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.

Roadmapping an emerging energy technology: An ex-ante examination of dimethyl ether development in China

Technology roadmapping has been used to strategise the development of energy technologies. However, there have been limited roadmapping applications that analyse the emergence of a new energy technology that then forms a new industry and propels broad-based low-carbon economic growth. This paper, therefore, attempts to develop a roadmapping framework by integrating the lifecycle analysis tool, in order to strategise the emergence of dimethyl ether, an alternative energy based on advanced engineering technologies such as carbon capture and storage. This paper compares two scenarios of dimethyl ether vs. diesel and finds that the superiority of dimethyl ether will not arise until 2030, when the complementary engineering technologies become available. This proposed framework can also be generalised to other clean energy industries, and we anticipate our paper will spark inspiration for roadmapping and strategising the 'right' technologies for the growth of Chinese energy industries. Copyright © 2012 Inderscience Enterprises Ltd.

Exploring an effective model of new product development in medical devices: A knowledge cluster approach

This study proposes a new product development (NPD) model that aims to improve the effectiveness of innovative NPD in the medical devices. By adopting open innovation theory and applying an in-depth investigation methodology, this paper proposes a knowledge cluster that improves the integration of interdisciplinary human resources and enhances the acquirement of innovative technologies. A knowledge cluster approach helps gather, organise, synthesise, and accumulate knowledge in order to become the impetus for innovation. Although enterprises are no longer the principals of research and development, they should still be capable of integrating professional physicians, external groups, and individuals through the knowledge cluster platform. However, in order to support an effective NPD model, enterprises should provide adequate incentives and trust to external individuals or groups willing to contribute their expertise and knowledge to this knowledge cluster platform. Copyright © 2013 Inderscience Enterprises Ltd.

Manufacturing excellent engineers: Skill development in a Masters programme

An MPhil programme, delivered by the Engineering Department at the University of Cambridge, claims to be excellent at preparing graduates for manufacturing industry careers. The course uses a combination of different educational experiences, including industry-based assignments, industrial visits and practical exercises. This research explores how problem solving skills are developed during the first module, Induction, which is designed to enable students to undertake their first industrial assignment. From the literature, four conditions necessary for skill development were identified: Provision of a skill description, making explicit key components A number of different experiences with a range of contextual variables A teaching process which includes regular feedback and student reflection Students motivated to learn. These were used to construct a skill development framework (SDF). Using a case study research design, multiple types of evidence were collected to test for the above conditions using both classroom observation and questionnaire methods. The results confirmed the presence of the SDF conditions at different levels, with reflection aspects considered the weakest. Conflicting results were obtained regarding the students' self-awareness of skill levels. A plausible explanation is a change in the students' frame of reference. This initial study set out to develop a better understanding of the process of skill development. Whilst the SDF appears reasonable, there is a need for further work in three broad areas of defining skills, assessing skills and developing reflection skills.

Lean product development in practice: Insights from 4 companies

This paper aims to elucidate practitioners' understanding and implementation of Lean in Product Development (LPD). We report on a workshop held in the UK during 2012. Managers and engineers from four organizations discussed their understanding of LPD and their ideas and practice regarding management and assessment of value and waste. The study resulted in a set of insights into current practice and lean thinking from the industry perspective. Building on this, the paper introduces a balanced value and waste model that can be used by practitioners as a checklist to identify issues that need to be considered when applying LPD. The main results indicate that organizations tend to focus on waste elimination rather than value enhancement in LPD. Moreover, the lean metrics that were discussed by the workshop participants do not link the strategic level with the operational one, and poorly reflect the value and waste generated in the process. Future directions for research are explored, and include the importance of a balanced approach considering both value and waste when applying LPD, and the need to link lean metrics with value and waste levels.

Damage development in an armor ceramic under quasi-static indentation

The objective of the present study is to assess the capabilities of a recently developed mechanism-based model for inelastic deformation and damage in structural ceramics. In addition to conventional lattice plasticity, the model accounts for microcrack growth and coalescence as well as granular flow following comminution. The assessment is made through a coupled experimental/computational study of the indentation response of a commercial armor ceramic. The experiments include examinations of subsurface damage zones along with measurements of residual surface profiles and residual near-surface stresses. Extensive finite element computations are conducted in parallel. Comparisons between experiment and simulation indicate that the most discriminating metric in the assessment is the spatial extent of subsurface damage following indentation. Residual stresses provide additional validation. In contrast, surface profiles of indents are dictated largely by lattice plasticity and thus provide minimal additional insight into the inelastic deformation resulting from microcracking or granular flow. A satisfactory level of correlation is obtained using property values that are either measured directly or estimated from physically based arguments, without undue reliance on adjustable (nonphysical) parameters. © 2011 The American Ceramic Society.