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

Life Sciences, Clinical Trials, Drug Discovery & Development, Laboratory Technology,
  • Thursday, December 08, 2022

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.

Speaker

http://Mark%20Wissel,%20Eurofins%20Viracor%20Biopharma

Mark Wissel, PhD, Director of Research & Development, Eurofins Viracor Biopharma

Mark Wissel is the Director of Research and Development at Eurofins Viracor BioPharma Services, where he is responsible for oversight of assay development and validation and scientific affairs. He led a restructure to improve quality and capacity as well as scientists’ career advancement opportunities. Prior to his current role, Dr. Wissel led assay development projects, two of which led to clinical evaluations in high impact factor journal publications while supporting business development and client education.

Dr. Wissel earned a PhD degree in microbiology from the University of Iowa and is a frequent speaker at national and international conferences typically related to biologics clinical trials testing. He has a strong interest in statistics.

Message Presenter

Who Should Attend?

  • Scientists and other technical professionals working in the development of antiviral therapeutics
  • Program/project leads with pharmaceutical and biotech companies developing therapies or vaccines for infectious disease

What You Will Learn

Join this webinar for a:

  • Review of procedures and challenges with developing and validating qPCR assays
  • Discussion of the need for harmonization of qPCR assay validation characteristics for supporting therapeutic trial applications
  • Review and recommendations of best practices and strategies for optimizing qPCR assays in vaccine and other therapeutic trials
  • Learnings from Eurofins-Viracor’s experience supporting the Moderna Phase 3 COVID-19 vaccine trial and the link between efficacy and validation performance

Xtalks Partner

Eurofins Viracor Biopharma

Truly innovative therapeutics are built on advanced science, disruptive technology, and reliable partnerships. From vaccines to cell and gene therapies, Eurofins Viracor BioPharma is a unique development partner with proven expertise across a broad array of industry-leading analytical technologies, providing integrated testing solutions to help advance your pioneering treatments to patients faster.

We are a team of highly experienced scientists and professionals, providing complex testing and assay development for clinical research. We offer broad experience in molecular infectious disease and immunogenicity testing, along with immune response monitoring, vaccine safety/efficacy assessment, and disease-associated biomarker testing.

Everyday our team works collaboratively with our sponsor partners to solve some of the toughest bioassay challenges, leveraging the unique combination of state-of-the-art technology, and specialized expertise, that drug development companies have come to rely on for their clinical study needs.

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