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-08:10am: | Opening Remarks, Admonition Statement, and Participants' introduction – Sankeetha Nadarajah |
| 08:10am-09:00am: | “Integrative Bioanalysis: Best strategy to handle multiple platforms in the same lab (Triple Quad, HRMS, Hybrid Assays (IA-MS), LBA, others) to answer complex bioanalytical questions” – Topic Leaders: Dawn Dufield, Aihua Liu, Shashank Gorityala |
| 09:00am-09:30am: | “Patient Centric Sampling for Clinical Trial vs Venipuncture and direct impact on CROs” – Topic Leader: Jérôme Bergeron, Steve Lowes, John Pirro |
| 09:30am-10:00am: | Morning Coffee and Refreshment Break |
| 10:00am-11:00am: | “Implementation of Emerging Technologies (ET) in CRO to meet Sponsors expectations: High Dimensional Flow Cytometry, NGS, O-link, Others”– Topic Leaders: Mark O'Dell, Tao Xu, Nathan Riccitelli, Varun Dwivedi |
| 11:00am-11:30am: | “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies: The new FDA Draft Guidance and impact on CRO”– Topic Leader: Steve Lowes |
| 11:30am-12:00pm: | “Sample Reconciliation Efforts Current gaps in CRO and how to improve them and need for a GCC Harmonization White Paper” – Topic Leaders: Jennifer Zimmer, Katie Matys |
| 12:00pm-01:00pm: | Buffet Lunch |
| 01:00pm-01:45pm: | “Discrepancies of ELISpot data among CROs: How can we fix the issues?” – Topic Leaders: Magdalena Tary-Lehmann, Travis Harrison, Annelies Turksma, Manisha, Travis |
| 01:45pm-02:45pm: | “Need for Cross-validation Harmonization & GCC Recommendations: Status of Cross-Validation for PK assays (ICH M10) & Agreement/disagreement on Pharma proposals for Cross-validation for ADA/NAb Assays” – Topic Leaders: Tao Xu, Derrick Jonson, Mark O'Dell, Daniel Sikkema |
| 02:45pm-03:15pm: | “Use of Ultrasensitive Platforms for Immunogenicity Assays and impact on Drug Tolerance: CRO Perspective and Regulatory Requirements” – Topic Leader: Daniel Sikkema |
| 03:15pm-03:45pm: | Afternoon Break and Wine/Beer/Cocktail |
| 03:45pm-04:15pm: | “Remote Regulatory Assessment (RRA): CRO Preparation and Inspection strategy – GCC Recommendations” – Topic Leader: Katherine Malone |
| 04:15pm-04:45pm: | “qPCR/ddPCR Shedding Assays: Issues in data interpretation, gaps in reporting, compliance to regulatory requirements” – Topic Leaders: Amanda Hays, Tracy Iles |
| 04:45pm-05:30pm: | “Next step of the White Paper: Biomarker Assay for Tissue on Matrix, Long Term Stability (LTS) and Assay Validation - GCC Recommendations - Initiative Started at 2023 GCC and outline of the paper has already been drafted” – Topic Leaders: Moucun Yuan, Aihua Liu |
| 05:30pm: | Meeting Adjourn |