As pharmaceutical companies increase their level of outsourcing, the models for partnering ar evolving. Preferred-provider relationship are highly collaborative and strategic partnerships between pharmaceutical companies and select CROs, CDMOs, and CMOs. The author examines recent examples of such collaborations.
Big Pharma partnersPfizer. In May 2011, Pfizer formed strategic partnerships with the CROs Icon and Parexel, both of which will serve as strategic providers of clinical-trial implementation services over a five-year period beginning in June 2011. The new partnerships will be fully implemented over an 18-to-24 month period.
In announcing the collaborations with Icon and Parexel, Pfizer said that the two-partner model will simplify its processes by reducing the number of external service providers that the company uses for clinical-trial execution. Pfizer says this new strategic partnership model does not substantially change the proportion of clinical-trial implementation services that the company outsources. Pfizer is retaining scientific ownership of the clinical-development process and is maintaining oversight and quality standards relating to patient safety and regulatory compliance.
"We've also [have] taken a look at the value chain inside our research organization and have outsourced a lot of our clinical work with a strategic partnership with Icon and Parexel," said Ian Read, chairman and CEO at Pfizer at the JPMorgan Healthcare Conference, which was held in January 2012 (1). "I think that's a major strategy for us. We've rationalized our efforts there. Before we were dealing with 18, 19, 20 plus partners. It was very difficult to control. It was very difficult to get quality work and get savings. We now have a strategic partnership with two global players."
Bristol-Myers Squibb has since followed with other preferred-provider arrangements. In March 2011, Bristol-Myers Squibb and the CRO WuXi AppTec formed a strategic partnership for stability studies of small-molecule new chemical entities. Under the agreement, WuXi will build, equip, and operate a dedicated, fully cGMP-compliant 25,000-ft2 analytical testing facility in Shanghai to store and test stability samples and to perform other services for Bristol-Myers Squibb. WuXi also will employ a dedicated staff for stability testing, sample management, analytical testing, pharmaceutical science, quality assurance, metrology, and other services, including stability-data reporting in support of all global dossier submissions by Bristol-Myers Squibb.
Bristol-Myers Squibb also had adopted a facility component in its preferred-provider relationship with Syngene International, a subsidiary of the Indian biotechnology company Biocon. In March 2009, Syngene opened a fully dedicated R&D facility for Bristol-Myers Squibb in Bangalore, India. The 200,000-ft2 facility is focused on discovery and early-drug development. Construction on the facility began in March 2007 when Bristol-Myers Squibb and Biocon entered into an agreement to develop integrated drug-discovery and development capabilities at Syngene.