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Overcoming the Constraints of Biosimilar Legislation through Creating Transparency

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Biosimilar pharmaceuticals are new lower-cost drugs awaiting large-scale approval within the United States (U.S). Biosimilar pharmaceuticals or simply biosimilars, are complex, large-molecule, and biologically-derived drugs that are deemed molecularly similar to currently approved reference biologics. Biologics and biosimilars both treat

Biosimilar pharmaceuticals are new lower-cost drugs awaiting large-scale approval within the United States (U.S). Biosimilar pharmaceuticals or simply biosimilars, are complex, large-molecule, and biologically-derived drugs that are deemed molecularly similar to currently approved reference biologics. Biologics and biosimilars both treat a wide range of conditions with no clinically meaningful difference between them. However, numerous states, with help from large pharmaceutical companies lobbying, are passing legislation complicating the prescribing and dispensing process for biosimilars by mandating a "notification" or "communication" requirement. The notification requirement requires pharmacists to contact prescribers when dispensing an interchangeable biosimilar in place of its reference biologic. This type of mandate is not only unprecedented in current U.S. pharmaceutical law, but it also incentivizes pharmacists to dispense more expensive biologics in place of biosimilars. The notification or communication requirement also falsely gives consumers the appearance that biosimilars are more dangerous in comparison to other types of biological medicines. These two factors, pharmacist hesitation and consumer distrust, serve as barriers to successful biosimilar market entry. High research and development costs and forecasted poor sales inhibit biosimilar companies from making the investment in innovating new drugs. The lack of investment in research and development prevents new biosimilars from entering the market to compete with currently approved biologics. In turn, current biosimilar legislation is reducing pharmaceutical competition and increasing drug prices. Information Measurement Theory supports the notion that in climates without competition (caused by a lack of transparency) sparks low quality and high costs. Transparency and improved biosimilar market conditions can be achieved through repealing the large pharmaceutical company backed notification requirement.

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2016-05

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Delivering Advancing Healthcare

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In the medical industry, there have been promising advances in the increase of new types of healthcare to the public. As of 2015, there was a 98% Premarket Approval rate, a 38% increase since 2010. In addition, there were 41

In the medical industry, there have been promising advances in the increase of new types of healthcare to the public. As of 2015, there was a 98% Premarket Approval rate, a 38% increase since 2010. In addition, there were 41 new novel drugs approved for clinical usage in 2014 where the average in the previous years from 2005-2013 was 25. However, the research process towards creating and delivering new healthcare to the public remains remarkably inefficient. It takes on average 15 years, over $900 million by one estimate, for a less than 12% success rate of discovering a novel drug for clinical usage. Medical devices do not fare much better. Between 2005-2009, there were over 700 recalls per year. In addition, it takes at minimum 3.25 years for a 510(k) exempt premarket approval. Plus, a time lag exists where it takes 17 years for only 14% of medical discoveries to be implemented clinically. Coupled with these inefficiencies, government funding for medical research has been decreasing since 2002 (2.5% of Gross Domestic Product) and is predicted to be 1.5% of Gross Domestic Product by 2019. Translational research, the conversion of bench-side discoveries to clinical usage for a simplistic definition, has been on the rise since the 1990s. This may be driving the increased premarket approvals and new novel drug approvals. At the very least, it is worth considering as translational research is directly related towards healthcare practices. In this paper, I propose to improve the outcomes of translational research in order to better deliver advancing healthcare to the public. I suggest Best Value Performance Information Procurement System (BV PIPS) should be adapted in the selection process of translational research projects to fund. BV PIPS has been shown to increase the efficiency and success rate of delivering projects and services. There has been over 17 years of research with $6.3 billion of projects and services delivered showing that BV PIPS has a 98% customer satisfaction, 90% minimized management effort, and utilizes 50% less manpower and effort. Using University of Michigan \u2014 Coulter Foundation Program's funding process as a baseline and standard in the current selection of translational research projects to fund, I offer changes to this process based on BV PIPS that may ameliorate it. As concepts implemented in this process are congruent with literature on successful translational research, it may suggest that this new model for selecting translational research projects to fund will reduce costs, increase efficiency, and increase success. This may then lead to more Premarket Approvals, more new novel drug approvals, quicker delivery time to the market, and lower recalls.

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2016-05

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The Elimination of Career Path Decision Making

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Abstract The purpose of this project is to utilize the models and concepts from Information Measurement Theory (IMT) to help minimize future decision making with respect to my career path. When I began this project, my future was clouded, my

Abstract The purpose of this project is to utilize the models and concepts from Information Measurement Theory (IMT) to help minimize future decision making with respect to my career path. When I began this project, my future was clouded, my initial conditions were unknown, my stress over future career-path decisions was high, and I had eight possible career paths in mind. I have narrowed my career-path options from eight to four. In addition, I have determined a one-year plan that enables me to be prepared to pursue any of the four career paths that I have found align with me. In this project, I explored my dominant initial conditions with respect to my career path. I tracked the job history of my grandparents and parents. These efforts allowed me to identify the strengths and weaknesses that I was exhibiting by the age of three. Natural law dictates that the strengths and weaknesses of my younger self will be the same strengths and weakness that I excel at and struggle with today. I then used my understanding of natural law and the event model process to map the strengths and weaknesses of my parents and grandparents and to compare and contrast these to my strengths and weaknesses, including those that were apparent by the time that I was three years old. Focusing in on what I really want from a job, four main goals were established to grade the various future career-path options. Finally, I documented my transition from uncertainty to clarity. It began with my sobriety and ended with a milestone one-year plan that will give me information that I need to commit to my career path. This transition has had significant impact. The elusive "who am I" has been addressed, not completely but addressed sufficiently so that the question no longer plagues me. I know from where I have come. I have gained significant insight from those around me who know me. All of this has been documented for my own personal use, and for my children someday. This process permitted me to eliminate outliers from my eight original career paths, reducing them to four. In addition, application of IMT models and concepts has allowed me to see one year into the future. With my new-found knowledge, I will listen and watch the doors close on three of the remaining four career paths, as there is only one path I am meant to take.

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2014-05

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Exercise: for Self and State

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Exercise is a great boon to both the health of individuals and the national as a whole. Exercise provides a wide range of significant and well established benefits to both physical and psychological health, with many benefits that are still

Exercise is a great boon to both the health of individuals and the national as a whole. Exercise provides a wide range of significant and well established benefits to both physical and psychological health, with many benefits that are still being discovered. The effects of exercise on health are somewhat unique, as exercise is one of a limited number of ways to improve health that is not harm a reduction strategy, but instead increases health through direct benefit, rather than increasing health by decreasing damage and harm. Support is also given to the proposal that individuals are in best position to determine the intensity of exercise and to choose primary activities to participate in, in order to provide near maximum physical and psychological benefit, with the understanding that frequency of exercise is of the upmost importance for benefit. The accessibility of exercise and the tremendous health benefit of exercise, makes exercise a huge asset in reducing the exorbitant health care spending and improving mediocre health outcomes in this country; a reasonable goal as numerous countries have better health the United States, even though the United States spends the more than any other country on health.

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Date Created
2015-05

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Emerging Information Technology, Storage and Evaluation within Healthcare: A Discerning IMT Analysis

Description

The introduction of novel information technology within contemporary healthcare settings presents a critical juncture for the industry and thus lends itself to the importance of better understanding the impact of this emerging "health 2.0" landscape. Simply, how such technology may

The introduction of novel information technology within contemporary healthcare settings presents a critical juncture for the industry and thus lends itself to the importance of better understanding the impact of this emerging "health 2.0" landscape. Simply, how such technology may affect the healthcare system is still not fully realized, despite the ever-growing need to adopt it in order to serve a growing patient population. Thus, two pertinent questions are posed: is HIT useful and practical and, if so, what is the best way to implement it? This study examined the clinical implementation of specific instances of health information technology (HIT) so as to weigh its benefits and risks to ultimately construct a proposal for successful widespread adoption. Due to the poignancy of information analysis within HIT, Information Measurement Theory (IMT) was used to measure the effectiveness of current HIT systems as well as to elucidate improvements for future implementation. The results indicate that increased transparency, attention to patient-focused approaches and proper IT training will not only allow HIT to better serve the community, but will also decrease inefficient healthcare expenditure.

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2015-05

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Improving the structure of a local non-profit clinic by implementing concepts from Information Measurement Theory (IMT).

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The Performance Based Studies Research Studies Group (PBSRG) at Arizona State University aims to evaluate and provide solutions to problems by using concepts derived from deductive logic. The research group identified that problems in most industries are due to the

The Performance Based Studies Research Studies Group (PBSRG) at Arizona State University aims to evaluate and provide solutions to problems by using concepts derived from deductive logic. The research group identified that problems in most industries are due to the traditional approach of management, direction and control, and offers a practical contrasting model. The author is a biological sciences major interested in the health care industry. As a volunteer at a local non-profit pregnancy clinic in Tempe, AZ, the author noticed characteristics of the clinic structure that resembled both the traditional approach of management, direction and control and the best value (BV) approach. Although the pregnancy clinic has existed for 30 years and has high patient satisfaction, it faces problems that jeopardize its long term sustainability. This study analyzes the stereotypical structure of non-profit health clinics through literature review and through a case study of a local non-profit pregnancy clinic in Tempe, Arizona. The study identified and analyzed the factors that contribute to inefficiency within non-profit health clinics. The conclusions of the research demonstrate that characteristics of non-profit health clinics that resemble the traditional model perform in a manner that is unsustainable. Recommendations were based on concepts derived from Information Measurement Theory (IMT) and aimed to improve efficiency and effectiveness. The study identifies sources of risks and examines the performance of such organizations; the study concludes that rejection of traditional models and adaptation of the new approach is preferable in improving performance and increasing patient, employee, and volunteer satisfaction.

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2016-05