Outsourcing Articles

this month marks the 10-year anniversary of Contract Pharma. Congratulations to the staff and contributors for a job well done! Since Contract Pharma does such a good job of identifying what the drug development industry is doing and where it is going, I thought this milestone presented an opportunity to look back (and forward) at preclinical drug development.

I was happy to participate in the premier issue of Contract Pharma by writing a column assessing the growth prospects for the pharmaceutical outsourcing industry. Following a robust period of expansion, 1999 had been “punctuated by numerous pricks in the sacred balloon of growth.”

Tom Branna, my editorial director, walked into my office in the summer of 1999, tossed a folder onto my desk, and announced, “Good news! We’re launching a new magazine and you’re going to be the editor!” (That’s how I remember it, although Tom may’ve actually structured it as a “Good News / Bad News” statement.)

The folder held the pages of the new magazine’s business plan. It opened with:

In the last decade, research in drug discovery and the life sciences has been dominated by two trends: increased automation and greater parallelization. Once, a researcher would focus on cloning a single gene at a time. Now, with the advent of robotic technology, they can clone thousands of them in parallel.

The pharmaceutical industry is in the process of an unprecedented evolution. It’s been said over and over that pharmaceutical companies must change the way they do business if they want to remain profitable. This evolution is bound to create many still unforeseen opportunities for suppliers and service providers to the pharmaceutical industry.

Where does the pharmaceutical industry stand in the shift toward outsourcing of manufacturing? Why is there such debate about using contract manufacturers and bulk supply?

The familiar metaphors for business competition — war, sports, chess — suggest that the leader’s job is to lead the company to victory. But in the real world of business, the game never ends; the goal posts constantly recede, and ultimate triumph never arrives. You can never win, only improve.

Actions needed by the pharmaceutical industry to meet the requirements of the European Union’s new Registration, Evaluation and Authorization of Chemicals (REACH) regulation are gradually becoming clearer now that the December 1, 2008 pre-registration deadline has passed.