Hood College Biomedical and Environmental

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    SURVEY OF CORHICULA FLUMINEA IN OWENS CREEK AND CONDITION INDEX VALUES
    (2016-12) Int Veldt, Sharon; Hood College Biology; Biomedical and Environmental Science
    Corbicula fiuminea is an invasive clam from Southeast Asia that can be found in waterways across the United States. However, little research has been done to determine how sediment organic matter effects clams' distribution and condition indices. A field survey established that the clams in a third order piedmont stream preferred low organic sediment, moderate flows, and the intermediate depths. Contrary to other research, the condition or length of the clams does not seem to change with various amounts of sediment organic content. Although this study did not show that clams' condition or abundance increased with rising sediment organic matter values, C. fiuminea could have major impacts on stream dynamics in this stream and other locations through bioturbation and filter feeding.
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    SELECT DNA SEQUENCE ANALYSIS OF THE FANCONI ANEMIA COMPLEMENTATION GROUP A GENE, FANCA, IN DIVERSE GEOETHNIC CONTROL POPULATIONS
    (2005-04) Hutchinson, Amy Ann; Hood College Biology; Biomedical and Environmental Science
    Fanconi anemia (FA) is a rare, autosomal recessive disorder characterized by bone marrow failure, a distinct dysmorpho logy and predisposition to certain cancers. Mutations within the FA complementation group A gene, FANCA, are responsible for up to 80% of Fanconi anemia cases. While greater than 200 FANCA mutations have been identified in patients, no comprehensive sequence analysis of non-disease causing alleles has been completed. In an effort to demonstrate how cancer predisposition in Fanconi anemia may be used as a model for the study of cancer susceptibility in healthy individuals, we have sequenced the FANCA gene in 402 control individuals from several geo-ethnic populations. Using sequencing data from two discrete regions of the FANCA gene, one area of high mutational rate and one of low mutational rate, we confirmed the hypothesis that genomic regions with a higher occurrence of disease-causing mutations would have a lower rate of genetic variation in normal populations.
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    ANALYSIS OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC PROFILES OF THE 16S rRNA GENE TO IDENTIFY GENERA OF BACTERIA
    (2002-08) Hurtle, William; Hood College Biology; Biomedical and Environmental Science
    Denaturing high performance liquid chromatography (DHPLC) is used in a wide variety of genetic applications. This report introduces a new application for this technique, the identification of bacteria. We combined the capability of DHPLC to detect sequence variation and the principles of rRNA genotyping analysis to develop a high throughput method of identifying microorganisms. Forty-six bacterial species from a broad spectrum of genera were tested to determine if DHPLC could be used for identification. Thirty-six of the 46 species of bacteria had a unique peak profile that could be used as a molecular fingerprint. Furthermore, a blind panel of 65 different bacterial isolates was analyzed to demonstrate the capability of this method to specifically identify Yersinia pestis and Bacillus anthracis. Ten of 10 Y. pestis samples and 12 of 14 B. anthracis were correctly identified. The procedure had an overall specificity of 100%, overall sensitivity of 91.7%, and a predictive value of 96.9%. The data suggest that DHPLC of amplicons spanning regions of genetic variability will be a useful application for bacterial identification.
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    OVEREXPRESSION OF ADENYLATE CYCLASE ISOFORMS ALTERS CELL SIGNALING PATHWAYS IN NFI-NULL MALIGNANT PERIPHERAL NERVE SHEATH TUMORS
    (2017-11) Hughes, JoAnna; Hood College Biology; Biomedical and Environmental Science
    The second messenger, cyclic-AMP (cAMP), is produced by ten adenylate cyclase (ADCY) isoforms. Previous studies indicate that ADCY isoforms may lead to either activation or inhibition of cAMP-dependent protein kinase (PKA), cAMP expression is increased in response to neurofibromin (NFI) mutations, and malignant peripheral nerve sheath tumors (MPNST) express more ADCY isoforms. ADCY expression and function are modulated by four adenosine receptors (ADORA), which have different effects on ADCY. We aimed to overexpress ADCY 3, 6, 7, and 9 in different cell lines to dissect the mechanism of how cAMP expression is altered after NFI loss. Overexpression of ADCY 7 significantly affected PKA activity. Overexpression of ADCY 9 led to increased expression of ADORA I, 2B, and 3 in MPNST cells. Overexpressed ADCY 3 and 7 increased ADORA 3 expression as well. These data indicate that changes in ADCY and ADORA expression in MPNSTs may account for changes in cAMP expression after loss of NFI.
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    ANALYSIS OF ULTRAVIOLET RADIATION-INDUCED DNA DAMAGE AND THE PRESENCE OF MYCOSPROINE-LIKE AMINO ACIDS (MAAs) IN THE SEA ANEMONE AIPTASIA .PALLIDA
    (2007-08) Hudson, Claire; Hood College Biology; Biomedical and Environmental Science
    Ultraviolet radiation (UVR) is a commonly occurring genotoxin in tropical marine environments. While shallow-water organisms have a variety of defenses against UVR, DNA damage can still occur. documented the extent of DNA damage and subsequent repair response in the sea anemone Aiptasia pallida under both laboratory and field conditions. In addition the presence of specific biological UVR sunscreens, mycosporine-like amino acids (MAAS) was determined. Cultured A. pallida and freshly collected field anemones from Walsingham Pond, Bermuda were examined for the presence of MAAs. In addition, an experiment was carried out to determine their efficiency to repair DNA damage incurred in cultured aposymbiotic anemones and field-collected animals when exposed to UVR using the comet assay. It was found that field anemones produce relatively large quantities of MAAs and efficiently repaired DNA damage incurred from a reduced level of natural UVR. Clonal aposymbiotic anemones produced much smaller quantities of MAAs than either the field-collected anemones or cultured symbiotic animals. In addition, aposymbionts appeared to less efficiently repair DNA damage under laboratory conditions than field-collected symbiotic counterparts. In the presence of photosynthetically available radiation (PAR), results presented here suggest that clonal aposymbionts maybe capable of producing the enzyme photolyase, which is responsible for the reactivation of UV-induced photoproducts. Results presented here suggest that the ability of A. pallida to repair DNA damage and/or protect themselves from the detrimental effects of UVR may be an important factor for their survival.
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    Increased Threshold Sensitivity of Viral Load Determinations Using an Optimized Sample Processing Method
    (2003-04) Hoffman, Andrea N.; Hood College Biology; Biomedical and Environmental Science
    A new sample processing method was developed to support quantitative RT-PCR (Reverse Transcription-Polymerase Chain Reaction) assays to determine plasma viral load in SIV-infected (Simian Immunodeficiency Virus) Rhesus macaques, an important model for HIV-1 (Human Immunodeficiency Virus Type 1) infection in humans. The method allows for up to 1.5 milliliters of plasma to be tested resulting in an assay threshold sensitivity as low as 20 copies of SIV RNA (ribonucleic acid) equivalents per milliliter of plasma. The method yields high and consistent recoveries of high quality RNA, demonstrated for a range of samples containing from 3 to 10,000 nominal virus particles. An inter-assay percent coefficient of variation of 36% and an intra-assay percent coefficient of variation of 19% were demonstrated, both consistent with the inherent variations in the RT-PCR assay itself and suggestive that the processing method does not contribute any additional, significant variation to the testing. It is also able to accommodate over 70,000 'contaminating' cells per sample with no effect on the RNA yield and amplification efficiency of the assay. Any carryover and concentration of potentially inhibitory material is negligible, as no effect on the efficiency and performance of the RT-PCR assay was noted for any cell-free sample. The method is convenient, with all operations performed in a single microcentrifuge tube, which also avoids any loss of RNA due to sample transfers as is common with other methods. This new processing method represents a significant improvement over that previously applied to quantitative RT-PCR assays for SIV load determinations in cell-free samples and can be readily extended to assays for other retroviral targets in clinical specimens, such as HIV-1.
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    THE EFFECTS OF ONCOGENIC RAS ON FAS EXPRESSION AND SUSCEPTIBILITY TO FAS-MEDIATED APOPTOSIS
    (1998-01) Hixon, Julie A.; Hood College Biology; Biomedical and Environmental Science
    Cancer is a disease characterized by unregulated cell accumulation resulting from either an increase in the rate of cell proliferation and/or a decrease in the rate of cell death. Regulation of these two processes is of great importance to the development and progression of cancer. One gene involved in the regulation of normal cell growth and differentiation is ras. Ras proteins alter gene expression by activating multiple downstream signal transduction pathways, resulting in the activation of protein kinases that translocate to the nucleus where they mediate the activation of various transcription factors. Mutations within the ras proto-oncogene generate constitutively active forms of Ras that disrupt normal controls on cellular growth and differentiation, leading to the development of a transformed state. Mutations within the ras proto-oncogene have been identified in 30% of human cancers, including cancers of the lung, colon, and pancreas. Although the effects of mutant ras oncogenes on tumor cell proliferation have been well characterized, little is known about the possible anti-apoptotic effects of mutant ras.
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    METHOD VALIDATION OF A MOUSE POTENCY BIOASSAY FOR THE RECOMBINANT BOTULINUM NEUROTOXIIN TYPE A, C-FRAGMENT rBoNTA(Hc) VACCINE (GLP STUDY)
    (1999-06) Hinz, Matthew; Hood College Biology; Biomedical and Environmental Science
    The method validation of the mouse potency assay examined the critical parameters of the assay and determined the suitability of the assay to produce credible data. The basic potency assay was examined to determine what impact different analysts, dose-challenge schedules and mouse shipments had on the method and its reproducibility. Groups of ICR mice were inoculated with varying doses of rBoNTA(Hc) vaccine, and 21 or 23 days later the animals were challenged with botulinum type a toxin, Hall A strain. The mice were observed for 5 days after challenge, and survival rates and the 50% effective doses (ED50) were calculated. The analysis of the potency assay was based on Repeatability, Intermediate Precision, Accuracy, Linearity, Specificity, Ruggedness and Suitability. The assay was highly precise for an in vivo assay, with an overall coefficient of variation (CV) of 9.02 % for the Log10 ED50. The potency exceeded expected values and thereby failed the acceptance criteria. The results of the assay were determined to be linear and followed the probit model in all but one assay, with an average p-value of 0.664. The specificity experiments demonstrated that the method could precisely measure (CV=11.8%) the potency of the vaccine despite changes in buffers and the addition of non-specific proteins, as long as the adjuvant concentration remained constant. The method was not rugged enough to allow for a change in the immunization and toxin challenge interval. Based on the results and the acceptance criteria set forth in the validation protocol, the mouse bioassay is a highly reproducible, specific method that can be used to evaluate the rBoNTA(Hc) potency of pilot and production lots.
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    DEVELOPMENT AND CHARACTERIZATION OF AN ATP-BASED METHOD FOR DETERMINING THE NUMBER OF VIABLE UNITS IN RECOMBINANT BACILLE CALMETTE, GUERIN VACCINE
    (2016-04) Hill, Krystal L.; Hood College Biology; Biomedical and Environmental Science
    The only licensed vaccine against human pulmonary tuberculosis is BCG; it is a live, attenuated vaccine whose viability is conventionally determined by the CFU assay. Due to the testing time requirements and the variability in the colony counts, the CFU assay has drawbacks for BCG/rBCG vaccine manufacturing in-process and quality control product release testing. By utilizing ATPs usefulness as a marker for cell viability, a faster assay was developed and characterized for validation feasibility. The ATP assay is an easy-to-perform alternative and was shown to correlate to the CFU. Overall, the data indicate that while the ATP is a rapid alternative method for quantifying the viability of BCG/rBCG, validation of the assay will have to be sample-specific.
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    ANALYSIS OF THE ROLE OF C/EBPß IN OVARIAN CELL TYPE SPECIFICATION IN THE MOUSE
    (2005-09) Hill, Heather L.; Hood College Biology; Biomedical and Environmental Science
    C/EBPß is a transcription factor essential for the differentiation of follicular granulosa cells in the mouse ovary. To further investigate the role of C/EBPß in ovarian cell type specification regulated by hormones, transplantation of ovaries between wild-type and C/EBP13-deficient mice were performed. We found that C/EBPß null granulosa cells are able to differentiate in a wild-type host if no host ovary is present. Furthermore, we found that C/EBPß-deficiency promotes transdifferentiation of granulosa cells to sertoli cells, which are normally found in testes but share a developmental precursor. Furthermore, transdifferentiation is under complex positive and negative regulation by systemic hormones. Ovarian sertoli-like cells are known to develop in aged ovaries and can lead to rare sertoli-form tumors. Our data demonstrate that C/EBPß and hormones participate in maintaining the granulosa cell phenotype, and shed some light on the molecular pathways that can lead to the generation of sertoli cells in ovaries.
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    THE EFFECTS OF POLYVINYL CHLORIDE AND POLYOLEFIN BLOOD BAGS ON RED BLOOD CELLS STORED IN A NEW ADDITIVE SOLUTION
    (2000-04) Hill, Heather R.; Hood College Biology; Biomedical and Environmental Science
    The standard collection system container for blood donation is composed of polyvinyl chloride (PVC), with a plasticizer, di-2-ethylhexyl phthalate (DEHP). There are several advantages to this system. Serendipitously, it was discovered that DEHP leaches from the bag into the blood and lengthens the storage life of red cells. Unfortunately, DEHP has been shown to be toxic in laboratory animals. While the degree to which this is applicable to toxicity in humans is unclear, many that have studied the animal data have advocated that an alternative collection system be found. More recently, other groups have been calling for an alternative based on the health and environmental concerns. The large-scale production of PVC and DEHP has resulted in widespread environmental contamination and occupational hazards. Additionally, the incineration of the blood bags as medical waste generates dioxins and other halogenated hydrocarbons. The process of providing blood for transfusion with the current system has not been an environmentally benign process. However, a new storage solution recently developed, Experimental Additive Solution #61 (EAS-61), showed promise that an alternative material could be used to store blood. This study examined whether this additive solution would permit acceptable shelf-life of blood in polyolefin (PO), eliminating the need for the chlorine-containing plastic as well as the plasticizer, by measuring the major in vitro parameters associated with red cell quality when stored in both plastics. While EAS-6I improves storage of red cells in PVC/DEHP, this study was unable to show that it would do the same in an alternative material. The quality of the red cells stored in PO does not meet the standards for blood provided for transfusion.
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    MARYLAND'S ANURAN POPULATIONS: ARE THEY AT RISK FROM ANTHROPOMORPHIC IMPACT
    (2005-01) Hildebrand, Wayne G.; Hod College Biology; Biomedical and Environmental Science
    From 1999 to 2003, roadside frog chorus surveys were conducted across the state of Maryland by volunteers per the North American Amphibian Monitoring Program protocol. The data generated was used to test the hypothesis that more anuran species are present in habitats with lower anthropomorphic impact. In other words, I predicted that more frog species would inhabit undeveloped areas compared to developed areas and agricultural areas. Statewide there was trend in anuran species diversity compared to land use. Anurans marginally preferred agricultural areas. Only one species, Rana virgatipes, significantly preferred undeveloped areas. It should be stressed that this study does not imply or support that agricultural wetlands are beneficial to all anurans. Only that a greater diversity of anurans were observed at the agricultural sites monitored in this study. Indeed the data for R. virgatipes suggests that some species were negatively impacted by agricultural land use. The populations of thirteen Maryland anuran species (R. catesbeiana, R. clamitans, R. palustris, R. sylvatica, R. virgatipes, R. sphenocephala, Bufo americanus, Acris crepitans, Pseudacris crucifer, P. feriarum, Hyla cinerea, Gastrophryne carolinensis, and Scaphiopus holbrookii) were stable during this study. Detection rates of two species, H chrysoscelis I versicolor and B. fowleri, increased over the course of this study. The remaining three species of Maryland anurans (R. pipiens, P. brachyphona, and H gratiosa) were not detected in this study.
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    EFFECTS OF BRYOSTATIN ON NATURAL KILLER CELLS ALONE OR IN COMBINATION WITH INTERLEUKIN-12
    (2008-05) Hilburn, Joanne M.; Hood College Biology; Biomedical and Environmental Science
    We investigated a possible new approach towards enhancing the immune response. We generated mRNA expression profiles upon treatment of the natural killer 92 (NK92) cell line with individual agents in comparison to treatment with two agents at the same time. The NK cells were either untreated, treated with interleukin-12 (IL-12), phorbol myristic acetate (PMA), bryostatin, or a combination of PMA + IL-12 or bryostatin + IL-12. mRNA from each treatment was converted to labeled cDNA and hybridized to oligonucleotide microarrays for measuring gene expression. Measurements from arrays and Q-PCR determined which genes might be potential biomarkers for bryostatin + IL-12 or bryostatin compared to PMA. These genes were RRM2B, TBCD2B, PLAU, LIMA1, CCR1, SPRED2 and FHOD1.. Analysis of functional terms in the Gene Ontology (GO) database for both bryostatin and bryostatin. + IL-12 treatments revealed good evidence that cells were active and proliferating, crucial for NK cell-based immunotherapy.
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    The Impact of Insects on the Invasive Plant, wavyleaf basketgrass (Oplismenus undulatifolius): A Field Exclusion Experiment
    (2015-05) Heiselmeyer, Tamara; Hood College Biology; Biomedical and Environmental Science
    The association between the insect community and an invasive grass, Oplismenus undulatifolius, in Maryland and Virginia was examined at two sites, one invaded and one un-invaded. A visual damage assessment was used to examine insect herbivory on leaves from the invaded site. Sticky and pitfall traps set in both sites were used to evaluate the community structure of ground-dwelling insects. Findings from this field experiment showed that 1) insects are feeding on 0. undulatifolius, but insect herbivory has no detectable impact on reproduction or growth and 2) an invasion of 0. undulatifolius does not appear to have a significant impact on the insect community structure. Implications of this study and future research are discussed.
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    SUBLETHAL EFFECTS OF TRICLOSAN ON POTAMOGETON PERFOLIATUS AND ELODEA CANADENSIS
    (2008-05) Heilman, Katherine E.; Hood College Biology; Biomedical and Environmental Science
    Triclosan is found in the aquatic environment throughout the United States and western Europe due to its extensive use as a household antimicrobial. Two species of aquatic vegetation native to the Chesapeake Bay, Potamogeton perfoliatus and Elodea canadensis, were exposed to triclosan. Responses measured after a 72-hour exposure to triclosan were peroxidase activity, chlorophyll-a, and dissolved oxygen production. Plants were also observed for changes in appearance, such as chlorosis. P. perfoliatus and E. canadensis treated with triclosan began to show statistically significant differences between concentrations as low as 3 and 30 ug/L. Tolerance to triclosan varied between the two species of aquatic vegetation.
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    Bi-directional Activity of the RARa Promoter is Inhibited by SV40-associated GC Repeats
    (2000-05) Hazen, Allison Ann; Hood College Biology; Biomedical and Environmental Science
    Retinoic acid receptors (RARs), are nuclear transcription factors that interact with other nuclear hormone receptors. Based on published data, the RARa promoter was PCR-amplified, ligated into the pGL3 basic luciferase reporter vector and transfected into Jurkat cells. Results showed that the RARa promoter was active in both the sense (RP) and the antisense (AsRP) orientations. Also, the promoter was inhibited in both orientations when ligated into the pGL3 enhancer vector. The mechanism of inhibition was further investigated. The enhancer portion of the pGL3 enhancer vector contains two different components of the SV40 virus DNA. One is the SV40 enhancer, which is composed of two 72 bp repeats (En). The other component is three 21 bp repeats that are elements of the SV40 early promoter (GC3). Each 21 bp repeat contains two binding sites for the transcription factor Sp1. Removal of the 21 bp repeats in the pGL3 enhancer resulted in enhancement of the AsRP activity, demonstrating that the repeats have a role in inhibition of the promoter. Bi-directional activity of the RARa promoter was also observed in MCF7, HepG2, RD131, CEM-SS and HeLa cell lines. However, the enhancement and inhibition caused by En and EnGC3 in Jurkat cells were found to be cell-type specific. The inhibition by the 21 bp repeats was further investigated by changing the arrangement of 21 bp repeats. Removing the first 21 bp repeat resulted in a 7-fold increase in promoter activity. Separation of the remaining two 21 bp repeat units by 6 bp resulted in inhibition of the promoter. A point mutation in this inhibitory region, causing disruption in one of the Sp1 binding sites, resulted in a 20-fold enhancement of promoter activity. These results indicate that the enhancement and inhibition of the RARa promoter is affected by the arrangement of Sp1 binding sites in the enhancer region. It is proposed that the mechanism of enhancement is due to physical association of Sp1 protein bound to the sites in the promoter and to sites in the enhancer, allowing interaction between the enhancer and the promoter. This association can stabilize the transcription apparatus. It is thought that the inhibition observed is due to changes in the spatial conformation of the Sp1 proteins bound to the GC units. These changes could alter the distance between the Sp1 domains that associate together such that association of the enhancer-bound Sp1 protein cannot occur with the Sp1 protein bound to the promoter region of the vector.
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    SAFETY PHARMACOLOGY STUDY OF HER1-ECD THERAPEUTIC CANCER PEPTIDE VACCINE IN A HUMANIZED MOUSE MODEL
    (2015-05) Haynesworth, Katarzyna; Hood College Biology; Biomedical and Environmental Science
    The purpose of this study is to conduct a Safety Pharmacology evaluation of HERT-ECD vaccine in a humanized mouse model as a part of the Investigational New Drug package to be submitted to the Food and Drug Administration (FDA). The humanized mice will be created via engraftment of human peripheral blood mononuclear cells (PBMCs) into adult SNOD/Lt-scidnull mice. The Safety Pharmacology assessment will consist of evaluation of the potential to cause undesirable effects on the cardiovascular and respiratory systems and a special safety study, an in vivo cytokine release syndrome (CRS) assay. After receiving one dose of treatment or controls, respectively, the mice will be bled at nine time intervals to obtain samples for human cytokine evaluation using the MSD Th1/Th2 ELISA kit (Meso Scale Discoveries). Additionally, the mice will be placed on an ECGenie (Mouse Specifics, Inc.) electrocardiogram for cardiovascular evaluation and into a FinePointe whole-body plethysmograph (Buxco Electronics) chamber for respiratory evaluation. Statistical appraisal of treatment versus control results will include two-way ANOVA and Student's t-test.
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    IDENTIFICATION OF PATHOGENS CORRELATED WITH MULTOPLE SCLEROSIS: A METAGENOMIC APPROACH.
    (2014-01) Harrington, Robin; Hood College Biology; Biomedical and Environmental Science
    The purpose of this study is to determine if pathogenic infections are associated with multiple sclerosis (MS). There have been numerous hypotheses advanced that attribute infections including viruses, bacteria, and fungi to the cause of MS. Infections have been implicated in causing other demyelinating diseases such as neuromyelitis optica (NMO), acute transverse myelitis (ATM), and acute disseminated encephalomyelitis (ADEM). A metagenomic analysis will be done using blood samples from three groups: subjects recently diagnosed with MS, healthy controls, and subjects with other demyelinating diseases. The study will use the Illumina HiSeq platform to sequence nucleic acids present in these samples. Using a metagenomic approach, the pathogenic sequences in the different groups will be compared to identify any pathogen(s) that have a higher prevalence in the MS group. The results will confirmed by PCR and Sanger sequencing and further analyzed to determine if there is a correlation between the MS group and the other demyelinating diseases control group using multinomial logistic regression. Additional studies will be needed to determine if any identified pathogen(s) are causative agents of MS or incidental infections.
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    IpaH7.8 intracellular location and secretion patterns.
    (2005-02) Hansen, Jason; Hood College Biology; Biomedical and Environmental Science
    Shigella is an environmental contaminant of water and food in many countries throughout the world. To infect cells of the large intestine Shigella employs the use of the type III secretion system (TTSS). The TTSS is present in many animal and plant pathogens other than Shigella. Several effector proteins secreted by Shigella via the TTSS during invasion show significant homology between species. In this study the intracellular location of IpaH7.8 and its secretion pattern in several key mutants (SF619, SF620 and SF621) was evaluated. Secretion patterns from IpaB and IpaC mutants suggest that wild type secretion of IpaH7.8 is dependent upon their presence. To determine intracellular location, fusions of IpaH7.8, IpaH9.8, lpgB1, and IpaB to GFP in mammalian expression vectors were used to transfect HeLa cells. HeLa cells transfected with IpaH7.8-GFP and IpaH9.8-GFP showed significant concentration of the IpaH proteins in the nucleus of the cells. lpgB1-GFP was located exclusively in the mitochondria and IpaB was located in the cytoplasm. The findings of this research show that IpaH7.8, like its homologs YopM and IpaH9.8, is transported to the nucleus of HeLa cells.
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    THE IMPACT OF ACCELERATED APPROVAL ON ONCOLOGY DRUGS AND THE APPARENT LACK OF DUE DILIGENCE BY PHARMACEUTICAL COMPANIES
    (2014-05) Hamre, John R. III; Hood College Biology; Biomedcial and Environmental Science
    The accelerated approval program was introduced in response to a need for faster approval times for new drugs in patients with severe illnesses. The goal of this analysis was to determine if accelerated approval is beneficial and to address the strengths and weaknesses. This project gathered additional data and updated previous results from Johnson et al. (2011). Drug data in this study was collected and tabulated in a similar fashion to Johnson et al. (2011) for the following three years, from July 1, 2010 to July 1, 2013. The results show that the program has been very successful at getting new drugs to patients faster. The data provides, however, evidence that many drugs are remaining on the market for statistically significant periods of time without confirmatory trials to prove efficacy. This is attributable to a lack due diligence by pharmaceutical companies and an absence of clear rules by the FDA.