Bioanalysis Zone

Ask the Experts – Biomarkers: Standardization and regulation of Biomarkers


In question two of Ask the Experts on Biomarkers, our experts provide their thoughts on how biomarkers in bioanalysis can be harmonized.

With the increase in demand and research for biomarkers can the field be standardized and regulated?

Devagi Mehta, Chris Stebbins, Danielle Graham and Lauren Stevenson (Biogen)

“We feel it is important that biomarkers aredeveloped using a fit-for-purpose philosophy, where the science drives the validation and regulatory approaches. Biomarkers are not one size fits all, thus biomarker development and implementation must be viewed in the context of use and shouldn’t beamenable to wholesale standardization.

Often a fit-for-purpose biomarker assay qualification can involve a more comprehensive and rigorous approach than what would be associated with a PK assay. Instead, what should be standardized are opportunities for frequent engagement with the regulators throughout the drug development process to help advance biomarkers used for internal decision-making to a point where they can enable patient treatment and regulatory decisions.  This is true both for the biomarkers themselves as well as for any novel technology used in their measurement.”


John Allinson (LGC Group)

Standardization in regulated bioanalysis for PK assays has been successfully achieved – sadly, not so for biomarkers. Unfortunately, unlike Biomarker science, PK allows for a single, simplified and standardized protocol to all assays – where the only differences encountered are technical differences in methods (eg LBA vs LC–MS/MS), which leads to different acceptance criteria for each technology – but which remains the same across all different drug molecules using that technique.

However, since the physiological differences in biomarkers can be marked, this system does not work if we are seeking the best outcome from our methods in terms of quality of data and correct clinical interpretation – all of which can impact  the decision making process in terms of potentially progressing or halting a drug’s development.  So today, we still do not have harmonization – even on some key issues. There has been a “mood change” I believe that I have witnessed over the last 12–18 months, where many more scientists are speaking out with a more unified message that “biomarker assays are NOT PK assays” – and this, if long overdue, is to be welcomed enthusiastically.

The fact that biomarker science is a complicated subject means that the solutions we need will also be complex. There is no  simple approach.. This is a subject where we need to get the science right – ultimately for the benefit of patients and healthcare in general.


Click here to return to ‘Ask the Experts – Biomarkers’ to read other instalments part of this series.


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