Webinar: Biomarker Discovery, Technical Qualification and Validation

Moving from Ambiguity to Clarity: Biomarker Discovery, Technical Qualification and Validation using LBA, LC-MS and HRAMS Assay Formats

As the FDA continues to push forward with the Biologics Effectiveness and Safety (BEST) Initiative, there has been an increased focus on formalizing the CDER Biomarker Qualification Program (BQP) as part of the Drug Development Tools process using recommendations put forth by the Critical Path Institute, their associated working groups; and those in public forums such as the Workshop on Recent Issues in Bioanalysis (WRIB) and American Association of Pharmaceutical Sciences (AAPS) meetings. The cumulation of these recommendations is likely to be incorporated into the revised Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry due to be released in late 2018.

Join Intertek’s Pharmaceutical Services expert, Stephen Rundlett, as he covers the evolving world of biomarker discovery, technical qualification and validation using assay formats such as Ligand Binding Assay (LBA), Liquid Chromatography – Mass Spectrometry (LC-MS) and High-Resolution Accurate Mass Spectrometry (HRAMS), and approaches taken to ensure regulatory compliance.

During this webinar you will learn how:

  • Bioanalytical Guidance for Biomarkers differs from that performed under different regulatory environments such as Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP).
  • Intertek applies a fit-for-purpose regulatory approach to studies performed using LBA, LC-MS and HRAMS platforms.
  • Intertek approaches the process of biomarker discovery, analytical qualification and analytical validation to ensure regulatory compliance.

As a Bioanalytical Laboratory focused in the discovery and fit-for-purpose regulatory analysis of many different types of biomarkers, Intertek Pharmaceutical Services is committed to supporting Clients in their quest to identify, technically qualify and analyze biomarkers as part of their IND submission, clinical studies and beyond using a clearly defined process.


About our Expert

Stephen Rundlett, PhD, is the Associate Director of the Biomarkers Program at Intertek’s Pharmaceutical Services in San Diego, CA. He develops and oversees strategic marketing, sales and operational plans for the biomarker franchise, provides scientific and regulatory support to clients in their need for fit-for-purpose biomarker analysis using a variety of LBA and LCMS platforms, and drives innovative operational support to maximize client responsiveness and profitability.

Need help or have a question? +1 800 967 5352

Need help or have a question?

+1 800 967 5352
+44 161 721 5247