19th GCC Closed Forum For Bioanalysis
8am to 5pm, April 17, 2026
Hyatt Regency Dallas
| 07:00am-08:00am: | Breakfast and Registration: |
| 08:00am-08:15am: | Opening Remarks, Admonition Statement, and Participants’ Introduction – GCC Facilitator & Notetaker: Jessica McGregor: |
| 08:15am-09:20am: | Topic 01: “GCC White Paper Drafting: Sample Reconciliation: Finalizing Draft1 of a CRO-focused White Paper based on 2024 & 2025 surveys, discussions and recommendations” – Topic Leaders: Jennifer Zimmer, Amanda Leskovar, Katherine Yahvah, Steve Lowes |
| 09:20am-09:50am: | Morning Coffee and Refreshment Break: |
| 09:50am-10:20am: | Topic 02: “Use of AI/ML in CRO: Are CRO using AI/ML & Data-Driven Approaches and in which field?” – Topic Leaders: Annika Carlsson, Todd Lester |
| 10:20am-11:20am: | Topic 03: “Mass Spec vs LBA for Large Molecules – Is there a CRO consensus on when to use one or the other?” – Topic Leaders: Dawn Dufield, Aihua Liu, Liz Nolff, Rathna Veeramachaneni, Shane Karnik, Shashank Gorityala |
| 11:20am-11:50am: | Topic 04: “Beyond ICH M10 – What next? How flexible are the Regulators during audits vs ICH M10?” – Topic Leaders: Aihua Liu, Adriane Spytko, Amy Lavelle, Megan Cooley, Philip Joyce, Steve Lowes |
| 11:50am-12:50pm: | Buffet Lunch: |
| 12:50pm-01:20pm: | Topic 05: “Have CRO implemented their SOPs for the use of S/N in Immunogenicity? When can S/N Complement/Replace Titers?” – Topic Leaders: Jo Goodman, Cheikh Kan, Kate Patterson, Liz Nolff, Todd Lester |
| 01:20pm-02:20pm: | Topic 06: “COU Limitations in Biomarker Assay Validation (BAV): What are the CRO current best practices for Biomarkers Method Development and BAV?” – Topic Leaders: Aihua Liu, Agostinho Rocha, Amanda Leskovar, Jingwen Tan, Jo Goodman |
| 02:20pm-02:50pm: | Topic 07: “SaaS / Cloud Based Software in Regulated Bioanalytical Operations” – Topic Leaders: Steve Lowes, Adriane Spytko |
| 02:50pm-03:20pm: | Afternoon Break and Wine/Beer/Cocktail: |
| 03:20pm-04:20pm: | Topic 08: “An update on the use of HRMS in CRO in Regulated Bioanalysis: How well-established is HRMS in CRO?” – Topic Leaders: Adriane Spytko, Aihua Liu, Mike Buonarati, Philip Joyce, Rathna Veeramachaneni, Shane Karnik, Shashank Gorityala, Steve Lowes, Troy Voelker |
| 04:20pm-05:00pm: | Topic 09: “Does CRO still have issues being in compliance with 2025 US FDA Guidance BMV for Biomarkers? – A follow-up from 2025 discussions” – Topic Leaders: Moucun Yuan, Adriane Spytko, Aihua Liu, Amy Lavelle, Philip Joyce, Steve Lowes |
| 05:00pm: | Meeting Adjourn: |