The field of bioanalytical biomarkers is constantly evolving and innovating; it’s an undertaking to keep up with its constant growth. As bioanalytical scientists we encounter challenges inherent in working with a scientific field that is still incomplete. The questions we ask ourselves on a daily basis are vital to developing a more robust understanding of how to continue to rapidly expand our knowledge of biomarkers as we move into the future.
Challenges in Working with Biomarkers
We all know biomarkers can prove vitally important in many areas of science and human health. The real challenge is in identifying one single biomarker out of a field of hundreds and thousands that all interact with each other in ways that is difficult to understand and define. Identifying a biomarker is not enough; rather the onus is on identifying the RIGHT biomarker. In order to be able to use a biomarker effectively we must be able to isolate one single biomarker as being associated with a specific disease.
Once biomarkers are defined, the complexity of data analysis creates another roadblock. We need to be able to look at data and identify strong correlations between the given biomarker and an associated disease as well as the outcome produced over time in a patient population. It is possible and quite often it happens that a biomarker doesn’t show that strong correlation and effectiveness we’re looking for. Analytical technology and treatments are constantly changing and improving, keeping those of us passionate about biomarker discovery motivated to continue pursuing the dream of finding the next “right” biomarker, and thereby helping to evolve this discipline.
Standardization and Regulation
Working with biomarkers is like working in the wild west of bioanalysis. The field is still relatively new, and there are few regulations and only some industry standards in place. Although we have made great progress in this field over the past few years, in my opinion this discipline is still in its infancy and there is still much more to learn. I, as well as most in the scientific community realize that solid science needs to drive forthcoming validation and regulatory approaches. Because biomarkers will never be a one size fits all solution, development and implementation need to be viewed in the context of use first and foremost, which makes creating a set of regulations more difficult than with other types of more standardized bioanalysis.
The fact that biomarker bioanalysis is such a complex subject means that the solutions we need will be equally as complex. There is no simple approach available. This is a subject where we as a scientific community need to get the science right so that future standards and guidelines can ultimately benefit patients and the healthcare system in general.
Technology is a major driving force of the development and innovation in the field of biomarkers. As more time passes with more scientists working with biomarkers, some platform systems will prove more effective than others. I feel that multiplexed systems, ultrasensitive platforms, and miniaturized automated systems prove invaluable in this field. However, improved technology is just one key component that drives advancement in the biomarker field and can provide the opportunity to expand overall scientific innovation.
The Collaboration of Scientists
In any field, collaboration consistently drives the best results and innovation from within a given group. Biomarkers are a novel science, which makes open communication about them among the scientific community all the more necessary. Collaboration is extremely important when you’re dealing with such a vast number of biomarkers, matrices, use data, etc., and sharing perspectives between expert scientists is an effective way to evaluate such a massive amount of information.
There is a solid foundation of key leaders and thought leadership content in this burgeoning field of study. Fortunately, there is no shortage of minds and resources when it comes to pulling together recommendations and expertise on biomarkers. The issues discussed at recent industry meetings, notably Crystal City VI and WRIB, make it apparent that scientists studying biomarkers are actively collaborating and thereby creating a more rich database of knowledge from which we all can continue to innovate.
Without a doubt the field of biomarkers will continue to grow and become more complex, as well as more thoroughly understood. Biomarker discovery will continue to expand within academia, medical and pharmaceutical research organizations. In coming years I foresee the validation of various biomarkers we classify today as “expletory” becoming solidified in the pharmaceutical development fields – similarly to how it has been previously done in the medical diagnostic fields for key biomarkers that have now been in use for several decades, and now today are offered on various automated clinical analyzers.
Alongside the development of the overall study of biomarkers, we are on the cusp of an overall proliferation of the understanding of the physiology in many disease areas. This more thorough understanding will allow us to enhance the targeting and effectiveness of a number of existing and yet to be discovered biomarkers. I believe that identifying biomarkers that are more involved at the early stage of slow progressing diseases will become more of a priority, allowing us to make additional breakthroughs in these arenas.
At BioAgilytix, we are committed to help you identify a robust, right-fit biomarker solution. We are able to leverage our menu of over 400 biomarkers – including 120 validated biomarkers – or will collaborate to develop and validate the novel assays you need. You can learn more about the biomarkers we work with here.
Also please feel free to reach out to me for further insight on how we conduct biomarker-related studies.