17th GCC Closed Forum For Bioanalysis

8am to 5pm, May 10, 2024

San Antonio River Walk (Marriott Rivercenter)

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: “Remote Records Assessment (RRA): CRO Preparation and Inspection strategy – GCC Recommendations” – Topic Leaders: Katherine Malone
09:30am-10:00am: Morning Coffee and Refreshment Break
10:00am-11:30am: “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
11:30am-12:00pm: “Sample Reconciliation Efforts Current gaps in CRO and how to improve them" – Topic Leader: Jennifer Zimmer, Katie Matys
12:00pm-01:00pm: Buffet Lunch
01:00pm-01:30pm: “Discrepancies of ELISpot data among CROs: How can we fix the issues?” – Topic Leader: Magdalena Tary-Lehmann
01:30pm-02:30pm: “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
02:30am-03:00pm: “Use of Ultrasensitive Platforms for Immunogenicity Assays and impact on Drug Tolerance: CRO Perspective and Regulatory Requirements” – Topic Leader: Daniel Sikkema
03:00pm-03:30pm: Afternoon Break and Wine/Beer/Cocktail
03:30pm-04:00pm: “Patient Centric Sampling for Clinical Trial vs Venipuncture and direct impact on CROs” – Topic Leader: Jérôme Bergeron
04:00pm-04:30pm: “qPCR/ddPCR Shedding Assays: Issues in data interpretation, gaps in reporting, compliance to regulatory requirements” – Topic Leaders: Amanda Hays, Tracy Iles
04:30pm-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