This week, the FDA will lose its most eloquent advocate for process analytical technologies (PAT): Ali Afnan, senior staff fellow at CDER's OPS. who leaves the Agency this Friday to pursue a career in independent consulting. A member of the original PAT team led by Ajaz Hussain, Dr. Afnan had pioneered the use of PAT at AstraZeneca in Europe.

From the Wharton business school, an interesting piece on an easy way to motivate employees...connect them to those who benefit from their work. Professor Adam Grant has tested this theory and found it works....I'm betting that plant accidents or quality problems wouldn't happen  as frequently if employees had regular contact, of some sort, with the end users of the products they make.  For more, read on.

AMS

Recent postings in the WSJ blog and elsewhere have asked the troubling question: Does Lean Manufacturing, by definition, lead to quality control problems? Click here for an interesting read. (For something that doesn't require registration, click here.)

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.” 

I've always found one of the most evocative terms in the Toyota lexicon to be “gemba” ----the real place, or as it has more poetically been translated, “the place where truth will be found.”  The word already implies that you may have preconceived notions of what the truth is and need a reality check. What better way to define the workplace, whether that's a laboratory or a factory?

This week I did some time traveling and was transported back to 2003, during a presentation given at the Bioprocess International conference in Raleigh.

It was a fiine presentation by a well-known professor at MIT. There was just one problem. It’s the identical presentation that we’ve seen again and again for the past six years.

Is it a timeless classic? Yes.

Every so often, one gets a major reminder of the strategic importance of manufacturing and the largely invisible "CGMP set" to the drug industry and, yes, its bottom line. Former FDA chief Mark McClellan gave pharma a good one years ago with his famous "potato chips and soap flakes"  comment, immortalized in a Wall Street Journal piece. Typically, manufacturing continues to be thought of something that will get done....quietly, invisibly, wherever and by whomever.

In a sad turning point in Toyota's history, and, perhaps the whole history of the Lean movement, Toyota  plans to liquidate the Lean showcase NUMMI plant in Fremont, California "by the end of August." Read more from yesterday's story in the San Francisco Business News.

Yesterday, we aired a webcast on Lean Six Sigma in pharma. Click here to view.