Outsourcing Articles

As today’s pharma and biotech companies become more dependent on third-parties for everything from research and development to manufacturing, improving these relationships has become essential. Based on extensive work and discussions with dozens of contract service providers and customers, we have developed a series of best practices to improve interactions between customers and suppliers.

wo years after filing a drug application, the FDA gives you the green light for your new medicine and you formally launch the product. But your work is far from done. In a few years, you can look forward to expiring patents, and if you don’t have a new blockbuster drug to maximize its sales exclusivity rights in the pipeline, you'll have a revenue gap of several billion dollars to fill.

The safety of medicines is always an important topic, but of late it has become even more critical. The availability of new medicines is also a focus for patients. In the past decade, there has been a shift to earlier (often conditional) approval of new medicines.

For a new drug, every day lost waiting for approval is a day of lost profits for the marketer. In the case of drugs intended to treat serious or life-threatening conditions such as cancer, it can literally be a matter of life and death for the patients seeking treatment.

Drug makers pursuing the clinical development of novel cancer therapeutics — as well as of high-potency prostaglandins, opiates and hormones — are finding they must balance the therapeutic promise of these agents with new fiscal challenges.

Photo courtesy of Baxter Healthcare Corp.

he prolific growth in outsourcing within the pharmaceutical industry began some 20 years ago and as we know has since become a major influence in steering the manufacturing and sourcing strategies of all pharmaceutical companies.

EDITOR'S NOTE: Mr. Snyder's commentary does not necessarily reflect the opinions of Contract Pharma LLC or any of its staff, but as the editor of this magazine and website, I decided that his opinion deserved a voice. If you'd like to discuss this column, or you have an issue with the facts and opinions as they're presented here, please e-mail me or Steve. --GYR]

After the acquisitions of Warner-Lambert and Pharmacia earlier this decade, Pfizer possessed a global network of 93 plants. The company added another seven plants as part of smaller acquisitions. Through an ongoing series of announced closures and divestitures, Pfizer will rationalize its plant network from 100 to 43.

The June 2008 issue of Contract Pharma includes our Strategic Partnering Supplement, a 16-page editorial feature exploring the new dynamics of drug development outsourcing. Produced by Covance Inc., this supplement will spark plenty of conversation about the evolution of CROs and their importance to R&D productivity.

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A 2005 study by Christopher Adams and Van Brantner of the Federal Trade Commission detailed the cost of prescription drug development based on more than 3,000 new molecular entities (NMEs)1. The researchers discovered costs that ranged from $500 million to $2 billion, with an average cost $868 million.