scholarly journals Tackling the challenges of nanomedicines: are we ready?

2021 ◽  
Author(s):  
John B Hertig ◽  
Vinod P Shah ◽  
Beat Flühmann ◽  
Stefan Mühlebach ◽  
Gunar Stemer ◽  
...  
Keyword(s):  
Complex Nature ◽  
Pharmaceutical Sciences ◽  
Patient Benefit ◽  
World Congress ◽  
Clinical Safety ◽  
Hospital Pharmacists ◽  
Drug Products ◽  
Regulatory Bodies ◽  
Regulatory Landscape

Abstract Purpose This review provides an overview of the proceedings of the symposium “Tackling the Challenges of Nanomedicines: Are We Ready?” organized by the International Pharmaceutical Federation (FIP) Hospital Pharmacy Section and Non-Biological Complex Drugs (NBCDs) Working Group at the 2019 FIP World Congress of Pharmacy and Pharmaceutical Sciences. Debate centered on reasons underlying the current complex regulatory landscape for nanomedicines and their follow-on products (referred to as nanosimilars) and the pivotal role of hospital pharmacists in selecting, handling, and guiding usage of nanomedicines and nanosimilars. Summary The evaluation and use of nanomedicines are recognized among scientific, pharmaceutical, and regulatory bodies as complex. Interchangeability and substitutability of nanomedicines and nanosimilars are confounded by a lack of pharmaceutical and pharmacological equivalence, reflecting the inherent complex nature of these drug products and manufacturing processes. Consequences include implications for clinical safety and efficacy and, ultimately, comparability. Local regulatory approvals of some nanomedicines have occurred, but there is no standard to ensure streamlined evaluation and use of consistent measures of therapeutic equivalence of reference products and their nanosimilars. Hospital pharmacists are expected to be experts in the selection, handling, and substitution of nanomedicines and familiarize themselves with the limitations of current methods of assessing pharmaceutical and clinical equivalence of nanosimilars in order to ensure informed formulary decision-making and eventual patient benefit. Conclusion Supportive guidance for pharmacists focusing on the substitutability and/or interchangeability of nanomedicines and their nanosimilars is needed. Current FIP guidance for pharmacists on therapeutic interchange and substitution should be extended to include nanomedicines and nanosimilars.

“Quasi industre giardiniero”

2016 ◽  
Vol 33 (4) ◽  
pp. 522-568
Author(s):  
Cory M. Gavito
Keyword(s):  
Complex Nature ◽  
Editorial Process ◽  
Fluid Exchange ◽  
Oral Transmission ◽  
Musical Practices

Among the roughly 150 Italian songbooks published between 1610 and 1665 with the guitar tablature known as alfabeto, about thirteen are anthologies. These anthologies often advertise the role of a compiler who has gathered together music by diverse authors. The extent to which compilers also functioned as authors and editors is not well understood. This essay considers the case of Giovanni Stefani, a compiler who, in the preface to his Scherzi amorosi of 1622, describes the anthology as a collection of his choosing that contains “varie compositioni de Virtuosi della prima classe” (various compositions of first-class virtuosos). Intriguingly, none of the settings Stefani prints (in both this alfabeto anthology and two others) include attributions. Since the 1880s, scholars have been preoccupied with matters of transmission and attribution, unearthing a network of textual and musical concordances. This article expands the nexus of Stefani’s songs and their concordant sources, revealing an array of examples that range from identical copies to “partial” concordances that take over motives, phrases, refrains, or harmonic schemes. These examples indicate that in preparing his anthologies, Stefani mined a corpus of existing prints and manuscripts while also relying heavily on oral transmission. The complex nature of Stefani’s approach, taken together with his complete avoidance of composer attributions, points toward an editorial process shaped by a fluid exchange between oral and written musical practices.

Political Communication: Redefining Contemporary Political Management Practices

2019 ◽  
Vol 118 (11) ◽  
pp. 255-268
Author(s):  
Amit Kumar
Keyword(s):  
Social Media ◽  
Political Communication ◽  
Management Practices ◽  
Complex Nature ◽  
Political Event ◽  
Indian Politics ◽  
Modern Politics ◽  
Political Branding ◽  
General Elections

Modern politics, particularly prevalent in the Western Democracies, is replete with instances wherein communication has come to play a pivotal role in the formation or dislodging a government. This is not to say that in traditional political scenario, the role of communication was any lesser. Far from it, communication has always characterized the build-up of events in politics. However, the significance of the same has increased manifold thanks to the advent of social media and complex nature of modern politics as well as due to rise of such concepts as political branding which has gained traction in the wake of proliferation of technology. The same holds true in the Indian political scenario as well. The last few years have redefined the role of communication and its tools in Indian politics, especially during a mega-political event like election. The last two general elections were testimonies to the same. The might of social media has been realized by even its staunchest critics. Along with it, the popular concept of permanent campaign has also characterized the phenomenon of political communication. This paper goes on to explore the underlying concept of political communication and how the same has come to influence the turn of events as well as the final outcome of an election.

PREPARING AN ACCOUNTING PROFESSIONAL: THE ARTICLES OF CLERKSHIP (1892–1897) OF GEORGE OLIVER MAY

2014 ◽  
Vol 41 (1) ◽  
pp. 61-78 ◽  
Author(s):  
Dale L. Flesher ◽  
Gary J. Previts
Keyword(s):  
Ohio State University ◽  
Professional Responsibility ◽  
State University ◽  
American Institute ◽  
World Congress ◽  
Public Accounting ◽  
Hall Of Fame ◽  
The Ohio State University ◽  
British Education

George O. May, one of, if not ‘the’ leading spokesman for the American Institute of CPAs for most of his lifetime, was the product of British education and an articled clerkship. This paper reviews the features and information about May's clerkship (indentureship) articles, including aspects of what is now called professional responsibility. Also mentioned are selected highlights and sources related to his career in public accounting, including his ‘cameo’ role at the l904 World Congress of Accountants in St. Louis where he participated with prominent leaders of the emerging United States CPA community, including Staub, Sterrett, Montgomery, and Sells, as well as his countrymen Pixley and Dickinson [Official Record, p. 164]. This study of George O. May's preparation provides details about a relatively unnoticed chapter in the career of an individual who was among the first group of inductees, in l950, along with William A. Paton and Robert H. Montgomery, to the Accounting Hall of Fame at The Ohio State University. Additionally, May's clerkship requirements are indicative of the role of professional responsibility in the decade before the turn of the twentieth century.

scholarly journals Assessing social preferences in reimbursement negotiations for new Pharmaceuticals in Oncology: an experimental design to analyse willingness to pay and willingness to accept

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dominik J. Wettstein ◽  
Stefan Boes
Keyword(s):  
Willingness To Pay ◽  
Real World ◽  
Cognitive Biases ◽  
Social Preferences ◽  
Standard Of Care ◽  
Added Value ◽  
Amazon Mechanical Turk ◽  
Patient Organisation ◽  
Patient Benefit

Abstract Background Price negotiations for specialty pharmaceuticals take place in a complex market setting. The determination of the added value of new treatments and the related societal willingness to pay are of increasing importance in policy reform debates. From a behavioural economics perspective, potential cognitive biases and other-regarding concerns affecting outcomes of reimbursement negotiations are of interest. An experimental setting to investigate social preferences in reimbursement negotiations for novel, oncology pharmaceuticals was used. Of interest were differences in social preferences caused by incremental changes of the patient outcome. Methods An online experiment was conducted in two separate runs (n = 202, n = 404) on the Amazon Mechanical Turk (MTurk) platform. Populations were split into two (run one) and four (run two) equally sized treatment groups for hypothetical reimbursement decisions. Participants were randomly assigned to the role of a public price regulator for pharmaceuticals (buyer) or a representative of a pharmaceutical company (seller). In run two, role groups were further split into two different price magnitude framings (“real world” vs unconverted “real payoff” prices). Decisions had real monetary effects on other participants (in the role of premium payers or investors) and via charitable donations to a patient organisation (patient benefit). Results 56 (run one) and 59 (run two) percent of participants stated strictly monotone preferences for incremental patient benefit. The mean incremental cost-effectiveness ratio (ICER) against standard of care (SoC) was higher than the initial ICER of the SoC against no care. Regulators stated lower reservation prices in the “real world” prices group compared to their colleagues in the unconverted payoff group. No price group showed any reluctance to trade. Overall, regulators rated the relevance of the patient for their decision higher and the relevance of their own role lower compared to sellers. Conclusions The price magnitude of current oncology treatments affects stated preferences for incremental survival, and assigned responsibilities lead to different opinions on the relevance of affected stakeholders. The design is useful to further assess effects of reimbursement negotiations on societal outcomes like affordability (cost) or availability (access) of new pharmaceuticals and test behavioural policy interventions.

scholarly journals Role of Regulatory Bodies in the Banking and Energy Sectors

2016 ◽  
Vol 5 (1) ◽  
pp. 5-23
Author(s):  
Miomir Jakšić
Keyword(s):  
Central Banking ◽  
The Public ◽  
The Status ◽  
Regulatory Bodies

Abstract The article discusses the status and role of regulatory bodies and the aftermaths of their independence and accountability to the public and the parliament. The author analyses different legal statuses of regulatory bodies in Montenegro and Serbia in the central banking and energy sectors and concludes that it is necessary that national constitutions, as the highest legal acts in each state, prescribe in a separate article that “Regulatory bodies are independent and accountable to Parliament”. Relevant separate legal acts should closely define the procedures for establishing, enforcing, and sanctioning of possible breaching of: 1) independence of regulatory bodies, 2) accountability of regulatory bodies to the parliament, and 3) transparency of their activities.

"THE SYNTHESIS OF WAR AND THEATRE": SOCIO-HUMANITARIAN DISCOURSE ON THE ESSENCE OF TERRORISM

2020 ◽  
pp. 10-23
Author(s):  
Irina V Malygina ◽  
◽  
Anna V Malygina ◽  
Keyword(s):  
International Terrorism ◽  
Complex Nature ◽  
Cultural Resources ◽  
Self Presentation ◽  
The Status ◽  
World Cultural Heritage ◽  
The One ◽  
Strategic Object ◽  
The Given

The article reveals the heuristic potential of social and humanitarian knowledge in understanding the complex nature of terrorism. The given research optics allows to expand traditional frameworks of considering terrorism as a phenomenon caused by political, ideological and economic factors; to reveal and substantiate deep cultural and mental reasons of the given phenomenon; make sense of terrorism as a destructive form of cultural identity. The cultural and historical origins of modern terrorism, which is closely connected with radical Islam, are analyzed in the civilizational system of coordinates “West–East”. The system of argumentation is based on scientific concepts and current artistic practices that interpret the causes of inter-civilizational tension resulting in international terrorism. The change of the status of the artist in the “epoch of terrorism” is analyzed; the theme of theatricalization and aestheticization of terrorist actions and the role of media in these processes are problematized. As a newest trend, which has not received any serious theoretical reflection, the text considers the phenomenon conditionally designated as “sublimation of terrorist activity into a symbolic sphere”, which is manifested in the destruction of monuments of world cultural heritage, in the orientation to culture as a new strategic object of terrorist attacks, on the one hand, and the use of cultural resources for self-presentation and promotion of their ideology by terrorist organizations, on the other

Early Experiences With PEGylated Carboxyhemoglobin Bovine in Anemic Jehovah’s Witnesses: A Case Series and Review of the Literature

2018 ◽  
Vol 33 (3) ◽  
pp. 372-377 ◽  
Author(s):  
Sean McConachie ◽  
Krista Wahby ◽  
Zinah Almadrahi ◽  
Sheila Wilhelm
Keyword(s):  
Case Series ◽  
Stable Condition ◽  
Complex Nature ◽  
Blood Transfusions ◽  
Oxygen Carriers ◽  
Jehovah’S Witnesses ◽  
Clinical Safety ◽  
Jehovah's Witnesses ◽  
Pharmacologic Management ◽  
Oxygen Carrying Capacity

Jehovah’s Witnesses (JW) represent a complex patient population due to their refusal to accept blood transfusions on religious grounds. Pharmacologic management of anemic JW patients is limited to stimulation of hematopoiesis by iron and erythropoietin supplementation and reduction of blood loss by prothrombin complex concentrates (PCCs). Hemoglobin-based oxygen carriers (HBOCs) represent the only pharmacologic modality for JW patients capable of acutely increasing a patient’s oxygen carrying capacity in the setting of organ failure, yet clinical safety and efficacy data are lacking in this population. We report 3 cases in which the HBOC, PEGylated carboxyhemoglobin bovine (Sanguinate®), was requested under emergent circumstances for severely anemic (hemoglobin <5 g/dL) JW patients who refused blood transfusions. Two patients received PEGylated carboxyhemoglobin infusions for severe anemia, while the third patient died prior to receiving the medication. One patient who received Sanguinate died after 5 units of medication. The other patient’s hemoglobin recovered and she was discharged in stable condition. This series demonstrates the complex nature of the critically anemic JW population and highlights the clinical considerations of using HBOCs in clinical practice and the critical need for further research before they can be broadly recommended.

scholarly journals Fit for Purpose? An Examination of the Jurisdiction of the Health and Disability Commissioner in New Zealand

2021 ◽  
Author(s):  
◽  
Adam Lothian Holloway
Keyword(s):  
New Zealand ◽  
Fit For Purpose ◽  
Regulatory Landscape

<p>This paper examines the role of the Health and Disability Commissioner. It does so by first describing the Commissioner's origins and place in the overall regulatory landscape for doctors in New Zealand. Different frameworks are then described within which the Commissioner's purpose, practice and outcomes can be assessed. Applying these frameworks, an assessment is made of the Commissioner's jurisdiction. Finally, informed by the foregoing assessment, this paper examines the regulatory landscape from a broader perspective, making tentative proposals for reforms.</p>

scholarly journals A rewarding experience in many ways: The 3rd World Congress of Environmental History

2020 ◽  
Vol 10 (1) ◽  
pp. 17-22
Author(s):  
Verena Winiwarter
Keyword(s):  
Environmental History ◽  
Field Trips ◽  
Environmental Cost ◽  
Short Paper ◽  
World Congress ◽  
Environmentally Conscious ◽  
Intergenerational Exchange ◽  
Global North ◽  
Great Acceleration

The 3rd World Congress of Environmental History, held in Florianópolis, Brazil had the theme: “Convergences: The Global South and the Global North in the Era of Great Acceleration”. The short paper gives an overview of the rewards such congresses can bring. It specifically deals with the plenary talks by Robert Billot and Brigitte Baptiste, highlights the role of scholarly co-operation and makes a case for the opportunity offered by such congresses to review the environment of the hosting country, for which the plenary roundtables, the excursions, and field trips and comparative panels are referred to as examples. World congresses might have an environmental cost, but they do provide unique opportunities for scholarly exchange, in terms of themes, methods, conceptual approaches, and sources used. Behaving in an environmentally conscious way but at the same time enabling and fostering international and intergenerational exchange is a challenge that will have to be taken up in the future.

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