SCIENTIFIC INSIGHTS

Learn practical approaches for designing, transferring and cross-validating bioanalytical assays across multiple laboratory sites in this 45-minute webinar and Q&A featuring scientific experts from BioAgilytix. 

Discover best practices for achieving inter-laboratory concordance while supporting reliable bioanalytical data and regulatory confidence throughout global clinical development.  

What will you learn?

As clinical programs become increasingly global, demonstrating consistent assay performance across multiple laboratory sites is essential for generating reliable bioanalytical data and supporting regulatory expectations. 

This webinar explores practical strategies for successful assay transfer and cross-validation, including approaches for aligning protocols, reagents, and instrumentation across participating laboratories. Our experts also discuss the use of reference standards, quality controls, and fit-for-purpose statistical methodologies, including bias assessment and equivalence testing, to evaluate inter-site performance and identify potential sources of variability. 

Whether supporting pharmacokinetic, immunogenicity, or biomarker assays, these strategies help sponsors reduce scientific risk while building confidence in multi-site bioanalytical programs.

Who may this interest?

• Bioanalytical Scientists

• Biomarker Scientists

• Immunogenicity Scientists

• Pharmacokinetic Scientists

• Clinical Development Teams

• Clinical Operations Professionals

• Translational Scientists

• Program Managers

• Regulatory Affairs Professionals

• Sponsors managing global or multi-site clinical studies 

• Lynn Kamen, PhD: Executive Director, Scientific Office, BioAgilytix
• Jessica Weaver, MRes: Associate Director, Scientific Office, BioAgilytix
• Pavan Prathipati, PhD: Manager II, BioAgilytix
• Bryan M. Gullick, PhD: Senior Director, Molecular Bioanalysis, BioAgilytix
• Michael Mullen: Scientist I, BioAgilytix
• Todd Lester: Senior Director, BioAgilytix

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