Search results for: qualified
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 302

Search results for: qualified

2 Characterizing and Developing the Clinical Grade Microbiome Assay with a Robust Bioinformatics Pipeline for Supporting Precision Medicine Driven Clinical Development

Authors: Danyi Wang, Andrew Schriefer, Dennis O'Rourke, Brajendra Kumar, Yang Liu, Fei Zhong, Juergen Scheuenpflug, Zheng Feng

Abstract:

Purpose: It has been recognized that the microbiome plays critical roles in disease pathogenesis, including cancer, autoimmune disease, and multiple sclerosis. To develop a clinical-grade assay for exploring microbiome-derived clinical biomarkers across disease areas, a two-phase approach is implemented. 1) Identification of the optimal sample preparation reagents using pre-mixed bacteria and healthy donor stool samples coupled with proprietary Sigma-Aldrich® bioinformatics solution. 2) Exploratory analysis of patient samples for enabling precision medicine. Study Procedure: In phase 1 study, we first compared the 16S sequencing results of two ATCC® microbiome standards (MSA 2002 and MSA 2003) across five different extraction kits (Kit A, B, C, D & E). Both microbiome standards samples were extracted in triplicate across all extraction kits. Following isolation, DNA quantity was determined by Qubit assay. DNA quality was assessed to determine purity and to confirm extracted DNA is of high molecular weight. Bacterial 16S ribosomal ribonucleic acid (rRNA) amplicons were generated via amplification of the V3/V4 hypervariable region of the 16S rRNA. Sequencing was performed using a 2x300 bp paired-end configuration on the Illumina MiSeq. Fastq files were analyzed using the Sigma-Aldrich® Microbiome Platform. The Microbiome Platform is a cloud-based service that offers best-in-class 16S-seq and WGS analysis pipelines and databases. The Platform and its methods have been extensively benchmarked using microbiome standards generated internally by MilliporeSigma and other external providers. Data Summary: The DNA yield using the extraction kit D and E is below the limit of detection (100 pg/µl) of Qubit assay as both extraction kits are intended for samples with low bacterial counts. The pre-mixed bacterial pellets at high concentrations with an input of 2 x106 cells for MSA-2002 and 1 x106 cells from MSA-2003 were not compatible with the kits. Among the remaining 3 extraction kits, kit A produced the greatest yield whereas kit B provided the least yield (Kit-A/MSA-2002: 174.25 ± 34.98; Kit-A/MSA-2003: 179.89 ± 30.18; Kit-B/MSA-2002: 27.86 ± 9.35; Kit-B/MSA-2003: 23.14 ± 6.39; Kit-C/MSA-2002: 55.19 ± 10.18; Kit-C/MSA-2003: 35.80 ± 11.41 (Mean ± SD)). Also, kit A produced the greatest yield, whereas kit B provided the least yield. The PCoA 3D visualization of the Weighted Unifrac beta diversity shows that kits A and C cluster closely together while kit B appears as an outlier. The kit A sequencing samples cluster more closely together than both the other kits. The taxonomic profiles of kit B have lower recall when compared to the known mixture profiles indicating that kit B was inefficient at detecting some of the bacteria. Conclusion: Our data demonstrated that the DNA extraction method impacts DNA concentration, purity, and microbial communities detected by next-generation sequencing analysis. Further microbiome analysis performance comparison of using healthy stool samples is underway; also, colorectal cancer patients' samples will be acquired for further explore the clinical utilities. Collectively, our comprehensive qualification approach, including the evaluation of optimal DNA extraction conditions, the inclusion of positive controls, and the implementation of a robust qualified bioinformatics pipeline, assures accurate characterization of the microbiota in a complex matrix for deciphering the deep biology and enabling precision medicine.

Keywords: 16S rRNA sequencing, analytical validation, bioinformatics pipeline, metagenomics

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1 Source of Professionalism and Knowledge among Sport Industry Professionals in India with Limited Sport Management Higher Education

Authors: Sandhya Manjunath

Abstract:

The World Association for Sport Management (WASM) was established in 2012, and its mission is "to facilitate sport management research, teaching, and learning excellence and professional practice worldwide". As the field of sport management evolves, it have seen increasing globalization of not only the sport product but many educators have also internationalized courses and curriculums. Curricula should reflect globally recognized issues and disseminate specific intercultural knowledge, skills, and practices, but regional disparities still exist. For example, while India has some of the most ardent sports fans and events in the world, sport management education programs and the development of a proper curriculum in India are still in their nascent stages, especially in comparison to the United States and Europe. Using the extant literature on professionalization and institutional theory, this study aims to investigate the source of knowledge and professionalism of sports managers in India with limited sport management education programs and to subsequently develop a conceptual framework that addresses any gaps or disparities across regions. This study will contribute to WASM's (2022) mission statement of research practice worldwide, specifically to fill the existing disparities between regions. Additionally, this study may emphasize the value of higher education among professionals entering the workforce in the sport industry. Most importantly, this will be a pioneer study highlighting the social issue of limited sport management higher education programs in India and improving professional research practices. Sport management became a field of study in the 1980s, and scholars have studied its professionalization since this time. Dowling, Edwards, & Washington (2013) suggest that professionalization can be categorized into three broad categories of organizational, systemic, and occupational professionalization. However, scant research has integrated the concept of professionalization with institutional theory. A comprehensive review of the literature reveals that sports industry research is progressing in every country worldwide at its own pace. However, there is very little research evidence about the Indian sports industry and the country's limited higher education sport management programs. A growing need exists for sports scholars to pursue research in developing countries like India to develop theoretical frameworks and academic instruments to evaluate the current standards of qualified professionals in sport management, sport marketing, venue and facilities management, sport governance, and development-related activities. This study may postulate a model highlighting the value of higher education in sports management. Education stakeholders include governments, sports organizations and their representatives, educational institutions, and accrediting bodies. As these stakeholders work collaboratively in developed countries like the United States and Europe and developing countries like India, they simultaneously influence the professionalization (i.e., organizational, systemic, and occupational) of sport management education globally. The results of this quantitative study will investigate the current standards of education in India and the source of knowledge among industry professionals. Sports industry professionals will be randomly selected to complete the COSM survey on PsychData and rate their perceived knowledge and professionalism on a Likert scale. Additionally, they will answer questions involving their competencies, experience, or challenges in contributing to Indian sports management research. Multivariate regression will be used to measure the degree to which the various independent variables impact the current knowledge, contribution to research, and professionalism of India's sports industry professionals. This quantitative study will contribute to the limited academic literature available to Indian sports practitioners. Additionally, it shall synthesize knowledge from previous work on professionalism and institutional knowledge, providing a springboard for new research that will fill the existing knowledge gaps. While a further empirical investigation is warranted, our conceptualization contributes to and highlights India's burgeoning sport management industry.

Keywords: sport management, professionalism, source of knowledge, higher education, India

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