Is Australia ready for biosimilars?

The biosimilars market is potentially the single fastest growing pharmaceutical sector with an estimated worth of US$67bn in global sales by 2020. This market generally refers to larger molecule, biological, protein-based pharmaceuticals which have lost its patent. This has stimulated the emergence of non-conventional pharmaceutical investors such as Fujifilm and Samsung as well as host countries such as Brazil, Mexico, China, India, South Korea, Turkey and Russia, which view biosimilars as a key macroeconomic driver of growth. Internationally, the European Medicines Agency has led the regulation of the quality, safety and efficacy of biosimilars; however, many countries have developed their own biosimilar regulatory frameworks. Despite the similarity of these with European guidelines, differences do exist across jurisdictions and have implications for cross-jurisdictional registration and regulation. The consideration of biosimilar regulation, however, demands attention beyond quality, safety and efficacy. The potential implications of extended patent protection, international trade and globalisation require a congruent policy approach to their regulation. Notwithstanding the fact that Australia is a relatively small pharmaceutical market and that there are only 14 biosimilar products currently approved for use, Australia’s geographical proximity to pharm-emerging countries and its trade relation with the major pharmaceutical markets have positioned Australia in a unique position to influence international development and regulation of biosimilars. Australia’s National Medicines Policy (2000) potentially provides the foundation for a partnership approach to biosimilar regulation, minimise duplication of regulatory efforts while at the same time fostering a viable pharmaceutical industry.

Feminism and Global Justice

This book attempts to persuade a new generation of scholars, criminologists, activists, and policy makers sympathetic to the quest for global justice to open the envelope, to step out of their comfort zones and typical frames of analysis to gaze at a world full of injustice against the female sex, much of it systemic, linked to culture, custom and religion. In some instances the sources of these injustices intersect with those that produce global inequality, imperialism and racism. This book also investigates circumstances where the globalising forces cultivate male on male violence in the anomic spaces of supercapitalism – the border zones of Mexico and the United States, and the frontier mining communities in the Australian desert. However systemic gendered injustices, such as forced marriage of child female brides, sati the cremation of widows, genital cutting, honour crimes, rape and domestic violence against women, are forms of violence only experienced by the female sex. The book does not shirk away from female violence either. Carrington argues that if feminism wants to have a voice in the public, cultural, political and criminological debates about heightened, albeit often exaggerated, social concerns about growing female violence and engagement in terrorism, then new directions in theorising female violence are required. Feminist silences about the violent crimes, atrocities and acts of terrorism committed by the female sex leave anti-feminist explanations uncontested. This allows a discursive space for feminist backlash ideologues to flourish. This book contests those ideologies to offer counter explanations for the rise in female violence and female terrorism, in a global context where systemic gendered violence against women is alarming and entrenched. The world needs feminism to take hold across the globe, now more than ever.

Determinants of second row passenger comfort

China is becoming an increasingly important automotive market. Customer’s vehicle usage, preferences and requirements differ from traditional western markets in a number of aspects – rear seat usage rates are higher, vehicles are used for business purposes as well as for private transport and rear seat usage is generally more important to Chinese customers compared to their western counterparts. The purpose of this project is to dimension and investigate these differences from an ergonomics perspective and use these results to guide the design of future products. The focus for this project will be specific to vehicles in the CD segment. More specifically, this project focuses on the second row ‘ambience’. Ambience refers to the global feeling perceived by second row passengers, and the main factors contributing to ambience are: ingress and egress comfort, seat comfort, roominess, and ease of use of the controls. In order to investigate the aforementioned parameters, an experimental study has been conducted in Shanghai, China. This experiment involved 80 healthy Chinese CD- and D-car customers. These subjects were asked to evaluate different features present in the second row environment of three different cars: A Ford Mondeo, Toyota Camry and Mercedes S-class. Various data has been collected during this experiment: First, the anthropometric dimensions of the subjects have been measured. The subjects were also asked to fill a questionnaire about demographics, their own car usage, and their perception of a various number of features present in the three tested cars. A great amount of technical data was also collected. The first part of this report presents the results given by the questionnaires. It includes Chinese demographics, vehicle usage habits, and the subjective perception of the features present in the tested cars. It also presents the results of the anthropometric measurements. This gives a first insight into Chinese customers’ habits and preferences. The second part deals with the technical data recorded during the experiment: second row seat adjustment ranges, roominess, optimal location of controls, and pressure mapping analysis. Analysis of technical data allows a deeper understanding of the factors contributing to comfort and ambience perception. Using the technical data together with the comfort ratings given by the subjects in the questionnaire, recommendations on several design parameters were provided. Finally, an experimental study of car ingress-egress has been conducted in a University laboratory controlled environment. During this study, the ingress and egress motion of 20 customers from Chinese origin was recorded using a motion capture system. The last part of this report presents the protocol and data processing that led to building an ingress-egress motion database that was provided to Ford.

Global sequence variation in the histidine-rich proteins 2 and 3 of Plasmodium falciparum: implications for the performance of malaria rapid diagnostic tests

Background Accurate diagnosis is essential for prompt and appropriate treatment of malaria. While rapid diagnostic tests (RDTs) offer great potential to improve malaria diagnosis, the sensitivity of RDTs has been reported to be highly variable. One possible factor contributing to variable test performance is the diversity of parasite antigens. This is of particular concern for Plasmodium falciparum histidine-rich protein 2 (PfHRP2)-detecting RDTs since PfHRP2 has been reported to be highly variable in isolates of the Asia-Pacific region. Methods The pfhrp2 exon 2 fragment from 458 isolates of P. falciparum collected from 38 countries was amplified and sequenced. For a subset of 80 isolates, the exon 2 fragment of histidine-rich protein 3 (pfhrp3) was also amplified and sequenced. DNA sequence and statistical analysis of the variation observed in these genes was conducted. The potential impact of the pfhrp2 variation on RDT detection rates was examined by analysing the relationship between sequence characteristics of this gene and the results of the WHO product testing of malaria RDTs: Round 1 (2008), for 34 PfHRP2-detecting RDTs. Results Sequence analysis revealed extensive variations in the number and arrangement of various repeats encoded by the genes in parasite populations world-wide. However, no statistically robust correlation between gene structure and RDT detection rate for P. falciparum parasites at 200 parasites per microlitre was identified. Conclusions The results suggest that despite extreme sequence variation, diversity of PfHRP2 does not appear to be a major cause of RDT sensitivity variation.

The True Cost of Greenhouse Gas Emissions: Analysis of 1,000 Global Companies

This study elucidated the shadow price of greenhouse gas (GHG) emissions for 1,024 international companies worldwide that were surveyed from 15 industries in 37 major countries. Our results indicate that the shadow price of GHG at the firm level is much higher than indicated in previous studies. The higher shadow price was found in this study as a result of the use of Scope 3 GHG emissions data. The results of this research indicate that a firm would carry a high cost of GHG emissions if Scope 3 GHG emissions were the focus of the discussion of corporate social responsibility. In addition, such shadow prices were determined to differ substantially among countries, among sectors, and within sectors. Although a number of studies have calculated the shadow price of GHG emissions, these studies have employed country-level or industry-level data or a small sample of firm-level data in one country. This new data from a worldwide firm analysis of the shadow price of GHG emissions can play an important role in developing climate policy and promoting sustainable development.

Correlations and volatility spillovers across commodity and stock markets: Linking energies, food, and gold

This paper employs a VAR-GARCH model to investigate the return links and volatility transmission between the S&P 500 and commodity price indices for energy, food, gold and beverages over the turbulent period from 2000 to 2011. Understanding the price behavior of commodity prices and the volatility transmission mechanism between these markets and the stock exchanges are crucial for each participant, including governments, traders, portfolio managers, consumers, and producers. For return and volatility spillover, the results show significant transmission among the S&P 500 and commodity markets. The past shocks and volatility of the S&P 500 strongly influenced the oil and gold markets. This study finds that the highest conditional correlations are between the S&P 500 and gold index and the S&P 500 and WTI index. We also analyze the optimal weights and hedge ratios for commodities/S&P 500 portfolio holdings using the estimates for each index. Overall, our findings illustrate several important implications for portfolio hedgers for making optimal portfolio allocations, engaging in risk management and forecasting future volatility in equity and commodity markets. © 2013 Elsevier B.V.

Contributions of the private sector to global biodiversity protection: case study of the Fortune 500 companies

Since the inception of the UN Convention on Biological Diversity (CBD) in 1992, little progress has been achieved in terms of involving the business community in protecting biological diversity worldwide. This article assesses the current activities of US Fortune 500 companies with respect to global biodiversity protection and the goals of the CBD. Data and information collected from 500 companies within eight major industrial sectors were further categorized at the company level to assess each company's involvement in global biodiversity protection. Our findings show that although companies' business profiles highly influence their decision-making process regarding the adoption of biodiversity protection policies and measures, their revenue profiles are less influential. We show that despite generating low revenues, companies in the utility sector are more active in the adoption of biodiversity protection policy than those in the financial sector, which generate high revenues. This study also demonstrates that companies must be convinced of the major effects of biodiversity loss on their bottom lines to be motivated to protect biological diversity. Companies' business and business-related risk profiles can also influence the adoption of biodiversity protection policies within the company. The study further demonstrates that a measurable biodiversity impact indicator is necessary for the companies to get seriously involved in the mitigation action. Finally, this study proposes a three-step biodiversity loss mitigation action framework that is drawn upon the assessment of the 500 companies that can contribute to develop an elaborative framework of business sector-specific mitigation plan. © 2013 Copyright Taylor and Francis Group, LLC.

Tests on price linkage between the U.S. and Japanese gold and silver futures markets

We tested the price linkage, the law of one price (LOP) condition, and the causality of the price linkage between the U.S. and Japanese gold and silver futures markets with consideration of structural breaks in the price series. The LOP condition did not hold for both the gold and silver markets when structural breaks were not considered but it sustained in some periods when it was tested for the break periods. We found from the causality test that the price linkage between the U.S. and Japanese gold and silver futures markets were led by the U.S. market.

Stock prices of clean energy firms, oil and carbon markets : a vector autoregressive analysis

Recent discussions of energy security and climate change have attracted significant attention to clean energy. We hypothesize that rising prices of conventional energy and/or placement of a price on carbon emissions would encourage investments in clean energy firms. The data from three clean energy indices show that oil prices and technology stock prices separately affect the stock prices of clean energy firms. However, the data fail to demonstrate a significant relationship between carbon prices and the stock prices of the firms.

Testing the international linkage in the platinum-group metal futures markets

This study tests whether an international market exists in the platinum-group metal (PGM) futures markets. For this purpose, we tested the law of one price (LOP) and the causality between the U.S. and Japanese platinum and palladium futures markets. We also performed the test when structural breaks are considered. Long-run price relationships were found in both platinum and palladium markets but the LOP only sustained in the palladium market. The causality test revealed that it is the U.S. market that leads the price to transmit information between the U.S. and Japanese markets. Structural breaks had large impacts on the test results, suggesting that incorporating breaks is important when investigating the international price linkage in the PGM futures markets.

Price linkages in the copper futures, primary, and scrap markets

This study investigates how markets for different levels of copper purity are interrelated by testing the long-run price linkage and causalities among the copper futures, primary, copper scrap, and brass scrap markets. It is expected that copper markets that deal with high purity levels, such as the futures, primary, and copper scrap markets, have a long-run relationship. However, brass scrap markets where copper with a lower purity is traded may not have a price linkage with other copper markets. The results reveal that a long-run relationship holds between the futures, primary, and copper scrap markets but the brass scrap market does not have a long-run relationship with the other markets. From the short-run and long-run causality tests, we determine that the futures market plays an important role in transmitting price information to other copper markets while such information flow is not found for the brass scrap market.

An e-support firm's response to local e-readiness and the global e-business environment

The purpose of this study is to understand a small e-support firm’s response to the local e-readiness and the global e-business environment in a developing context. E-Support firms provide Web development and consultancy services to user organizations, assisting them in their uptake and maintenance of their Internet applications. Within the e-readiness research area, little is known about e-support firms, particularly in connection with their interaction with their local and the global e-business environment. As yet the emphasis on e-readiness studies has been at the national level. Nevertheless, the e-support sector is very significant in the successful adoption and diffusion of the Internet and related applications in any economy. It is thus important to understand how such firms relate to their e-business environments.That said, this study draws on the interpretive case study of a small e-support firm in Ghana, a developing context, to investigate the firm’s response to the e-readiness level of the local and the global e-business environment. Findings show that the firm could employ resources from the global environment to address most of the infrastructural challenges posed by a relatively poor local e-readiness context. However, its attempt to transfer advanced e-business technologies from the global e-business environment to the local e-business context did not succeed. This chapter offers implications for practice and research concerning the notion of reconciling local and global e-business environments in the small e-support sector.

Global outsourcing, production and logistics

Supply chains are the core of most industrial networks in which your business operates. They provide the pipeline through which the products and services flow from supplier to customer across each element within the business activity system. Global supply chain relationships have become the basis for many industries with an international network of firms engaged in the supply of goods and services that must be produced to quality standards in one country and delivered just-in-time for assembly or integration into further production processes in another country, frequently many thousands of miles apart. This topic examines the nature of supply chain management and their role in strategic networking. The previous learning tasks have focused on having the correct internal mechanism to effectively manage the inputs and outputs of the organisation by implementing an effective and transparent management system. This learning task takes a look at how management intent strategy and innovation are used to measure the external factors that influence the overall performance of the organisation and develop new strategies by understanding the business cycle and the people within your market environment.

An urban design perspective to classify knowledge precincts : a typological analysis of global best practices

Purpose: The paper seeks to investigate emerging knowledge precincts under the urban design lens in order to identify recurrent spatial patterns of urban forms and functions to gather an understanding of physical aspects that contribute to the creation of place quality. Scope: This paper focuses on the physical design and layout of specific precincts. Although socio-economic and other factors come into play imparting the distinctiveness; this paper only focuses on the spatial dimensions. Method: The research first develops a design typology framework through the lead of literature, and then utilizes it to identify recurrent elements in knowledge precinct design in order to develop taxonomy of patterns and layouts. Results: The research reported in this paper provides preliminary insights into the various form and functional factors playing role in the design of knowledge precincts and evaluates the elements that contribute to the success of these urban interventions. Recommendations: The paper recommends the use of particular design-based solutions in order to enhance the place making in knowledge precincts. Conclusions: The study concludes that despite the locational, regulatory and other contextual differences, the underlying driving principle of providing place quality to people leads to the emergence of identifiable spatial patterns across the knowledge precincts.