Appropriate Medical Care: A Mixed Method Study of Perceptions of Athletics Directors in National Collegiate Athletic Association Division II Colleges and Universities

The National Collegiate Athletic Association (NCAA) Division II (DII) Colleges and Universities face expanding athletic seasons, more teams, more athletes, increasingly complex medical protocols, and an increasingly litigious society. Athletic Trainers (ATs) are responsible for development and implementation of appropriate athletic health care for Student-Athletes (SAs). Athletics Directors (ADs) are the administrative decision-makers and the agents of change when dealing with these competing interests. Athletics Directors allocate the budget and control hiring processes. Athletic Trainer workload poses a moral and legal threat to SAs, ATs, and universities. The problem continues to persist in NCAA DII Universities despite ample research. The purpose of this convergent mixed-methods study was to increase understanding of NCAA DII ADs perceived barriers to providing appropriate medical care to NCAA DII SAs. The researcher addressed additional research questions about defining appropriate event coverage, athletic training practice, advocacy, and prioritization of hiring practices and budget allocation. The online survey and semi-structured interviews captured information about AD knowledge and perception of appropriate medical care. This study utilized the parallel-databases variant. The quantitative data were analyzed using descriptive and inferential statistics. The qualitative data were analyzed using procedures of theme development. The researcher identified similarities and differences within and between the two datasets to create a comparison discussion. The results provided a comparison of AD perceptions that may create direction for future efforts to improve appropriate medical care for NCAA DII SAs

Hershey’s Entry to the Australian Market with a New Brand: An Accounting and Marketing Perspective

This paper discusses the entry of Hershey’s Chocolates Company tothe Australian market with a new brand. For this purpose, background information and key performance indicators about the firm are presented. Also target customers and market summary, market demographics and target customer profile of the firm are mentioned in the context of situational analysis. Then,Hershey’s entry to the Australian market with a new product is proposed by providing and commenting on SWOT analysis, competition environment, accounting-finance indicators, marketing strategy and marketing mix (4P) factors. Thus, a deeper focus on the organization is realized and shared. As aresult, firm’s entry to the Australian market is discussed with a new product by suggesting recent and altered target customer base, customer profile,marketing strategy and marketing mix. Our study evaluates the potential disadvantages and advantages in detail and argues that there is a need for Hershey’s to enter the Australian market with a new product. In general, this article discusses and defends the entry of Hershey’s to Australian market witha new product by logical reasoning and draws a strategic roadmad to reach this goal

Moving Beyond a Protective Approach to Stopping Sexual Violence of People with Intellectual and Developmental Disabilities

Individuals with intellectual and developmental disabilities (I/DD) have some of the highest rates of sexual violence of any group—at least 7 times the rate for people without disabilities. (6) Attempts to alleviate this problem have been unsuccessful and based on the Medical Model of Disability, which views people with I/DD as inherently vulnerable and in need only of protection. Viewing people with I/DD as inherently vulnerable further stigmatizes them and increases dependency on others, instead of fostering capabilities and independence. Minnesota needs to move beyond taking a protective “recognize, report, and respond” approach, to taking a comprehensive approach to sexual violence prevention. We must invest in an array of Primary Prevention and Risk Reduction strategies to address the serious and pervasive problem of sexual violence perpetrated against children, adolescents, and adults with I/DD. Primary prevention and risk reduction need to start early with children and their caregivers in the places where they live, learn, and play to teach skills for self-advocacy, healthy relationships, distinguishing harmful caregiving from respectful caregiving, where to report crimes, and where to get help. We need to provide education and support self-determination through self-advocacy of people with I/DD as equal partners in our comprehensive approach. (2) We need to create change in cultural attitudes, norms, and policies to promote opportunity, freedom to make meaningful choice, inclusion, self-determination, and increased quality of life for all people with I/DD. Every person has a right to safety and a right to live their life free of sexual violence. At the forefront of Minnesota’s comprehensive approach must be the voices of people with I/DD

Integrated scalable cyto-technology for recombinant protein bioprocessing

Biological knowledge of infectious diseases and other diseases for which vaccines may provide therapeutic benefits, such as cancer, is growing at an accelerated pace. The implications of this knowledge are improved stratification of diseases, possibilities for personalized treatments, and explicit understanding of protective immune responses to be elicited by vaccines. With this knowledge, it is becoming increasingly feasible to engineer vaccines for specific responses rather than relying on empirical development. Despite this potential, the challenge of routine, low-cost manufacturing of vaccines creates a barrier to transforming health care in both high- and low-resource countries. Vaccines today do not benefit from well-defined, platform-like processes for manufacturing, and concepts such as continuous bioprocessing remain largely within the realm of biopharmaceutical products. The InSCyT platform is an advanced prototype manufacturing system that provides integrated and automated production and purification of multiple protein therapeutics. The system allows end-to-end manufacturing of 100\u27s to 10,000\u27s of doses of recombinant protein drugs in days. It uses a state-of-the-art approach to process design and implementation that takes advantage of a fast-growing, tractable microbial host (Pichia pastoris) and continuous processing for automated, hands-free purification through simple 2- or 3-stage chromatographic processes. The platform design is highly modular, allowing facile process development and process deployment for multiple products. This feature emerges from the predictable behavior of the fermentation and cell culture fluids, and rapid cloning of new molecules, that together facilitate fast development of entirely new processes in weeks. To date, this system has been used to reproducibly manufacture high-quality human growth hormone (hGH), granulocyte-colony stimulating factor (G-CSF), and interferon-α2b (IFN-α2b) in an integrated, automated manner. The speed of production using the InSCyT prototype allows volumetric productivities that compare favorably to those for mammalian-based production. This talk will outline the design and capabilities of the InSCyT system, demonstrate the quality of biologic drugs made to date on the system, and outline opportunities for advancing the platform to provide new capabilities in manufacturing recombinant proteins for use in vaccines. As part of a Gates Foundation-funded Grand Challenge called ULTRA, we have begun to assess the feasibility of manufacturing millions of doses of a trivalent recombinant rotavirus vaccine annually on a small-scale production system like InSCyT. Integrated bioprocessing enabled by systems such as these could offer potential advantages for routine production in local regions with minimal infrastructure, and for democratization of manufacturing capacity for new vaccine concepts and personalized treatments in cancer

Accelerated process development for integrated end-to-end biologics manufacturing

With the exception of monoclonal antibodies, biologics typically require bespoke manufacturing processes that vary widely in the type of and number of unit operations. This constraint leads to custom facility designs and unique strategies for process development for every new molecule. To enable flexible, multi-product manufacturing facilities and to reduce the speed to clinic for new molecules, streamlined manufacturing processes and associated strategies for process development are needed. We have developed a bench-scale, integrated and automated manufacturing platform capable of rapidly producing a variety of recombinant proteins with phase-appropriate quality for early development1. The system comprises three modules for fermentation via perfusion, straight-through chromatographic purification, and formulation. To facilitate the production of multiple products on the same system, we have also developed a holistic strategy for process design to manufacture new products in as few as twelve weeks after obtaining the product sequence. While upstream process development in our host (Pichia pastoris) has been relatively straightforward, there are not many tools currently available for developing fully integrated straight-through chromatographic processes. Therefore, we developed an in silico tool for the prediction of fully integrated purification processes based on a one-time collection of host-related data combined with conventional high-throughput chromatographic screening data for each new target molecule2. We used this tool to develop fully integrated, end-to-end production processes for three molecules (hGH, IFNα-2b, and G-CSF) with at least 45% fewer steps than traditional processes. While our in silico tool allows for rapid resin selection, it may not predict the optimal process for each individual molecule since it is based on conventional high-throughput screening techniques which seek to optimize each chromatographic step independently rather than optimizing a fully integrated, multi-column process. To address this limitation, we have also developed a DoE-like framework for the optimization of fully integrated purification processes once the resins have been selected. First, a series of range finding experiments are carried out on each individual column, similar to conventional screening but with limited analytics. Next, we carry out fully integrated (multi-column) testing of the proposed operational area with more extensive analytics, including host cell protein, DNA, and yield measurements. We use this methodology to develop optimized processes for the end-to-end production of a variety of single domain antibodies with high yield and purity. Further, we present a method for predicting the optimal operating conditions for a new molecule within the same class based only on its biophysical characteristics, reducing the timeline from sequence to early stage, phase-appropriate product to only six weeks. Using these holistic strategies for process development, we have produced over ten different recombinant proteins on our manufacturing platform including enzymes, cytokines, singe domain antibodies, and vaccine subunits. We believe that such integrated strategies for process design could enable the rapid translation from sequence to early stage clinical development of products for a variety of molecules and potentially allow clinical testing of a greater number of high quality molecules for vaccines and biopharmaceuticals. 1. Crowell, L. E. et al. On-demand manufacturing of clinical-quality biopharmaceuticals. Nat. Biotechnol. (2018). doi:10.1038/nbt.4262 2. Timmick, S. M. et al. An impurity characterization based approach for the rapid development of integrated downstream purification processes. Biotechnol. Bioeng. 1–13 (2018). doi:10.1002/bit.2671

1991 Ruby Yearbook

A digitized copy of the 1991 Ruby, the Ursinus College yearbook.https://digitalcommons.ursinus.edu/ruby/1094/thumbnail.jp

Undergoing varicocele repair before assisted reproduction improves pregnancy rate and live birth rate in azoospermic and oligospermic men with a varicocele: a systematic review and meta-analysis

OBJECTIVE: To evaluate how varicocele repair (VR) impacts pregnancy (PRs) and live birth rates in infertile couples undergoing assisted reproduction wherein the male partner has oligospermia or azoospermia and a history of varicocele. DESIGN: Systematic review and meta-analysis. SETTING: Not applicable. PATIENT(S): Azoospermic and oligospermic males with varicoceles and in couples undergoing assisted reproductive technology (ART) with IUI, IVF, or testicular sperm extraction (TESE) with IVF and intracytoplasmic sperm injection (ICSI). INTERVENTION(S): Measurement of PRs, live birth, and sperm extraction rates. MAIN OUTCOME MEASURE(S): Odds ratios for the impact of VR on PRs, live birth, and sperm extraction rates for couples undergoing ART. RESULT(S): Seven articles involving a total of 1,241 patients were included. Meta-analysis showed that VR improved live birth rates for the oligospermic (odds ratio [OR] = 1.699) and combined oligospermic/azoospermic groups (OR = 1.761). Pregnancy rates were higher in the azoospermic group (OR = 2.336) and combined oligospermic/azoospermic groups (OR = 1.760). Live birth rates were higher for patients undergoing IUI after VR (OR = 8.360). Sperm retrieval rates were higher in persistently azoospermic men after VR (OR = 2.509). CONCLUSION(S): Oligospermic and azoospermic patients with clinical varicocele who undergo VR experience improved live birth rates and PRs with IVF or IVF/ICSI. For persistently azoospermic men after VR requiring TESE for IVF/ICSI, VR improves sperm retrieval rates. Therefore, VR should be considered to have substantial benefits for couples with a clinical varicocele even if oligospermia or azoospermia persists after repair and ART is required

Manufacturing strategies for sustainable supply of ultra-low cost vaccines for global health

economics, optimisation, decisional tools, process intensification, process integration, perfusion, facility design The ability for governments across the globe to protect infants from diseases caused by viruses such as polio, human papillomavirus and rotavirus through immunization is highly contingent on the development and manufacture of efficacious and cost-effective vaccines. Historically, vaccine manufacturers operate at large, and at times, overstretched capacities to benefit from economies of scale. However, this has led to expensive batch failures that have added to cost and interrupted supply. This presentation describes a detailed economic analysis of multiple approaches for the manufacture of a Pichia pastoris-based vaccine with the aim of proposing strategies to produce a ultra-low cost vaccine against rotavirus with a target COG per dose of ¢15 for the finished drug product. This analysis was carried out using an advanced integrated decisional tool developed in-house. The case study assesses the cost-effectiveness of multiple manufacturing flowsheets combining different upstream and downstream techniques (e.g. fed-batch v perfusion, chromatography v crystallisation) as well as different facility designs (e.g. in-house v outsourced reagent production, fully integrated process v segregated process steps), across different geographic locations (Europe v India) and number of manufacturing sites. The key cost drivers across these scenarios were identified through a detailed sensitivity analysis. This allowed for process performance targets for sustainable supply of ultra-low cost rotavirus vaccines to be identified using an optimization algorithm. The key output of this work is to break the economies of scale model and explore how advances in manufacturing can be integrated into decisional tools models to facilitate the guaranteed, uninterrupted supply for low cost vaccines for Global Health

Shoreline change patterns in sandy coasts. A case study in SW Spain

Coastal changes on sandy shorelines are continuous and occur at diverse spatial and temporal scales. Gaining knowledge on beach change processes increases our capability tomanage risks, especially shoreline erosion, affecting the increasing population living in coastal areas. Processes and factors involved in medium- and short-term beach changes depend on the morphological and dynamic characteristics of the coast. In this work, the decadal behaviour of 58 sandy beaches along the 150 km long South-Atlantic coast of Spain, between the Guadalquivir rivermouth and the Strait of Gibraltar, is analysed in order to investigate the relationships between shoreline change patterns and the diverse morphological and dynamic factors controlling beach evolution in the area. For this purpose, georectified aerial photographs spanning the period 1956–2008 were compared in a GIS environment to calculate rates of shoreline change. Short-term evolution of beach profiles was also analysed in selected areas of interest. Results show that the study area exhibits a great variety of shoreline evolution trends, with erosion prevailing in the northern and central sectors and stability or even accretion in the southern sector. In general, sediment availability is the main factor determining coastal erodibility in the area, largely conditioned by the reduction in fluvial sediment supply caused by river basin regulation. Nearshore bathymetry also has a great significance, as it controls wave refraction-diffraction patterns and wave energy concentration on certain zones. Human interventions on the coast also represent a major influence on beach erodibility in the study area. Severe detrimental effects are caused at certain points by shore-normal engineering structures blocking longshore drift. Additionally extensive urban development in backbeach environments has a significant influence on the sediment budget at certain areas. On the basis of these results, a morphological and evolutionary classification of sandy beaches is proposed taking into account the way beach morphology influences erosion/accretion processes. Rectilinear beaches and enclosed beaches typically show dynamic equilibrium or even accretion trends, whereas reef-supported beaches tend to be dominated by erosion. Headland-bay beaches show complex evolution patterns greatly influenced by local conditions, such as specific shoaling processes or local winds. This classification is useful not only in forecasting general shoreline behaviour in the near future, but also in selecting the most appropriate type of intervention when managing retreating coasts

North Park Street Roundabouts design plan : archaeological resource impact assessment : geotechnical monitoring

In June 2013, Davis MacIntyre & Associates (DM&A) Ltd. was contracted by GENIVAR Inc. on behalf of the Halifax Regional Municipality as part of a project to design roundabout conversions at the intersections of North Park / Rainnie / Cogswell / Trollope / Ahern and North Park / Cunard / Agricola in Halifax. The first phase of the archaeological component of this project included mapping and a summary of potentially significant archaeological areas and features within the study area, for which a previous report was submitted in July 2013. In response to recommendations following the initial assessment, Davis MacIntyre & Associates Limited was again retained to conduct monitoring of geotechnical testing within the footprints of the proposed roundabouts. Four geotechnical test pits were excavated. This assessment was conducted under Category C (Archaeological Resource Impact Assessment) Heritage Research Permit 2013NS055 issued by the Department of Communities, Culture and Heritage. This report conforms to the standards required by the Heritage Division under the Special Places Protection Act (R.S., c. 438, s. 1)