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January, 2020​


Time is certainly a curious thing.  As I prepared to write this update by reviewing the update from last year, I was struck with two conflicting thoughts:


  1. How has so much time gone by so quickly, and

  2. How is it that so little was accomplished during that time?


For example, I opened the 2019 update with a synopsis of where I thought the industry was and where it would be in terms of standards and guidelines.  Frustratingly, I find I could repeat the text verbatim and it would still be largely correct.  USP chapters on materials used in pharmaceutical applications and biological reactivity assessment continue to take shape and are in various stages of development, review, and implementation.  To be fair, some progress has been made.  The chapters relevant for packaging, <661>, <661.1>, <661.2> and <1661>, have received minor facelifts and are likely be become official shortly, with implementation delayed until December of 2025.  While this is progress to be sure, it was achieved by essentially kicking the can that is extracted elements down the road into the next USP cycle, as a consensus on this topic could not be realized.  The chapters relevant to components used in manufacturing, <665> and <1665> are undergoing yet another revision and will shortly proceed to their next step, likely to be another round of review and comments.  Unfortunately, the E&L community is so polarized on this topic (and others) that it is unlikely that these chapters will find the balance where nobody is exactly happy with the chapters but everybody is willing to agree that they are good enough.  The transformation of ISO 10993:18 on the use of chemical characterization to support biocompatibility assessment of medical devices is complete and it is certain that Part 18 will become official this year.  Although I believe that part 18 is a quantum leap forward in terms of providing science-based and actionable requirements and recommendations for designing, performing and reporting chemical assessments, again it falls short of what I hoped it might accomplish due largely to the inability to drive to consensus among the various stakeholders on key issues.   In 2019, I wondered whether that would be the year that the PQRI PDP and ODP Recommendation are published. Turns out that we will have to wait for this year for that to happen, although it likely that publication is imminent.  Worst yet, the document moves forward only by taking certain more controversial topics (like the proper value for the QT) off the table.   


I understand that there is an effort afoot in ICH to write the definitive text on extractables and leachables, driven by the conviction that such a definitive text (or texts) does not currently exist.  Having some experience with writing standards in the E&L space, I wish the writers of ICH Q3E good luck and God speed. I believe the writers will find that it is easy (relatively) to take a stand on a certain topic (for example, about specifying specific extraction solvents to use).  However, when it becomes necessary to get the community of practice behind the standard, they will find the community to be fragmented.  One group will love the standard, another will hate it, a third will say “not invented here” and the standard will go nowhere.  The need to be rigorous will conflict with the need to be practical and again it goes nowhere.  Competent, knowledgeable and passionate scientists will disagree on key and fundamental principles and applications of “good science” and the again the standard will go nowhere.


Thus, the challenge to anyone writing an E&L standard is not writing the standard, it is driving a consensus.  If the writers are lucky (and I assure you luck has little to do with it) and they can find the consensus, then something will move forward.  I hope that what the writers have to give up in order to achieve consensus is not so great that the standard essentially becomes meaningless.  If the writers are unlucky and they cannot find the consensus, they will be stuck in the endless cycle of revision and review that is the current status quo in other situations.


If one develops the mindset that “we will write what we think is right and then it will be so great that everybody will want to follow it” or ‘we will write that we think is right and then force people to follow it”, then they do not understand this industry and its dynamics very well.   Neither of these approaches are tenable.    


I believe that the E&L community will reach that point where consensus is possible and will mature to the point where the burden of consensus will be accepted, albeit grudgingly.  That is the point where writing the standard becomes a reality and not a fantasy.  I do not know when we will reach that point, I can only say that I believe we are not there today. 


It hardly seems possible that it has been three years ago this month that Triad Scientific Solutions, LLC opened for business, based on the bold premise that “good science, judiciously applied for the benefit of patients and users, provides integrated solutions to suitability for use challenges”.  Where has all that time gone?


So much for “preaching to the masses”.


Considering the small portion of the E&L world that is Triad Scientific Solutions, I thank those past and current clients who have challenged me with their projects and circumstances and I celebrate the success that we have had.  I apologize that there is not always an easy and obvious answer but note that there is always a path forward.  I look forward to continuing our collaborations and making continued progress in terms 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 desire 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 contact me.  To my friends, colleagues and all who continue to selflessly give their time and talent 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,


Dennis Jenke


Chief Executive Scientist

Triad Scientific Solutions, LLC

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