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.

....not a banner season for scientific integrity, as WSJ's Eric Felten points out in a nice editorial, pointing to, among others, Scott S.

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

The compliance consultants, Vectech, are now offering virtual cGMP consulting services, to help drug manufacturers deal with FDA compliance questions immediately via videoconferencing. The company is promoting this as a way to eliminate travel costs, yet ensure "face time." Costs are said to be a fraction of what traditional consulting runs. For more, read on.

FDA has been advocating process knowledge and understanding for a long time now. The Agency's statements always generate "hear, hear's" and motherhood-and-apple-pie type assents and approvals among industry types...."Of course, we need to understand our processes."

But at times I wonder: Is everyone paying attention? Is anyone? Must full-out production always trump product quality and patient safety?

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.)

Ever get stuck behind a loud bore on an airplane? I had that misfortune last week. Eventually tuned him out, but couldn’t help but pity his quiet seat-mate, who didn’t know a peptide from a Pepsi, as he got sucked deeper and deeper into a one-sided verbal black hole, a diatribe about the axis of evil: the pharmaceutical industry and its “ally,” the FDA.

This bore was well-read, but essential bits of knowledge were missing from everything he talked about, from his description of peptides and how cox-2 inhibitors work to his characterization of the evil FDA.

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?

At the USP science meeting in Toronto, I met Janeen Skutnik of Pfizer, currently chair of IPEC Americas, and former IPEC chair, Colorcon's David Schonecker. (Also met incoming chair,  William Dale Carter of JM Huber, who will start his new role next year).