scholarly journals Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

PLoS ONE ◽  
2022 ◽  
Vol 17 (1) ◽  
pp. e0262537
Author(s):  
Louise C. Druedahl ◽  
Sofia Kälvemark Sporrong ◽  
Timo Minssen ◽  
Hans Hoogland ◽  
Marie Louise De Bruin ◽  
...  
Keyword(s):  
Pharmaceutical Industry ◽  
Scientific Data ◽  
Data Driven ◽  
Policy Debate ◽  
Structured Interviews ◽  
Study Objective ◽  
Scientific Certainty ◽  
The Us ◽  
Almost All ◽  
Near Future

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018–August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.

scholarly journals Japan and Foreign Territory Strike: Debate, Deterrence, and Defense Strength

2021 ◽  
Vol 1 (2) ◽  
pp. 30-77
Author(s):  
Corey Wallace
Keyword(s):  
Use Of Force ◽  
Policy Debate ◽  
Missile Defense ◽  
Initial Attack ◽  
Self Defense ◽  
The Us ◽  
Defense Transformation ◽  
Post War ◽  
Near Future ◽  
Key Questions

The increased frequency of debate in Japan over foreign territory strike points to it being officially affirmed as a Japanese Self-Defense Force (SDF) mission in the near future. This article explores the foreign territory strike debate through the lens of the four key questions that have structured the post-war debate on all new overseas SDF operations: is it constitutional?; is it (militarily) plausible?; is it (strategically) wise?; and, is it (politically) acceptable? After discussing the contours of the Japanese post-war legal and policy debate on the use of force in foreign territory, the article describes contemporary doubts over the tactical effectiveness and strategic opportunity cost of configuring the SDF to conduct overseas strike operations—especially for missile defense purposes. Foreign territory strike would divert scarce fiscal resources and political attention from adaptations that enhance the US-Japan alliance’s posture resilience and enable it to sustainably generate force even after an initial attack, thereby augmenting regional deterrence. The article concludes by noting that political barriers could also still prevent the mission from being substantively and credibly implemented. Acrimonious domestic debate on foreign territory strike could also hamstring government attempts to attract public buy-in for future defense transformation in areas of greater priority and that add more to deterrence than the acquisition of modest strike capabilities.

American tourists in Cuba: Is the communist country a forbidden or a tainted fruit?

2015 ◽  
Vol 16 (1) ◽  
pp. 6-18 ◽  
Author(s):  
Jackson Wilson ◽  
Pavlína Látková
Keyword(s):  
Destination Image ◽  
Communist Country ◽  
Market Place ◽  
Positive Side ◽  
The Us ◽  
Before And After ◽  
History Of ◽  
The Caribbean ◽  
Almost All ◽  
Near Future

Americans are the majority of tourists in the Caribbean, but the US embargo against Cuba prevents almost all American tourists from visiting Cuba. This study uses mixed methods to examine a group of American tourists' destination image of Cuba before and after a tour in Cuba. The American tourists in this study described Cuba as a forbidden fruit, a desirable destination that Americans are not allowed to or at least should not visit. On the positive side, travelling to Cuba was seen as a scarce opportunity that has the allure of the prohibited and the attraction of viewing communism from a previous era. Conversely, the image of Cuba was also tainted by the history of political antagonism with America and associated concerns about tourist safety, cost, and a limited market place. However, actual and potential changes in Cuba are likely to heavily impact the destination image in the near future.

scholarly journals Addressing Sexual Problems in German Primary Care: A Qualitative Study

2021 ◽  
Vol 12 ◽  
pp. 215013272110464
Author(s):  
Ronja Zannoni ◽  
Elisa Dobberkau ◽  
Hanna Kaduszkiewicz ◽  
Aglaja Valentina Stirn
Keyword(s):  
Qualitative Study ◽  
Qualitative Content Analysis ◽  
Sexual Problems ◽  
Sexual Medicine ◽  
Health Issues ◽  
Structured Interviews ◽  
Study Objective ◽  
Doctor Patient Communication ◽  
Complex Disorders ◽  
Almost All

Although general practitioners (GPs) are often the first contact for patients’ sexual issues, little is known about how German GPs approach, diagnose, and treat sexual problems and disorders. Therefore, the present qualitative study explores approaches and management of sexual health issues used by GPs. The sample included 16 GPs from Kiel and surroundings and Sachsen-Anhalt. The in-depth, semi-structured interviews were coded according to the qualitative content analysis by Mayring using MAXQDA. The results revealed 5 main themes, 2 of which are explored in more detail in relation to the study objective (2 and 4): (1) sexual issues that arise in general practice, (2) addressing sexuality, (3) influencing factors in doctor-patient communication about sexuality, (4) diagnosing and treating sexual dysfunctions, and (5) changes in the approach to sexuality over time. Most GPs did not routinely ask their patients about sexual problems. Common barriers included lack of time, suspected embarrassment on both sides, and fear of offending patients. Almost all GPs tended to diagnose sexual problems individually adapted to patients’ issues, not following a standardized approach. Medication was offered as the main treatment for sexual problems. For complex disorders, most GPs lack sexual medicine knowledge, and they requested a better range of training courses in sexual medicine.

BP Global Energy Outlook 2030

2013 ◽  
pp. 109-128 ◽  
Author(s):  
C. Rühl
Keyword(s):  
Emerging Economies ◽  
Energy Demand ◽  
Fossil Fuels ◽  
Net Energy ◽  
Global Energy ◽  
The Past ◽  
Market Shares ◽  
The Us ◽  
Almost All ◽  
Oil Gas

This paper presents the highlights of the third annual edition of the BP Energy Outlook, which sets out BP’s view of the most likely developments in global energy markets to 2030, based on up-to-date analysis and taking into account developments of the past year. The Outlook’s overall expectation for growth in global energy demand is to be 36% higher in 2030 than in 2011 and almost all the growth coming from emerging economies. It also reflects shifting expectations of the pattern of supply, with unconventional sources — shale gas and tight oil together with heavy oil and biofuels — playing an increasingly important role and, in particular, transforming the energy balance of the US. While the fuel mix is evolving, fossil fuels will continue to be dominant. Oil, gas and coal are expected to converge on market shares of around 26—28% each by 2030, and non-fossil fuels — nuclear, hydro and renewables — on a share of around 6—7% each. By 2030, increasing production and moderating demand will result in the US being 99% self-sufficient in net energy. Meanwhile, with continuing steep economic growth, major emerging economies such as China and India will become increasingly reliant on energy imports. These shifts will have major impacts on trade balances.

The Alliance between Fundamentalist Christians and the Pro-Israel Lobby: Christian Zionism in US Middle East Policy

2004 ◽  
Vol 2 (2) ◽  
pp. 163-187
Author(s):  
Donald E. Wagner
Keyword(s):  
Middle East ◽  
Political Influence ◽  
Conservative Movement ◽  
International Media ◽  
Christian Zionism ◽  
The Us ◽  
Run Up ◽  
Middle East Policy ◽  
Near Future ◽  
Political Scene

It is a common assumption in the international media that the fundamentalist Christian Right suddenly appeared on the US political scene following the 11 September 2001 tragedy, and that it became a major force in shaping US policy in the Middle East. While it is true that fundamentalist Christians have exercised considerable influence during the George W. Bush administration, their ascendance is neither new nor surprising. The movement has demonstrated political influence in the US and England intermittently for more than a hundred years, particularly in the formation of Middle East policy. This article focuses on the unique theology and historical development of Christian Zionism, noting its essential beliefs, its emergence in England during the nineteenth century, and how it grew to gain prominence in the US. The alliance of the pro-Israel lobby, the neo-conservative movement, and several Christian Zionist organizations in the US represents a formidable source of support for the more maximalist views of Israel's Likud Party. In the run-up to the 2004 US presidential elections this alliance could potentially thwart any progress on an Israeli–Palestinian peace plan in the near future. Moreover, Likud ideology is increasingly evident in US Middle East policy as a result of this alliance.

scholarly journals User-driven efforts in creating knowledge graph information system

2020 ◽  
Vol 36 (2) ◽  
pp. 97-111
Author(s):  
Stanislava Gardasevic
Keyword(s):  
Information System ◽  
Information Seeking ◽  
Information Needs ◽  
Resource Discovery ◽  
The Body ◽  
Knowledge Graph ◽  
Structured Interviews ◽  
Community Members ◽  
Study Objective ◽  
Content Type

Purpose This paper presents the results of a qualitative study that involved students of an interdisciplinary PhD program. The study objective was to gather requirements to create a knowledge graph information system. The purpose of this study was to determine information-seeking practices and information needs of this community, to inform the functionalities of a proposed system, intended to help students with relevant resource discovery and decision-making. Design/methodology/approach The study design included semi-structured interviews with eight members of the community, followed by a website usability study with the same student participants. Findings Two main information-seeking styles are recognized and reported through user personas of international and domestic (USA) students. The findings show that the useful information resides within the community and not so much on the program website. Students rely on peer communication, although they report lack of opportunities to connect. Students’ information needs and information seeking are dependent on their progress through the program, as well as their motivation and the projected timeline. Practical implications Considering the current information needs and practices, a knowledge graph hosting both information on social networks and the knowledge produced by the activities of the community members would be useful. By recording data on their activities (for example, collaboration with professors and coursework), students would reveal further useful system functionalities and facilitate transfer of tacit knowledge. Originality/value Aside from the practical value of this research that is directly influencing the design of a system, it contributes to the body of knowledge on interdisciplinary PhD programs.

scholarly journals Covid-19 FAQ’s in Paediatric and Congenital Cardiology – AEPC position paper.

2021 ◽  
pp. 1-21
Author(s):  
Skaiste Sendzikaite ◽  
Ruth Heying ◽  
Ornella Milanesi ◽  
Katarina Hanseus ◽  
Ina Michel-Behnke
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Health Care Systems ◽  
Scientific Data ◽  
Position Paper ◽  
Paediatric Cardiology ◽  
European Paediatric ◽  
Care Systems ◽  
The Times ◽  
Almost All

Abstract The Covid-19 pandemic has had a huge influence in almost all areas of life, affecting societies, economics and health care systems worldwide. The paediatric cardiology community is no exception. As the challenging battle with Covid-19 continues, professionals from the Association for the European Paediatric and Congenital Cardiology (AEPC) receive many questions regarding Covid-19 in a Paediatric and Congenital Cardiology setting. The aim of this paper is to present the AEPC position on frequently asked questions based on the most recent scientific data, as well as to frame a discussion on how to take care of our patients during this unprecedented crisis. As the times are changing quickly and information regarding Covid-19 is very dynamic, continuous collection of evidence will help guide constructive decision-making.

Scientific data-driven evaluation of academic publications on environmental Kuznets curve

2021 ◽  
Vol 28 (14) ◽  
pp. 16982-16999
Author(s):  
Muhammad Farhan Bashir ◽  
Benjiang Ma ◽  
Muhammad Adnan Bashir ◽  
Bilal ◽  
Luqman Shahzad
Keyword(s):  
Environmental Kuznets Curve ◽  
Scientific Data ◽  
Data Driven ◽  
Kuznets Curve ◽  
Academic Publications

scholarly journals Albanian National Action Plan for Roma Inclusion 2016–2020: A Study on the Program Achievements at the Halfway Mark

SAGE Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 215824402110361
Author(s):  
Gentian Qejvanaj
Keyword(s):  
Action Plan ◽  
Communist Regime ◽  
Background Information ◽  
Structured Interviews ◽  
National Action Plan ◽  
Current State ◽  
The Us ◽  
Implementation Period ◽  
Education And Employment

Roma segregation in Albania has been causing growing concern since the fall of the communist regime. In this study, we analyze the effectiveness of the Albanian national action plan for Roma inclusion 2016–2020, in 2018, halfway in its implementation period. We gathered data on education and employment from the pre-implementation period (2015) and compared it with the latest available data in 2018. Interviews with local experts and surveys by the Balkan Barometer will provide background information to assess the current state of Roma integration in Albania. Moreover, descriptive statistics from national and international institutions and structured interviews will draw an independent narrative of Roma affairs. In our conclusion, we suggest moving beyond the “us and them” approach with programs run on inertia; our findings highlight that although encouraging achievements have been reached under the 2016–2020 action plan, real inclusion is still far, as statistical achievements do not say much about the quality of the education or job training provided under the 2016–2020 action plan.

scholarly journals Artificial Intelligence: The Attitude of the Public and Representatives of Various Industries

2021 ◽  
Vol 14 (8) ◽  
pp. 339
Author(s):  
Tatjana Vasiljeva ◽  
Ilmars Kreituss ◽  
Ilze Lulle
Keyword(s):  
Artificial Intelligence ◽  
Primary Data ◽  
Structured Interviews ◽  
The Public ◽  
Qualitative And Quantitative ◽  
Public Survey ◽  
Significant Difference ◽  
Main Factors ◽  
Negative Factors ◽  
Near Future

This paper looks at public and business attitudes towards artificial intelligence, examining the main factors that influence them. The conceptual model is based on the technology–organization–environment (TOE) framework and was tested through analysis of qualitative and quantitative data. Primary data were collected by a public survey with a questionnaire specially developed for the study and by semi-structured interviews with experts in the artificial intelligence field and management representatives from various companies. This study aims to evaluate the current attitudes of the public and employees of various industries towards AI and investigate the factors that affect them. It was discovered that attitude towards AI differs significantly among industries. There is a significant difference in attitude towards AI between employees at organizations with already implemented AI solutions and employees at organizations with no intention to implement them in the near future. The three main factors which have an impact on AI adoption in an organization are top management’s attitude, competition and regulations. After determining the main factors that influence the attitudes of society and companies towards artificial intelligence, recommendations are provided for reducing various negative factors. The authors develop a proposition that justifies the activities needed for successful adoption of innovative technologies.

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