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 – Sumit Kar
08:10am-09:00am: "Internal Standard Variability - Does it has value as a measure of batch performance?" – Topic Leaders: Jennifer Zimmer and Shane Karnik
09:00am-09:50am: "Recommendations on practical considerations of Flow Cytometry Validation" – Topic Leaders: Shabnam Tangri and Naveen Dakappagari
09:50am-10:20am: Morning Coffee and Refreshment Break
10:20am-11:10am: "What's the status of the ICH M10 implementation after a year from its issuing?" – Topic Leaders: Beth Hyer and Mark O'Dell
11:10am-12:00pm: "Recommendations for Validation of NGS assays" – Topic Leader: David Willoughby
12:00pm-01:00pm: Buffet Lunch at International North and at Poolside
01:00pm-01:50pm: "Biomarker Assay for Tissue: Matrix, Long term stability (LTS) and Assay Validation" – Topic Leader: Moucun Yuan
01:50pm-02:40pm: "Does ddPCR validation requires independent recommendation from qPCR?" – Topic Leaders: Amanda Hayes, Amy Lavelle, and Manisha Diaz
02:40am-03:30pm: "Current Disagreements in Immunogenicity Harmonization" – Topic Leader: Todd Lester
03:30pm-04:00pm: Afternoon Break and Wine/Beer/Cocktail
04:00pm-04:50pm: "Changes to Bioanalytical industry – staffing, supply chain, capacity / lead time and costs" – Topic Leader: Eric Thomas
04:50pm-05:00pm: "GCC Membership & Emerging Technologies in Bioanalysis" – Topic Leaders: Eric Thomas and Stephanie Cape
05:00pm: Meeting Adjourn