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 |