At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.

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.” 

FDA Commissioner Margaret Hamburg, whose speech on enforcement objectives and public health was just videocast live by the FDLI., appears  to be the kind of leader this Agency has needed for a long time, one who communicates equally effectively to the public, politicians, industry and to colleagues within  the Agency. Projecting authority in a very "natural" way, and describing her first few months on the job as "head spinning," Dr.

Even though we now have incontrovertible evidence that nobody reads blogs anymore, couldn't condense this one into a chirp or tweet. Please bear with me.

From Chemical Engineering Progress, Girish Malhotra presents his prescription for the pharmaceutical industry----QbD, PAT and control all play a key role, and chemical engineers will make it happen. The ultimate goal will be entirely new business models for pharma. Mr Malhotra discusses a new "Open Lab" open source R&D initiative in India that involves Sun Microsystems.

For a closer look at FDA's process validation guidance, here's the link to our archived webcast.