Suchergebnisse

Background In recent years a large number of biomarker-stratified targeted and immunological treatment procedures were introduced in oncology. Higher efficacy has been shown in subgroups of patients with these drugs compared to the standard of care; however, due to the low numbers of patients within some subgroups confirmatory phase III trials are sometimes not feasible and the proof-of-principle is increasingly shifted towards early study phases. The approval authorities in the USA and the European Union have recognized these difficulties and established new instruments to accelerate and simplify drug approval. This development is accompanied by innovative trial designs that can provide relevant data for drug approval in early study phases. Objective Summary and discussion of innovative trial designs and approval procedures in oncology. Material and methods A systematic search was carried out in the medical literature database PubMed () for articles on approval procedures and trial designs in oncology as well as the websites of the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Federal Institute for Drugs and Medical Devices (Bundesamt fur Arzneimittel und Medizinprodukte, BfArM). Results and discussion A growing number of drugs are being approved within accelerated approval procedures in oncology. The FDA programs, such as the breakthrough designation and the accelerated approval procedures have been especially successful. Systematic analyses revealed that the time to the first use in patients was significantly shortened. Based on new designs, such as basket trials, approvals were granted in the USA for histology-independent personalized treatment for patient subgroups. Despite these achievements, criticism has arisen concerning the sometimes preliminary nature of data on safety and efficacy on which accelerated approval is based.

Following the vote for Brexit, the UK is facing a formidable challenge: designing a new trade policy to address its new strategic interests. Considering the different and frequently opposing interests, this task is far from straightforward. Many Brexit supporters have argued for a need to redefine the role of the UK in international politics, with trade at the centre. From the use of international development assistance to the negotiation of trade agreements, trade is regarded as the basis on which to pursue national interests as well as retain global leadership. Unfortunately, little attention has focused on how a new UK trade policy could contribute to development. The potential to define a new trade strategy, agree new trade agreements and use new aid and trade tools constitutes a major opportunity for the UK to continue championing the cause of trade and development. It is also an opportunity for the UK to make trade policy work more effectively and efficiently in delivering development opportunities. At the same time, there are significant concerns over whether the UK is willing and able to assume such a role. The challenge of defining a new trade policy is considerable, and one for which the UK Government is ill-prepared. Given the magnitude of the tasks and the number of negotiations that the UK will face in the next few years, there is a major risk that developing countries will be overlooked. This collection of essays offers a number of perspectives on how a new UK trade policy towards developing countries and regions could be designed and implemented, in both the short and longer term. It also conveys the concerns, opportunities and expectations from a group of leading trade specialists from academia, international organisations and think tanks in the UK and elsewhere.

Cover title. ; Includes bibliographical references. ; Mode of access: Internet.

The National Drugs Strategy 2009-16 is a cross cutting area of public policy and service delivery. It is based upon a co-ordinated approach across the full range of Government Departments and Agencies involved in delivering drugs policy. The overall objective of the Strategy is to tackle the harm caused to individuals, families and communities as a result of problem drug and alcohol use through the five pillars of supply reduction, prevention, treatment, rehabilitation and research. The progress achieved across the 63 Actions of the National Drugs Strategy by Government Departments and Agencies is reported here. Click here to download PDF 295kb Â

Background: Drug utilization (DU) research intends to support health authorities in the development of evidence‐informed pharmaceutical policy and practice guidelines, with the interest of the patients and communities in mind. DU data is often proprietary and challenging to access for researchers, in particular in resource‐restricted settings. Therefore, governments in low‐ and middle‐income countries should facilitate access to these data, from public and private sources, to researchers in the field of health economics, pharmacoepidemiology, drug utilization, and pharmacovigilance. Objectives: The workshop intends (1) to provide an overview of challenges that researchers encounter when studying drug utilization in different parts of the world, (2) to identify barriers and enablers of access to DU data, and (3) to propose an action plan to increase DU data access. The workshop is of general interest for all those involved in global DU research and of particular interest for policymakers and researchers confronted with limited access to DU data in their own constituencies. Description: After an introduction (Monique Elseviers) highlighting the importance to have access to high quality DU data at a regional and national level, an overview of specific challenges of access to DU data will be given for Central and Eastern Europe (Ria Benko), Africa (Johanita Burger), Latin America (Claudia Osorio‐de‐Castro), and Asia (Frank May). Thereafter, participants will assemble per region to identify barriers and enablers to DU data access and propose strategies to address them. Results of the discussion will be noted on poster boards and panellists will register the most important conclusions. During the final panel debate and discussion with the audience (moderated by Robert Vander Stichele), participants will jointly develop an action plan to increase DU data access (panel of all presenters together with Veronika Wirtz, Katja Taxis, Björn Wettermark)

This study reviewed the role of a law providing enhanced penalties for drug dealing within 1,000 feet of a school in 443 drug-dealing cases in three cities in Massachusetts: Fall River, New Bedford, and Springfield. We reviewed district attorneys' case files and mapped drug-dealing incidents using a combination of geographic information systems and location visits with a hand-held geographic positioning system. School zones – the areas within 1,000 feet of schools – cover 29% of the areas of the study cities and 56% of the high-poverty areas within the cities. Although less than 1% of the drug-dealing cases involved sales to minors, approximately 80% of the cases occurred within school zones, apparently because of the density of schools in high-poverty/high-drug-dealing areas. Most school zone cases are "broken down" – defendants plead to lesser charges and receive less than the two-year mandatory minimum sentence for dealing in a school zone. Decisions to "break down" charges are not influenced by proximity to schools or time of day. Most drug dealers commit their offenses close to home, and most dealers charged with dealing in school zones reside in school zones. Overlapping school zone boundaries are chaotic and confusing in the inner city areas studied. The school zone statute fails to push drug dealing away from schools: the density of dealing within 250 feet of schools is similar to the density of dealing at greater distances.

After studying technical metallurgy for one semester at Universitas Indonesia, Jakarta, Lenny Pattikawa (1973) decided to pursue a master's degree in economics at the Erasmus University Rotterdam. She specialized in economics and business economics and graduated in May 2000. In September 2000, she became a research assistant at the same university in which she carried out a study on the determinants of new product performance. In October 2002, she joined ERIM as a PhD candidate and started research on the pharmaceutical industry. Lenny has published her work in the European Journal of Marketing, ERIM working paper series, and in several international proceedings. She also presented her research at national and international conferences, including those of Prebem, Marketing Science, the Academy of Management, and the American Marketing Association. ; In de afgelopen jaren is de kritiek op de farmaceutische industrie toegenomen. Marketing uitgaven die groter zijn dan R&D uitgaven, de sterke groei van incrementele innovaties gecombineerd met de hoge winstgevendheid in de industrie hebben de publieke opinie over farmaceutische bedrijven sterk beïnvloed. Tegen deze achtergrond voerden wij drie studies uit naar de farmaceutische industrie in de V.S. De eerste studie presenteert een analyse van de industrie vanuit een theoretisch raamwerk dat is gebaseerd op de economische literatuur. We beschrijven factoren die van invloed zijn op de industrie zoals vraag en aanbod condities, marktstructuur en regelgeving vanuit de overheid. Wij laten zien dat farmaceutische bedrijven hierop reageren met bijvoorbeeld juridische en marketingstrategieën. Wij evalueren tevens de prestaties van de industrie in termen van winstgevendheid, productiviteit en innovatie. De tweede studie tracht de winstgevendheid van de farmaceutische bedrijven in de loop van de tijd te verklaren. Onze bevindingen tonen aan dat de bedrijven op succesvolle wijze hun immateriële activa weten te benutten. Wij vonden dat het grootste deel van prestaties wordt verklaard door de marketing activiteiten van bedrijven. De derde studie richt zich op productdifferentiatie strategieën van farmaceutische bedrijven. Gebruik makend van real-option theorie en een repeated events model veronderstellen wij dat bedrijven de levenscyclus van hun product verlengen als antwoord op onzekerheid over situaties binnen en buiten de organisatie. Wij identificeren een aantal variabelen dat de beslissing van productextensies beïnvloedt zoals de volatiliteit van aandelenprijzen, financiële barrières, concurrentiedruk en de groei van marketing uitgaven. Het proefschrift besluit met een reeks implicaties voor industriebeleid, bedrijfsstrategieën en toekomstig onderzoek. ; Society benefits the most when pharmaceutical industries supply drug products at competitive prices and when they simultaneously maintain optimal innovation rates. Nowadays, however, the U.S. pharmaceutical industry has been under thorough scrutiny. The increasing cost of healthcare, intensive marketing activities, the strong rise of me-too drugs, and, despite all, the high industry profitability have contributed to public skepticism. On the other hand, developing a new drug is a high-risk activity that can only be compensated by market protection schemes and attractive rates of returns. High profitability is needed to fund R&D that can, in turn, advance innovation. Against this background we present three studies on the U.S. pharmaceutical industry. The first part performs an industry analysis by using theoretical frameworks from economics. We describe several forces that have shaped the industry, including supply and demand conditions, market structure, and government regulations. We show how firms respond to these by implementing various conducts such as legal and marketing strategies. Thereafter, we assess performance of the industry in terms of profitability, productivity, and innovativeness. The second part explains the industry's profitability over time as a function of their intangible assets by using a market valuation model. Our results show that firms have successfully utilized their intangible resources to sustain high market performance. Additionally, we found an increasing contribution of advertising on firms' performance. Part three focuses on product differentiation strategies. We use a real option framework that perceives a line extension as a firm's response to uncertainty. Using a repeated events duration model, we identify several determinants that affect firm decisions concerning line extensions. These include uncertainty regarding stock volatility, financial constraints, competitive pressure, and advertising growth. We conclude with implications for public policies, firms' strategies, and future research.

South Africa's new competition policy and law were drafted during the early years of South Africa's new democracy, a period characterized by important domestic policy and regulatory reform. These reforms were not only part of the comprehensive program for the country's economic, social, and political transformation, but also its integration into the global economy after decades of isolation under the apartheid regime. In the case of competition policy, however, concerns about specific development challenges entrenched by the previous era of political and economic control, had to be explicitly reflected in the new South Africa's law and policy. It was clear that a robust competition law would only be politically possible if the law specifically addressed public interest concerns. The core focus of economic efficiency had to be tempered by a strong emphasis on development. In the end, the new competition law, even with the broad sweep of its objectives, puts economic efficiency center-stage. Public interest objectives are articulated alongside the goal of economic efficiency. Only as the jurisprudence develops will the nature of the trade-offs within this nexus of objectives become clear. This paper reviews briefly the new 1998 Competition Act ("Competition Act" or "Act") and the institutions established to enforce the new law. The new Act marks a significant step in the development of effective market governance in South Africa. However, much remains to be done to develop capacity, in particular the institutional capacity for effectively enforcing competition law, and complementary regulatory frameworks that will support the broad competition policy objectives that reach beyond efficiency to encompass public interest objectives. And perhaps even more important, especially in light of recent investigations into alleged restrictive practices and cases that have been heard, there remains much to be done to change firm behaviour from mere maneuvering around competition law to effective compliance.

AbstractAs opium cultivation is increasingly controlled in the Golden Triangle, producers and traffickers have created new markets for methamphetamines (ATS) amongst highland and lowland populations. At the same time, evolving forms of drug abuse also reflect a larger order of social change that directly shapes the consumer market. This article explores how demand for methamphetamines in mainland Southeast Asia emerges in sync with changing value systems fostered by development trajectories within a globalized commodity culture. The primary focus is on Akha highlanders in northwestern Laos for whom dual processes of opium eradication and village relocation directly encourage the currently prominent uptake of ATS. As Akha move into the lowlands to engage in modern capitalist systems of production, increased methamphetamine use emerges as a means to facilitate a greater reliance on sedentization and petty commodity trade. Rather than the uptake of heroin that took place in neighbouring countries, the transition from opium to methamphetamines is a highly charged sign of new social and material relations adopted by the Lao Akha as they enter primitive forms of capital accumulation and wage‐labour.