Shane Karnik, Jennifer Zimmer, Matthias Gutekunst, Shashank Gorityala, Jo Goodman, Erik Jerks, Virginia Litwin, Xiaonan Tang, Amanda Leskovar, Magdalena Tary‐Lehmann, Stephen Lowes, Amy Lavelle, Moucun Yuan, Aihua Liu, Kyla O’Brien, Kelly Dong, Kurt Sales, Scott Reuschel, Anahita Keyhani, Derrick Johnson, Mark Odell, Sanofar Abdeen, Amanda Hays, Dave Beyerlein, Michael Johnson, Mathilde Yu, Sophie Cotton, Philip Joyce, Wendy W. T. Fang, Wei Garofolo, Sankeetha Nadarajah, Adriane Spytko, Dawn Dufield, Lindsay Rutherford, Todd Pankratz, Allan Xu, Daniel Sikkema, Elizabeth Hyer, Tracy Iles, Eric Bonner, Chantal DiMarco, Georgios Hristopoulos, Kate Patterson, Brad Nash, Vera Bretton, Agostinho Rocha, Christina Satterwhite, Jim Yamashita, Jim McNally, Xinping Fang, Leimin Fan
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.