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1.
Bioanalysis ; 11(23): 2099-2132, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31833782

RESUMO

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA on 1-5 April 2019 with an attendance of over 1000 representatives 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, immunogenicity and gene therapy. 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 bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 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 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on the 2018 FDA BMV guidance, 2019 ICH M10 BMV draft guideline and regulatory agencies' input on bioanalysis, biomarkers, immunogenicity and gene therapy. Part 1 (Innovation in small molecules and oligonucleotides and mass spectrometry method development strategies for large molecules bioanalysis) and Part 3 (New insights in biomarker assay validation, current and effective strategies for critical reagent management, flow cytometry validation in drug discovery and development and CLSI H62, interpretation of the 2019 FDA immunogenicity guidance and gene therapy bioanalytical challenges) are published in volume 10 of Bioanalysis, issues 22 and 24 (2019), respectively.


Assuntos
Bioensaio/normas , Biomarcadores/análise , Guias como Assunto , Fenômenos Imunogenéticos , Relatório de Pesquisa , United States Food and Drug Administration/legislação & jurisprudência , Humanos , Estados Unidos
2.
Bioanalysis ; 11(18s): 1-228, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31565956

RESUMO

The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.


Assuntos
Biomarcadores/análise , Guias como Assunto , Humanos , Reprodutibilidade dos Testes , Projetos de Pesquisa
4.
Bioanalysis ; 11(12): 1129-1138, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31319683

RESUMO

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.


Assuntos
Certificação , Técnicas de Química Analítica , Citometria de Fluxo , Espectrometria de Massas , Oligonucleotídeos/análise , Controle Social Formal , Sociedades Científicas , Indicadores e Reagentes/química
5.
Bioanalysis ; 11(7): 645-653, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30993999

RESUMO

Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy. As the regulatory agencies are routinely making decisions based on biomarker data, there has been significant scrutiny on the validation of biomarker methods. Contract research organizations regularly use commercially available immunoassay kits to validate biomarker methods. However, adaptation of such kits in a regulated environment presents significant challenges and was one of the key topics discussed during the 12th Global Contract Research Organization Council for Bioanalysis (GCC) meeting. This White Paper reports the GCC members' opinion on the challenges facing the industry and the GCC recommendations on the classification of commercial kits that can be a win-win for commercial kit vendors and end users.


Assuntos
Bioensaio/métodos , Biomarcadores/análise , Bioensaio/normas , Descoberta de Drogas , Humanos , Ligantes , Preparações Farmacêuticas/química , Preparações Farmacêuticas/metabolismo , Preparações Farmacêuticas/normas , Controle de Qualidade , Kit de Reagentes para Diagnóstico , Padrões de Referência , Sociedades Farmacêuticas , Inquéritos e Questionários
6.
Bioanalysis ; 9(7): 505-516, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28339299

RESUMO

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.


Assuntos
Biomarcadores/análise , Técnicas de Química Analítica/normas , Coleta de Dados/normas , Guias como Assunto , Preparações Farmacêuticas/análise , Estabilidade de Medicamentos , Regulamentação Governamental , Humanos , Relatório de Pesquisa
7.
Bioanalysis ; 8(22): 2363-2378, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27712081

RESUMO

The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including 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 LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 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. This white paper is published in 3 parts due to length. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LCMS. Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in the Bioanalysis journal, issue 23.

8.
Bioanalysis ; 6(18): 2385-90, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25384591

RESUMO

The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the seventh annual Workshop on Recent Issues in Bioanalysis (WRIB) held in Long Beach, CA, USA, in April 2013, and at the Global CRO Council for Bioanalysis (GCC) meeting preceding it. Discussion at both events focused on the use of incurred samples for ISS purposes in light of results from a recent GCC survey completed by member companies. This paper reports the consensus resulting from these discussions and serves as a useful reference for depicting ISS issues and concerns, summarizing the GCC survey results and providing helpful recommendations on ISS in the context of bioanalytical method development and application.


Assuntos
Testes de Química Clínica , Coleta de Dados , Reprodutibilidade dos Testes
10.
Bioanalysis ; 3(18): 2081-96, 2011 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-21942519

RESUMO

The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.


Assuntos
Preparações Farmacêuticas/análise , Calibragem , Cromatografia Líquida de Alta Pressão/métodos , Cromatografia Líquida de Alta Pressão/normas , Teste em Amostras de Sangue Seco/métodos , Teste em Amostras de Sangue Seco/normas , Indústria Farmacêutica , Regulamentação Governamental , Guias como Assunto , Humanos , Espectrometria de Massas/instrumentação , Espectrometria de Massas/métodos , Espectrometria de Massas/normas , Transferência de Tecnologia , Análise Serial de Tecidos/métodos , Análise Serial de Tecidos/normas , Estudos de Validação como Assunto
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