Engineers Nail QbD in Philadelphia

Last week posed a scheduling quandary for anyone interested in Pharmaceutical Quality by Design and Process Analytical Technologies.  Three important meetings were taking place....of course, the AAPS annual meeting in Atlanta, but also the Eastern Analytical Symposium and....the American Institute of Chemical Engineers meeting in Philadelphia.

I had resolved to focus on AAPS but made a brief detour to Philadelphia for AIChE on Monday afternoon. Several presentation tracks were devoted entirely to pharmaceutical Quality by Design. Most of Monday's presentations were unusually good---particularly those from Pfizer scientists and engineers, who presented economic results and detailed data (in one case, for a much-anticpated blockbuster that didn't make it past clinical trials, in another, for the controversial smoke cessation product, Chantix); other presentations from Merck, GSK and other companies were outstanding.

Anyone working with these concepts should consider attending AIChE meetings...because, clearly, they're not just for engineers, and they are framed in practical and realistic terms. And we didn't see the usual conceptual diagrams with the ubiquitous quote from Janet Woodcock, and all the schematics..."design space", puffy clouds and arrows, "control space"...etc. (Is it any wonder that so many people in the industry say they still don't understand what qbd is, and can't justify increased spending on it to their managers?)

AAPS meeting was good, and QbD was a major theme...I was pleased to interview Steve Simmons an Aventis alumnus and Wyeth's new QbD/product development chief.  I'd asked him about staffing, and whether it was better to hire a process engineer or a chemometrician...he said he'd generally take the chemometrician and train them on the proces side...(reminded me of questions about wheher to hire a journalist or a technical expert to write and report...usually prefer journalists because they are not afraid to ask questions that the experts might be too quick to dismiss)

 For some of the AAPS conferece tracks, though, billed "panel discussions" never materialized....notably, the one on heparin. 

Pssssst.  Wanna buy a used laptop?
Only problem?  My laptop mysteriously disappeared from a ballroom full of scientists, during the major QbD session, a  fine one. 

Can't cry about this. It was my own fault for leaving the laptop, in a zipped conference bag,  at my seat...I never leave my laptop anywhere, not at a seat, not in a hotel room.  But I didn't want to assault speakers head on and try to set up interviews, schlepping all the bags, as I had the day before.  For the very first time, I overruled my extreme caution.  "C'mon, these are all scientists.  They all have their own laptops. What on earth would they want with yours.  It's not as if you have any trade secrets in there..."

For a second after it was gone, I wondered if the competition had borrowed the laptop, a ridiculous concept. Trade publishing is such a cut-throat, cloak and dagger world. (Well actually, these days it kind of is, but that's more on the sales side...)

There were no wandering cleaning crew or catering people in the room...

The security people and police assured me that someone took the bag by mistake...but no sign of it so far...That laptop has become an appendage, a third arm, especially since I began telecommuting.  Its loss is very keenly felt.

Had hoped that, like pickpockets who return the wallet, whoever took it would return my cell phone charger, camera charger, and handwritten paper notes in the bag.Between the notes on the computer, paper, audio and video files just transferred from recorders to the computer, there was easily enough for 10 articles there...

Fortuately, Mr. Simmons' interview is still on my recorder.  It may take time to reconstruct everything else, but, eventually, those of you who care will read articles and interviews based on many of these presentations, on our web site and in the pages of our magazine.

My first [unfair] conclusion?  A graduate student, in need of funds and desperate for a laptop, took the computer, assuming that it wouldn't be a great loss for my company. If that's the case, I hope he or she actually reads and listens to the files on it...the approaches described in some of them have the potential to change drug development, forever, for the better, so I'd be contributing, in some small way, to the advancement of one pharmaceutical scientist....

That was probably wrong...A note in my hotel room, which I read after the theft, noted that laptops should be placed in the room safe, and never left in the locked room.  

Atlanta is a lovely city, and the people I met there were, without exception, polite and very nice, but...if there are jokes about the Big Apple being rotten at the core, there may be something going on in the peach pit.  BIO's going to be held there next year, if I remember correctly...so, leave your laptops at home if you can (or keep them with you at all times). Until a wearable version is develope, maybe the new touch-screen Blackberry offers a solution?

Emil Ciurczak chaired a track at EAS, and has promised to send reporting on that conference shortly so stay tuned...

-AMS

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  • <p>The truth is that engineers are so meticulous and concerned with their work that is why quality is always one of the priorities. They want to protect their profession and what is the best way to do it? Yes, giving us quality products. - <a href="http://www.facebook.com/DrNaveedFazlani">Dr. Naveed Fazlani</a> </p>

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