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.

Closed Forums. These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified bioanalytical recommendations specifically in relation with the new EMA guideline.The Global CRO Council for Bioanalysis (GCC) [101] is a global independent group of many Contract Research Organization (CRO) leaders. The GCC was formed in September 2010 to meet regularly and discuss bioanalytical issues and regulatory challenges, many of them unique to the outsourcing industry. The outcome of the discussions held as part of these GCC closed forum meetings are shared with the global bioanalytical community via pertinent publications [2][3][4][5][6] and appropriate conference presentations.Prior to the issue of this new guideline, the November 2009 Draft EMA Guideline on BMV defined the proposed guideline and criteria of the EMA on validation of bioanalytical methods and their application in the analysis of study samples from animal and human studies [7].The EMA Guideline states that the validation of the bioanalytical methods to be used on non-clinical pharmacotoxicological studies to be submitted in a marketing authorization application should be performed following the Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC) "These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified bioanalytical recommendations specifically in relation with the new EMA guideline.

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.

Each year, the Workshop on Recent Issues in Bioanalysis (WRIB) gathers a wide range of industry opinion leaders and regulatory authorities working on bioanalysis, biomarkers and immunogenicity to discuss the most current topics of interest, and to provide potential solutions aiming to improve quality, increase regulatory compliance and achieve scientific excellence.These yearly 'hot' topics (covering both small and large molecules), are the starting point for fruitful exchanges of knowledge, and extensive sharing of ideas among presenters, regulators and attendees, and are distilled into a series of relevant recommendations. The resultant White Papers summarizing these conclusions and consensus points from each WRIB provide the global bioanalytical community with key information and practical solutions on topics and issues addressed each year. This series of White Papers has always been among the 'most read' articles in Bioanalysis over the past 10 years [17].WRIB White Papers are designed to be 'horizontal' documents providing consensus on multiple topics rather than 'vertical' (i.e., 'consensus documents on a single topic for standardizing industry practice'). It is a cumulative effort spanning more than a year, with tremendous work behind the scenes by each co-author, starting from exhaustive preparation/design of each issue long before the WRIB, then extensive working-dinner discussions to prepare open panel discussions at the WRIB, and finally the refinement and critical review of the draft recommendations before turning it into a consensus paper.In recent years, to reflect the new structure of three sequential, core workshop days at WRIB, each White Paper has been divided into three parts to reflect the focus of each core workshop day: Part 1 on LCMS, Part 2 on hybrid ligand-binding assays (LBA)/LCMS and Regulatory Inputs and Part 3 on LBA.Although the recommendations presented in this article demonstrate that some topics have been extensively discussed repeatedly in the last decade, the evolution of bioanalysis, biomarkers and immunogenicity, and the accompanying technologies and regulations continue to bring additional challenges and solutions to existing problems. Continued assembly of industry and regulators will ensure that best practices continue in order to market safe and effective pharmaceutical products. The future publication of the 2017 White Paper in Bioanalysis signals the global bioanalytical community's intent to continue providing a consensus document for such discussions.After a decade of discussions and consensus, this article acts as a general index, organized by topic in alphabetic order, to easily consult all these recommendations and their evolution over time.

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