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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 3) covers the recommendations on TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness. Part 1A (Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC), Part 1B (Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine) and Part 2 (ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry) are published in volume 14 of Bioanalysis, issues 9 and 10 (2022), 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, 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.

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 3) covers the recommendations on TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9CAR-T Immunogenicity; PCRVaccine Assay Performance; ADA Assay ComparabilityCut Point Appropriateness. Part 1A (Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC), Part 1B (Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, GeneCell Therapy and Vaccine) and Part 2 (ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/OralMultispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry) are published in volume 14 of Bioanalysis, issues 9 and 10 (2022), 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.

We utilized Amplicon-Rescue Multiplex PCR (ARM-PCR) and microarray hybridization to develop and validate the iC-GPC Assay, a multiplexed, in vitro diagnostic test that identifies five of the most common gram positive bacteria and three clinically relevant resistance markers associated with bloodstream infections (BSI). The iC-GPC Assay is designed for use with the iC-System™, which automates sample preparation, ARM-PCR, and microarray detection within a closed cassette. Herein, we determined the limit of detection for each of the iC-GPC Assay targets to be between 3.0 × 105–1.7 × 107 CFU/mL, well below clinically relevant bacterial levels for positive blood cultures. Additionally, we tested 106 strains for assay inclusivity and observed a target performance of 99.4%. 95 of 96 non-target organisms tested negative for cross-reactivity, thereby assuring a high level of assay specificity. Overall performance above 99% was observed for iC-GPC Assay reproducibility studies across multiple sites, operators and cassette lots. In conclusion, the iC-GPC Assay is capable of accurately and rapidly identifying bacterial species and resistance determinants present in blood cultures containing gram positive bacteria. Utilizing molecular diagnostics like the iC-GPC Assay will decrease time to treatment, healthcare costs, and BSI-related mortality.

This collection of papers compiled by Anthony McElligott and Jeffrey Herf focuses on whether the Holocaust made any difference to attitudes toward antisemitism and the incidence of its manifestatio...

Jeremy Corbyn's election as leader of the British Labour Party in September 2015 came as a great surprise to many people, not least himself. After more than thirty years on the backbenches, arguing...

The effects of two different handwriting readiness programs on handwriting-related skills of students in Head Start classrooms were explored. For 16 weeks, two experimental classrooms received small group handwriting instruction twice a week during center time. Each classroom used a different occupational therapist–developed handwriting readiness program. All participants were pre- and posttested using the Shore Handwriting Screening with modified scoring. The mean changes in scores indicate a positive change for all classrooms with the experimental classrooms change being greater than the control but not statistically significant. Results of the study suggest that handwriting readiness programs are a positive addition to the Head Start center time.

The Dearing Report’s most substantial and rigorous piece of work on funding has been rendered irrelevant by the government’s decision to adopt a different approach which Dearing had not considered. Much time, effort and money could have been saved if the government had made its objectives clear before the Report was finalised rather than on the day it was published. Yet the Dearing chapters on funding are not wasted because they provide the case for a student contribution to tuition costs on the grounds of equity. These arguments are examined and supported in the paper. The Report is criticised for missing the opportunity to argue for credit-based funding in relation to both the public and student contributions. The reasons for the government preferring its particular mix of means-tested fee and loan instead of means-tested maintenance grant are explained in terms of its political objectives. The effect of the government’s proposals is that no student or parent pays more now for higher education than under existing arrangements. The extra private costs are incurred by graduates in repaying their additional loans out of their future income. Finally, the misplaced emphasis on dealing with the full-time student funding problem led the Committee to give insufficient attention to other students. The adoption of a genuine lifelong learning model of higher education might have generated more relevant proposals not only on funding but elsewhere.

Appropriate use of nursing resources in the pediatric hematology and oncology inpatient settings demands a patient acuity system that is easy to use and accurate, and that objectively measures nursing care needs of a specialized patient population. Structured survey of 13 comprehensive cancer centers and a review of the literature show no valid and reliable acuity tools for this pediatric population. The purpose of this project was to study the validity and reliability of a newly developed pediatric hematology and oncology acuity system designed to quantify patient care needs. A new acuity tool for this pediatric population was developed based on the patient classification tool used at Johns Hopkins Hospital Oncology Center (JHHOC). The levels of care from the JHHOC tool were adopted, with therapeutic indicators modified to reflect nursing diagnoses relevant to the pediatric inpatient. Nursing care hours required for each level of care were also identified. Validity was studied using a content validity index (CVI). Experts from the pediatric unit where the tool would be used were asked whether each therapeutic indicator was assigned to the correct level of care (1 thru 5) based on patient care hours. CVIs for items ranged from .5 to 1.0; the overall CVI for the tool was .93. Interrater reliability was studied using two raters from the unit. Data were collected for 150 patient observations on a 12-bed pediatric hematology and oncology inpatient and short-stay outpatient unit. The resulting Pearson correlation coefficient was r = .97 (P

Revision of earlier cost calculations for the Open University and Conventional Universities in the U.K. for 1973 confirms the findings of a significant cost advantage to the Open University. An analysis of developments at the Open University since 1973 indicates, however, that there has been little reduction in average cost in real terms and no improvement is likely on known developments to 1979. This is surprising for it might be expected that as student numbers rise average costs would fall. A more detailed analysis of the structure of Open University costs indicates why this has not happened. A major determinant of costs is the number of courses and these have continued to grow rapidly since 1973. The rate of increase of new courses has been faster than the rate of increase of new students. In effect the University has been using the economies provided by increased student numbers to increase student choice through the provision of more courses rather than reduce average cost.

I have attended and participated in a large number of conferences about higher education over the last decade and I cannot recall the word flexible being in the title of any of them; that itself is a thought to which I will return. Yet, as I turned the word over in my mind, I knew I had heard it somewhere before. The answer came as I opened the latest missive from my favourite credit card company: “Access, your flexible friend”, it said. Industry, or at least commerce it would seem, is ahead of higher education in linking access to flexibility. Nor is this a flippant remark; for there is at the heart of our concerns today a great irony and, for those of us in higher education, not a little pain. It is high time to discuss how the use of credit accumulation and transfer, together with other flexible approaches to learning, can enable higher education to better meet the needs of industry. It is an important subject, one that is as vital for the future of higher education as it is for that of industry.

The study was prompted by a long-standing concern how best to educate nurse administrators for work in health service organizations. In the last decade, has been increasingly widespread agreement in that advanced education for clinical specialization may be insufficient. To improve understanding of for nursing administration (NA), the suggestions 3? publications printed between 1976 and 1985 were Inferences were made from these publications curriculum content, program structure, instrucplacement, and practicum experiences. Content most often pertained to health systems, nursing research, and policy. Reference was least often to perspectives in organization theory, ethics, and studies. Suggestions for international NA were in only one publication. Administration majors with clinical nursing emphasis in multidisciplinary programs by schools of nursing were widely recommended, as were administrative practicums of variable length. Few suggestions were made about the epistemological considerations needed to guide the development of interdisciplinnursing administration. In the future, consideration of the overlap - from nursing and management science - of concepts, research problems, and modes of inquiry, will be important for the education of nurse administrators. In the 1960s and early 1970s, clinical specialization was the central focus of graduate nursing education. During this period of time, emphasis on nursing administration (NA) declined, as did the number of NA programs, resulting in a critical shortage of nurse administrators academically prepared to manage health services (Blair, 1976a-b). By 1977, it was estimated that as few as 24% of the nations nurse administrators had master's degrees and that the portion with doctorates was barely .6% (American Nurses' Association [ANA], 1980; Fine, 1983). Knudson (1968), Kramer (1968), Leininger (1974), and Miller (1968) warned the profession of an impending leadership crisis. Responding to the shortage, the threat of non-nurses managing nursing services (Jordan, 1979; Rotkovitch, 1979a), and to nurses being educated for management in disciplines other than nursing (Cleland, 1984), the number of NA programs more than doubled between the mid 1970s and 1982, increasing from 24 to 51. The ascendancy of NA had begun. Recognizing the problem of too few well-educated nurses to manage nursing services, and the need for sound academic programs in NA, the Institute of Medicine (1983) recommended that federal funding be allocated for improvements in NA education. By 1985, an administration component was an element of over 65 nursing programs (National League for Nursing [NLN], 1985). Considerable concern has been expressed, however, about the curriculums and structures of these programs, which in some cases have been developed hurriedly - in a brief period of time - and with relatively few resources (Cleland, 1984; Poulin, 1984; Stevens, 1977a).