Recommendations on Biomarker Bioanalytical Method Validation By Gcc

Hougton, Richard; Gouty, Dominique; Allinson, John; Green, Rachel; Losauro, Mike; Lowes, Steve; LeLacheur, Richard; Garofolo, Fabio; Couerbe, Philippe; Bronner, Stéphane; Struwe, Petra; Schiebl, Christine; Sangster, Timothy; Pattison, Colin; Islam, Rafiq; Garofolo, Wei; Pawula, Maria; Buonarati, Mike; Hayes, Roger N.; Cameron, Mark J.; Nicholson, Robert Ian; Harman, Jake; Wieling, Jaap; Boer, Theo de; Reuschel, Scott; Cojocaru, Laura; Harter, Tammy; Malone, Michele; Nowatzke, William

doi:10.4155/bio.12.197

Cited by 57 publications

(37 citation statements)

References 12 publications

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“…CLSI guidelines are generally more rigorous than BAV and are required only for in vitro diagnostic devices (IVDs) and for companion diagnostics (CDx) in a commercial diagnostic laboratory setting. Existing literature outlining the FFP validation requirements [51,54] should be used for exploratory biomarkers in drug development, and layers of validation from CLSI documents may be added as appropriate to the COU. It is a continuum.…”

Section: Challenges and Cutting-edge Solutions In Biomarker Assays For mentioning

confidence: 99%

2017 White Paper on Recent Issues in Bioanalysis: A Global Perspective on Immunogenicity Guidelines & Biomarker Assay Performance (Part 3 – Lba: Immunogenicity, Biomarkers and PK Assays)

et al. 2017

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The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3–7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule analysis involving LC–MS, hybrid ligand-binding assay (LBA)/LC–MS and LBA approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large-molecule bioanalysis, biomarkers and immunogenicity using LBA. Part 1 (LC–MS for small molecules, peptides and small molecule biomarkers) and Part 2 (hybrid LBA/LC–MS for biotherapeutics and regulatory agencies’ inputs) are published in volume 9 of Bioanalysis, issues 22 and 23 (2017), respectively.

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Section: Challenges and Cutting-edge Solutions In Biomarker Assays For mentioning

confidence: 99%

2017 White Paper on Recent Issues in Bioanalysis: A Global Perspective on Immunogenicity Guidelines & Biomarker Assay Performance (Part 3 – Lba: Immunogenicity, Biomarkers and PK Assays)

et al. 2017

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“…The draft FDA BMV guideline [17] references biomarkers; however, this document is undergoing additional changes prior to finalization and care should be taken when applying recommendations to industry processes. Based upon a prior GCC Closed Forum in 2012, some recommendations regarding the validation of biomarkers were made [27]. However, considering the extensive dialogue around biomarker bioanalysis that has happened since, it was decided to revisit those recommendations with the GCC membership; an extensive survey of 35 q uestions was sent.…”

Section: Biomarker Assay Validationmentioning

confidence: 99%

“…Attendees of these Closed Forum meetings discuss several interesting subjects related to bioanalytical CROs. In order to advance industry thinking on the topics discussed, conference reports [2][3][4][5][6][7] and white papers [8][9][10][11][12][13] are available summarizing the opinions and unique challenges CROs face as well as recommendations for several approaches to a wide range of topics across the c ommunity.…”

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confidence: 99%

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

Cape¹,

Islam²,

Nehls³

et al. 2017

Bioanalysis

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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.

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“…As plenary keynote presenter, John Allinson, presenting on behalf of the EBF, gave a comprehensive review of past and present publications relating to BM assay validation and compared and contrasted those used in drug development with those used in the clinical diagnostic arena. From a drug development perspective, he also included comparison of publications from regulators and other papers [1,6,7]. The major focus was:…”

Section: A Developing Regulated Environment For Bm Assay Validationmentioning

confidence: 99%

Feedback from The EBF – Focus Workshop: Bringing Assay Validation and Analysis of Biomarkers Into Practice

et al. 2017

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European Bioanalysis Forum Focus Workshop, Lisbon, Portugal, 9–10 June 2016 At the recent European Bioanalysis Forum's Focus Workshop ‘Bringing Assay Validation and Analysis of Biomarkers into Practice’, the discussion on best practice for biomarker assay validation continued. Both the presentations and the adjacent panel discussions yielded valuable food for thought for the broader bioanalytical community. The present conference report summarizes the essence from these discussions and from the proposals or conclusions made by all delegates on how to increase the necessary connectivity of the stakeholders involved in the bioanalysis of biomarkers.

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Recommendations on Biomarker Bioanalytical Method Validation By Gcc

Abstract: The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendations on biomarker bioanalytical method validation.

Cited by 57 publications

References 12 publications

2017 White Paper on Recent Issues in Bioanalysis: A Global Perspective on Immunogenicity Guidelines & Biomarker Assay Performance (Part 3 – Lba: Immunogenicity, Biomarkers and PK Assays)

2017 White Paper on Recent Issues in Bioanalysis: A Global Perspective on Immunogenicity Guidelines & Biomarker Assay Performance (Part 3 – Lba: Immunogenicity, Biomarkers and PK Assays)

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

Feedback from The EBF – Focus Workshop: Bringing Assay Validation and Analysis of Biomarkers Into Practice

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