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​January, 2021​


When one works for one company for many years as I did, one can develop a world view that is rather focused and not particularly worldly at all.  It is remarkable how quickly this becomes apparent when one puts their own shingle out there and takes on clients from all the corners of the E&L world.


To put this in context, I remember the parable of the blind men and the elephant.  In this parable, several blind men are asked to describe an elephant based on the body part that they can touch.  One bind man, touching the elephant’s truck, exclaimed that the elephant is like a thick snake. Another, touching the elephant’s tail, described the elephant as a rope.  A third blind man, who touched the elephant’s ear, suggested that the elephant was like a fan.  And so it went, with each blind man in turn touching a different body part and therefore describing the elephant in a different manner.  


Ultimately, none of the blind men described the elephant correctly.  And yet not one of the blind men was wrong, it was just that their individual viewpoints were simply too narrow for them to visualize “the bigger picture”. 


I looked back at what I wrote in the review of Triad’s third year and found the text to be a little gloomier than I think I intended it to be when I noted how hard it is to drive towards consensus on issues fundamental to the technical but practical discipline we collectively call E&L.  Nevertheless, another year’s experience has done little to change the essence of my opinion on this subject.  I do not see the E&L community of practice getting closer to consensus.  Yes, it is true that some issues have been resolved (I think).  For example, when manufacturing equipment first appeared on the E&L radar, driven by the emergence of Single-use Systems (SUS), people who suggested that “maybe downstream processes clear the process stream of extractables and the risk is not as great as one might think” were patted in their head and told to “come back when you have some data”.  Well, they went back to the lab and went back to their processes and they got the data.  Equally importantly, they published the data so that everyone had access to the data and could review it.  So today the preponderance of available data is arguably compelling enough that maybe the concept of “it truly is not as bad as we thought it could be” can be translated into actionable guidance and required/recommended practice.


Here I am going to use another analogy.  I find progress in the science and practice in E&L to be like the game “Whack-A-Mole”.  No sooner do you whack one mole back into its hole, then two other Moles pop out of two other holes.   The same thing is true in E&L.  “Solve” one problem and two others jump it to take its place.


So, what is it that makes so hard to reach a consensus?  I think I could offer any number of causes.  But there is one I would like to specifically address.  It is the lack of a common foundation of knowledge.  Let me pose a scenario.  Three E&L scientists walk onto a bar.  Scientist A and B went to the same graduate school and have worked in the same Big Pharma company since they graduated.  They routinely talk shop and share studies, data and experiences.  Scientist C has the same education background but attended a different university.  After working a few years as a “LC/MS jockey”, scientist C now is the E&L SME at a start-up going into Phase 3 clinicals with their first candidate molecule.  The scientists, who know each other from meetings, workshops and the like, start to talk about the selection of simulating extraction solvents.  After a period of animated debate, two of the three scientists come to an agreement in principle while the third scientist is convinced the other two haven’t a clue in terms of what they think they know.  So, let me ask you; which of the three scientists are the two that agree? 


This is not a trick question and logic suggests that the most likely correct answer is that Scientists A and B have come to an agreement.  Why? Because they share the same knowledge, the same background and the same experience!


You see, if we do not have a common understanding, are we not like the blind men trying to describe the elephant?    


Interesting point, Dennis, but so what?  We can’t make all E&L go to the same school, work for the same company, or share their data and experiences. 


Of course, that is true.  But we can do the next best thing.  It’s called publication.  It’s what scientists do.  In fact, I would argue it is one of the responsibilities that come with the title.


Let’s be fair, it is a burden for industrial and regulatory scientists to publish.  You don’t have to tell me that.  I have always thought that it is a shame that there are no academic organizations that have an active research program in pharma E&L because you can be darn sure they would publish.  The closest I can come to an academic research group in Pharma E&L are the people at the National Institute for Bioprocessing Research and Training (NIBRT) and if you follow E&L applied to manufacturing you know how well-published they are. 


But I digress.  It is through publication that the community of practice gains a common foundation of information, data and insight.  And it is that on that foundation that consensus will be built and from that consensus that guidance will be developed.


So, let’s get to writing!  I look forward to reading about your experiments, reviewing your data, debating your conclusions and moving our profession forward.  If there is anything that I can do to help, you know how to get a hold of me.


Considering the small portion of the E&L world that is Triad Scientific Solutions, I again want to thank the growing number of past and current clients who have come to me with their issues, challenged me with their projects, and trusted me with their products and I celebrate the successes that we have had.  I apologize that there is not always an easy and obvious answer and that the solution is not always simple   but I note that there has always been, and there will always be, a path forward.  I look forward to new and ongoing collaborations and working together making continued progress towards the worthy goal of sustaining and saving lives.  To potential future clients I would say that “help is only a phone call away”, although to be perfectly honest I answer e-mails much more quickly than I answer the phone.  If you seek a partner whose commitment to the patient is as strong as your own and who sees “good science practically applied” as two sides of the same coin, then I do hope you will contact me.


To my friends, colleagues and all who continue to selflessly give their time and talent in service to our profession and in the pursuit of “the greater good”, I wish you boundless energy, uncommon insight, the wisdom of Solomon, an infinite budget, a thick skin, and continued success.


 With humility, regards, respect, and gratitude, and yours in science and in practice,


Dennis Jenke


Chief Executive Scientist

Triad Scientific Solutions, LLC

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