1. Implementation of ICH M10

• 1.1 Implementation of Chromatographic Assays - Topic Leaders: Jennifer Zimmer, Shane Karnik, Orlando Bravo

• 1.2 Implementation of Ligand Binding Assays - Topic Leaders: Kelly Colletti, Todd Lester

• 1.3 GCC Harmonization on Critical Reagent Management - Topic Leader: Chris Beaver

  • Action from GCC ICH M10 feedback paper “GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline” (Page 146) Link: https://www.future-science.com/doi/pdf/10.4155/bio-2019-0207

• 1.4 GCC Harmonization on Cross Validation - Topic Leaders: Rob Wheller

  • Mass Spec assays

  • LBA

• 1.5 Endogenous Compounds Validation - Topic Leader: Jing Shi

  • For PK Assay

  • For Biomarkers Assays (BAV)

  • CRO harmonization on Best Practices in Endogenous Compounds Validation

2. Immunogenicity - ADA Cross Validation & Method Transfer - Topic Leader: Jason Wang, Hong Chen

• What should be included in the validation, and what's the acceptance criteria?

• What parameters requires re-assess and what does not need (i.e. can use the validated data from other lab)?

3. qPCR/ddPCR Harmonization (Step 2) - Topic Leaders: Mark Wissel, Martin Poirier, Rafiq Islam

• The submitted GCC White Paper was only the first step towards a harmonization process of qPCR/ddPCR validation and now we need to define the details and leftover disagreements.

• Recommendations on qPCR/ddPCR AssayValidation by GCC (Step 1): https://www.future-science.com/doi/pdf/10.4155/bio-2022-0109

4. Patient Centric Sampling & Microsampling implementation at CRO - Topic Leader: Steve Lowes

• Practical uses of volumetric whole blood microsampling for Bioanalytical Studies by Mass Spec and LBA

5. Sample management & Clinical trial data transfers - Topic Leaders: Heather Coales, Edward Tabler

• CRO harmonization on increased in requests by sponsors to reconcile bioanalytical sample descriptors with the various clinical databases used throughout the clinical trial

• CRO Recommendations for bioanalytical data import / export agreements

6. Practical implementation of Surrogate Matrices in preclinical PK and ADA assays - Topic Leaders: Eric Tewalt, Moucun Yuan

• This topic is of particular interest for CROs due to matrix shortages

7. Immunogenicity - Minimum Significant Ratio (MSR) for immunogenicity titration assays - Topic Leader: Mike Brown, Robert Kernstock

• Developing a GCC survey on this approach recommended in the USP Chapter 1106 referenced by the US FDA in the Immunogenicity Guidance.

• Has MSR been adopted by CRO?

• Assessing the current status in the industry at the GCC meeting