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TRIAD SECOND YEAR IN REVIEW

January 2019

It hardly seems possible that it has been two 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?

 

The year 2019 opens with much happening in the E&L world.  USP chapters on materials used in pharmaceutical applications and biological reactivity assessment are taking shape and are in various stages of development/review/implementation.  ISO 10993 chapters on biocompatibility assessment of medical devices are undergoing major transformations, most notably chemical characterization, Part 18, and toxicological safety assessment, part 17.   Could this be the year that the PQRI PDO and ODP Recommendation are published?  What is ELSIE working on these days?

 

Moreover, good science continues to be investigated, formalized and communicated, key documents that reflect the careful balancing of that good science with the practical realities of the pharmaceutical industry and which clearly articulate requirements and recommended practices have either been published or are the verge of publication, and the various stakeholders continue to rely on their dedication to science and patients as the common foundation for compromise and consensus building.

 

 Although so much has been accomplished, we must acknowledge that there is still much more that needs to be done before we can say that our practices, procedures, policies and positions reflect the practical, judicious and proper application of the best available science to insure the best possible clinical outcome for patients.  In some cases, it is simple matter of figuring out how to properly and practically apply the good science that we already know.  In other cases, it is the more complex matter of establishing a common understanding of what is “good science” and reaching a consensus on how that good science is properly applied.   In still other cases, the good science must be discovered, meaning that insights have to occur, hypotheses need to be developed, experiments need to be designed and implemented, data needs to be processed into information, conclusions need to be drawn and findings need to be shared.

 

Progress can be frustratingly slow and at times it can seem like there is little support of and appetite for the compromise that is necessary to properly reconcile differing needs, desires, capabilities, constituencies and purposes.   And yet when the times seem the most difficult and chaos appears to reign supreme, there is that insight, a concession, an inspiration or a discovery that is the catalyst that drives progress forward.  

 

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 all 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

dennisjenke@triadscientificsolutions.com

 

 

 

 

TRIAD FIRST YEAR IN REVIEW

February 2018

 

It was a year 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”.  While the calendar says its only been a year, my own internal clock says it sure feels like a lifetime.

 

Although business anniversaries are largely an arbitrary circumstance of time, they provide an opportunity to reflect on and celebrate the accomplishments of the past year and afford the occasion to look forward to the future.  Considering the bigger picture of “extractables and leachables” as a discipline, there is much progress to commend.  Good science continues to be investigated, formalized and communicated, key documents that reflect the careful balancing of that good science with the practical realities of the pharmaceutical industry and which clearly articulate requirements and recommended practices have either been published or are the verge of publication, and the various stakeholders continue to rely on their dedication to science and patients as the common foundation for compromise and consensus building.

 

Despite the speed with which the bar has been properly raised, we must acknowledge that there is still much more that needs to be accomplished before we can say that our practices, procedures, policies and positions reflect the practical, judicious and proper application of the best available science to insure the best possible clinical outcome for patients.  In some cases, it is simple matter of figuring out how to properly and practically apply the good science that we already know.  In other cases, it is the more complex matter of establishing a common understanding of what is “good science” and reaching a consensus on how that good science is properly applied.   In still other cases, the good science must be discovered, meaning that insights have to occur, hypotheses need to be developed, experiments need to be designed and implemented, data needs to be processed into information, conclusions need to be drawn and findings need to be shared.

 

Progress can be frustratingly slow and at times it can seem like there is little support of and appetite for the compromise that is necessary to properly reconcile differing needs, desires, capabilities, constituencies and purposes.   And yet when the times seem the darkest and chaos appears to be imminent, there is an insight, a concession, an inspiration or a discovery that is the catalyst that drives progress forward.   

 

Considering the smaller portion of the E&L world that is Triad Scientific Solutions, just surviving that first year is accomplishment enough.  In a very real sense, Triad serves two purposes, providing me with the means to remain active in the E&L scientific and standards setting community and “keeping the lights on and the refrigerator full”.  I thank those past and current clients who have challenged me with their situations 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 all 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 and a thick skin.  

 

With humility, regards, respect and gratitude,

 

Dennis Jenke

Chief Executive Scientist

Triad Scientific Solutions, LLC

dennisjenke@triadscientificsolutions.com