Digital Commons Network^™

Hatch-Waxman’S Safe-Harbor Provision For Pharmaceutical Development: A Free Ride For Patent Infringers?, 13 J. Marshall Rev. Intell. Prop. L. 445 (2014), Kate Y. Jung

UIC Review of Intellectual Property Law

The Safe-Harbor provision of the Hatch-Waxman Act allows generic drug manufacturers to use a patented invention during pre-market testing of generic drugs. However, the U.S. Court of Appeals for the Federal Circuit’s recent interpretation of the Safe-Harbor provision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. created controversy when it extended the Safe-Harbor exemption to post-FDA approval. This extension was done in an unprecedented manner and would “allow almost all activity by pharmaceutical companies to constitute ‘submission’ and therefore justify a free license to trespass.” The U.S. Supreme Court has yet to settle this matter, and courts are now faced …

Review And Reflection: Copyright Hearings And Related Discourse In The Nation’S Capital, 13 J. Marshall Rev. Intell. Prop. L. 487 (2014), Maria A. Pallante

UIC Review of Intellectual Property Law

On February 28, 2014, the Register of Copyrights of the United States and Director of the U.S. Copyright Office Maria A. Pallante delivered a keynote speech on the copyright hearings and related discourse in the nation’s capital. The speech was given at The John Marshall Law School’s 58th Annual Intellectual Property Conference. This article is based on her speech at the Conference.

Adopting Pharmacogenomics And Parenting Repurposed Molecules Under The Orphan Drug Act: A Cost Dilemma?, 13 J. Marshall Rev. Intell. Prop. L. 667 (2014), David C. Babaian

UIC Review of Intellectual Property Law

The business model under which the pharmaceutical industry has operated in the recent past has become untenable. The era that has seen a consistent pipeline of blockbuster medicines for common chronic diseases is waning. New paradigms for more efficient and more economical drug development are being sought and implemented. Recent growth both in the repurposing of existing drugs and in the orphan product market has signaled the new hope for success and profit. New technology and the promise of personalized medicine augment the sense of optimism in this time of complementary transition in the wider healthcare industry. Yet, are the …

Protecting Traditional Knowledge In International Intellectual Property Law: Imperatives For Protection And Choice Of Modalities, 14 J. Marshall Rev. Intell. Prop. L. 25 (2014), Tesh Dagne

UIC Review of Intellectual Property Law

The need for protecting traditional knowledge (TK) has been acknowledged in discussion and negotiations under the umbrella of a number of inter-governmental organizations that deal with biodiversity, the environment, indigenous peoples’ rights, human rights, food and agriculture, among others. It has, however, proved difficult to arrive at a consensus on the proper modality that can serve the needs and desires of Indigenous and Local Communities (ILCs) in their economic and cultural participation. The article examines the imperatives for the protection of TK and explores the modalities of TK protection at the international level for regulating the control of, access to …

Struggles On The Path To Renewable Energy: Lessons From Sunzia, Rachel Giron

Natural Resources Journal

The SunZia Southwest Transmission Project is a high-voltage transmission line under development in southern New Mexico and Arizona. The project was created to allow the expansion of the renewable energy production economy, and is also part of larger efforts at climate change mitigation. It has the support of federal and state governments, and has been fast-tracked by the Obama Administration. However, in spite of its potential to increase the availability of clean energy, conflicts between local environmental groups and government agencies over siting difficulties have impeded its development. Efforts to streamline the permitting process have been largely unsuccessful, as they …

Migrating Towards An Incidental Take Permit Program: Overhauling The Migratory Bird Treaty Act To Comport With Modern Industrial Operations, Alexander K. Obrecht

Natural Resources Journal

In 1918, Congress passed the Migratory Bird Treaty Act (MBTA) to curb mass avian extermination caused by hunting and poaching. Despite Congress’s initial concern with these activities, the U.S. Fish and Wildlife Service (FWS) expanded the scope of MBTA enforcement to include bird deaths caused by industrial activities. This created a glaring split of authority among U.S. Circuit Courts of Appeals, with one side applying strict liability under the MBTA for all deaths of protected birds caused by industrial activities and the other side refusing to apply the MBTA to indirect and unintentional bird deaths. This article argues that the …

An Environmental Conversation, William Murray Tabb

Natural Resources Journal

Federal environmental law and policy ambitiously purports to provide clean air and water, protect endangered and threatened species, clean-up hazardous and toxic waste sites, and infuse environmental considerations into the decision-making process of all federal agencies with respect to major proposals impacting the environment. Despite such lofty goals and an expansion of the regulatory state, certain types of activities and associated risks have eluded statutory coverage. Additionally, these uncoordinated federal environmental statutes typically embody a singular and sometimes myopic focus, leading to unpredictable or undesirable regulatory gaps, constraints, and inefficiencies. Further, limitations on standing and judicial review may significantly limit …

The Discursive Commons: The Establishment, "Outside Agitators," And "Communist Subversives" In Gadsden's Depression-Era Political Environment, John Disque Agricola

Electronic Theses and Dissertations

This thesis addresses a turbulent and often violent political environment in Gadsden, Alabama during the Great Depression. Using a theoretical construct called the discursive commons my analysis suggests how very particular ideas such as the trope of the outside agitator, and the idea of the communist radical, were used by the establishment to incite violence against United Rubber Workers union organizers who came to Gadsden to enlist members in the 1930s and early 1940s. It is my contention that these discursive formations had affective power over the people who committed acts of violence against their own class interests. This thesis …

Comparing Distance-Based Vs. Time-Based Exercise Prescriptions Of Walking And Running For Improvement Of Cardiovascular Disease Risk Factors, Cody Edward Morris

Electronic Theses and Dissertations

The many benefits of participation in a regular physical activity program are well-documented (Haskell et al., 2007; Pate et al., 1995). Brisk walking and jogging are commodes of exercise that is easily measured and evaluated by a self-report method that is comin both clinical and research settings. Some research has suggested that walking for distance as opposed to walking for time may be a stronger predictor of overall amount of accumulated exercise or physical activity (Williams, 2012a). To our knowledge, research has not been conducted directly comparing a distance-based versus time-based brisk walking prescription for the improvement of cardiovascular risk …

The Effects Of Stress Hormones On Preferences For Acoustic Signals In Female Green Treefrogs (Hyla Cinerea) And Barking Treefrogs (Hyla Gratiosa), Anna Gabriell Davis

Electronic Theses and Dissertations

Ecological stressors (i.e., high predator density, low food availability) are often associated with increased variation in mate choice by females. The association between environmental stressors and variation in mate choice suggests that circulating stress hormones (i.e., glucocorticoids) may mediate such effects, but this idea remains largely unexplored. I examined how circulating glucocorticoids affect preferences for male advertisement calls in female green treefrogs, Hyla cinerea, and barking treefrogs, Hyla gratiosa. Specifically, I examined whether administration of corticosterone (CORT) decreases preferences for call rate and/or call duration - two acoustic features that are highly variable and characteristically under directional selection via mate …

Firesetting And Maltreatment, Amy L. Burnett, Hatim A. Omar

Pediatrics Faculty Publications

In this chapter we try to determine if a link exists between firesetting offenders and a past history of maltreatment. A literature review was performed using research from various studies and populations. Firesetting is a significant problem that affects the world's youth today. Even though there is substantial loss of property and life from juvenile firesetters, there is not a great deal of research to provide insight into early identification of those at risk. In the literature review performed, 6 of 7 studies found a link with maltreatment and firesetting behaviors. There does seem to be a correlation between the …

The Journal Of Undergraduate Research: Volume 12

The Journal of Undergraduate Research

This is the complete issue of the South Dakota State University Journal of Undergraduate Research, Volume 12.

Table Of Contents, Journal Staff

Journal of Pedagogy, Pluralism, and Practice

No abstract provided.

Impact Of Gain-Of-Function Mutations In The Low-Density Lipoprotein Receptor Related Protein 5 (Lrp5) On Glucose And Lipid Homeostasis, Dinah Foer

Yale Medicine Thesis Digital Library

IMPACT OF GAIN-OF-FUNCTION MUTATIONS IN THE LOW DENSITY LIPOPROTEIN RECEPTOR RELATED PROTEIN 5 (LRP5) ON GLUCOSE AND LIPID HOMEOSTASIS. Dinah Foer, Meiling Zhu, Christine Simpson, Grace Lee, Rebecca Sullivan, and Karl L. Insogna. Section of Endocrinology, Department of Internal Medicine, Yale University, School of Medicine, New Haven, CT.

Investigations in animal models suggest a physiologic link between LRP5 and glucose and lipid homeostasis. However, the data in human studies is far from consensus. While LRP5 has been shown to be critical to Wnt signaling, the molecular mechanism for the effect on metabolism is unknown. We hypothesize that a high bone …

Prospective Trial Comparing Topical Steroid Application To Wet Versus Dry Skin In Children With Atopic Dermatitis, Lucinda Shuangyuan Liu

Yale Medicine Thesis Digital Library

PROSPECTIVE TRIAL COMPARING TOPICAL STEROID APPLICATION TO WET

VERSUS DRY SKIN IN CHILDREN WITH ATOPIC DERMATITIS.

Lucinda S. Liu, Yanna Kang, and Richard J. Antaya.

Department of Dermatology, Yale University School of Medicine, New Haven, CT.

The aim of this study was to determine whether "soak and smear," a technique where hydration via a 10-minute soak in lukewarm plain water followed by topical corticosteroid application to wet skin, is efficacious for the treatment of atopic dermatitis in pediatric patients. A randomized, investigator-blinded study was conducted with 45 patients, 4 months to 16 years of age, with moderate to severe atopic …

Role Of Embolic Protection In Transcatheter Aortic Valve Replacement: Results From The Deflect I Study, Stephanie Michelle Meller

Yale Medicine Thesis Digital Library

Utilization of a cerebral protection device during transcatheter aortic valve replacement (TAVR) will reduce the rate of periprocedural stroke as well as the occurrence and volume of new lesions on diffusion weighted magnetic resonance imaging (DW-MRI), which may serve as a potential surrogate endpoint for clinical studies. The DEFLECT I study is a prospective, multi-center, single arm study that aims to demonstrate the safety and performance of the TriGardTM Embolic Deflection Device (EDD) (Keystone Heart, Caesarea Business Park, Israel), among patients undergoing TAVR. Primary endpoints were device performance and in-hospital device-related safety. A powered secondary endpoint was the number and …

A Novel Controlled Release Platform For In Situ Vascular Tissue Engineering, Joseph Thomas Patterson

Yale Medicine Thesis Digital Library

Autologous tissue engineered vascular grafts (TEVGs) are limited by graft stenosis. Small diameter TEVGs implanted as unseeded scaffolds are prone to failure by occlusive luminal proliferation of smooth muscle cells derived from endothelial precursors within a critical period of two weeks. The development, validation, and application novel platform for controlling TEVG performance by local delivery of peptide and/or small molecule therapeutic agents from the TEVG scaffold is presented with insights into the autologous TEVG biology and development.

We hypothesized that inhibition of TGF-βR1 by local delivery of SB-431542, a competitive inhibitor of ALK5/TGFβR1 signaling, is superior to systemic administration of …

Evaluation And Characterization Of The Biomechanical Properties Of Tissue Engineered Vascular Grafts Implanted In The Arterial Circulation, Brooks Van Udelsman

Yale Medicine Thesis Digital Library

We used a murine model to assess the in vivo evolving biomechanical properties of tissue engineered vascular grafts (TEVGs) implanted in the arterial circulation. The initial polymeric tubular scaffold was fabricated from (poly)lactic acid (PLA) and coated with a 50:50 copolymer of (poly)caprolactone and (poly)lactic acid (P[PC/LA]). Following seeding with syngeneic bone marrow derived mononuclear cells, the TEVGs (n=50) were implanted as aortic interposition grafts in wild-type mice and monitored serially using ultrasound. A custom biaxial mechanical testing device was used to quantify in vitro the circumferential and axial mechanical properties of grafts explanted at 3 or 7 months. At …

Identification Of Novel Anti-Brain Tumor-Initiating Cell Compounds Using High-Throughput Screening, Garth William Strohbehn

Yale Medicine Thesis Digital Library

Glioblastoma multiforme is the most common malignant primary intracranial tumor in adults. Despite years of advances in basic science knowledge about this disease including but not limited to cellular hierarchy, genetics, and mechanisms of proliferation and spread, overall survival of patients has remained unmoved for the past fifteen years, and long-term survivors are nearly nonexistent. Barriers to improved treatment occur in the realms of engineering and drug discovery: creation of an efficient delivery vehicle and identification of novel, efficacious small molecule compounds are necessary to achieve survival benefit in this disease.

In the following thesis, I describe efforts made by …

Brainstem Auditory Evoked Potentials And Network Dysfunction In Mild Traumatic Brain Injury, Theresa Lynn Williamson

Yale Medicine Thesis Digital Library

Brainstem Auditory Evoked Potentials and Network Dysfunction in Mild Traumatic Brain Injury

Theresa L. Williamson BS1,2, Amanda R. Rabinowitz PhD1, Victoria E. Johnson MD1, John A. Wolf PhD1, Michael L. McGarvey MD3, Douglas H. Smith MD1 University of Pennsylvania Department of Neurosurgery Philadelphia, PA 191041, Yale School of Medicine New Haven, CT 065112, University of Pennsylvania Department of Neurology Philadelphia, PA 191043

Introduction:

Mild traumatic brain injury (mTBI) challenges clinicians as symptoms do not map in a lesion-specific manner and there is no objective diagnostic measure. Diffuse axonal injury is a main mechanism of injury in mTBI [1, 2]. Injury …

Commonthought (2014), Commonthought Staff

Commonthought

This issue features works created by Lesley University students and covers a broad range of topics. The work itself crosses many disciplines from creative writing to visual arts.

Town Of New Castle, Nh Annual Report 2014 (July 1, 2013 To June 30, 2014)., New Castle Town Representatives

New Castle, NH Annual Reports

This is an annual report containing vital statistics for a town/city in the state of New Hampshire.

Soil And Biosolid Nano- And Macro-Colloid Properties And Contaminant Transport Behavior, Jessique L. Ghezzi

Theses and Dissertations--Plant and Soil Sciences

Despite indications that they are potential contaminant transport systems and threats to groundwater quality, very little effort has been invested in comparing contaminant transport behavior of natural environmental nanocolloids and their corresponding macrocolloid fractions in the presence of As, Se, Pb, and Cu contaminants. This study involved physico-chemical, mineralogical, stability and contaminant-transport characterizations of nano- (< 100 nm) and macro-colloids (100-2000 nm) fractionated from three Kentucky soils and one biosolid waste. Particle size was investigated with SEM/TEM and dynamic light scattering. Surface reactivity was estimated using CEC and zeta potential. Mineralogical composition was determined by XRD, FTIR, and thermogravimetric analyses. Sorption isotherms assessed affinities for Cu²⁺, Pb²⁺, AsO₃^-, and SeO₄^-2 contaminants, while settling kinetics experiments of suspensions at 0, 2 and 10 mg/L contaminants determined stability and transportability potential. Undisturbed 18x30 cm KY Ashton Loam soil monoliths were also used for …

Mass Arbitration And Democratic Legitimacy, David Horton

University of Colorado Law Review

This Article reviews Margaret Jane Radin's dazzling new book, Boilerplate. Radin makes two central claims about the widespread use of adhesion contracts. First, she argues that the heavy saturation of fine print causes "normative degradation," the erosion of contract law's bedrock requirement of consent. Second, and more provocatively, she contends that the lockstep use of standard forms permits private actors to override the public laws and thus causes "democratic degradation." This Article uses developments in consumer and employment arbitration as a proving ground for Radin's democratic degradation thesis. Spurred on by the United States Supreme Court's interpretation of the Federal …

The Marine Microbial Eukaryote Transcriptome Sequencing Project (Mmetsp): Illuminating The Functional Diversity Of Eukaryotic Life In The Oceans Through Transcriptome Sequencing, Patrick J. Keeling, Fabien Burki, Heather M. Wilcox, Bassem Allam, Eric E. Allen, Linda A. Amaral-Zettler, E. Virginia Armbrust, John M. Archibald, Arvind K. Bharti, Callum J. Bell, Bank Beszteri, Kay D. Bidle, Connor T. Cameron, Lisa Campbell, David A. Caron, Rose Ann Cattolico, Jackie L. Collier, Kathryn Coyne, Simon K. Davy, Phillipe Deschamps, Sonya T. Dyhrman, Bente Edvardsen, Ruth D. Gates, Christopher J. Gobler, Spencer J. Greenwood, Stephanie M. Guida, Jennifer L. Jacobi, Kjetill S. Jakobsen, Erick R. James, Bethany Jenkins, Uwe John, Matthew D. Johnson, Andrew R. Juhl, Anja Kamp, Laura A. Katz

Biological Sciences: Faculty Publications

No abstract provided.

Safety And Efficacy Of Ceftaroline Fosamil In The Management Of Community-Acquired Bacterial Pneumonia, Heather F. Debellis, Kimberly L. Barefield

PCOM Scholarly Works

Ceftaroline fosamil is a new fifth-generation cephalosporin indicated for the treatment of community-acquired bacterial pneumonia (CABP). It possesses antimicrobial effects against both Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), but not against anaerobes. Organisms covered by this novel agent that are commonly associated with CABP are Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis, and Klebsiella pneumoniae; however, ceftaroline fosamil lacks antimicrobial activity against Pseudomonas and Acinetobacter species. FOCUS 1 and FOCUS 2 clinical trials evaluated the use of ceftaroline fosamil in the treatment of CABP as compared to ceftriaxone. These non-inferiority trials provided evidence that ceftaroline fosamil …

Antibiotic Lock Therapy: Review Of Technique And Logistical Challenges, Julie Ann Justo, P Brandon Bookstaver

Faculty Publications

Antibiotic lock therapy (ALT) for the prevention and treatment of catheter-related bloodstream infections is a simple strategy in theory, yet its real-world application may be delayed or avoided due to technical questions and/or logistical challenges. This review focuses on these latter aspects of ALT, including preparation information for a variety of antibiotic lock solutions (ie, aminoglycosides, beta-lactams, fluoroquinolones, folate antagonists, glycopeptides, glycylcyclines, lipopeptides, oxazolidinones, polymyxins, and tetracyclines) and common clinical issues surrounding ALT administration. Detailed data regarding concentrations, additives, stability/compatibility, and dwell times are summarized. Logistical challenges such as lock preparation procedures, use of additives (eg, heparin, citrate, or ethylenediaminetetraacetic …

Alternative Splicing In The Variable Domain Of Camkiiβ Affects The Level Of F-Actin Association In Developing Neurons., Jun Zheng, Lori R. Hardy, Chengshi Xu, Jing Kuang, Weijing Liao

PCOM Scholarly Works

The Ca(2+)/calmodulin (CaM)-dependent protein kinase II (CaMKII) β has an essential function in dendritic spines via binding to and reorganization of the actin cytoskeleton during plasticity events not shared by CaMKIIα isoform. CaMKIIβ and CaMKIIα isoforms have remarkable structural differences within the variable region. Three exons (E1, E3, and E4) are present in CaMKIIβ but not in CaMKIIα gene. Four splice variants of CaMKIIβ isoforms (CaMKIIβ, β', βe and β'e) were discovered in embryonic and adult brains. Exons E1 (lacked in βe and β'e) and E4 (lacked in β' and β'e) are subject to differential alternative splicing. We hypothesized that …

Sorting Sheep And Goats In Medieval Iceland And Greenland Local Subsistence, Climate Change, Or World System Impacts?, Thomas Mcgovern, Ramona Harrison, Konrad Smiarowski

Publications and Research

Large archaeofaunal collections recovered from Viking Age and Medieval sites in Iceland and Greenland during intensive collaborative fieldwork over the past decade have demonstrated a diverging pattern in sheep and goat (caprine) management after ca. 1200 CE in the two Norse communities. Since Landnám (first settlement), flocks in both places contained a mixture of sheep and goats and survivorship profiles suggest a very mixed milk-meat-wool production strategy. By the late 13^th century Icelandic herds were nearly all sheep, and zooarchaeological evidence suggests an increasing focus on wool production. Greenlandic archaeofauna indicate that farmers maintained the old Viking Age pattern …

Rna Silencing Suppression Activity Of The Proteins Encoded By The Brome Mosaic Virus Rna Genome, Philipp Heinrich Weber

Graduate Research Theses & Dissertations

The purpose of this study was to investigate the RNA silencing suppression activity of the proteins expressed by the Brome mosaic virus (BMV). For this purpose a binary, pCambia-based vector containing a GFP (Green Fluorescence Protein) gene was introduced into leaves of Nicotiana benthamiana (N. benthamiana) by agroinfiltration. The GFP gene gets transiently expressed, visualized by fluorescence activity under UV-light, and partially silenced by the RNA silencing activity (RNAi) of N. benthamiana, as described before. The RNAi-based silencing in turn can be suppressed by a co-infiltrated and also transiently expressed vector, which carries a RNA silencing suppressor-gene. The suppression of …