In an effort to accelerate drug development and reduce costs, contract research organizations (CROs), contract manufacturing
organizations (CMOs), and bio/pharmaceutical companies are implementing new approaches to improve clinical development and
production of clinical-trial materials (CTM). These strategies include new partnership models between CROs and sponsor companies,
alliances among CMOs, and adding new capabilities in contract services, including biopharmaceutical services.
Patricia Van Arnum
The changing requirements in drug development are leading CROs and sponsor companies to form more collaborative and strategic
partnerships. "Since 2005, the biopharmaceutical industry has seen a steady increase in strategic outsourcing relationships
between pharmaceutical companies and CROs," says John Watson, corporate vice-president and president of strategic partnering
and integrated drug development at the CRO Covance (Princeton, NJ). "The CRO industry, which primarily started in the mid-to-late
'80s and early '90s, has also evolved considerably over the last several years from a very nascent industry—used primarily
as spillover capacity—to become strategic partners in drug development. Sponsors have been looking to new strategic/partner-based
models of outsourcing such as multiphase integrated development, dedicated capacity agreements, and asset transfers, to help
them advance their pipelines and take the time and cost out of drug development," he says.
Covance's 10-year, $1.6-billion drug-development services pact with Eli Lilly (Indianapolis, IN), which was signed in October
2008, shows the trend toward greater strategic partnerships. Under the deal, Covance acquired Lilly's Greenfield, Indiana,
preclinical research facility for $50 million, and Covance received a broad range of drug-development services work over the
next 10 years for a minimum contract value of $1.6 billion. Covance also assumed responsibility for all of Lilly's toxicology
testing and discovery-support activities at Greenfield.
PHOTO: RAINER DITTRICH, GETTY IMAGES
"This alliance has truly been a win-win-win for Lilly and Covance, the employees at both companies, and our communities,"
says Watson. Since the agreement, more than 95% of the original 264 employees hired from Lilly are still with Covance. The
company has added more than 70 new employees to the Greenfield facility and plans to expand staffing with an additional 300
employees as the company is awarded work by other biopharmaceutical companies, says Watson. Since the agreement, Covance also
added three new service lines in its biomarkers, nutritional-chemistry, and biotechnology businesses in Greenfield. Lilly
and Covance also expanded their existing partnership in March 2010 through a three-year biotechnology services agreement under
which Lilly transferred bioproduct analytical testing to Covance's Greenfield facility.
In executing the partnership, the companies share common goals. "Lilly and Covance identified a path to achieving Lilly's
goal of '1000 Days to Patient' by reducing drug-development cycle times," says Watson. "1000 Days to Patient" begins when
Lilly researchers identify a lead molecule to begin clinical testing and ends when Phase II efficacy studies begin in patients.