A QUM partnership approach to regulating biosimilars in Australia

Despite the realisation of the potential implications from biosimilars is relatively recent, much has already been written about raising the awareness of differences between biosimilars and originating/ reference listed (innovator) pharmaceuticals. The European Medicines Agency has led the global charge in regulating biosimilars. Regardless of sufficient similarities across international regulations, differences do exist across jurisdictions. The consideration of regulating biosimilars demands a congruent approach across all stages: pre-registration (Australian copyright protection, patent, international obligations), registration (confidential information, international regulators, safety and efficacy), post-registration (Pharmaceutical Benefit Scheme, prescriber and dispenser awareness). Our National Medicines Policy could provide the necessary congruent framework and function for national and international regulation of biosimilars. The Policy concedes that pharmaceuticals will be affected by financial policies and trade considerations, international treaty obligations, industrial policies, education policies and the need for public-private partnerships.

Department of Social Services Options Paper : Options for Replacement Arrangements Following the Abolition of the Australian Charities and Not-for-profits Commission : Response

Submission in response to government options paper regarding arrangements for regulation of charities following abolition of the Australian Charities and Not-for-profits Commission.

Keynote address : aligning HR with a changing business landscape

"Firstly, I thank you sincerely for your kind invitation and warm welcome to Sri Lanka and to this national HR conference, I particularly acknowledge the initiative of Chairman of the Technical Committee, Dr Asoka Jinadasa in making it possible for me to be here, and to offer this contribution to your conference. I congratulate you on assembling such an impressive array of talent to aid your discussions. I hope I can add usefully to your conversations. In particular I congratulate you on developing such a good definition of HRM: “A strategic and integrated approach in acquisition, development and engagement of talent using relevant tools, with proper policies, products and processes in creating a conducive climate towards achieving organizational excellence and societal well-being” To me, that means that HR has to add value to the organisation, through an integrated set of tools, competencies, and policies, which are all consistent with the business model..."

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.

Reducing bubble defect on the outsole production process in the footwear manufacturing industry

The purpose of this study is to discover the significant factors causing the bubble defect on the outsoles manufactured by the Case Company. The bubble defect occurs approximately 1.5 per cent of the time or in 36 pairs per day. To understand this problem, experimental studies are undertaken to identify various factors such as injector temperature, mould temperature; that affects the production of waste. The work presented in this paper comprises a review of the relevant literature on the Six Sigma DMAIC improvement process, quality control tools, and the design of the experiments. After the experimentation following the Six Sigma process, the results showed that the defect occurred in approximately 0.5 per cent of the products or in 12 pairs per day; this decreased the production cost from 6,120 AUD per month to 2,040 AUD per month. This research aimed to reduce the amount of waste in men’s flat outsoles. Hence, the outcome of research presented in this paper should be used as a guide for applying the appropriate process for each type of outsole.

The drive towards user-centred engineering in automotive design

Falling sales in Europe and increasing global competition is forcing automotive manufacturers to develop a customer-based approach to differentiate themselves from the similarly technologically-optimised crowd. In spite of this new approach, automotive firms are still firmly entrenched in their reliance upon technology-driven innovation, to design, develop and manufacture their products, placing customer focus on a downstream sales role. However the time-honoured technology-driven approach to vehicle design and manufacture is coming into question, with the increasing importance of accounting for consumer needs pushing automotive engineers to include the user in their designs. The following paper examines the challenges and opportunities for a single global automotive manufacturer that arise in seeking to adopt a user-centred approach to vehicle design amongst technical employees. As part of an embedded case study, engineers from this manufacturer were interviewed in order to gauge the challenges, barriers and opportunities for the adoption of user-centred design tools within the engineering design process. The analysis of these interviews led to the proposal of the need for a new role within automotive manufacturers, the “designeer”, to bridge the divide between designers and engineers and allow the engineering process to transition from a technology-driven to a user- centred approach.

The effect of ß-alanine on buffering capacity and exercise performance during and following high-intensity exercise in healthy males

Introduction Intense exercise induced acidosis occurs from the accumulation of hydrogen ions as by-products of anaerobic metabolism. Oral ingestion of ß-alanine, a limiting precursor of the intracellular physiochemical buffer carnosine in skeletal muscle, may counteract any detrimental effect of acidosis and benefit performance. The aim of this study was to investigate the effect of ß-alanine as an ergogenic aid during high intensity exercise performance in healthy males. Methods Five males ingested either ß-alanine (BAl) (4.8 g.d-1 for 4wk, then 6.4 g.d-1 for 2wk) or placebo (Pl) (CaCO3) in a crossover design with 6 wk washout between. Following supplementation, participants performed two different intense exercise protocols over consecutive days. On the first day a repeated sprint ability (RSA) test of 5 x 6s, with 24s rest periods, was performed. On the second day a cycling capacity test measuring the time to exhaustion (TTE) was performed at 110% of their max workload achieved in a pre supplementation max test (CCT110%). Non-invasive quantification of carnosine, prior to, and following each supplementation, with magnetic resonance spectrometry was performed in the soleus and gastrocnemius. Time to fatigue (CCT110%), peak and mean power (RSA), blood pH, and plasma lactate were measured. Results Muscle carnosine concentration was not different prior to ß-alanine supplementation and increased 18% in the soleus and 26% in the gastrocnemius, respectively with 6 wk supplementation. There was no difference in the measured performance variables during the RSA test (peak and average power output). TTE during the CCT110% was significantly enhanced following the ingestion of BAl (155s ± 19.03) compared to Pl (134s ± 26.16). No changes were observed in blood pH during either exercise protocol and during the recovery from exercise. Plasma lactate in the BAl condition was significantly higher than Pl only from the 15th minute following exercise during the CCT110%. FIG. 1: Changes in carnosine concentration in the gastrocnemius prior and post 6 week chronic supplementation of placebo and β-alanine. Values expressed as mean.* p<0.05 from Pl at 6 weeks, # p<0.05 from pre supplementation. Conclusion/Discussion Greater muscle carnosine content following 6wk supplementation of ß-alanine enhanced the potential for intracellular buffering capacity. However, this only translated into enhanced performance during the CCT110% high intensity cycling exercise protocol, with no change observed during the RSA test. No differences in post exercise and recovery plasma lactates and blood pH, indicates that 6wks ß-alanine supplementation has no effect on anaerobic metabolism during multiple bout high intensity exercise. Changes in plasma lactate during recovery supports that ß-alanine supplementation may affect anaerobic metabolism however during single bout high intensity.

Revisiting the adoption of innovative products on Australian road infrastructure projects

Construction product innovation can exert a positive influence on project and industry performance. However, guidance is scarce on product innovation diffusion for road infrastructure, in contrast to the large body of literature on the manufacturing industry. A conceptual framework is proposed to understand these processes. Advice is given to managers based on the framework and a large quantitative survey. The framework focuses on contextual characteristics that influence the decision to adopt new-to-industry product innovation, as part of a diffusion process. Case study data are interpreted within the revised framework to test its value and disaggregate the broad obstacles to innovation. A large quantitative survey was then conducted to rank the relative importance of the obstacles constraining the adoption of innovative products on road construction projects. The three most important obstacles were found to be: (1) overemphasis on up-front project costs during tender stage; (2) disagreement over who carries the risk of new product failure; and (3) adversarial contract relations. The results suggest refinements to the conceptual framework to make it a more powerful tool for categorizing and analysing construction innovation obstacles. Results also suggest well-resourced repeat interactions within complementary procurement and regulatory systems will enhance the project teams’ ability to recognize and address innovation obstacles. Further, improved relationships are expected to decrease the need for an overly conservative approach to product approval and prescriptive specifications.

Productive inefficiency analysis and toxic chemical substances in US and Japanese manufacturing sectors

Corporate social responsibility is imperative for manufacturing companies to achieve sustainable development. Under a strong environmental information disclosure system, polluting companies are disadvantaged in terms of market competitiveness, because they lack an environmentally friendly image. The objective of this study is to analyze productive inefficiency change in relation to toxic chemical substance emissions for the United States and Japan and their corresponding policies. We apply the weighted Russell directional distance model to measure companies productive inefficiency, which represents their production technology. The data encompass 330 US manufacturing firms observed from 1999 to 2007, and 466 Japanese manufacturing firms observed from 2001 to 2008. The article focuses on nine high-pollution industries (rubber and plastics; chemicals and allied products; paper and pulp; steel and non-ferrous metal; fabricated metal; industrial machinery; electrical products; transportation equipment; precision instruments) categorized into two industry groups: basic materials industries and processing and assembly industries. The results show that productive inefficiency decreased in all industrial sectors in the United States and Japan from 2001 to 2007. In particular, that of the electrical products industry decreased rapidly after 2002 for both countries, possibly because of the enforcement of strict environmental regulations for electrical products exported to European markets.

Which industry is greener? An empirical study of nine industries in OECD countries

This study analyzed the relationship between the CO2 emissions of different industries and economic growth in OECD countries from 1970 to 2005. We tested an environmental Kuznets curve (EKC) hypothesis and found that total CO2 emissions from nine industries show an N-shaped trend instead of an inverted U or monotonic increasing trend with increasing income. The EKC hypothesis for sector-level CO2 emissions was supported in the (1) paper, pulp, and printing industry; (2) wood and wood products industry; and (3) construction industry. We also found that emissions from coal and oil increase with economic growth in the steel and construction industries. In addition, the non-metallic minerals, machinery, and transport equipment industries tend to have increased emissions from oil and electricity with economic growth. Finally, the EKC turning point and the relationship between GDP per capita and sectoral CO2 emissions differ among industries according to the fuel type used. Therefore, environmental policies for CO2 reduction must consider these differences in industrial characteristics. © 2013 Elsevier Ltd.

Demand for refilled reusable products

The conversion of one-way polyethylene terephthalate (PET) bottles into reusable bottles helps reduce environmental burden. Recently, the Ministry of the Environment in Japan began discussing the introduction of reusable bottles. One of the barriers to introducing the new type of bottle is consumer unwillingness to accept refilled reusable bottles. We administered the questionnaires to consumers in a pilot test on reusable PET bottles organized to analyze the demand for these products. To increase the demand for refilled reusable bottles, it is necessary to supply refilled reusable bottles that are acceptable to consumers who are concerned about container flaws and stains.

Energy price-induced and exogenous technological change : Assessing the economic and environmental outcomes

In this paper, we distinguish between factor/output substitution and shifts in the production technology frontier. Our model includes the by-products of carbon dioxide and sulfur dioxide emissions where the function requires the simultaneous expansion of good outputs and reductions in emissions. We estimate a directional output distance function for 80 countries over the period 1971-2000 to measure the exogenous and oil price-induced technological change. On average, we find substantial oil price-induced technological progress at the world level when long-term oil prices are rising, although the growth rate is more volatile in developed countries than in developing countries. The results also show that developed countries experience higher exogenous technological progress in comparison with developing countries, and the gap between the two has increased during the period of our study.

The social shaping of packaged software selection

As organisations increasingly engage in the selection, purchase, and adoption of packaged software products, how these activities are carried out in practice becomes increasingly relevant for researchers and practitioners. Our focus in this paper is to propose a framework for understanding the packaged software selection process. The functionalist literature on this area of study suggests a number of generic recommendations, which are based on rational assumptions about the process and view the decision making that takes place as producing the “best technology solution.’” To explore this, we conducted a longitudinal, in-depth study of packaged software selection in a small organisation. For interpretation of the case, we draw upon the Social Construction of Technology, a theoretical framework arguing that technology is socially constituted and regarding the process of development as contradictory and uncertain. We offer a number of contributions. First, we further our understanding of packaged software selection with the critique that we offer of the functionalist literature, drawing insights from the emerging critical/constructivist literature and expanding our domain of interest to encompass the wider environment. Second, we weave this together with our experiences in the field, drawing on social constructivism for theoretical support, to develop a framework of packaged software selection that shows how various actors shape the process.

Asymmetric price range effects on vertical extensions

Vertical line extensions, both step-up and step-down, are common occurrence in consumer products. For example, Timex recently launched its luxury high-end Valentino line. On the other hand, many companies use downscale extensions to increase the overall sales volume. For instance, a number of luxury watch brands recently introduced watch collections with lower price points, like TAG Heur’s affordable watch the Aquaracer Calibre 5. Previous literature on vertical extensions has investigated how number of products in the line (Dacin and Smith 1994), the direction of the extension, brand concept (Kim, Lavack, and Smith 2001), and perceived risk (Lei, de Ruyter, and Wetzels 2008) affect extensions’ evaluation. Common to this literature is the use of models based on adaptation-level theory, which states that all relevant price information is integrated into a single prototype value and used in consumer judgments of price (Helson 1947; Mazumdar, Raj, and Sinha 2005). In the current research we argue that, while adaptation-level theory can be viewed as a useful simplification to understanding consumers’ evaluations, it misses out important contextual influences caused by a brand’s price range. Drawing on research on range-frequency theory (Mellers and Cooke 1994; Parducci 1965) we investigate the effects of price point distance and parent brand’s price range on evaluations of vertical extensions. Our reasoning leads to two important predictions that we test in a series of three experiments...

Online Copyright Infringement Discussion Paper July 2014

The Paper, by consideration of the issue of authorisation, addresses a very practical development in commerce. Online copyright infringement is now not only about unauthorised uses of cinematograph films but has filtered down to become more prevalent amongst small to medium enterprises (SME), as some competitors embrace online trading by aggressively and often unlawfully, seeking market share. It is understandable that internet service providers (ISPs), as gatekeepers of internet traffic, may be considered as being more than a conduit of contravening conduct but not a joint tortfeasor involved in a common design. In between those extremes lies the concept of authorisation in copyright which has a long history in Australia since the Copyright Act 1905 (Cth). The text of s 101(1A) of the Copyright Act, in particular s 101(1A)(a) and (c), derived from statements of Gibbs J in Moorhouse.