Browsing by Subject "Pharmaceuticals"

Now showing 1 - 6 of 6
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    Balancing Novelty, Safety, and Availability: The Trifecta of Outcomes in Pharmaceutical Supply Chains
    (2024-05) Tyagi, Hanu
    Global pharmaceutical supply chains have garnered unprecedented attention, particularly in the wake of the COVID-19 pandemic. Despite their importance, pharmaceutical supply chains are plagued by numerous challenges such as stagnating innovation, increasing drug shortages, and drugs with compromised quality reaching patients. While efforts to resolve these issues hold potential, their implementation often inadvertently leads to unintended consequences. Such tradeoffs, i.e., solutions to one problem unintentionally creating another problem, present a challenge for pharmaceutical supply chains. Despite the central role of tradeoffs in Operations Management research, their understanding within the pharmaceutical supply chain context remains limited. This dissertation serves as an exploration of the tradeoffs within pharmaceutical supply chains. Titled “Balancing Novelty, Safety, and Availability: The Trifecta of Outcomes in Pharmaceutical Supply Chains,” it delves into fundamental questions, such as What is the nature and the extent of these tradeoffs? and, How can supply chain stakeholders mitigate their impact? By concentrating on three pivotal outcomes – novelty, safety, and availability – I examine how efforts meant to improve one of the three outcomes could unintendedly impact other outcomes. Chapter 1 serves as a motivation for the topic and provides a brief overview of the ensuing dissertation essays. In Chapter 2, I show how enhanced transparency in clinical trials, intended to enhance patient safety, may hinder drug novelty. In Chapter 3, I examine the adverse effects of the expedited approval process, aimed at improving the availability of novel drugs, on drug safety. In Chapter 4, I delve into the impact of quality failures on drug availability, discerning when failures help or hurt availability. Chapter 5 concludes with insights the dissertation entails for Operations Management scholars, managers, and policymakers. These dissertation essays aim to evaluate the inherent tradeoffs within the pharmaceutical industry and propose interventions for mutually enhancing operational outcomes. While the overarching goal is to improve outcomes within the pharmaceutical supply chain, the insights from this work also inform a wider array of Operations Management questions beyond the confines of the pharmaceutical industry.
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    Fish as indicators of ecosystem health: Assessing the impact of contaminants of emerging concern
    (2021-08) Deere, Jessica
    Water is arguably the most essential natural resource in the world, yet the use of industrial, healthcare, and household products threaten freshwater ecosystems. Contaminants of emerging concern (CECs) are a diverse group of chemicals - often defined as chemicals that were previously unknown, unrecognized, or unregulated - that comprise pharmaceuticals, personal care products, and hormones. CECs now have a ubiquitous distribution worldwide and their presence is only increasing as quantitative detection limits continue to be lowered and new chemicals make their way onto the global market. Concern over their biological effects at the molecular, organism, and population level in aquatic ecosystems is also increasing. CECs are identified throughout the Great Lakes Basin and may have a variety of adverse effects on aquatic life. However, data describing the specific risks these contaminants pose to human, wildlife, and environmental health are scarce. The goal of this thesis was to characterize CECs in freshwater ecosystems of northeastern Minnesota and evaluate their potential impact on the health of subsistence fish species. We investigated CECs and fish health within the Grand Portage Indian Reservation (GPIR) and 1854 Ceded Territory, where the Grand Portage Band of Lake Superior Chippewa rely on subsistence hunting, fishing and gather as the foundation for their culture and way of life. Thus, to establish a baseline understanding of CECs on these Tribal lands and their potential impact on fish health, we assessed important subsistence fish species in waterbodies that have value as fish harvesting locations for Band members. Further, due to a gap in knowledge regarding the distribution of CECs in rural and Tribal areas, we targeted waterbodies along a spectrum of anthropogenic pressures: waterbodies with no human development along their shorelines, those with development, and those directly impacted by wastewater effluent. Chapter 1 provides background for why it is essential that we better understand the potential impact CECs might be having on aquatic ecosystems, and thus Ojibwe culture. Chapter 2 characterizes the occurrence of CECs in water, sediment, and subsistence fish species in 28 locations. We detected 117 different chemicals in water, sediment, and/or fish in wastewater effluent-impacted, developed, and undeveloped sites. Chapter 3 prioritizes the chemical hazards of the detected chemicals through a rapid assessment of chemical-specific information - including detection frequency, persistence, endocrine disruption, toxicity, and bioaccumulation - to evaluate the potential for these contaminants to cause adverse effects on aquatic life. We identified 50 contaminants in water, 21 in sediment, seven in fish as high priority, including antimicrobials, antihistamines, antidepressants, cardiovascular modulating agents, and insect repellant. Chapter 4 evaluates the health of wild fish exposed to CECs across varying anthropogenic pressures. We compared the utility of three different approaches that could be used to evaluate the health of fish exposed to CECs: a refined fish health assessment index (rFHI), a histopathological index, and high-throughput (ToxCast) in vitro assays. We mapped adverse outcome pathways (AOPs) associated with identified ToxCast assays to determine potential impacts across levels of biological organization within the aquatic system. The health of fish in undeveloped sites was as poor, or sometimes poorer, than fish in developed and wastewater effluent-impacted sites. Chapter 5 is a general discussion to conclude the relevance of this work and explore important future directions. Collectively, this thesis provides evidence of the potential hazards of CECs and their impact on fish health in a region that is important for sustaining Indigenous culture through subsistence fishing.
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    Privatizing Biomedical Citizenship: Risk, Duty, and Potential in the Circle of Pharmaceutical Life
    (Minnesota Journal of Law, Science and Technology, 2014-05) Kahn, Jonathan
    Genomic research is at an impasse. In the decade since the completion of the first draft of the human genome, progress has been made, but few of the grandest promises of genomics have materialized. Biomedical researchers largely agree that one critical thing is essential to propel genomics into the future and maintain its legitimacy: more bodies. This Article will examine recent efforts at massive recruitment of subjects to participate in biomedical research and will argue that such efforts, while clearly motivated by a desire to drive biomedical research to its next stage of promised critical breakthroughs, also promote a privatized conception of citizenship that configures citizens’ duties as serving the public good primarily through serving the good of private corporations—pharmaceutical manufacturers in particular. This reconfiguration of citizenship, in turn, implicates the allocation of related public resources to support drug development.
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    Science as an element of innovation strategy: evidence from the pharmaceutical industry
    (2013-07) Vandaie, Ramin
    An extensive literature has informed us that science matters for firm innovation. But the primary question of interest to strategy research in this regard has remained unanswered: what drives the differences among firms in how tightly they couple science with the other elements of their innovation strategy, and what implications do such differences hold for firms' innovativeness. This study takes a first step to answer this question by focusing on the relationship between science and R&D alliances representing key elements of any firm's innovation strategy. Specifically, I conceptualize absorptive capacity as a latent construct that mediates the link between science productivity and the extent of new R&D alliance formations. I then hypothesize that two sets of factors (scientist-based and firm-based) moderate the strength of the baseline relationship by impacting either the resulting absorptive capacity for a given level of science productivity or the substitutability of absorptive capacity as a driver of new R&D alliance formations. I then move on to explore the role of absorptive capacity at the time of forming new R&D alliances on the long-term benefits of those alliance for the firm's innovative output. The results of the analysis of a longitudinal database on 216 publicly-traded pharmaceutical companies in US between 1990 and 2009 provide general support for the proposed theoretical framework of the study.
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    Supporting data for "A chemical prioritization process: Applications to contaminants of emerging concern in freshwater ecosystems (Phase 1)"
    (2022-09-08) Deere, Jessica R; Streets, Summer; Jankowski, Mark D; Ferrey, Mark; Chenaux-Ibrahim, Yvette; Convertino, Matteo; Isaac, E.J.; Phelps, Nicholas B.D.; Primus, Alexander; Servadio, Joseph L; Singer, Randall S; Travis, Dominic A; Moore, Seth; Wolf, Tiffany M; deere007@umn.edu; Deere, Jessica R
    These data describe contaminants of emerging concern (CECs) detected in subsistence fish species and freshwater ecosystems on the Grand Portage Indian Reservation and adjacent 1854 Ceded Territory in Northeastern Minnesota, USA. They also contain chemical-specific information, including acute toxicity, endocrine activity, physicochemical properties, and frequency of occurrence data used to prioritize detected CECs based on their potential environmental hazard.