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The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on biomarker assay development and validation (BAV) (focused on clarifying the confusion created by the increased use of the term “Context of Use – COU”); mass spectrometry of proteins (therapeutic, biomarker and transgene); state-of-the-art cytometry innovation and validation; and, critical reagent and positive control generation were the special features of the 15th edition. This 2021 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 2021 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1A) covers the recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC. Part 1B covers the Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine. Part 2 (ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry) and Part 3 (TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparabil ity & Cut Point Appropriateness) are published in volume 14 of Bioanalysis, issues 10 and 11 (2022), respectively.

This study investigates main and moderating factors that influence Millennials' intention to participate in a social networking community (SNC). The authors modified the unified theory of consumers' acceptance and use of technology (UTAUT2) to incorporate six main and two moderating factors to explain Millennials' SNC participation intention. By considering the implications of the unique characteristics of Millennials on their social networking behavior, the authors' model is better suited to answer what drives these tech-savvy individuals to participate in a SNC via such sites as Facebook. Specifically, the authors find that hedonic motivation, trust in technology, trust in community, and social influence are significant factors in influencing Millennials' SNC participation intention, with hedonic motivation being the most influential factor. In addition, gender and educational background moderate the main effects of these determinants in different manner. Theoretical and practical implications of these findings are discussed.

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15–29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by Mass Spectrometry (hybrid assays, LCMS and HRMS) were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global 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 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 1) Hybrid Assays, Innovation in Small Molecules, & Regulated Bioanalysis. Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation), Part 2B (Regulatory Input) and Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 5, and 6 (2021), respectively.

The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on biomarker assay development and validation (BAV) (focused on clarifying the confusion created by the increased use of the term "Context of Use - COU"); mass spectrometry of proteins (therapeutic, biomarker and transgene); state-of-the-art cytometry innovation and validation; and, critical reagent and positive control generation were the special features of the 15th edition. This 2021 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 2021 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1A) covers the recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC. Part 1B covers the Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, GeneCell Therapy and Vaccine. Part 2 (ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/OralMultispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry) and Part 3 (TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9CAR-T Immunogenicity; PCRVaccine Assay Performance; ADA Assay Comparabil ityCut Point Appropriateness) are published in volume 14 of Bioanalysis, issues 10 and 11 (2022), respectively.

Purpose The purpose of this paper is to present an educational approach to elevating problem-solving and numeracy competencies of business undergraduates to meet workplace demand. The approach is grounded in the theory of constraints following the Decoding the Discipline model. The authors investigated a cognitive bottleneck involving problem modeling and an affective bottleneck concerning low self-efficacy of numeracy and designed specific interventions to address both bottlenecks simultaneously. The authors implemented the proposed approach in an introductory level analytics course in business operations. Design/methodology/approach The authors use an empirical study to evaluate the effectiveness of the proposed approach in addressing deficiency in numeracy and problem-solving skills. Cognitive and affective learning interventions were introduced in an undergraduate core course in analytics. The perceived effectiveness of the interventions was evaluated with the use of a survey at the end of the course. To further investigate the effectiveness of the proposed interventions beyond self-reporting, the impact of the interventions on actual learning was evaluated by comparing the exam scores between classes with and without the interventions. Findings Students who underwent the interventions successfully overcame both learning bottlenecks and indicated a positive change in attitude toward the analytics discipline as well as achieved higher exam scores in the analytics course. Research limitations/implications This study succeeds in strengthening the body of research in teaching and learning. The authors also offer a holistic treatment of cognitive and affective learning bottlenecks, and provide empirical evidence to support the effectiveness of the proposed approach in elevating numeracy and problem-solving competencies of business undergraduates. Practical implications The proposed approach is useful for business educators to improve business students’ quantitative modeling skill and attitude. Researchers can also extend the approach to other courses and settings to build up the body of research in learning and skill development. Educational policy makers may consider promoting promising approaches to improve students’ quantitative skill development. They can also set a high standard for higher education institutions to assess students’ numeracy and problem-solving competencies. Employers will find college graduates bring to their initial positions the high levels of numeracy and problem-solving skills demanded for knowledge work to sustain business growth and innovation. Social implications As students’ numeracy and problem-solving skills are raised, they will develop an aptitude for quantitative-oriented coursework that equips them with the set of quantitative information-processing skills needed to succeed in the twenty-first century society and global economy. Originality/value The proposed approach provides a goal-oriented three-step process to improve learning by overcoming learning bottlenecks as constraints of a learning process. The integral focus on identifying learning bottlenecks, creating learning interventions and assessing learning outcomes in the proposed approach is instrumental in introducing manageable interventions to address challenges in student learning thereby elevating students’ numeracy and problem-solving competencies.

The primary goal of this paper is to examine the role that sustainability assessment and reporting plays in creating a sustainable campus for academic excellence. A prototype sustainability assessment and reporting system is developed for triple bottom line impact analysis of the built environment of the newly expanded and renovated Gatton College of Business and Economics at the University of Kentucky. The prototype system utilizes a toolkit to collect environmental, social, and economic data of the building's built environment for sustainable design performance analyses. The system also employs a comprehensive set of sustainability metrics to measure and report the building's triple bottom line impacts on academic success. In sum, our study succeeds in (1) expanding the definition and evaluation of campus buildings' sustainability to include environmental, social, and economic factors, (2) providing campus stakeholders with a toolkit for assessing the sustainability of campus buildings, and (3) creating a comprehensive sustainability metric for benchmarking and tracking campus buildings' triple bottom line impacts on academic success.

This study investigates main and moderating factors that influence Millennials' intention to participate in a social networking community (SNC). The authors modified the unified theory of consumers' acceptance and use of technology (UTAUT2) to incorporate six main and two moderating factors to explain Millennials' SNC participation intention. By considering the implications of the unique characteristics of Millennials on their social networking behavior, the authors' model is better suited to answer what drives these tech-savvy individuals to participate in a SNC via such sites as Facebook. Specifically, the authors find that hedonic motivation, trust in technology, trust in community, and social influence are significant factors in influencing Millennials' SNC participation intention, with hedonic motivation being the most influential factor. In addition, gender and educational background moderate the main effects of these determinants in different manner. Theoretical and practical implications of these findings are discussed.

We propose a learning innovation called 3-in-1 Hybrid environment as a solution for educational institutions to meet the challenge of balancing campus reopening against public health risks amid the...