The 10th GCC Closed Forum: Rejected Data, GCP in Bioanalysis, Extract Stability, BAV, Processed Batch Acceptance, Matrix Stability, Critical Reagents, Eln and Data Integrity and Counteracting Fraud

Abstract

The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO–Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report.

2018 White Paper on Recent Issues in Bioanalysis: ‘A Global Bioanalytical Community Perspective on Last Decade of Incurred Samples Reanalysis (ISR)’ (Part 1 – Small Molecule Regulated Bioanalysis, Small Molecule Biomarkers, Peptides & Oligonucleotide Bioanalysis)

“…Thus, development of prescribed guidance for bioanalysis of biomarkers presents a great challenge, and the pace has been understandably slow. In the interim, several articles and White Papers have been published to attempt to fill the gap [12,13,[15][16][17][18][35][36][37]. In 2017, the Biomarker Assay Collaborative Evidentiary Considerations Writing Group, which includes contributing authors from US FDA, published what is known as the C-Path White Paper [23].…”

11th GCC Closed Forum: Cumulative Stability; Matrix Stability; Immunogenicity assays; Laboratory Manuals; Biosimilars; Chiral methods; Hybrid LBA/LCMS Assays; Fit-for-Purpose Validation; China Food and Drug Administration Bioanalytical Method Validation

“…Attendees informed the GCC membership that deficiencies were also being received requesting that the whole blood stability be tested in this way. Discussions concerning bioanalytical laboratories' reactions to this Notice began at the 10th GCC Closed Forum [8], occurred as part of the 2016 and 2017 Workshop on Recent Issues in Bioanalysis [19,20] and continued at this Forum. A survey released to CRO and Pharma participants indicated that, prior to this Notice, 70% of respondents exposed a single tube to stability conditions and then assayed at least three replicates from this tube.…”

Recommendations for the Content and Management of Certificates of Analysis for Reference Standards from the GCC for Bioanalysis

“…The GCC was created in 2010 as an independent global consortium bringing together many CRO leaders to discuss various topics and challenges on scientific and regulatory issues related to bioanalysis [1]. Since its formation, GCC has held regular meetings and published conference reports to share discussions and opinions [2][3][4][5][6][7][8][9][10]. White Papers on specific topics of widespread interest in bioanalysis have also been published to provide unified GCC recommendations helpful to the Global Bioanalytical Community [11][12][13][14][15][16][17][18].…”