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Webinar: Opportunities and Challenges of Developing and Validating qPCR Assays in Pivotal Vaccine Trials and Beyond

The challenges of developing and validating qPCR assays in vaccine and therapeutic trials are manifold and hampered by a lack of harmonization of CRO’s.

The webinar will explore the advantages of qPCR in advancing life-enhancing therapeutics and why patients deserve the effort to harmonize.  Validation performance characteristics are explored with a special focus on precision and sensitivity.  Regarding precision, acceptable values for percent coefficient of variation is not clearly defined in the scientific literature or health agency publications. Uncertainty around precision is exacerbated by qPCR CV’s that are commonly higher than other traditional bioanalysis assays (e.g., ligand binding and chromatographic assays).  Regarding sensitivity, the selection of PCR is based on its exceptional sensitivity (and specificity).  Yet there is a lack of clarity around how to measure this and what the minimal requirements are.

The best practices and strategies for optimizing assays are discussed as is the importance of assay context of use in deciding acceptable precision and sensitivity. In-house summaries from analyses of more than 50 qPCR validations as well as experimental data comparing bead- vs column-based extraction will be presented. Finally, a case study is presented to link acceptable RT-qPCR validation performance with the efficacy of the Moderna Phase 3 COVID-19 vaccine.

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