Ask the Experts: collaborating in biomarker assay qualification & validation

In the penultimate installment of Ask the Experts on Biomarkers we ask our experts the importance of collaboration among bioanalysts especially in the challenges of assay qualification & validation.

How important is collaboration among Bioanalysts to determine Biomarker assay qualification and validation?

Patrick Bennett (PPD)

“Collaboration is extremely important.  The tremendous amount of different biomarkers, matrices, use of the data and technology platforms make the decisions on how to qualify or validate methods challenging.  Sharing perspectives, advantages and disadvantages/shortcomings will be extremely helpful to bioanalysts working on various challenging problems with biomarkers.”

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

“In any field, collaboration drives innovation and best practices. It is important for bioanalysts involved in biomarker assay development to use a scientifically driven approach for assay qualification or validation.

This often requires collaboration not only with other bioanalysts for advice about analytical challenges and regulatory experiences, but also with their counterparts in research and clinical sciences. Bioanalysts can benefit from their colleagues’ deep scientific expertise to help contextualize the fit-for-purpose biomarker assay development.

Additionally, our research and clinical colleagues benefit from the bioanalysts’ analytical insight into appropriate interpretation of the biomarker data, ultimately guiding the context of use. Beyond internal company collaboration, engagement with the external community is also necessary for the industry to advance the clinical utility of biomarkers.”

John Allinson (LGC Group)

“This is extremely important. I would also suggest that key opinion leaders in the field could come together to draw up the recommendations required – particularly on those issues discussed at recent meetings, notably: Crystal City VI, WRIB, AAPS-NBC and EBF.  I would expect and hope that this group includes clinical laboratory biomarker expertise.

Over many years there has been opposition to moving away from the PK guidance for validation of biomarker assays and I hope (based on discussions at the meetings above) that this is now past us. Some of us have been working in the biomarker field for many, many years – both in clinical diagnostic and drug development research – and have had no problems in adequately validating biomarker assays for a wide range of clinical utilities. There seems to be a myth around that clinical labs only conduct biomarker assays for the purpose of diagnosis of disease – this is nonsense. The methods used can diagnose disease but also determine drug dosage adjustment (often very finely tuning it on a personal basis), demonstrate drug efficacy, stratify patients, etc., etc.

Therefore, we can use some of that long established science in biomarker analysis to build a very robust set of guidelines. However, make no mistake, this will not be a boiler-plated template! Individual biomarker methods must deliver results that will answer the questions being asked of the biomarker for the particular clinical utility for which it is being used. Therefore, it will be the responsibility of the individual laboratory to interpret the critical criteria used in the validation and the application of the method and acceptance of results in the sample analysis phase of each study.”

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