Progress,innovation and regulatory science in drug development: the politics of international standard-setting

This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and 'progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of 'technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the 'technical trajectories' of regulatory science.     

A Testing Issue: Key skills assessment in Australia

Maintenance of academic standards, assessment and monitoring are key tasks for tertiary education, as the system attempts to meet government targets for universal participation. Tertiary education therefore demands more attention to the measurement of outcomes. However, the use of a graduate skills assessment test, we contend--particularly in the form this currently takes in Australia--implies a limited sense of the value added by a university education. We question the validity of national testing both on grounds of its suitability to assess the skills cultivated by university study and on grounds of equity and cultural inclusiveness.     

Virtual Knowledge‐Sharing Communities of Practice at Caterpillar: Success Factors and Barriers

This article reports the results of a qualitative study of success factors and barriers to the development of virtual knowledge‐sharing communities of practice at Caterpillar Inc., a Fortune 100 multinational corporation. The study identified several prerequisites for successful knowledge management through virtual communities of practice: knowledge sharing as a key element of the corporate culture; employees regarding knowledge as a public good belonging to the whole organization, and not as their individual asset; communities self‐organizing around specific performance‐related problems or areas of professional interest of their members; and communities supported by volunteer managers and active core groups of experts. At the same time, the study has identified a number of important barriers to virtual community development. Specifically, even when employees give the highest priority to the interests of the organization, they tend to shy away from contributing knowledge for a variety of other reasons not related to information hoarding. In addition, corporate security considerations and concerns about the accuracy of the information and the potential information overload could clash with the need to promote spontaneous generation of information. Suggestions for overcoming the identified barriers, future research directions, and implications for HRD professionals are formulated.