time that a pharmaceutical company and a CRO 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.”

The partnership will enable PRA to utilize its internal resources and expertise to manage an entire pipeline of studies for Takeda, across phases I-IV and provide regulatory, pharmacovigilance and other operational services for both development and marketed product portfolios. The transformation is expected to result in approximately 300 Takeda employees supporting drug development and marketed products to be given the opportunity to transition to PRA in the U.S. and Europe, subject to appropriate information and consultation with works councils, unions, and employee representatives. Discussion regarding Japan employees is ongoing between Takeda and PRA.