Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.

Chemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, which have limited investment in their research and development (R&D). These barriers include above-average clinical trial scales, lengthy time frames between discovery and Food and Drug Administration approval, liability risks (because they are given to healthy individuals), and a growing funding gap for early-stage candidates. The longer time frames and risks associated with chemoprevention also cause exclusivity time on core patents to be limited or subject to significant uncertainties. We conclude that chemoprevention uniquely challenges the structure of incentives embodied in the economic, regulatory, and patent policies for the biopharmaceutical industry. Many of these policy issues are illustrated by the recently Food and Drug Administration-approved preventive agents Gardasil and raloxifene. Our recommendations to increase R&D investment in chemoprevention agents include (a) increased data exclusivity times on new biological and chemical drugs to compensate for longer gestation periods and increasing R&D costs; chemoprevention is at the far end of the distribution in this regard; (b) policies such as early-stage research grants and clinical development tax credits targeted specifically to chemoprevention agents (these are policies that have been very successful in increasing R&D investment for orphan drugs); and (c) a no-fault liability insurance program like that currently in place for children's vaccines.

Cost of innovation in the pharmaceutical industry.

The research and development costs of 93 randomly selected new chemical entities (NCEs) were obtained from a survey of 12 U.S.-owned pharmaceutical firms. These data were used to estimate the pre-tax average cost of new drug development. The costs of abandoned NCEs were linked to the costs of NCEs that obtained marketing approval. For base case parameter values, the estimated out-of-pocket cost per approved NCE is $114 million (1987 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a 9% discount rate yielded an average cost estimate of $231 million (1987 dollars).

The price of innovation: new estimates of drug development costs.

The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug development. The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per new drug is 403 million US dollars (2000 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 11% yields a total pre-approval cost estimate of 802 million US dollars (2000 dollars). When compared to the results of an earlier study with a similar methodology, total capitalized costs were shown to have increased at an annual rate of 7.4% above general price inflation.

The distribution of sales revenues from pharmaceutical innovation.

OBJECTIVE: This report updates our earlier work on the returns to pharmaceutical research and development (R&D) in the US (1980 to 1984), which showed that the returns distributions are highly skewed. It evaluates a more recent cohort of new drug introductions in the US (1988 to 1992) and examines how the returns distribution is emerging for drugs with life cycles concentrated in the 1990s versus the 1980s. DESIGN AND SETTING: Methods were described in detail in our earlier reports. The current sample included 110 new drug entities (including 28 orphan drugs), and sales data were obtained for the period 1988 to 1998, which represented between 7 and 11 years of sales for the drugs included. 20 years was chosen as the expected market life for this cohort, and a 2-step procedure was used to project future sales for the drugs--during the period until patent expiry and then beyond patent expiry until the 20-year time-horizon was completed. Thus, the values in the first half of the life cycle are essentially based on realised sales, while those in the second half are projected using information on patent expiry and other inputs. MAIN OUTCOME MEASURES AND RESULTS: Peak annual sales for the top decile of drugs introduced between 1988 and 1992 in the US amounted to almost $US1.1 billion compared with peak sales of less than $US175 million (1992 values) for the mean compound. In particular, the top decile accounted for 56% of overall sales revenue. Although the sales distributions were skewed in both our earlier and current analysis, the top decile in the later time-period exhibited more rapid rates of growth after launch, a peak that was more than 50% greater in real terms than for the 1980 to 1984 cohort, and a faster rate of expected decline in sales after patent expiry. One factor contributing to the distribution of sales revenues becoming more skewed over time is the orphan drug phenomenon (i.e. most of the orphan drugs are concentrated at the bottom of the distribution). CONCLUSION: The distribution of sales revenues for new drug compounds is highly skewed in nature. In this regard, the top decile of new drugs accounts for more than half of the total sales generated by the 1988 to 1992 cohort analysed. Furthermore, the distribution of sales revenues for this cohort is more skewed than that of the 1980 to 1984 cohort we analysed in previous research.

New business models for antibiotic innovation.

The increase in antibiotic resistance and the dearth of novel antibiotics have become a growing concern among policy-makers. A combination of financial, scientific, and regulatory challenges poses barriers to antibiotic innovation. However, each of these three challenges provides an opportunity to develop pathways for new business models to bring novel antibiotics to market. Pull-incentives that pay for the outputs of research and development (R&D) and push-incentives that pay for the inputs of R&D can be used to increase innovation for antibiotics. Financial incentives might be structured to promote delinkage of a company's return on investment from revenues of antibiotics. This delinkage strategy might not only increase innovation, but also reinforce rational use of antibiotics. Regulatory approval, however, should not and need not compromise safety and efficacy standards to bring antibiotics with novel mechanisms of action to market. Instead regulatory agencies could encourage development of companion diagnostics, test antibiotic combinations in parallel, and pool and make transparent clinical trial data to lower R&D costs. A tax on non-human use of antibiotics might also create a disincentive for non-therapeutic use of these drugs. Finally, the new business model for antibiotic innovation should apply the 3Rs strategy for encouraging collaborative approaches to R&D in innovating novel antibiotics: sharing resources, risks, and rewards.

The induced innovation hypothesis and energy-saving technological change

We develop a methodology for testing Hicks's induced innovation hypothesis by estimating a product-characteristics model of energy-using consumer durables, augmenting the hypothesis to allow for the influence of government regulations. For the products we explored, the evidence suggests that (i) the rate of overall innovation was independent of energy prices and regulations; (ii) the direction of innovation was responsive to energy price changes for some products but not for others; (iii) energy price changes induced changes in the subset of technically feasible models that were offered for sale; (iv) this responsiveness increased substantially during the period after energy-efficiency product labeling was required; and (v) nonetheless, a sizable portion of efficiency improvements were autonomous.

The paradox of openness revisited: Collaborative innovation and patenting by UK innovators

© 2016 The Authors.We revisit the "paradox of openness" in the literature which consists of two conflicting views on the link between patenting and open innovation-the spillover prevention and the organizational openness views. We use the data from the Survey of Innovation and Patent Use and the Community Innovation Survey (CIS6) in the UK to assess the empirical support for the distinct predictions of these theories. We argue that both patenting and external sourcing (openness) are jointly-determined decisions made by firms. Their relationship is contingent upon whether the firms are technically superior to their rivals and lead in the market or not. Leading firms are more vulnerable to unintended knowledge spillovers during collaboration as compared to followers, and consequently, the increase in patenting due to openness is higher for leaders than for followers. We develop a simple framework that allows us to formally derive the empirical implications of this hypothesis and test it by estimating whether the reduced form relationship between patenting and collaboration is stronger for leaders than for followers.

Modernity, the new republic and Sing Sing: The creation of a disciplined workforce and citizenry

[Author's description] Bringing together new research on punishment and control in the 19th and 20th centuries, this collection begins by examining the development of the modern prison, gender, social control and punishment, and psychiatry and the criminal justice system. Further, it explores penal olicy, prison practice, and discourses on offenders, providing case studies of: the 'respectable' criminal, the female inebriate and the juvenile offender. The final part examines the experiences of confinement, discipline and resistance, through prisoner memoirs, prison riots and resistance and identity in residential institutions.

Knowledge networks change during radical and incremental innovation episodes: a case study on software developmen

The role intra-organizational knowledge exchanges play in innovation processes has been widely acknowledged in the organizational literature. This paper contributes to the understanding of which specific configurations knowledge networks assume during different phases of radical and incremental innovation processes. The case study we selected is a FLOSS (Free/Libre Open Source Software) community consisting of 233 developers committed to the development of a web browser application since November 2002. By harvesting the mailing list, official blog and code repository of a FLOSS community, we investigate the patterns of knowledge exchange and individual contributions of its developers. We measure structural cohesion and compare global and local network properties at different points in time. Preliminary results show that phases of radical and incremental innovation are associated with specific configurations of the knowledge network as a whole as well as with different network positions of the core developers of the software.

Profitability and the poor: corporate strategies, innovation and sustainability

Based on empirical evidence, the article looks at the implications of private sector participation (PSP) for the delivery of water supply and sanitation to the urban and peri-urban poor in developing countries, with particular reference to Africa and Latin America. More precisely, the article addresses the impact produced by multinational companies’ (MNCs) strategies, in light of the pursuit of profitability, on the extension of connections to the pipeline network. It does so by questioning the assumptions that greater private sector efficiency and innovation, together with contract design, will enable the sustainable extension of service coverage to low income dwellers. The strategies of the major water MNCs are considered both in relation to the global expansion of their operations and the adjustment of local strategies to commercial considerations. The latter might result in identifying proWtable markets, modifying contractual provisions, attempting to reduce costs and increase income, reducing risks and exiting from non-performing contracts. The evidence reviewed allows for re-assessing the relative roles of the public and private sectors in extending and delivering water services to the poor. First, the most far reaching innovative approaches to extending connections are more likely to come from communities, public authorities and political activity than from MNCs. Secondly, whenever MNCs are liable to exit from non-profitable contracts, the public sector has no other option than to deal with external risks aVecting continuity of provision. Finally, market limitations affecting MNCs’ ability to serve marginal populations and access cheap capital do not apply to well-organised, politically led public sector undertakings

South East London Palliative and End of Life Care Education and Training Strategy: Meeting the Education and Training Needs of the Health & Social Care Workforce Involved in the Care of Patients and Carers at the End of Life.

EXECUTIVE SUMMARY Aims 1. The aims of this strategy are • to ensure that a full range of education and training related to the adult end of life care pathway is available across South East London to meet the needs of our health and social care workforce • to enable those responsible for end of life care education and training commissioning to procure comprehensively from a full range of education providers in a systematic and strategic manner. Background 2. The work that underpins this strategy was begun by the South East London Cancer Network via its Palliative and End of Life Care Coordinating Group and then developed by way of the Marie Curie Delivering Choice Programme’s Education and Training work stream.

The impact of the nursing workforce on patient outcomes in intensive care

Introduction: Evidence from studies conducted mainly in the US and mainland Europe suggests that characteristics of the workforce, such as nurse patient ratios and workload (measured in a number of different ways) may be linked to variations in patient outcomes across health care settings (Carmel and Rowan 2001). Few studies have tested this relationship in the UK thus questions remain about whether we are justified in extrapolating evidence from studies conducted in very different health care systems. Objectives: To investigate whether characteristics of the nursing workforce affect patient mortality UK Intensive Care Units. Data: Patient data came from the case mix programme, Intensive Care National Audit and Research Centre (ICNARC), while information about the units came from a survey of all ICUs in England (Audit Comission 1998). The merged data set contained information on 43,859 patients in 69 units across England. ICNARC also supplied a risk adjustment variable to control for patient characteristics that are often the most important determinants of survival. Methods: Multivariate multilevel logistic regression. Findings: Higher numbers of direct care nurses and lower scores on measures of workload(proportion of occupied beds at the time the patient was admitted and mean daily transfers into the unit) were associated with lower mortality rates. Furthermore, the effect of the number of direct care nurses was greatest on the life chances of the patients who were most at risk of dying. Implications: This study has wide implications for workforce policy and planning because it shows that the size of the nursing workforce is associated with mortality (West et al 2006). Few studies have demonstrated this relationship in the UK. This study has a number of strengths and weaknesses and further research is required to determine whether this relationship between the nursing workforce and patient outcomes is causal.