Pfizer is reducing substantially the number of external service providers it uses to execute its clinical trials by entering into five-year strategic alliances with Parexel and ICON.
The two-partner model is designed to simplify Pfizer’s outsourcing processes and to clarify accountability in risk and quality management as trials get underway.
No financial details were disclosed but Pfizer said its partnerships with Parexel and ICON would be fully implemented over an 18-to-24 month period.
The new arrangements do not alter significantly the proportion of clinical trial implementation services outsourced by Pfizer.
However, they do consolidate the provision of those services, enabling Pfizer to focus internally on its core capabilities in clinical trial design while “leveraging the strengths and scale of ICON and Parexel to implement clinical development programmes with greater efficiency and rigour”, the company explained.
Last February, Pfizer announced a “comprehensive programme of change” in research and development to sharpen its research focus, deliver differentiated innovation, and create a more flexible cost base through external partnerships for certain R&D services, the US company noted.
In future, it added, Pfizer’s externalisation efforts will allow the company to adjust investment and activity according to the changing needs of its R&D portfolio.
Under the partnerships with Parexel and ICON, Pfizer will retain scientific ownership of the clinical development process while keeping up strict oversight and quality standards in patient safety and regulatory compliance, the company stressed.
The alliances are structured to incentivise Pfizer’s new partners on four key parameters: quality, speed, cost management and innovation.
“We conducted a thorough selection process to find the right partners and selected ICON and Parexel because of the strength of their services and their steadfast commitment to quality and regulatory compliance, a deep belief in collaboration, and a strong drive to deliver success,” commented John Hubbard, senior vice president of Development Operations at Pfizer.
Clinical and eClinical
Parexel said the impact of the strategic alliance will be factored into the financial guidance it provides to investors on 1 June 2011.
The US-based biopharmaceutical services provider will work with Pfizer to improve the speed and cost-efficiency of the company’s clinical development programmes, while delivering a high level of quality and innovation, Parexel noted.
Specifically, it will draw on a combination of established clinical processes, a geographical footprint extending to 52 countries, and expertise in eClinical technology.
.“We are focused on applying best-practice operational models, supported by a combination of our eClinical solutions and clinical processes, to help Pfizer reduce the time and cost of development,” said Josef von Rickenbach, chairman and chief executive officer (CEO) of Parexel International.
“Leveraging our global resources and worldwide technology infrastructure, we can enable more effective information flow and improve data access, which results in greater visibility into trials – and ultimately in better decision-making.”
Parexel also has strategic alliances for clinical development services with pharmaceutical multinationals such as Bristol-Myers Squibb, Eli Lilly, Merck Bioventures (Merck & Co) and GlaxoSmithKline.
According to ICON, the global provider of outsourced development services based in Ireland, Pfizer will leverage the company’s expertise in programme initiation and management; site and country feasibility; data management and reporting set-up; study drug logistics; scientific and medical communications; and quality assurance.
ICON CEO Peter Gray said the partnership, which is expected over time to have a “significant positive impact” on the company’s future growth, is “another significant indicator of ICON’s ability to partner with major companies in helping them transform their drug development model and validates the investments that we are making to capitalise on the changing market environment”.
In June 2010, the company joined Parexel in a three-year agreement with Bristol-Myers Squibb for “joint strategic, operational and capability support” of the latter’s clinical development programme.
ICON also looks after Eli Lilly’s clinical data management in Europe, Japan, Canada, Latin America, Australia and Asia, and is responsible for the site set-up and monitoring of Lilly-managed clinical trials in Europe.