The Decennial Index of The White Papers in Bioanalysis:  ‘A Decade of Recommendations (2007–2016)’

Abstract

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.

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( Part 2 – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

“…Discussions between regulators and industry on testing matrix stability with co-administered compounds (coformulated or specific drug regimens) started in 2010, and until 2014, no cases of stability issues were reported in the literature [29]. Until the 2018 FDA BMV guidance, regulatory expectations have been conveyed via regulatory inspections and questions arising during submission review.…”

“…Original and re-integrated chromatograms with results are now required in reports for BE studies. Regarding manual integrations, it has been reiterated many times that this approach is not recommended [29]. However, in cases where manual integrations are justified, the same approach should be applied consistently across the study.…”

“…The number of replicates per factor was selected to mimic the A&P evaluation. An excerpt from the Decennial Index [29] suitably highlights the efforts for a single harmonized BMV guideline: "One of the major impacts WRIB has had in the field of bioanalysis has been the effort to globally harmonize bioanalytical method validation and sample analysis. In 2010, the consensus was reached that global harmonization of bioanalytical guidance is an important and necessary step in facilitating global submissions of studies supporting the release of new drugs.…”

“…While single-well analysis has been widely established as the standard in clinical diagnostic and LCMS laboratories, this practice has not been routinely adopted by the regulated bioanalytical community for LBAs. Over the years, regulators have been willing to consider the application of a single-well analysis approach in LBA method validation and sample analysis [5,9,15,29], but the burden of proof lies with pharmaceutical companies and CROs to demonstrate suitability. Current industry practice is to utilize 'conventional duplicate analysis', where the same sample is pipetted into two adjacent microplate wells.…”

Adaptation of Commercial Biomarker Kits and Proposal for ‘Drug Development Kits’ to Support Bioanalysis: Call for Action

“…Another recommendation from recent guidelines is to utilize guidelines from CLSI and CLIA, which have been measuring biomarkers for over 40 years in the clinical and diagnostic laboratory environment [6,12,14].…”