16th GCC Closed Forum For Bioanalysis

8am to 5pm, June 23, 2023

Hilton Orlando Lake Buena Vista

07:00am-08:00am: Breakfast and Registration
08:00am-08:10am: Opening Remarks, Admonition Statement, and Participants’ introduction – Natasha Savoie
08:10am-08:50am: “Implementation of ICH M10 - Chromatographic Assays” – Topic Leaders: Jennifer Zimmer, Shane Karnik, Orlando Bravo
08:50am-09:20am: “Implementation of ICH M10 - Ligand Binding Assays” – Topic Leaders: Kelly Colletti, Todd Lester
09:20am-09:50am: “Practical implementation of Surrogate Matrices in preclinical PK and ADA assays”– Topic Leaders: Eric Tewalt, Moucun Yuan
09:50am-10:20am: Morning Coffee and Refreshment Break
10:20am-11:20am: “Endogenous Compounds Validation for PK Assays (ICH M10 BMV) and Biomarkers Assays (BAV) - Proposal to update the 2012 GCC White Paper on BAV – Topic Leaders: Jim.Yamashita, Jing Shi
11:20am-12:00pm: “Implementation of ICH M10 - Harmonization on Critical Reagent Management and Proposal for a GCC White Paper on Critical Reagent Management – Topic Leader: Chris Beaver
12:00pm-12:30pm: “Patient Centric Sampling & Microsampling implementation at CRO” – Topic Leader: Steve Lowes
12:30pm-01:30pm: Buffet Lunch at Pavillion Courtyard
01:00pm-01:30pm: “Immunogenicity - Minimum Significant Ratio (MSR) for immunogenicity titration assays” – Topic Leaders: Mike Brown, Robert Kernstock
01:30am-02:00pm: “Immunogenicity - ADA Cross Validation & Method Transfer” – Topic Leader: Jason Wang, Hong Chen
02:00pm-03:00pm: “qPCR/ddPCR Development/Validation Harmonization (Step 2 white paper) - Proposal of a step 2 GCC White Paper for expanding the Recommendations in more details – Topic Leaders: Mark Wissel, Martin Poirier, Rafiq Islam
03:00pm-03:30pm: Wine and Cheese, and Ice Cream Break
03:30pm-04:00pm: “Sample management & Clinical trial data transfers” – Topic Leaders: Heather Coales, Edward Tabler
04:00pm-04:30pm: “Implementation of ICH M10 - Harmonization on Cross Validation” – Topic Leader: Rob Wheller
04:30pm: Meeting Adjourn