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From Bench to Bedside: Bioanalysis and Translational Science
Hot Topic

Hot Topic: Panel Discussion on Neutralizing Antibody Sample Testing and Report Harmonization

Monday, May 5, 2025
3:00 PM - 4:00 PM ET
Location:Otis

Bench to Bedside Hot Topic

This presentation will benefit scientists at all levels and career tracks from students, industry, or government entities that require bioanalysis or interpretations of data from bioanalysis of neutralizing antibodies.

This presentation will summarize the findings and conclusions for developing the cross-industry harmonized NAb assay reporting recommendations and provided a bioanalytical report (BAR) submission editable template developed to facilitate agency filings.

Learning Objectives:

  • Upon completion of the presentation, participants will understand what neutralizing antibodies (Nabs) are and how they are developed during an immune responses.
  • Upon completion of the presentation, participants will understand how Nabs decrease treatment efficacy and the challenges and parameters required to measure them in bioanalytical assays.
  • Upon completion, participants will understand what cross-industry data were compiled to generate the harmonized recommendations for the bioanalytical report (BAR) submission with an editable template developed to facilitate agency filings.