Biomarker assays – bioanalytical meets CLIA

Wednesday 9 December 2020
10:00 [EST] 07:00 [PST]  15:00 [GMT]
Alternative time zones


Reliable diagnostic, prognostic, predictive, pharmacodynamic and pharmacokinetic biomarkers are critical to assure correct patient selection, drug dosing and monitoring to get a patient a drug that is going to work for them. How a biomarker assay is being applied to a drug’s development will determine when an assay should evolve from research quality to a clinical diagnostic test. The requirements for a lab developed test with regard to assay performance, validation requirements and when the assay is used for patient selection and risk determination within a clinical study will be presented.

What will you learn?

  • What are the regulatory requirements for a biomarker assay when used as a primary, secondary or exploratory clinical endpoint?
  • What is involved in developing a biomarker assay for exploratory use, for determining clinical efficacy and safety endpoints and as a companion diagnostic?

Who may this interest?

  • Clinical pharmacologists
  • Bioanalytical scientists
  • Medical technologists
  • Diagnostic kit vendors


Roger Hayes
Vice President, Bioanalytical Services, ICON (NY, USA)

Vice President of Bioanalytical Services within the ICON Laboratory Services group with overall management responsibility for ICON’s Bioanalytical laboratory in Whitesboro, New York. Dr Hayes has held numerous leadership positions in the global life sciences industry and academia, leading teams in the development of state-of-the-art bioanalytical and analytical techniques to bring medical and chemical products to market. For nearly 2 decades, he led strategic and research initiatives for large pharmaceutical companies that included both GLP and non-GLP preclinical studies as well as clinical trials.


Andrew Roche, PhD
Senior Director, Scientific Affairs, ICON (Dublin, Ireland)

Dr Roche has a Degree and PhD from Trinity College Dublin and has since accumulated 20 years experience within the clinical trials industry with particular focus on the intricacies of biomarkers, associated laboratory methods and their ability to facilitate an efficient and accurate assessment of the clinical safety and efficacy of therapeutics moving through clinical trials.



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