Economics of new oncology drug development.

PURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. RESULTS: We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. CONCLUSION: The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.

Philosophers and practical men: Charles Babbage, Irish merchants and the economics of information

Before the emergence of coordination of production by firms, manufacturers and merchants traded in markets with asymmetric information. Evidence suggests that the practical knowledge thus gained by these agents was well in advance of contemporary political economists and anticipates twentieth-century developments in the economics of information. Charles Babbage, who regarded merchants and manufacturers as the chief sources of reliable economic data, drew on this knowledge as revealed in the evidence of manufacturers and merchants presented to House of Commons select committees to make an important pioneering contribution to the theory of production and exchange with information asymmetries.

Value-oriented impact assessment: the economics of a new approach to impact assessment

Environmental Impact Assessment has gained a prominent position as a tool to evaluate the environmental effects of economic activities. However, all approaches proposed so far use a burden-oriented logic. They concentrate on the different environmental impacts in order to ascertain the overall environmental damage caused by economic activity. This paper argues that such a burden-oriented view is (a) hampered by a series of methodological shortcomings which hinders its widespread use in practice; and (b) is analytically incomplete. The paper proposes a value-oriented approach to impact assessment. For this purpose an economic analysis of the optimal use of environmental and social resources is conducted from both a burden-oriented and a value-oriented standpoint. The basic logic of a value-oriented impact assessment is explained, as well as the resulting economic conditions for an optimal use of resources. In addition, it is shown that value- and burden-oriented approaches are complementary to achieve optimality. Finally, the paper discusses the conditions under which the use of burden- or value-oriented impact assessments is appropriate, respectively.

The early-stage risk capital market in Scotland since 2000: issues of scale, characteristics and market efficiency

In this paper we provide a detailed profile and analysis of the regional risk capital market in Scotland, using an innovative methodology and specially developed databases which cover risk capital investment in young companies in the periods 2000–04 and 2005–07. This identifies the investment activity of all actors in the market and provides estimates of the total flow of risk capital investment into early-stage Scottish companies over the period. The paper concludes by drawing out the implications for policy makers (providing a more robust evidence base for the development, implementation and monitoring of policy) and for academic researchers (on the methodologies for estimating market scale and efficiency).