18 th GCC Closed Forum: Compliance with FDA Biomarkers Guidance, Novel ELN/LIMS Platforms, Sample Reconciliation, Emerging Technologies, Improvements in ELISpot, Post-extraction Sample Stability, LBA Singlicate, Regulatory Inspections, Chicken anti-Human IgG, Cross-validation Harmonization

The 18th GCC Closed Forum was held in New Orleans, LA, USA, on 11 April 2025. Representatives from international bioanalytical Contract Research Organizations were in attendance to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: Compliance with US FDA Guidance for Biomarkers; Emerging Technologies; Sample Reconciliation Efforts; Chicken anti-Human IgG antibody; Post-extraction Sample Stability; Singlicate for LBA; Discrepancies of ELISpot data; Regulatory Inspection Experiences; Cross-validation Harmonization in Regulated Bioanalysis; and ELN/LIMS. Conclusions and consensus from discussions of these topics are included in this article.