Everyone keeps talking about how the industry is on the brink of great change….it’s the death of the blockbuster….the birth of…what? The niche-buster? Personalized medicine?
Just keeping up and fire-fighting may be difficult enough so it is tempting to be like Scarlet O’Hara, as in “we’ll just deal with those issues tomorrow.”
The problem is that this is just the kind of thinking that may ensure that one won’t be around tomorrow. Generics manufacturers are giving Big Pharma just this kind of wake up call, every day….why not be prepared?
Lars Petersen, director of automation at Genentech, summarized the situation very neatly at a life sciences panel discussion at Emerson’s Users Exchange recently. The industry needs to become more agile and responsive, than ever before, he said. It needs to stop creating unnecessary business processes. “Quality did not create these processes. We did,” he told industry peers. He described a working environment where a simple software improvement, taking only hours to make, consumes huge amounts of documentation and approval time. (Hey, wait a minute, you may argue, but FDA created that environment…does it really matter now?)
Perhaps, too, Petersen suggested, more pharma companies should embrace the whole concept of modularization and standardized recipes, and the essence of S-88, a point that another biotech engineer, Paul McKenzie of Centocor, made at the Bioprocess International conference last week (here's a link to a summary of his presentation). Hmmmm. Do these biotech engineers know something that some of you don’t and should? Maybe it's time to check out WBF...
Like McKenzie, he also mentioned the need to connect this work with clinical...
Here’s a link to a video clip of some of what he had to say (we will be posting refined videos on our site, but here’s YouTube for now).
BTW, in December, we will be featuring a futuristic look at how facilities will look and operate in the future, the technologies they will use, and singling out a few that are already being designed with tomorrow's needs in mind. If you have a spare moment, please feel free to send your thoughts about issues affecting the pharma plant of the future, your visions of the future, and the impact that will have on your jobs.
AMS
