Therapeutic Dose: Avoiding the “Cool Hand Luke” Effect

Isolation and too narrow a focus limits possibilities — for your career and life, your organization, and the industry. Sure, you may be doing your job right, but are you doing the right job?

By Emil W. Ciurczak, Cadrai Technology Group

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For those of you who have endured my recent “observations,” I want to assure you that there were ties to PAT in them all. I am quite fond of “Connections,” a PBS program, now seen on the Science Channel (what a geek I am). Host John Burke will spin a tale, relating, for example, Roman chariots through printing presses through atomic submarines to iPods, for example.

Cool Hand Luke still
(For our Gen X readers and anyone else who isn’t familiar with the classic Paul Newman film, view the trailer here www.imdb.com/title/tt0061512/trailers.) Photo courtesy of imdb.com.

As a fan of history (especially in the Pharma industry), I think I have observed trends in society that touch upon our ability to be successful in supplying the world’s medicines. The one trend I have been watching is computers. “So,” you might say, “where’s the news there?” Well, as with any drug (or any chemical, for that matter), any technology is a two-edged sword. As for my favorite topic, near-infrared, it would be still a nice, simple technique for produce and grains without computers. With computer assistance, NIR has blossomed into a super tool for PAT. What could be the down side?

I addressed that in an earlier column: with computers came the internet. This is a wonderful invention(s)! It has made day-to-day living easier in so many ways: online banking, researching term papers, checking out company websites, etc. But (and, in my writings, there is almost always a “but”), as I pointed out, it has isolated us from our fellow humans. The slow death of professional societies is but a single symptom of this isolation. It carries over to our everyday jobs.

Where we might meet with someone to discuss the latest journal article over coffee or in the library, we check the internet. While it doesn’t seem like it, there are fewer face-to-face meetings; it is far easier to email everyone. [And I assure you, no one really reads all 6,000 emails he/she gets every day. That is not only an excuse for ignoring unsavory tasks, but genuinely allows topics to slide by without notice.] With the advent of more specialized meetings and journals, there is less and less knowledge about anything outside our narrow jobs. (Remember, I noted how we now think in terms of “jobs,” not “careers,” anymore?) So, what happens when an enlightened person in your company starts a PAT committee?

Well, it becomes populated with a group of people with special interests, almost totally unfamiliar (or uninterested) with the jobs of the other sections represented. We then all start giving our opinions of how PAT should proceed (in order to make our own jobs easier). The resultant discussion reminds me of the blind men describing an elephant: “It resembles a wall,” “It resembles a snake,” “It resembles a rope,” etc. The Tower of Babel would be as apt an analogy as possible. This is what brought to mind the title of this piece. Wait for it… wait for it…”What we have here…is failure to communicate!”

Just as in our (Center for Professional Advancement) PAT course, we point out that all data are not information, thus, not all inputs at a PAT meeting are salient. (Oh my! The howls of indignation!) What ANY PAT program calls for (nay, begs for) is triage. Even the largest pharmaceutical company cannot try every analytical tool on each step of every product line at the same time. We need to have some idea where the biggest “bang for the buck” will happen. Before the first meeting, all the ideas should be sent to a team core (not corps) for consideration. These suggestions are taken under consideration by the core, who evaluate the potential of return ($$$$), availability of personnel, product problems, etc. Then, and only then, should the topic for the first PAT Committee meeting be chosen.

Now, speaking with another human is pretty much like riding a bicycle: it comes back with a little practice. The ones that I worry about are the internet-generation scientists, who have always dealt with the world through the filter of the computer. Not going to general meetings, it is possible they don’t have a clue what the other departments even do…

A problem with only knowing your own tasks is summed up in a pair of statements I ran across in a time management course: “Being efficient is doing your job correctly. Being effective is doing the correct job.” The example of this I choose is the QC of incoming raw materials. The departments do a very good job of ensuring that the material in the bag matches the label on the bag. It seems to me that a well-oiled “vendor validation” program would allow that to happen. What the QC department almost never does is test for the parameters that will make a good product: polymorphic form, degree of crystallinity, surface or crystalline moisture, particle size distribution, and other physio-chemical parameters.

With little or no communication between QC and Product Development or Product Development and Production, the “correct” tests may not be performed. Yes, the chemical/physical tests are performed correctly by QC, but are they the correct ones to make a good, reproducible product? (This will be a topic for a later article.)

Communication, another part of cross-training (to borrow from the fitness gurus) is desperately needed. We need some time spent “walking a mile in another’s moccasins.” We need more generalists and fewer specialists. What we need is a program such as I was fortunate enough to participate in back in 1970. At Ciba (Pharmacy Research), I spent a week making tablets, a week in pre-formulation, a week in sterile products, a week making suppositories, a week in clinical packaging, and then I went to my job of performing compatibility studies between he products and the new-fangled invention of plastic bottles. I got to spend time in Production, QC, Analytical R&D, in addition to watching the drug delivery systems be developed.

Obviously not everyone can do all this training, but some of us has to… or PAT ain’t gonna survive as it should. So, wanna go for a cuppa java and chat about some journal articles?

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