That's how Control magazine's executive editor Jim Montague described the pharmaceutical industry in a recent and very memorable op-ed (read it here), in which he interviews experts including E-55 insider Gawayne Mahboubian-Jones. Jim brings to the the "so what" detachment of one who has covered PAT and process control as it has advanced in other industries over the years. We may appear to be a bit "gee wiz" on the subjects, if only to encourage the adoption of PAT and the open discussions of best practices, but Jim makes great points.
An accompanying review of pharmaceutical PAT asks whether it's a silver bullet for pharma? (The bullet was used, in legend, to kill the devil or werewolves...in the case of pharma, it's killing a Frankenstein monster of pharma's own creation, paralyzed on the lab table ---although FDA played a major role in the vignette...which role....Igor? Remember Marty Feldman and Abbie Normal? Sniff. What was once a great Mel Brooks film is now another overblown Broadway musical). Our own recent survey of pharma op ex practices found an uptick in pharma PAT adoption...although PAT is no longer the top motto (it's now Quality by Design, as enabled by PAT)
Noticed that a number of great blogs are blogging from BIO 2008. Patent Baristas has entitled its blog "The Road to BIO". I'm still on that road tonight, quite literally, having made the decision to take the younger children with me on a road trip that started last week...beautiful stretches in New Mexico, particularly....but long stretches.
Had hoped to be able to cover both Honeywell User's Group in Phoenix and BIO, but their schedules overlap completely....fortunately, our colleagues on Control have promised to help us provide coverage of HUG's extremely interesting pharma and biopharma track. BTW, Control's editor-in-chief, Walt Boyes, was very recently elected an ISA Fellow.
