AGENDA

September 30, 2022 - Hilton Atlanta

08:00am-08:20am: Opening Remarks, Admonition Statement, and Participants’ introduction – Natasha Savoie
08:20am-09:20am: “ELISpot Assay Validation - Recommendations from GCC (target White Paper)” – Session Leader: Rafiq Islam
09:20am-09:50am: “Is the Sciex 7500 the new standard for Bioanalytical CRO?” – Session Leader: Allan Xu
09:50am-10:20am: Short Break
10:20am-10:50am: “Bioanalytical Run Efficiency” – Session Leaders: Stephanie Cape, Mark O’Dell
10:50am-11:50am: “qPCR/ddPCR Assay Validation - Recommendations from GCC (target White Paper)” – Session Leader: Christina Satterwhite
11:50am-12:20pm: “Hybrid LBA/LCMS Methods - Bioanalytical Method Validation (BMV) Requirements” – Session Leaders: William Mylott, Moucun Yuan
12:20pm-01:00pm: Short Break
01:00pm-02:00pm: “Biomarkers Assay Validation (BAV) - BMV or CLIA?” – Session Leaders: Mark O'Dell, Eric Thomas, Mark Arnold
02:00pm-02:30pm: “Updating Documentation at CRO” – Session Leaders: Stephanie Cape, Steve Lowes
02:30pm-03:00pm: “Run Re-injection” – Session Leader: Shane Karnik
03:00pm-03:30pm: Short Break
03:30pm-04:00pm: “Singlicate” – Session Leader: Rafiq Islam
04:00pm-05:00pm: “Recent Findings/483s Cases” and “What would you do - Dilemma Cases” – Session Leaders: Jennifer Vance, Jennifer Vija; Speakers on Individual Topics: Edward Tabler, Roger Hayes, Hao Wang
05:40pm: Meeting Adjourn