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 |