Therapeutic Dose: Fractal Pharma

When the whole so closely resembles the individual parts, where is the big picture, or the path to continuous improvement?

By Emil W. Ciurczak, Contributing Editor

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A few days ago, my wife’s collection of matroshka, or nesting “mother” dolls from Russia, got me thinking about the industry I’ve spent most of my life in. They reminded me of fractals, those repeating mathematical patterns found in nature, in such commonplace things as snowflakes and ferns. With fractals, the closer you get, the more the parts resemble the whole.

The same applies to the pharmaceutical industry. As you get closer to it, each of its parts seems to resemble the whole.

Let’s start at the bottom of the totem pole, which is, in reality, where the most important totems are placed. Pharma’s lab rats develop analyses that are “as good as needed” but no better. For a typical HPLC analysis in pharma R&D, industry pressures, particularly time to market and NDA filing, prevent us from truly optimizing the analysis before sending it to QC. Have I seen some dogs over the years!
Backing up a notch, consider the behavior we see at the final drug product stage of the value chain. A company develops a product that works “OK,” and, after clinical trials, immediately begins to sell it. We bang out a production process, then are stuck with it for decades.

Moving further up and away, we see the actual discovery-marketing paradigm. With the introduction of the first multi-mega-buck selling products, we made our companies large enough to crank out a “biggie” every time.

There was just one problem. With this mindset, ONLY biggies could generate a profit.  So, the goal shifted to increasing the size of the company. Organic growth would be too slow, so a merger and acquisition feeding frenzy began.

In the mid-1970s, when I was a young lab rat, I saw this happen in my own company.  We would buy a firm with one or two money-making products, shed the properties and employees, and sell the product under our label. Over time, though, our continuously increasing overhead caused marginally profitable products to become non-profitable. Sound familiar?

Let’s move a bit farther away, and closer to viewing the “big picture,” and we see pharma’s lemmings, er, uh, decisionmakers still chasing the blockbuster concept. Today’s already bloated companies are running to see how many biotech companies they can ingest, and how many buildings and bodies they can divest. Abbott won’t be the last caterpillar to come out of its cocoon looking very different.

Now let’s zoom in to the micro-level again, and picture an image etched into my memory from my first HPLC course. Imagine a mountain range with a large number of peaks. The method development/optimization process was presented as climbing a single peak. Attaining the peak was “success.” However, higher peaks, in the form of better methods, were in range.  Would they even be used? If you were working under time constraints to get the project “finished,” these territories would remain forever uncharted.

Those higher peaks may take the form of a better application of an existing technique, an upgraded method, a different concept of measurement, a different way of making a product, or even a whole new direction for the drug industry.

If I always knew the “correct” direction, I would be rich. But I would at least suggest is that companies stop running in lockstep every time someone produces a bestseller drug. The resulting stampede resembles the gold rush in 1849 California . . . and we know that most miners came home broke.

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