Recent Regulatory findings/483s for Mass Spec and LBA - A tradition and a must discussion at each GCC

Topic Leaders: Jenifer Vija

ELISpot Assay Validation - Recommendations from GCC (target White Paper) - Starting the discussion within CROs, getting consensus on CRO best & simpler/faster practices with an aim to have this become a white paper

Topic Leaders: Rafiq Islam

Is the Sciex 7500 the new standard for Bioanalytical CRO? - An unbiased evaluation on sensitivity vs. 6500 and other brands of Mass Spec

Topic Leaders: Allan Xu

Bioanalytical Run Efficiency - What is necessary from a compliance standpoint and how to be more efficient in how CRO work (Including: How many blanks, duplicate curves, treating two plates as separate batches or applying the M10 approach, etc.)

Topic Leaders: Stephanie Cape, Mark O'Dell

qPCR/ddPCR Assay Validation - Recommendations from GCC (target White Paper) - Starting the discussion within CROs, getting consensus on CRO best & simpler/faster practices with an aim to have this become a white paper

Topic Leaders: Christina Satterwhite

Hybrid LBA/LCMS Methods - Bioanalytical Method Validation (BMV) Requirements

Topic Leaders: William Mylott, Moucun Yuan

Biomarkers Assay Validation (BAV) - BMV or CLIA? - When Clinical Biomarker Assay should be performed in a certified clinical lab or bioanalytical labs

Topic Leaders: Eric Thomas, Mark O'Dell, Mark Arnold

Updating Documentation at CRO - CRO ability to accommodate recent regulatory recommendations in light of new guidance inclusions of more documentation requirements (e.g.: MD reports, eCTD, ICH M10 requirements)

Topic Leader: Stephanie Cape, Steve Lowes

Run Re-injection - When is it acceptable and unacceptable to re-inject a run?

Topic Leaders: Shane Karnik

Singlicate - As GCC, are we comfortable to adopt singlicate approach for LBA-based assay at least for some platforms where CV% between two duplicates are generally low (e.g. ADA using MSD platform and other reproducible PK assays)?

Topic Leaders: Rafiq Islam

"What would you do?" - Present case studies where you have faced dilemma's, approaches being used and advice and feedbacks from other CRO members

Topic Leader: Jennifer Vance