18th GCC Closed Forum For Bioanalysis
8am to 5pm, April 11, 2025
Hilton New Orleans Riverside
| 07:00am-08:00am: | Breakfast and Registration: |
| 08:00am-08:15am: | Opening Remarks, Admonition Statement, and Participants’ introduction - Sankeetha Nadarajah: |
| 08:15am-09:15am: | Topic 01: “HOT TOPIC: How can CRO assure to sponsors a full compliance to the 2025 US FDA Guidance BMV for Biomarkers?” – Topic Leaders: Moucun Yuan, Amy Lavelle |
| 09:15am-09:45am: | Topic 02: “Emerging Technologies in CRO: Continuing GCC discussions & harmonization on CRO implementation of: Spectral Cytometry, NGS, O-link, NULISA, HRMS, Immunogenicity assessment using Flow Cytometry” – Topic Leaders: Shashank Gorityala, Virginia Litwin, Amy Lavelle |
| 09:45am-10:15am: | Morning Coffee and Refreshment Break: |
| 10:15am-11:15am: | Topic 03: “Sample Reconciliation Efforts: Current gaps in CRO, how to improve them and need for a GCC Harmonization White Paper” – Topic Leaders: Jennifer Zimmer, Amanda Leskovar, Steve Lowes |
| 11:15am-11:45am: | Topic 04: “Consideration of Chicken Anti-Human IgG Antibody (IgY): Unique properties of IgY as a generic LBA critical reagents tool for total IgG concentrations to evaluate PK/TK of candidate mAb therapeutics in pre-clinical species” – Topic Leaders: Sanofar J. Abdeen |
| 11:45am-12:15pm: | Topic 05: “Post-extraction Sample Stability Assessments: Recent FDA inspection experience and a proposal for an alternate approach” – Topic Leaders: Steve Lowes, Shane Karnik, Kelly Dong |
| 12:15pm-01:15pm: | Buffet Lunch: |
| 01:15pm-02:15pm: | Topic 06: “Singlicate for LBA in CRO: What’s new?” – Topic Leaders: Kyla O'Brien, Annika Carlsson, Richard Hughes |
| 02:15pm-02:45pm: | Topic 07: “Follow-up on Discrepancies of ELISpot data among CROs: How can we fix the issues?” – Topic Leaders: Magdalena Tary-Lehmann, Matthias Gutekunst |
| 02:45pm-03:15pm: | Topic 08: “Sharing Regulatory Inspection experiences from the previous year with each other” – Topic Leaders: Amanda Leskovar |
| 03:15pm-03:45pm: | Afternoon Break and Wine/Beer/Cocktail: |
| 03:45pm-04:45pm: | Topic 09: “Cross-validation Harmonization in Regulated Bioanalysis & GCC Recommendations: Finalizing the 2023 & 2024 GCC discussion in a White Paper” – Topic Leaders: Steve Lowes, Jo Goodman, Aihua Liu |
| 04:45pm-05:30pm: | Topic 10: “ELN/LIMS homegrown vs commercial: CROs at a crossroad” – Topic Leaders: Xiaonan Tang, Erik Jerks, Dave Masters-Moore |
| 05:30pm: | Meeting Adjourn: |