Pharmaceutical Executive-04-01-2003

Table of Contents

The pharmaceutical industry is experiencing unprecedented late-stage setbacks, product recalls, and difficulties in generating high-quality drug candidates. The problems are not specific to any one company or research effort but rather a result of the industry's limited knowledge of biology and chemistry.

When it comes to recruiting and enrolling individuals in clinical trials, the industry's challenge is similar to the one that General Riggs cites in his call to modernize the US Army.

The trick in understanding any contentious public debate is to figure out what's being left out of the discussion. What, for example, is the assumption that's so obvious that no one thinks to bring it up? More often than not, when you've located that assumption, you've found the secret core of the argument -- the part that everyone's really fighting over and no one can bear to mention.

As scientists' knowledge of biochemical pathways increases, so does the number of patents issued for generic treatment claims. Such claims represent methods of treating disease by modulating a particular protein in the body.

The competition for generics' 180-day marketing exclusivity is fierce, and Dr. Reddy's Laboratories filed the first court case calling into question FDA's methods for determining exclusivity on a patent-by-patent basis.

In hindsight, it seems Catherine Angell Sohn, PharmD, was destined to become vice-president, worldwide business development for GlaxoSmithKline Consumer Healthcare (GSKCH). Sohn, a former pharmacist, architect of three Rx blockbuster launches, and engineer of innumerable partnerships and licensing agreements, is a pivotal link between GSK's pharmaceuticals and consumer healthcare.