Eurofins Viracor Biopharma presented a webinar on Thursday, December 8th, 2022 | Time: 11am EST titled "Opportunities and Challenges of Developing and Validating qPCR Assays in Pivotal Vaccine Trials and Beyond", presented by Mark Wissel, PhD, Director of Research and Development, Eurofins Viracor BioPharma.
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.
About our presenter:
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.