PRA Health Sciences and Takeda Pharmaceutical Co. have entered into a new partnership agreement under which PRA will serve as Takeda’s primary strategic partner for the company’s pipeline and marketed products clinical development and post-approval needs.
 
The partnership operating model combines operational expertise, transferred from Takeda to PRA, with PRA’s range of global capabilities. This model aims to improve operating efficiencies, drive globalization and reduce fixed infrastructure costs. The flexible approach aims to facilitate the development of new medicines by focusing resources, teams and activities where needed.
 
“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.”
 
“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 clinical research organization (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.”
 
PRA will use its internal resources and services to manage pipeline 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.