PRA Health Sciences, a full-service global contract research organization (CRO) that provides product development and data solution services to pharmaceutical and biotechnology companies, teamed up with Takeda Pharmaceutical Company of Japan in 2016. On June 1 PRA completed the buyout of its joint venture with Takeda, reported Amirah Al Idrus in Fierce Biotech.
The Takeda PRA Development Center has been renamed PRA Health Sciences K.K. It is operating in Japan as a subsidiary of PRA. As a result, PRA’s staff in Japan will increase to 450 “with opportunity for additional growth in the near term,” according to the CRO.
In September 2016, the companies agreed that PRA would manage “an entire pipeline of studies” encompassing all phases of clinical development for Takeda. Additionally, PRA agreed to provide regulatory, pharmacovigilance and other services for pharmaceuticals in development or on the market. The partners anticipated that about 300 Takeda employees would move over to PRA, which assumed pipeline development activities for Takeda in American and European markets. In early 2017, PRA and Takeda expanded this contract to include Japan, getting ready to start the joint venture. In addition, PRA acquired all the shares of Takeda Pharmaceutical Data Services.
According to Al Idrus, “Takeda transferred about 140 Takeda employees to the new company ‘to support drug development and marketed products in Japan,’ according to the company. The joint venture closed in April of 2017. The “Takeda PRA Development Center” was established through a joint venture in June 2017, which resulted in the transfer of Takeda employees who have extensive pharmaceutical development experience, as well as a clinical development system that is efficient and flexible, PRA said.
Through this integration, PRA expects to offer a wide range of services to pharmaceutical companies, biotech companies and academia. The service provision developed based on the partnership with Takeda will continue to be in effect after the dissolution of the joint venture.
With the expansion into Japan, PRA anticipates that it will become a true pharma partner in the market, providing innovative solutions, expertise and significant experience as a leading global CRO. Since 2000, PRA has received approval for more than 85 medicines. The company conducts more than 3,800 clinical tests throughout the world. According to PRA, “Global services include robust and flexible infrastructure, end-to-end clinical development across all phases, and technology and data science solutions. In addition to monitoring operations, PRA provides resources that are essential for conducting clinical trials in Japan, including pharmaceutical affairs, medical writing, medical monitoring, clinical pharmacology, data management and pharmacovigilance.”
PRA President and CEO Colin Shannon concluded, “In recent years, clinical development that bridges simultaneous global development has become a common practice. Through the wealth of experience and expertise in advanced clinical trials in Japan acquired through the joint venture, and our strengths in clinical development across 90 countries, we strive to become an ideal drug development partner for our clients on a global scale.”