6th GCC Closed Forum for Bioanalysis (at the WRIB)

The 6th GCC Meeting for Bioanalysis at the WRIB was a whole day meeting taking place on March 27, 2012 in San Antonio, TX, USA.It was chaired by Bob Nicholson and attended by 46 CRO representatives representing 33 CRO members

Agenda of the Meeting:

Download the PDF Version


Breakfast and Registration


Opening Remarks, Admonition Statement, and Participants' introduction


" Updates on the Co-ad open letter "

– Chaired by Steve Lowes


" Bridging and qualification strategies for critical reagents, positive controls, and reference standards following lot changes "

– Chaired by Dan Mamelak and Afshin Safavi


Morning Refreshment Break


" Feedbacks on the GCC recommendations on EMA guideline "

– Chaired by Maria Caturla


" How are we demonstrating convincing specificity for endogenous analytes "

– Chaired by Rafiqul Islam

Access the Survey on Specificity for Endogenous Analytes




" Biomarker recommendation: Continuing the discussions on Assay qualification and validation: attaining clear definitions in relation to biomarker assays "

– Chaired by John Allinson

Access the Survery on Biomarker


" Acceptance criteria for LC-MS-based assay validation and sample analysis: should we follow large molecule or small molecule convention "

– Chaired by Bob Nicholson


Afternoon Wine and Cheese Break (of course also coffee and sweets)


New Regulatory Findings

– Open Discussions Chaired by Bob Nicholson


Bioanalytical approach for biosimilars

– Chaired by Masood Khan and Dominique Gouty

Access the Survey on Biosimilar


Be ready for the New FDA Draft Guidance – Preparing the next GCC Closed Forum at the Crystal City Meeting – Building sub teams based on topics

– Chaired by Bob Nicholson


GCC Financial Report

– Reported by Wei Garofolo

Due to the Welcome Reception of 6th WRIB from 5:30pm to 6:30pm on March 27, the traditional GCC Member Reception will be postponed to be held on Thursday March 29 at the Hotel Bar from 6pm to 9pm. Please drop by the hotel bar to continue the informal discussions and networking with other members.