Comprehensive Study Identifies a Sensitive, Low-Risk, Closed-System Model for Detection of Fungal Contaminants in Cell and Gene Therapy Products

2021 ◽  
Author(s):  
Nicole E. Putnam ◽  
Anna F. Lau
Keyword(s):  
Closed System ◽  
Test Performance ◽  
The United States ◽  
Diverse Range ◽  
Sterility Testing ◽  
Delayed Entry ◽  
Test Sensitivity ◽  
Food And Beverage ◽  
Testing Algorithm ◽  
Fungal Contaminants

The United States Food and Drug Administration (FDA) regulates manufacturing and testing of advanced therapeutic medicinal products (ATMPs) to ensure the safety of each product for human use. Gold standard sterility testing (USP<71>) and alternative blood culture systems have major limitations for the detection of fungal contaminants. In this study, we evaluated the performance of i LYM media (designed originally for the food and beverage industry) to assess its potential for use in the biopharmaceutical field for ATMP sterility testing. We conducted a parallel evaluation of four different test systems (USP<71>, BacT/ALERT, BACTEC, and Sabouraud Dextrose Agar [SDA] culture), three different bottle media formulations ( i LYM, i FA + , and Myco/F Lytic), and two incubation temperatures (22.5°C and 32.5-35°C) using a diverse set of fungi ( n =51) isolated from NIH cleanroom environments and previous product contaminants. Additionally, we evaluated the effect of agitation versus “delayed entry” static pre-incubation on test sensitivity and time to detection (TTD). Overall, delayed entry of bottles onto the BacT/ALERT or BACTEC instruments (with agitation) did not improve test performance. USP<71> and SDA culture continued to significantly outperform each automated culture condition alone. However, we show for the first time, that a closed-system, dual-bottle combination of i LYM 22.5°C and i FA + 32.5°C can provide high fungal sensitivity, statistically comparable to USP<71>, when tested against a diverse range of environmental fungi. Our study fills a much-needed gap in biopharmaceutical testing and offers a favorable testing algorithm that maximizes bacterial and fungal test sensitivity whilst minimizing risk of product contamination associated with laboratory handling.

The Impact of Oil Price Fluctuations on Industry Stock Returns: Evidence from International Markets

2018 ◽  
Vol 5 (1) ◽  
pp. 1-12
Author(s):  
Elias Randjbaran ◽  
Reza Tahmoorespour ◽  
Marjan Rezvani ◽  
Meysam Safari
Keyword(s):  
Stock Returns ◽  
Oil And Gas ◽  
Negative Relationship ◽  
The United States ◽  
Oil Price ◽  
Price Variation ◽  
Price Changes ◽  
Price Fluctuations ◽  
Food And Beverage ◽  
The Impact

This study investigates the impact of oil price variation on 14 industries in six markets, including Canada, China, France, India, the United Kingdom, and the United States. Panel weekly data were collected from June 1998 to December 2011. The results indicate that price fluctuations primarily affect the Oil and Gas as well as the Mining industries and have the least influence on the Food and Beverage industry. Furthermore, in three out of six of these countries (Canada, France, and the U.K.), oil price changes negatively affect the Pharmaceutical and Biotechnology industry. One possible reason for the negative relationship between oil price changes and the Pharmaceutical and Biotechnology industries in the above-mentioned countries is that the governments of these countries fund their healthcare systems. Portfolio managers and investors will find the results of this study useful because it enables adjusting portfolios based on knowledge of the industries that are impacted the most or the least by oil price fluctuations.

scholarly journals Food Bank Donations in the United States: A Landscape Review of Federal Policies

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3764
Author(s):  
Katelin M. Hudak ◽  
Emily Friedman ◽  
Joelle Johnson ◽  
Sara E. Benjamin-Neelon
Keyword(s):  
United States ◽  
Nutritional Quality ◽  
Food System ◽  
The United States ◽  
Healthy Food ◽  
Food Banks ◽  
Food Bank ◽  
Federal Policies ◽  
Food And Beverage

Rates of food insecurity have increased substantially in the United States (US), and more families are turning to the charitable food system to help meet their needs. Prior studies have examined the nutritional quality of foods offered through food banks, but little is known about what government policies may shape the healthy food donation landscape. The purpose of this study was to review US federal policies that impact food and beverage donations to food banks and assess whether policies encourage healthy food donations. In spring 2020, two researchers independently reviewed federal food and beverage donation policies using predefined search terms in two legal databases. We identified six categories of policies based on the existing food donation literature and themes that emerged in the policy review. We identified 42 federal policies spanning six categories that addressed food and beverage donations to food banks. The largest category was “government programs,” with 19 (45%) policies. The next largest category was “donation via schools,” with 12 (29%) policies. However, no policies specifically addressed the nutritional quality of food donations. There is an opportunity for the federal government to strengthen food bank donation policies and improve the nutritional quality of donated foods and beverages.

scholarly journals Relative and Absolute Availability of Healthier Food and Beverage Alternatives Across Communities in the United States

2014 ◽  
Vol 104 (11) ◽  
pp. 2170-2178 ◽  
Author(s):  
Shannon N. Zenk ◽  
Lisa M. Powell ◽  
Leah Rimkus ◽  
Zeynep Isgor ◽  
Dianne C. Barker ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Food And Beverage

American Urban History

Urban Studies ◽  
2021 ◽  
Keyword(s):  
United States ◽  
Social History ◽  
20Th Century ◽  
Urban History ◽  
Population Distribution ◽  
The United States ◽  
Spatial Development ◽  
Late 20Th Century ◽  
Diverse Range ◽  
Historical Profession

American urban history embraces all historiography related to towns, cities, and metropolitan regions in the United States. American urban history includes the examination of places, processes, and ways of life through a broad and diverse range of themes including immigration, migration, population distribution, economic and spatial development, politics, planning, race, ethnicity, gender, and sexuality. Urban history emerged as an identifiable subfield of United States history in the mid-20th century, admittedly well after the establishment of similar areas of inquiry in other professional fields and academic disciplines, particularly sociology. Beginning in the 1930s and 1940s, a small number of academics, led by noted social historian Arthur M. Schlesinger, Sr., commenced the first wave of scholarly interest in American urban history with works on colonial seaports and select 19th-century cities. By the 1950s, urban history coalesced as a recognizable subfield around a reformulation of American history, emphasizing the establishment of towns, rather than the pursuit of agriculture, as the spearhead for the formation and growth of the nation. The 1960s and 1970s witnessed a second round of interest in American urban history, set against the backdrop of the tremendous political and social changes that swept the nation and transformed the historical profession. Through innovative models of scholarship that broke with traditional consensus history, notably pioneering quantitative research methods, a self-identified “new urban history” emerged that emphasized spatial development as well as social, economic, and political mobility, conflict, and change. Over time, this new urban history was largely subsumed within social history, given the fields’ intersecting and overlapping interests in social and political issues viewed through the lenses of race, class, and gender. Social history’s broad focus resulted in an explosion of scholarship that all but dominated the American historical profession by the late 20th century. From the mid-1970s through the 1990s, books with urban settings and themes, most of them well within the camp of social history, won an impressive number of Bancroft prizes and other prestigious awards. Urban history itself has survived—even thrived—without a widely agreed upon canon or dominant research methodology. Scholars continue to make significant contributions to urban history, whether or not they embrace the title of urbanist. Note that attendance at the biannual meetings of the Urban History Association has grown significantly over the last two decades. The sources in this article’s twenty subject headings have been arranged to illustrate the depth and breadth of each prominent theme in the field and are by no means an exhaustive list of such scholarship, but rather a sampling of the most influential and innovative examinations of America’s urban canvas.

Case Studies and Caveats

2019 ◽  
pp. 83-101
Author(s):  
Jonathan H. Marks
Keyword(s):  
Public Health ◽  
United States ◽  
Case Studies ◽  
The United States ◽  
Framing Effects ◽  
Noncommunicable Diseases ◽  
Systemic Effects ◽  
Public Health Agencies ◽  
Health Agencies ◽  
Food And Beverage

This chapter outlines several partnership case studies involving the food and beverage sector, especially soda companies. These case studies are drawn from the United States, Britain, and India. The analysis highlights certain problematic features—for example, use of corporate logos, trademarks, and color schemes that are likely to promote consumption of products that are exacerbating obesity and diet-related noncommunicable diseases (NCDs). But, more fundamentally, the analysis ties the case studies to the broader systemic effects discussed in the preceding chapters. These include framing effects, agenda distortion, and impacts on the integrity of and trust in public health agencies.

Financial relationships between neurologists and industry

Neurology ◽  
2019 ◽  
Vol 92 (21) ◽  
pp. 1006-1013 ◽  
Author(s):  
Aditi Ahlawat ◽  
Pushpa Narayanaswami
Keyword(s):  
Conflicts Of Interest ◽  
The United States ◽  
Prescribing Practices ◽  
Regional Trends ◽  
Food And Beverage ◽  
Data Book ◽  
Retrospective Database Analysis ◽  
Incorrect Information ◽  
Open Payments ◽  
Retrospective Database

ObjectiveTo analyze research and nonresearch payments from the pharmaceutical and device industry to neurologists in 2015 using the Centers for Medicare and Medicaid Services (CMS) Open Payments Database.MethodsIn this retrospective database analysis, we computed the percentage of neurologists in the United States receiving payments, the median/mean payments per neurologist, payment categories, regional trends, and sponsors. We computed the number of practicing neurologists from the Association of American Medical Colleges State Physician Workforce Data Book, 2015.ResultsIn 2015, approximately 96% of US neurologists received nonresearch payments totaling $93,920,993. The median payment per physician was $407. The highest proportion of neurologists (24%) received between $1,000 and $10,000. Food and beverage was the most frequent category (83% of the total number of payments). The highest amount was paid for serving as faculty/speaker for noncontinuing medical education activities (49%). The top sponsor of nonresearch payments was Teva Pharmaceuticals ($16,461,055; 17.5%). A total of 412 neurologists received $2,921,611 in research payments (median $1,132). Multiple sclerosis specialists received the largest proportion ($285,537; 9.7%). Daiichi Sankyo paid the largest amount in research payments ($826,029; 28%).ConclusionsThe Open Payments program was established to foster transparent disclosure of physician compensations from industry, in response to legislative and public concerns of the effect of conflicts of interest on practice, education, and research. The effects of this program remain unclear and studies of changes in prescribing practices, costs, and other outcomes are necessary. CMS should ensure that incorrect information can be rectified quickly and easily.

scholarly journals Dietary Sources of Plasma Trans-Fatty Acids Among Adults in the United States: NHANES 2009–2010

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1436-1436
Author(s):  
Chaoyang Li ◽  
Patricia Richter ◽  
Laura Cobb ◽  
Heather Kuiper ◽  
Jennifer Seymour ◽  
...  
Keyword(s):  
United States ◽  
Fatty Acids ◽  
Trans Fatty Acids ◽  
Vaccenic Acid ◽  
Density Lipoprotein ◽  
The United States ◽  
Lipoprotein Cholesterol ◽  
Gas Chromatography Mass Spectrometry ◽  
Food Groups ◽  
Food And Beverage

Abstract Objectives Trans-fatty acids (TFAs) increase low-density lipoprotein cholesterol, decrease high-density lipoprotein cholesterol, and increase risk of heart disease morbidity and mortality. There are two major sources from foods: industrially produced or artificial TFAs and ruminant or natural TFAs. Dietary TFA intake is estimated to cause half a million deaths annually worldwide and WHO has called for elimination of industrially produced TFAs from the global food supply by 2023. Little is known about these dietary sources for plasma TFAs. The objective of this study was to examine associations between foods consumed and plasma TFA levels using linked data of 24-hour dietary recall and plasma TFA measures among adults aged ≥20 years who participated in the NHANES 2009–2010 in the United States. Methods Over 4400 food products in the dietary interview data were categorized into 32 food and beverage groups/subgroups. Four major plasma TFAs (palmitelaidic acid, elaidic acid, vaccenic acid, linolelaidic acid) were analyzed using gas chromatography-mass spectrometry. Multivariable regression analyses were conducted to identify associations of plasma TFAs with all 32 food and beverage groups/subgroups, controlling potential confounding effects of 11 demographic, socioeconomic, behavioral, lifestyle, and health-related risk factors. Results Consumption of foods in the following food groups/ subgroups were positively associated with elevated plasma TFA levels: cream substitute (P &lt; 0.0001); cakes, cookies, and pies (P &lt; 0.001); milk and milk desserts (P &lt; 0.05); beef and lamb (P &lt; 0.05); and butter (P &lt; 0.05). Conclusions The findings suggest that these five food groups/ subgroups could be the main dietary sources of plasma TFAs among adults in the United States in 2009–2010. Funding Sources N/A.

Rapid HIV testing with same-day results: a field trial in Uganda

1998 ◽  
Vol 9 (3) ◽  
pp. 134-138 ◽  
Author(s):  
William J Kassler ◽  
Mary Grace Alwano-Edyegu ◽  
Elizabeth Marum ◽  
Benon Biryahwaho ◽  
Peter Kataaha ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Test Performance ◽  
Predictive Value ◽  
Field Trial ◽  
Time Frame ◽  
Clinic Visit ◽  
Post Test ◽  
Testing Algorithm ◽  
Aids Information ◽  
Hiv 1

Rapid, on-site HIV testing with same-day results may improve services and increase the number of clients who learn their serostatus in developing countries. To validate test performance under field conditions and assess the change in the proportion of clients who learn their serostatus, we conducted a field trial using the Capillus HIV-1/HIV-2 assay (Cambridge Diagnostics) at the AIDS Information Centre counselling and testing sites in Uganda. Compared to the standard 2-EIA testing algorithm, the sensitivity of Capillus was 99.6% (95% CI; 98.5%, 99.9%), the specificity was 98.8% (95% CI; 98.1%, 99.3%), the positive predictive value was 96.5% (95% CI; 94.5%, 97.8%), and the negative predictive value was 99.9% (95% CI; 99.5%, 100%). It took less than 5 min to perform a single test, and results were returned to clients in less than an hour, during which time clients were counselled. This resulted in a 27% increase in the proportion of clients who learned their serostatus and received counselling. We conclude that simple, rapid HIV tests can be performed accurately on-site within the time frame of a clinic visit, increasing the number of clients who learn their serostatus and receive post-test counselling.

Performance of Older Japanese American Adults on Selected Cognitive Instruments

2013 ◽  
Vol 19 (7) ◽  
pp. 773-781 ◽  
Author(s):  
Nobuko Kemmotsu ◽  
Yurika Enobi ◽  
Claire Murphy
Keyword(s):  
Test Performance ◽  
Verbal Learning ◽  
The United States ◽  
Demographic Variables ◽  
Cognitive Test ◽  
Japanese American ◽  
Trail Making Test ◽  
Third Generation ◽  
Trail Making ◽  
Fluency Test

AbstractThis study examined cognitive test performance of second- and third-generation Japanese American (JA) adults, a relatively homogeneous Asian American subgroup. Sixty-five JA and 65 non-Hispanic White (NHW) adults, ages between 45 and 91, were administered the Boston Naming Test-2 (BNT), Letter Fluency Test, Semantic Fluency Test, California Verbal Learning Test (CVLT), Brief Visuospatial Memory Test-Revised (BVMT-R), and Trail Making Test. Levels of acculturation, quality of educational attainment, and generation status in the United States, were also collected. There were no significant differences in the scores between the two groups on the tests administered. JA and NHW groups, however, differed in the patterns of the associations between some of the test performance and demographic variables. JA adults showed a stronger age-score relationship on BNT, CVLT, and the BVMT-R. Furthermore, second-generation JA adults performed lower than the third-generation adults even after controlling for basic demographic variables on CVLT and Trail Making Test. Acculturation on the other hand did not explain score differences once demographic variables were considered. Our results suggest the importance of considering unique history and characteristics of ethnic groups, and interactions of the aging process and culture on tasks with different cognitive demands. (JINS, 2013, 19, 1–9)

The Political Effects of Religious Cues

2019 ◽  
Author(s):  
Aubrey Westfall ◽  
Özge Çelik Russell
Keyword(s):  
Political Behavior ◽  
Religious Identity ◽  
Complex Dynamics ◽  
The United States ◽  
Religious Language ◽  
Religious Values ◽  
The Political ◽  
Diverse Range ◽  
Political Candidate ◽  
The Way

Religion is a central and comprehensive identity for billions of people all over the world. Politicians and other political actors recognize the vitality of religion and use it for political purposes, deliberately signaling religion, religiosity, or religious values and connecting them to political outcomes or behaviors in an effort to influence the political preferences of religious practitioners. The most efficient way to make the connection between religion and politics is through religious cues. Religious cues create information shortcuts linking religious identity or values with a political candidate or issue. Religious cues are used by political and religious actors in secular and religious contexts and are typically one of two general types: identity cues, which engage an individual’s religious identity and activate an in-group/out-group effect, and linkage cues, which link religious values or beliefs with an issue or candidate. Identity cues are particularly tricky to use in secular contexts because they have been shown to have strong alienating effects on nonreligious people, thereby defeating the intended purpose of the cue sender. For this reason, coded religious language called “implicit cues” is used with greater frequency in political discourse where only the religious cue receiver recognizes the religious cue for what it is. This strategy allows a political candidate to reap the benefits of the cue without risking alienation. While scholars have made substantial progress in using experimental methods to disentangle the ways religious cues influence political behavior, there is ample opportunity for more research exploring different types of religious cues and the way they interact with other forms of cues and identities. Furthermore, most of the research on religious cues has focused on Christian cues in the United States, and a more diverse range of religions and contexts should be explored to understand the way religious cues influence political behavior. Researchers should also expand the definition of “religious practitioners” to explore how religious cues influence the growing number of people who do not affiliate with a religion or engage in practices traditionally associated with religiosity but do identify as religious. This would help to expand conceptualization of political behavior to more accurately reflect lived political experiences. Embracing these opportunities will allow the scholarly community to gain a better understanding of the varied political dynamics of religious cueing, which offers insights into how fundamental identities and attitudes are linked, thereby shedding more light on the complex dynamics of political behavior.

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