Development, manufacturing, and supply of MSD’s Ebola vaccine

Ebola was first discovered in 1976 and is a member of the filoviridae family of viruses. There are multiple strains of Ebola and infection can lead to hemorrhagic fever and death. In March 2014, a historic Ebola outbreak occurred in three Western African countries, Guinea, Liberia, and Sierra Leone. Over 28,000 cases were reported and led to more than 11,000 deaths, more than ten times the amount of cases compared to all past outbreaks combined. On August 8th 2014, the World Health Organization declared a Public Health Emergency of International Concern (PHEIC). Merck Sharp & Dohme (MSD) partnering with NewLink Genetics entered into an exclusive worldwide licensing agreement to research, develop, manufacture, and distribute an investigational Ebola vaccine candidate based on recombinant Vesicular Stomatitis Virus (rVSV) technology. Working with multiple partners, Merck Sharp & Dohme have brought forward an efficacious vaccine candidate from Phase I trials in October 2014, to Phase III consistency studies by August 2015. This presentation will provide background into Merck Sharp & Dohme’s strategy to bring the vaccine to licensure, product development activities to scale-up the process from clinical to commercial, and the challenges faced during product development

Changes in Farm Financial Conditions and Farming Practices in Ohio, 1986-1990

Highlights of a five year study of farm households are reported. Two facets of farm households, their financial condition and those farming practices affecting the environment, are analyzed. Results indicate improvements in farm household financial condition, changes to less soil erosive farming practices, but little adoption of low input farming systems

Ethical Guidelines for Social Work Supervisors in Rural Settings

Little research literature exists integrating ethics, supervision, and rural/small community practice. This paper reports results of a study conducted by a joint student-faculty team. The study engaged supervisors in rural and small communities in two Midwestern states in semi-structured interviews. Interview data were then used to develop guidelines for BSW students about what constitutes ethical supervisory practice in rural environments

Rebuilding Theories of Technology Acceptance: A Qualitative Case Study of Physicians\u27 Acceptance of Technology

The Technology Acceptance Model has been widely applied and has been quite successful at explaining the behavioral intention to use technology in many organizations. One of the most significant variables in the Technology Acceptance Model is perceived ease of use. The Technology Acceptance Model purports that perceived ease of use contributes to the behavioral intention to use technology. Additionally, the model purports that perceived ease of use is an antecedent of perceived usefulness. In the adoption and use of technology by physicians, previous studies show that the Technology Acceptance Model predictions have been incorrect. Specifically, the aforementioned perceived ease of use prediction is not repeatedly supported in health care environments. In order to further investigate and ultimately explain this abnormality in the Technology Acceptance Model\u27s predictive ability in the health care industry, a positivist case study using various coding techniques was conducted to investigate physicians\u27 behavioral intention to use a Personal Digital Assistant in their work environment. The Physicians\u27 Technology Acceptance Model is a major result of this case study. The Physicians\u27 Technology Acceptance Model, which is based on the Extended Technology Acceptance Model (Venkatesh et al. 2000), is absent of the perceived ease of use construct and includes two additional constructs: perceived substitution, which is defined as, the degree to which an individual perceives that alternate sources are available to deliver the same information or assistance as the technology in question and facilitating conditions (Venkatesh et al. 2003) , which is defined as, the degree to which an individual believes that an organizational and technical infrastructure exists to support use of the system (p. 453). This organizational case study rigorously follows a positivist approach ( natural-science model of social-science research (Lee 1989b))

Stability and Instability of Extreme Reissner-Nordstr\"om Black Hole Spacetimes for Linear Scalar Perturbations I

We study the problem of stability and instability of extreme Reissner-Nordstrom spacetimes for linear scalar perturbations. Specifically, we consider solutions to the linear wave equation on a suitable globally hyperbolic subset of such a spacetime, arising from regular initial data prescribed on a Cauchy hypersurface crossing the future event horizon. We obtain boundedness, decay and non-decay results. Our estimates hold up to and including the horizon. The fundamental new aspect of this problem is the degeneracy of the redshift on the event horizon. Several new analytical features of degenerate horizons are also presented.Comment: 37 pages, 11 figures; published version of results contained in the first part of arXiv:1006.0283, various new results adde

Stability for linearized gravity on the Kerr spacetime

In this paper we prove integrated energy and pointwise decay estimates for solutions of the vacuum linearized Einstein equation on the Kerr black hole exterior. The estimates are valid for the full, subextreme range of Kerr black holes, provided integrated energy estimates for the Teukolsky Master Equation holds. For slowly rotating Kerr backgrounds, such estimates are known to hold, due to the work of one of the authors arXiv:1708.07385. The results in this paper thus provide the first stability results for linearized gravity on the Kerr background, in the slowly rotating case, and reduce the linearized stability problem for the full subextreme range to proving integrated energy estimates for the Teukolsky equation. This constitutes an essential step towards a proof of the black hole stability conjecture, i.e. the statement that the Kerr family is dynamically stable, one of the central open problems in general relativity. The proof relies on three key steps. First, there are energy decay estimates for the Teukolsky equation, proved by applying weighted multiplier estimates to a system of spin-weighted wave equations derived from the Teukolsky equation, and making use of the pigeonhole principle for the resulting hierarchy of weighted energy estimates. Second, working in the outgoing radiation gauge, the linearized Einstein equations are written as a system of transport equations, driven by one of the Teukolsky scalars. Third, expansions for the relevant curvature, connection, and metric components can be made near null infinity. An analysis of the dynamics on future null infinity, together with the Teukolsky Starobinsky Identity plays an important role in the argument

Proton Driven Plasma Wakefield Acceleration

Plasma wakefield acceleration, either laser driven or electron-bunch driven, has been demonstrated to hold great potential. However, it is not obvious how to scale these approaches to bring particles up to the TeV regime. In this paper, we discuss the possibility of proton-bunch driven plasma wakefield acceleration, and show that high energy electron beams could potentially be produced in a single accelerating stage.Comment: 13 pages, 4 figure

Enabling technologies for manufacturing thermostable and cost-effective vaccines

Biopharmaceuticals are often intrinsically unstable and can rely on freeze-drying as a standard approach for stabilization. Although a standard, this process has long cycle times, is a batch drying process, and is incompatible with flexible manufacturing. There is need for advancing novel approaches that enable the vision for “a maximally efficient, agile, flexible, manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight;” (2004, FDA Pharmaceutical Quality for the 21st century). Please click Download on the upper right corner to see the full abstract

Effects of high-intensity interval training on cardiometabolic risk factors in overweight/obese women

The purpose of this study was to evaluate two practical interval training protocols on cardiorespiratory fitness, lipids, and body composition in overweight/obese women. Thirty women (mean ± SD; Weight: 88.1 ± 15.9 kg; BMI: 32.0 ± 6.0 kg·m2) were randomly assigned to ten 1-minute high-intensity intervals (90%VO2peak, 1min recovery), or five 2-minute high-intensity intervals (80-100% VO2peak, 1 min recovery), or control. Peak oxygen uptake (VO2peak), peak power output, body composition, and fasting blood lipids were evaluated before and after 3 weeks of training, completed 3 days per week. Results from ANCOVA analyses demonstrated no significant training group differences for any primary variables (p>0.05). When training groups were collapsed, 1MIN and 2MIN resulted in a significant increase in peak power output (∆18.9 ± 8.5 watts; p=0.014) and time to exhaustion (∆55.1 ± 16.4 sec; p=0.001); non-significant increase in VO2peak (∆2.36 ± 1.34 ml·kg−1·min−1; p=0.185); and a significant decrease in fat mass (∆−1.96 ± 0.99kg; p=0.011). Short-term interval exercise training may be effective for decreasing fat mass and improving exercise tolerance in overweight and obese women