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Insights

Clash of the Cultures

Apr 07, 2016

Insights

Clash of the Cultures

Apr 07, 2016

Andromeda, Apollo, Ares, Argos, Artemis, Athena, Cassiopeia, Cepheus, Demeter, Hera, Hermes, Hestia, Marmara, Pegasus, Perseus, Poseidon, and Zeus… Pharmaceuticals?!

It’s official: all the gods and mortals from the cast of Clash of the Titans have started some sort of company claiming to serve up biotechnology on the menu, with only one exception—Hades. Apparently, biotechnology entrepreneurs around the globe are staying clear of the god of the underworld; even credible domain names like www.hadespharma.com and www.hadestherapeutics.com appear to be available (time to go shopping for domains).

THIS HAS TO MEAN SOMETHING. Do we have a biomythotechnological battle of historic proportion on the horizon? Below is a short multiple choice of the possibilities (feel free to pick more than one):

  1. We are looking at a pandemic lack of brand originality, and in the coming years we will see biotechnology companies named Zeus 2, Zeus 3, Batman, and Wonder Woman.
  2. The term ‘biotechnology’ has become so common and generalized that McDonalds and Samsung are now being marketed as biotechnology companies. (Uh-Oh!)
  3. Clash of the Titans was an epic film that has inspired nations worldwide.
  4. Text books on Greek mythology were widely available and distributed to schools between 1960 and 1980.
  5. It is the eve of a very competitive, epic battle between companies and economies heavily invested in biosimilars, start-ups, and branded biotechnology worldwide.
  6. All of the above.

My vote is for number six.

If you are part of a life science organization or are currently treating and/or being treated for anything from H1N1 to Alzheimer’s, you know the term “drug shortage.” Life science companies from Texas to Taiwan are developing new and/or reformulating existing medicines based on living organisms. Hundreds of thousands of liters of drug production capacity is being put in place in an effort to significantly reduce the shortage in the next five to 10 years. The interesting part is that cultural geography is and will continue to play a key role in the future of biotechnology, as well as the drug shortage. Organizations like the CFDA, USFDA, WHO, and EMEA set governing drug development guidelines that are recognized worldwide as edict. Many of us who design drug manufacturing facilities for a living read and re-read these guides on a weekly basis. Yet, none of the guides are 100 percent prescriptive, and even if they were, cultural geography will always play a role in how humans find exceptions and/or interpret the guides to suit subjective influences.

With this said, we are all faced with a math problem that may not be easily solved. The majority of the prevailing drug development guides have been drafted by organizations with very similar cultural demographics—by people who wake each morning to clean water, paved roads, robust education systems, sanitation, etc. It is very clear that the capacity being created to compete for business and overcome the drug shortage is being developed in geographical locations where some or even none of the luxuries mentioned above can be found or perhaps understood in a similar way. Organizations can only do so much to influence compliance with international guides when faced with profound differences in philosophy, infrastructure, climate, and culture. So what can they do but manage the exceptions, some acceptable and some not so acceptable? How will the biotechnology companies of the world manage the various differences in their cultural geography in the short term while we wait for normalization? With needed production capacity coming available in the next five years and 20 years or more time required to redefine history and longstanding customs, the math could be something to consider as we plan for the future.

In our business of designing, building, and qualifying drug facilities, we often talk about reducing the project life cycle to increase speed to market; nearly 100 percent of the time this refers to shortening the duration of engineering, construction, procurement, commissioning, and/or validation of the facilities and systems. To significantly reduce this drug shortage, solving the clash of the cultures may be what dictates the real critical path of the schedule.

This article originally appeared on Pharmaceutical Processing World.

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