Opportunities and Challenges of Developing and Validating qPCR Assays in Pivotal Vaccine Trials and Beyond, Upcoming Webinar Hosted by Xtalks

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In this free webinar, learn the procedures and challenges with developing and validating qPCR assays. The featured speaker will discuss the need for harmonization of qPCR assay validation characteristics for supporting therapeutic trial applications. Attendees will get a review and recommendations of best practices and strategies for optimizing qPCR assays in vaccine and other therapeutic trials. Attendees will hear learnings from Eurofins-Viracor’s experience supporting the Moderna Phase 3 COVID-19 vaccine trial and the link between efficacy and validation performance.

A case study is presented to link acceptable RT-qPCR validation performance with the efficacy of the Moderna Phase 3 COVID-19 vaccine.

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.

Register for this webinar to learn the opportunities and challenges of developing and validating qPCR assays in vaccine and therapeutic trials.

Join Mark Wissel, PhD, Director of Research & Development, Eurofins Viracor Biopharma, for the live webinar on Thursday, December 8, 2022, at 1pm EST (10am PST).

For more information, or to register for this event, visit Opportunities and Challenges of Developing and Validating qPCR Assays in Pivotal Vaccine Trials and Beyond.

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Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: vkovacevic@xtalks.com

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Vera Kovacevic
Xtalks
+1 (416) 977-6555 x371
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