RESUMEN
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.
Asunto(s)
Biomarcadores/análisis , Guías como Asunto , Humanos , Reproducibilidad de los Resultados , Proyectos de InvestigaciónRESUMEN
The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The second CRO-Pharma Scientific Interchange Meeting was held on 7 April 2017, which included Pharma representatives' sharing perspectives on the topics discussed earlier in the week with the CRO members. The issues discussed at the meetings included cumulative stability evaluations, matrix stability evaluations, the 2016 US FDA Immunogenicity Guidance and recent and unexpected FDA Form 483s on immunogenicity assays, the bioanalytical laboratory's role in writing PK sample collection instructions, biosimilars, CRO perspectives on the use of chiral versus achiral methods, hybrid LBA/LCMS assays, applications of fit-for-purpose validation and, at the Global CRO Council Closed Forum only, the status and trend of current regulated bioanalytical practice in China under CFDA's new BMV policy. Conclusions from discussions of these topics at both meetings are included in this report.
Asunto(s)
Bioensayo/métodos , Biomarcadores/análisis , Biosimilares Farmacéuticos/uso terapéutico , China , Humanos , Proyectos de InvestigaciónRESUMEN
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.
Asunto(s)
Biomarcadores/análisis , Técnicas de Química Analítica/normas , Recolección de Datos/normas , Guías como Asunto , Preparaciones Farmacéuticas/análisis , Estabilidad de Medicamentos , Regulación Gubernamental , Humanos , Informe de InvestigaciónRESUMEN
The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.
Asunto(s)
Biomarcadores/análisis , Biosimilares Farmacéuticos/análisis , Evaluación Preclínica de Medicamentos/métodos , Biomarcadores/sangre , Registros Electrónicos de Salud , Laboratorios , Sociedades Médicas , Estudios de Validación como AsuntoRESUMEN
The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation--The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.
Asunto(s)
Técnicas de Química Analítica/normas , Guías como Asunto , Estudios de Validación como Asunto , Biomarcadores/análisis , Calibración , Ligandos , Límite de Detección , Juego de Reactivos para Diagnóstico , Reproducibilidad de los Resultados , Estados Unidos , United States Food and Drug AdministrationRESUMEN
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.
Asunto(s)
Pruebas de Química Clínica , Recolección de Datos , Reproducibilidad de los ResultadosAsunto(s)
Biomarcadores/análisis , Biosimilares Farmacéuticos/análisis , Preparaciones Farmacéuticas/análisis , Biosimilares Farmacéuticos/farmacocinética , Biosimilares Farmacéuticos/normas , Cromatografía Líquida de Alta Presión/normas , Industria Farmacéutica , Espectrometría de Masas/normas , Preparaciones Farmacéuticas/normas , Control de Calidad , Estándares de ReferenciaRESUMEN
The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.
Asunto(s)
Técnicas de Química Analítica/normas , Guías como Asunto , Organizaciones sin Fines de Lucro/normas , United States Food and Drug Administration/normas , Métodos Analíticos de la Preparación de la Muestra , Calibración , Química Farmacéutica , Documentación , Combinación de Medicamentos , Estabilidad de Medicamentos , Europa (Continente) , Estándares de Referencia , Reproducibilidad de los Resultados , Estados UnidosRESUMEN
"The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry"