The Experts below are selected from a list of 11499 Experts worldwide ranked by ideXlab platform
Trudo Lemmens - One of the best experts on this subject based on the ideXlab platform.
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why the shift taking a closer look at the growing interest in Niche Markets and personalized medicine
Social Science Research Network, 2015Co-Authors: Shannon Gibson, Hamid Reza Raziee, Trudo LemmensAbstract:Pharmaceutical research and development is increasingly focused on Niche Markets, most notably treatments for rare diseases and “personalized” medicine. Drawing on the results of a qualitative study of 34 key Canadian stakeholders (including drug regulators, funders, scientists, policy experts, pharmaceutical industry representatives, and patient advocates), we explore the major trends that are reportedly contributing to the growing interest of the pharmaceutical industry in Niche Markets. Informed by both these key informant interviews and a review of the relevant literature, our paper provides a critical analysis of the many different — and sometimes conflicting — views on the reasons for and extent of the shift toward Niche Markets. We consider some of the potential advantages to industry, as well the important implications and risks that arise from the increasing pursuit of Niche Markets and pharmacogenomics. While there are many potential benefits associated with targeted therapies and drug development for historically neglected rare diseases, Niche market therapies also present evidentiary challenges (e.g., smaller clinical trials and enrichment strategies) that can make approval decisions difficult, and uncertainties remain around the true benefits of many therapies.
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Niche Markets and evidence assessment in transition a critical review of proposed drug reforms
Medical Law Review, 2014Co-Authors: Shannon Gibson, Trudo LemmensAbstract:In response to rising demands and treatment costs, and the need to achieve better value for money in the face of tight fiscal constraints, both the National Health Service and the public drug reimbursement system are undergoing important reforms. Concurrently, the pharmaceutical sector itself is also alleged to be experiencing significant changes, perhaps most notably, a decline of the blockbuster model of drug development and a growing focus on Niche market products. As pharmaceutical development strategies evolve and the resulting drug products become more complex, regulatory and policy responses must be able to evolve along with them. We explore how in numerous jurisdictions, including the UK, proposals for 'adaptive licensing' on the regulatory side and 'performance-based risk sharing agreements' on the funding side are shifting the focus of drug regulation and reimbursement towards more incremental access to new therapies and more post-market evidence generation. However, serious questions remain about how such reforms can be successfully implemented and whether they can balance demands for earlier access to promising new therapies with the need for robust evidence on safety, efficacy, and cost-effectiveness.
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Niche Markets and evidence assessment in transition a critical review of proposed drug reforms
Social Science Research Network, 2013Co-Authors: Shannon Gibson, Trudo LemmensAbstract:As pharmaceutical development strategies evolve and drug products become more complex, regulatory and policy responses must be able to evolve along with them. We explore, with particular attention to UK developments, how proposals for “adaptive licensing” on the regulatory side and “performance-based risk sharing agreements” on the funding side are shifting the focus of drug regulation and reimbursement towards more incremental access to new therapies and more post-market evidence generation. At first glance, both reform proposals may appear as an effective response to managing the evidentiary challenges associated with Niche Markets, which have particularly been developed also in the context of pharmacogenomics, since they provide regulators and funders with mechanisms for controlling the risks and cost-implications of approving or reimbursing Niche market products that may have been tested in smaller clinical trials and have a reduced evidence profile. However, a primary concern with both adaptive licensing and PBRSA proposals is that they may contribute to, respectively, a lowering of regulatory standards at the approval stage and premature market entry, and subsequently, mounting pressure to fund costly new pharmaceutical products with uncertain evidence profiles. We discuss the challenges associated with these developments, and argue that given the widely recognized problems associated with the evidence in existing regulatory and funding processes, measures to improve the reliability and independence of this evidence, such as improved transparency, must be incorporated into any reform efforts towards adaptive licensing and PBRSA, including consideration of how to implement such measures in the post-market phase.
Shannon Gibson - One of the best experts on this subject based on the ideXlab platform.
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why the shift taking a closer look at the growing interest in Niche Markets and personalized medicine
Social Science Research Network, 2015Co-Authors: Shannon Gibson, Hamid Reza Raziee, Trudo LemmensAbstract:Pharmaceutical research and development is increasingly focused on Niche Markets, most notably treatments for rare diseases and “personalized” medicine. Drawing on the results of a qualitative study of 34 key Canadian stakeholders (including drug regulators, funders, scientists, policy experts, pharmaceutical industry representatives, and patient advocates), we explore the major trends that are reportedly contributing to the growing interest of the pharmaceutical industry in Niche Markets. Informed by both these key informant interviews and a review of the relevant literature, our paper provides a critical analysis of the many different — and sometimes conflicting — views on the reasons for and extent of the shift toward Niche Markets. We consider some of the potential advantages to industry, as well the important implications and risks that arise from the increasing pursuit of Niche Markets and pharmacogenomics. While there are many potential benefits associated with targeted therapies and drug development for historically neglected rare diseases, Niche market therapies also present evidentiary challenges (e.g., smaller clinical trials and enrichment strategies) that can make approval decisions difficult, and uncertainties remain around the true benefits of many therapies.
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Niche Markets and evidence assessment in transition a critical review of proposed drug reforms
Medical Law Review, 2014Co-Authors: Shannon Gibson, Trudo LemmensAbstract:In response to rising demands and treatment costs, and the need to achieve better value for money in the face of tight fiscal constraints, both the National Health Service and the public drug reimbursement system are undergoing important reforms. Concurrently, the pharmaceutical sector itself is also alleged to be experiencing significant changes, perhaps most notably, a decline of the blockbuster model of drug development and a growing focus on Niche market products. As pharmaceutical development strategies evolve and the resulting drug products become more complex, regulatory and policy responses must be able to evolve along with them. We explore how in numerous jurisdictions, including the UK, proposals for 'adaptive licensing' on the regulatory side and 'performance-based risk sharing agreements' on the funding side are shifting the focus of drug regulation and reimbursement towards more incremental access to new therapies and more post-market evidence generation. However, serious questions remain about how such reforms can be successfully implemented and whether they can balance demands for earlier access to promising new therapies with the need for robust evidence on safety, efficacy, and cost-effectiveness.
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Niche Markets and evidence assessment in transition a critical review of proposed drug reforms
Social Science Research Network, 2013Co-Authors: Shannon Gibson, Trudo LemmensAbstract:As pharmaceutical development strategies evolve and drug products become more complex, regulatory and policy responses must be able to evolve along with them. We explore, with particular attention to UK developments, how proposals for “adaptive licensing” on the regulatory side and “performance-based risk sharing agreements” on the funding side are shifting the focus of drug regulation and reimbursement towards more incremental access to new therapies and more post-market evidence generation. At first glance, both reform proposals may appear as an effective response to managing the evidentiary challenges associated with Niche Markets, which have particularly been developed also in the context of pharmacogenomics, since they provide regulators and funders with mechanisms for controlling the risks and cost-implications of approving or reimbursing Niche market products that may have been tested in smaller clinical trials and have a reduced evidence profile. However, a primary concern with both adaptive licensing and PBRSA proposals is that they may contribute to, respectively, a lowering of regulatory standards at the approval stage and premature market entry, and subsequently, mounting pressure to fund costly new pharmaceutical products with uncertain evidence profiles. We discuss the challenges associated with these developments, and argue that given the widely recognized problems associated with the evidence in existing regulatory and funding processes, measures to improve the reliability and independence of this evidence, such as improved transparency, must be incorporated into any reform efforts towards adaptive licensing and PBRSA, including consideration of how to implement such measures in the post-market phase.
David A Marca - One of the best experts on this subject based on the ideXlab platform.
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e business and social networks tapping dynamic Niche Markets using language action and artificial intelligence
International Conference on Software and Data Technologies, 2010Co-Authors: David A MarcaAbstract:“That social networks are hard to penetrate” is an often given reason for recent corporate investment decreases in this technology. The cause is the traditional mass market perspective: firms use social networks to connect with, and eavesdrop on, customers. The result: online ads weakly aligned to customer conversations. One alternative: adopt a Language–Action Perspective; identify the market created by a conversation in a social network. The result: online ads strongly aligned to that conversation. One measure of this alignment is the mental distance between the intent of a social network conversation and the intent of the online ads that surround it. This paper will: explore the nature of “intention” in social networks, introduce its elements, show how these elements can create data and software architecture, and show how to create better online ads.
Ali Ferjani - One of the best experts on this subject based on the ideXlab platform.
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exchange rate effects a case study of the export performance of the swiss agriculture and food sector
The World Economy, 2018Co-Authors: Andreas Kohler, Ali FerjaniAbstract:The Swiss franc appreciated strongly against the currencies of Switzerland's most important trading partners after the global financial crisis in 2008. This has raised the question of how sensitive Swiss exports are with respect to exchange rate movements. We analyse this question for exports of the Swiss agriculture and food sector, using both time series and dynamic panel data models based on data from 1999 to 2012. We find that in the long run a one per cent appreciation of the Swiss franc leads on average to a decrease in exports of agricultural and food products between 0.8 and 0.9 per cent. Our results suggest that on average, producers in the Swiss agriculture and food sector are able to successfully avoid price competition by differentiating their products, producing high†quality products for Niche Markets.
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exchange rate effects a case study of the export performance of the swiss agriculture and food sector
Research Papers in Economics, 2015Co-Authors: Andreas Kohler, Ali FerjaniAbstract:The Swiss franc appreciated strongly against the currencies of Switzerland’s most important trading partners after the global financial crisis in 2008. This has led to renewed interest in the question of how sensitive Swiss exports are with respect to exchange rate movements. We analyze this question for exports of the Swiss Agriculture and Food Sector, using both time series and dynamic panel data models based on data from 1999 to 2012. We find that in the long-run a one percent appreciation of the Swiss franc leads on average to a decrease in exports of agricultural and food products of approximately 0.9 percent. Our results suggest that on average, producers in the Swiss Agriculture and Food Sector are able to successfully avoid price competition by differentiating their products, producing high-quality products for Niche Markets.
Mark A Grey - One of the best experts on this subject based on the ideXlab platform.
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those bastards can go to hell small farmer resistance to vertical integration and concentration in the pork industry
Human Organization, 2000Co-Authors: Mark A GreyAbstract:Vertical integration and concentration in hog production have made it difficult for small, family hog farms to survive. This article examines a small group of Iowa hog farmers who formed a cooperative to raise and sell "free-range" pork to Niche Markets. By forming a cooperative, these farmers actively sought to resist structural change in the pork industry. Despite the availability of Markets and adequate hog supplies, this fledgling cooperative faced a number of obstacles, including social pressure from other farmers and disagreements about the adequacy of their hog-raising methods. The future of this cooperative is uncertain, and it faces an uphill battle against the dominant pork producers.
