Regulation: A Burden in Biopharmaceutical Industry? The Case of EU-Risk Management Plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market.

Regulation: A burden in biopharmaceutical industry? The case of EU-risk management plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market. © 2010 IEEE.

Managing global network operations along the engineering value chain

Purpose: This paper aims to improve understanding of how to manage global network operations from an engineering perspective. Design/methodology/approach: This research adopted a theory building approach based on case studies. Grounded in the existing literature, the theoretical framework was refined and enriched through nine in-depth case studies in the industry sectors of aerospace, automotives, defence and electrics and electronics. Findings: This paper demonstrates the main value creation mechanisms of global network operations along the engineering value chain. Typical organisational features to support the value creation mechanisms are captured, and the key issues in engineering network design and operations are presented with an overall framework. Practical implications: Evidenced by a series of pilot applications, outputs of this research can help companies to improve the performance of their current engineering networks and design new engineering networks to better support their global businesses and customers in a systematic way. Originality/value: Issues about the design and operations of global engineering networks (GEN) are poorly understood in the existing literature in contrast to their apparent importance in value creation and realisation. To address this knowledge gap, this paper introduces the concept of engineering value chain to highlight the potential of a value chain approach to the exploration of engineering activities in a complex business context. At the same time, it develops an overall framework for managing GEN along the engineering value chain. This improves our understanding of engineering in industrial value chains and extends the theoretical understanding of GEN through integrating the engineering network theories and the value chain concepts. © Emerald Group Publishing Limited.

Mapping the global flow of steel: from steelmaking to end-use goods.

Our society is addicted to steel. Global demand for steel has risen to 1.4 billion tonnes a year and is set to at least double by 2050, while the steel industry generates nearly a 10th of the world's energy related CO₂ emissions. Meeting our 2050 climate change targets would require a 75% reduction in CO₂ emissions for every tonne of steel produced and finding credible solutions is proving a challenge. The starting point for understanding the environmental impacts of steel production is to accurately map the global steel supply chain and identify the biggest steel flows where actions can be directed to deliver the largest impact. In this paper we present a map of global steel, which for the first time traces steel flows from steelmaking, through casting, forming, and rolling, to the fabrication of final goods. The diagram reveals the relative scale of steel flows and shows where efforts to improve energy and material efficiency should be focused.

The roles of energy and material efficiency in meeting steel industry CO2 targets.

Identifying strategies for reducing greenhouse gas emissions from steel production requires a comprehensive model of the sector but previous work has either failed to consider the whole supply chain or considered only a subset of possible abatement options. In this work, a global mass flow analysis is combined with process emissions intensities to allow forecasts of future steel sector emissions under all abatement options. Scenario analysis shows that global capacity for primary steel production is already near to a peak and that if sectoral emissions are to be reduced by 50% by 2050, the last required blast furnace will be built by 2020. Emissions reduction targets cannot be met by energy and emissions efficiency alone, but deploying material efficiency provides sufficient extra abatement potential.

Polymer film packaging for food: An environmental assessment

Plastics packaging is ubiquitous in the food industry, fulfilling a range of functions including a significant role in reducing food waste. The public perception of packaging, however, is dominated by end-of-life aspects, when the packaging becomes waste often found littering urban, rural and marine environments. A balanced analysis of the role of packaging demands that the whole lifecycle is examined, looking not only at the packaging itself but also at the product being packaged. This paper focuses on packaging in the meat and cheese industry, analysing the impact of films and bags. The functions of packaging are defined and the environmental impact of delivering these functions is assessed. The influence of packaging on levels of waste and energy consumption elsewhere in the system is examined, including the contentious issue of end-of-life for packaging. Strategies for minimizing the environmental impact of the packaging itself involve reduction in the amount of material used (thinner packaging), rather than emphasizing end-of-life issues. Currently, with polymer recycling not at a high level, evidence suggests that this strategy is justifiable. Biodegradable polymers may have some potential for improving environmental performance, but are still problematic. The conclusion is that although current packaging is in some ways wasteful and inefficient, the alternatives are even less desirable. © 2013 Elsevier B.V. All rights reserved.

A global assessment of manufacturing: Economic development, energy use, carbon emissions, and the potential for energy efficiency and materials recycling

We present in two parts an assessment of global manufacturing. In the first part, we review economic development, pollution, and carbon emissions from a country perspective, tracking the rise of China and other developing countries. The results show not only a rise in the economic fortunes of the newly industrializing nations, but also a significant rise in global pollution, particularly air pollution and CO2 emissions largely from coal use, which alter and even reverse previous global trends. In the second part, we change perspective and quantitatively evaluate two important technical strategies to reduce pollution and carbon emissions: energy efficiency and materials recycling. We subdivide the manufacturing sector on the basis of the five major subsectors that dominate energy use and carbon emissions: (a) iron and steel, (b) cement, (c) plastics, (d) paper, and (e) aluminum. The analysis identifies technical constraints on these strategies, but by combined and aggressive action, industry should be able to balance increases in demand with these technical improvements. The result would be high but relatively flat energy use and carbon emissions. The review closes by demonstrating the consequences of extrapolating trends in production and carbon emissions and suggesting two options for further environmental improvements, materials efficiency, and demand reduction. © 2013 by Annual Reviews. All rights reserved.