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Pesquisa : I01.880.604.583.458 [Categoria DeCS]
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[PMID]:29224409
[Au] Autor:Glorikian H; Warburg RJ; Moore K; Malinowski J
[Ad] Endereço:a New Ventures , VA , USA.
[Ti] Título:Intellectual property considerations for molecular diagnostic development with emphasis on companion diagnostics.
[So] Source:Expert Opin Ther Pat;28(2):123-128, 2018 Feb.
[Is] ISSN:1744-7674
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: The development of molecular diagnostics is a complex endeavor, with multiple regulatory pathways to consider and numerous approaches to development and commercialization. Companion diagnostics, devices which are "essential for the safe and effective use of a corresponding drug or diagnostic product" (see U.S. Food & Drug Administration, In Vitro Diagnostics - Companion Diagnostics, U.S. Dept. of Health & Human Services(2016), available at https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/ucm407297.htm ) and complementary diagnostics, which are more broadly associated with a class of drug, are becoming increasingly important as integral components of the implementation of precision medicine. Areas covered: The following article will highlight the intellectual property ('IP') considerations pertinent to molecular diagnostics development with special emphasis on companion diagnostics. Expert opinion/commentary Summary: For all molecular diagnostics, intellectual property (IP) concerns are of paramount concern, whether the device will be marketed only in the United States or abroad. Taking steps to protect IP at each stage of product development is critical to optimize profitability of a diagnostic product. Also the legal framework around IP protection of diagnostic technologies has been changing over the previous few years and can be expected to continue to change in the foreseeable near future, thus, a comprehensive IP strategy should take into account the fact that changes in the law can be expected.
[Mh] Termos MeSH primário: Propriedade Intelectual
Técnicas de Diagnóstico Molecular
Patologia Molecular/legislação & jurisprudência
[Mh] Termos MeSH secundário: Seres Humanos
Patentes como Assunto
Medicina de Precisão/métodos
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180215
[Lr] Data última revisão:
180215
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171212
[St] Status:MEDLINE
[do] DOI:10.1080/13543776.2018.1409209


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[PMID]:27771996
[Au] Autor:Bayon Y; Van Dyke M; Buelher R; Tubo R; Bertram T; Malfroy-Camine B; Rathman M; Ronfard V
[Ad] Endereço:1 Medtronic-Sofradim Production , Trévoux, France .
[Ti] Título:How Regenerative Medicine Stakeholders Adapt to Ever-Changing Technology and Regulatory Challenges? Snapshots from the World TERMIS Industry Symposium (September 10, 2015, Boston).
[So] Source:Tissue Eng Part B Rev;23(2):159-162, 2017 04.
[Is] ISSN:1937-3376
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Regenerative medicine (RM) is a fascinating area of research and innovation. The huge potential of the field has been fairly underexploited so far. Both TERMIS-AM and TERMIS-EU Industry Committees are committed to mentoring and training young entrepreneurs for more successful commercial translation of upstream research. With this objective in mind, the two entities jointly organized an industry symposium during the past TERMIS World Congress (Boston, September 8-11, 2015) and invited senior managers of the RM industry for lectures and panel discussions. One of the two sessions of the symposium-How to overcome obstacles encountered when bringing products to the commercial phase?-aimed to share the inside, real experiences of leaders from TEI Biosciences (an Integra Company), Vericel (formerly Aastrom; acquirer of Genzyme Regenerative Medicine assets), RegenMedTX (formerly Tengion), Mindset Rx, ViThera Pharmaceuticals, and L'Oreal Research & Innovation. The symposium provided practical recommendations for RM product development, for remaining critical and objective when reviewing progress, for keeping solutions simple, and for remaining relevant and persistent.
[Mh] Termos MeSH primário: Medicina Regenerativa/legislação & jurisprudência
Medicina Regenerativa/métodos
Controle Social Formal
[Mh] Termos MeSH secundário: Terapia Genética/legislação & jurisprudência
Seres Humanos
Propriedade Intelectual
Engenharia Tecidual/legislação & jurisprudência
[Pt] Tipo de publicação:CONGRESSES
[Em] Mês de entrada:1707
[Cu] Atualização por classe:171129
[Lr] Data última revisão:
171129
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE
[do] DOI:10.1089/ten.TEB.2016.0292


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[PMID]:29048862
[Au] Autor:Kapczynski A
[Ad] Endereço:Yale Law School.
[Ti] Título:Order Without Intellectual Property Law: Open Science in Influenza.
[So] Source:Cornell Law Rev;102(6):1539-648, 2017.
[Is] ISSN:0010-8847
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Today, intellectual property (IP) scholars accept that IP as an approach to information production has serious limits. But what lies beyond IP? A new literature on "intellectual production without IP" (or "IP without IP") has emerged to explore this question, but its examples and explanations have yet to convince skeptics. This Article reorients this new literature via a study of a hard case: a global influenza virus-sharing network that has for decades produced critically important information goods, at significant expense, and in a loose-knit group--all without recourse to IP. I analyze the Network as an example of "open science," a mode of information production that differs strikingly from conventional IP, and yet that successfully produces important scientific goods in response to social need. The theory and example developed here refute the most powerful criticisms of the emerging "IP without IP" literature, and provide a stronger foundation for this important new field. Even where capital costs are high, creation without IP can be reasonably effective in social terms, if it can link sources of funding to reputational and evaluative feedback loops like those that characterize open science. It can also be sustained over time, even by loose-knit groups and where the stakes are high, because organizations and other forms of law can help to stabilize cooperation. I also show that contract law is well suited to modes of information production that rely upon a "supply side" rather than "demand side" model. In its most important instances, "order without IP" is not order without governance, nor order without law. Recognizing this can help us better ground this new field, and better study and support forms of knowledge production that deserve our attention, and that sometimes sustain our very lives.
[Mh] Termos MeSH primário: Saúde Global
Vacinas contra Influenza
Influenza Humana/epidemiologia
Influenza Humana/prevenção & controle
Disseminação de Informação/métodos
Propriedade Intelectual
Cooperação Internacional
Pandemias/prevenção & controle
Saúde Pública
Ciência
[Mh] Termos MeSH secundário: Animais
Capitalismo
Financiamento Governamental
Seres Humanos
Vírus da Influenza A Subtipo H5N1
Influenza Aviária/epidemiologia
Disseminação de Informação/legislação & jurisprudência
Modelos Teóricos
Motivação
Patentes como Assunto
Aves Domésticas
Editoração
Pesquisa
Vigilância de Evento Sentinela
Organização Mundial da Saúde
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Influenza Vaccines)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171031
[Lr] Data última revisão:
171031
[Sb] Subgrupo de revista:T
[Da] Data de entrada para processamento:171020
[St] Status:MEDLINE


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[PMID]:29028755
[Au] Autor:Padula WV; McQueen RB; Pronovost PJ
[Ad] Endereço:*Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD †Center for Pharmaceutical Outcomes Research, Skaggs School of Pharmacy & Pharmaceutical Sciences, University of Colorado, Aurora, CO ‡Departments of Anesthesiology & Critical Care Medicine and Surgery, Johns Hopkins Medicine, Baltimore, MD.
[Ti] Título:Finding Resolution for the Responsible Transparency of Economic Models in Health and Medicine.
[So] Source:Med Care;55(11):915-917, 2017 Nov.
[Is] ISSN:1537-1948
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Second Panel on Cost-Effectiveness in Health and Medicine recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses has a number of questions unanswered with respect to the implementation of transparent, open source code interface for economic models. The possibility of making economic model source code could be positive and progressive for the field; however, several unintended consequences of this system should be first considered before complete implementation of this model. First, there is the concern regarding intellectual property rights that modelers have to their analyses. Second, the open source code could make analyses more accessible to inexperienced modelers, leading to inaccurate or misinterpreted results. We propose several resolutions to these concerns. The field should establish a licensing system of open source code such that the model originators maintain control of the code use and grant permissions to other investigators who wish to use it. The field should also be more forthcoming towards the teaching of cost-effectiveness analysis in medical and health services education so that providers and other professionals are familiar with economic modeling and able to conduct analyses with open source code. These types of unintended consequences need to be fully considered before the field's preparedness to move forward into an era of model transparency with open source code.
[Mh] Termos MeSH primário: Análise Custo-Benefício
Modelos Econômicos
[Mh] Termos MeSH secundário: Seres Humanos
Propriedade Intelectual
Medicina
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171026
[Lr] Data última revisão:
171026
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171014
[St] Status:MEDLINE
[do] DOI:10.1097/MLR.0000000000000813


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[PMID]:29028754
[Au] Autor:Cohen JT; Wong JB
[Ad] Endereço:*Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center †Department of Medicine, Division of Clinical Decision Making, Tufts Medical Center, Boston, MA.
[Ti] Título:Can Economic Model Transparency Improve Provider Interpretation of Cost-Effectiveness Analysis? A Response.
[So] Source:Med Care;55(11):912-914, 2017 Nov.
[Is] ISSN:1537-1948
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:To enhance the credibility and the value of health economic analyses, we argue that the computer model source code underlying these analyses should be made publicly available. Only with open publication is it possible for others to assess whether alternative assumptions, beyond those examined by the model authors, alter the model's findings. Because reproducibility is critical for scientific acceptance and because computation increasingly permeates scientific inquiry, other fields have moved toward open publication of computer models, and health economics should avoid falling behind. Making source code available shines a light on these otherwise black boxes and facilitates their complete evaluation and understandability. The preceding commentary makes 2 arguments against open publication. It claims first that open publication would undermine intellectual property rights and discourage work in this field. We respond that the impact on intellectual property would be minimal, and that open publication could even increase model value. The second argument against open publication is the possibility of model misuse. If anything, however, open publication would reduce this risk by making the model implementation completely transparent. We argue finally that open publication of models would have ancillary benefits by making the research more amenable for adaptation and innovation. Moving toward open publication will present challenges, but we believe that the benefits of increased scientific credibility and utility, particularly for health policy and clinical practice decisions, will certainly outweigh the harms.
[Mh] Termos MeSH primário: Análise Custo-Benefício
Modelos Econômicos
[Mh] Termos MeSH secundário: Política de Saúde
Seres Humanos
Propriedade Intelectual
Reprodutibilidade dos Testes
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171026
[Lr] Data última revisão:
171026
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171014
[St] Status:MEDLINE
[do] DOI:10.1097/MLR.0000000000000811


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[PMID]:29028753
[Au] Autor:Padula WV; McQueen RB; Pronovost PJ
[Ad] Endereço:*Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD †Center for Pharmaceutical Outcomes Research, Skaggs School of Pharmacy & Pharmaceutical Sciences, University of Colorado, Aurora, CO ‡Departments of Anesthesiology & Critical Care Medicine and Surgery, Johns Hopkins Medicine, Baltimore, MD.
[Ti] Título:Can Economic Model Transparency Improve Provider Interpretation of Cost-effectiveness Analysis? Evaluating Tradeoffs Presented by the Second Panel on Cost-effectiveness in Health and Medicine.
[So] Source:Med Care;55(11):909-911, 2017 Nov.
[Is] ISSN:1537-1948
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Second Panel on Cost-Effectiveness in Health and Medicine convened on December 7, 2016 at the National Academy of Medicine to disseminate their recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses (CEAs). Following its summary, panel proceedings included lengthy discussions including the field's struggle to disseminate findings efficiently through peer-reviewed literature to target audiences. With editors of several medical and outcomes research journals in attendance, there was consensus that findings of cost-effectiveness analyses do not effectively reach other researchers or health care providers. The audience members suggested several solutions including providing additional training to clinicians in cost-effectiveness research and requiring that cost-effectiveness models are made publicly available. However, there remains the questions of whether making economic modelers' work open-access through journals is fair under the defense that these models remain one's own intellectual property, or whether journals can properly manage the peer-review process specifically for cost-effectiveness analyses. In this article, we elaborate on these issues and provide some suggested solutions that may increase the dissemination and application of cost-effectiveness literature to reach its intended audiences and ultimately benefit the patient. Ultimately, it is our combined view as economic modelers and clinicians that cost-effectiveness results need to reach the clinician to improve the efficiency of medical practice, but that open-access models do not improve clinician access or interpretation of the economics of medicine.
[Mh] Termos MeSH primário: Análise Custo-Benefício
Disseminação de Informação/métodos
Modelos Econômicos
Publicação de Acesso Aberto
Revisão da Pesquisa por Pares
[Mh] Termos MeSH secundário: Congressos como Assunto
Seres Humanos
Propriedade Intelectual
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171020
[Lr] Data última revisão:
171020
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171014
[St] Status:MEDLINE
[do] DOI:10.1097/MLR.0000000000000810


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[PMID]:28863170
[Au] Autor:Fast AA; Olson KR; Mandel GN
[Ad] Endereço:Department of Psychology, University of Washington, Seattle, Washington, United States of America.
[Ti] Título:Intuitive intellectual property law: A nationally-representative test of the plagiarism fallacy.
[So] Source:PLoS One;12(9):e0184315, 2017.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Studies with convenience samples have suggested that the lay public's conception of intellectual property laws, including how the laws should regulate and why they should exist, are largely incommensurate with the actual intended purpose of intellectual property laws and their history in the United States. In this paper, we test whether these findings generalize to a more diverse and representative sample. The major findings from past work were replicated in the current study. When presented with several potential reasons for IP protection, the lay public endorsed plagiarism and felt that acknowledging the original source of a creative work should make copying that work permissible-viewpoints strongly divergent from lawmakers' intent and the law itself. In addition, we replicate the finding that lay people know remarkably little about intellectual property laws more generally and report little experience as users or creators of creative works.
[Mh] Termos MeSH primário: Propriedade Intelectual
Plágio
[Mh] Termos MeSH secundário: Adolescente
Adulto
Idoso
Atitude
Feminino
Seres Humanos
Internet
Masculino
Meia-Idade
Opinião Pública
Estados Unidos
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171023
[Lr] Data última revisão:
171023
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170902
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0184315


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[PMID]:28673648
[Au] Autor:Voss T; Paranjpe AS; Cook TG; Garrison NDW
[Ad] Endereço:Technology Transfer and Business Development, Oregon Health & Science University, Portland, OR.
[Ti] Título:A Short Introduction to Intellectual Property Rights.
[So] Source:Tech Vasc Interv Radiol;20(2):116-120, 2017 Jun.
[Is] ISSN:1557-9808
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Intellectual property (IP) is a term that describes a number of distinct types of intangible assets. IP protection allows a rightsholder to exclude others from interfering with or using the property right in specified ways. The main forms of IP are patents, copyrights, trademarks, and trade secrets. Each type of IP protection is different, varying in the subject matter that can be covered, timeframe of protection, and total expense. Although some inventions may be covered by multiple types of IP protection, it is important to consider a number of business and legal factors before selecting the best protection strategy. Some technologies require strong IP protection to commercialize, but unnecessary costs can derail bringing a product to market. IP departments of organizations weigh these various considerations and perform essential IP protection functions. This primer introduces researchers to the main forms of IP and its legal aspects.
[Mh] Termos MeSH primário: Setor de Assistência à Saúde
Necessidades e Demandas de Serviços de Saúde
Propriedade Intelectual
Determinação de Necessidades de Cuidados de Saúde
Avaliação da Tecnologia Biomédica
[Mh] Termos MeSH secundário: Direitos Autorais
Difusão de Inovações
Desenho de Equipamento
Setor de Assistência à Saúde/legislação & jurisprudência
Necessidades e Demandas de Serviços de Saúde/legislação & jurisprudência
Necessidades e Demandas de Serviços de Saúde/organização & administração
Seres Humanos
Determinação de Necessidades de Cuidados de Saúde/legislação & jurisprudência
Determinação de Necessidades de Cuidados de Saúde/organização & administração
Patentes como Assunto
Avaliação da Tecnologia Biomédica/legislação & jurisprudência
Avaliação da Tecnologia Biomédica/organização & administração
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170918
[Lr] Data última revisão:
170918
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170705
[St] Status:MEDLINE


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[PMID]:28671001
[Au] Autor:Garattini L; Padula A
[Ad] Endereço:a IRCCS Institute for Pharmacological Research "Mario Negri" , Ranica , Italy.
[Ti] Título:Between pharmaceutical patents and European patients: is a compromise still possible?
[So] Source:Expert Opin Ther Pat;27(10):1073-1076, 2017 Oct.
[Is] ISSN:1744-7674
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Pharmaceutical regulation has always attempted to balance the public health objective to make safe and effective drugs available for patients while providing commercial incentives through patents. Here we discuss whether it is still possible to find a balance between the incentives on the supply side and the regulatory framework on the demand side. Areas covered: The current regulatory framework on pharmaceutical exclusivity has been harshly criticized by many experts, arguing about whether it is still fit for public purposes and needs. Here we envisage a different scenario without 'revolutionizing' the whole present system. The main radical change should concern the present management of pharmaceutical patents by introducing a specific agency dedicated to them. Secondly, specific pharmaceutical patents could be restricted to compounds for one (or more) declared indication(s). Thirdly, pharmaceutical patents should be kept only for compounds that start a first clinical trial within five years from the granting date. Expert opinion: We think it is time to reconsider the regulation of pharmaceutical patents in the light of their relevance in terms of public health. New models of enhancing research investments are required for long-term sustainability of public pharmaceutical expenditure and the EU can still play a leading role.
[Mh] Termos MeSH primário: Indústria Farmacêutica/legislação & jurisprudência
Patentes como Assunto/legislação & jurisprudência
Preparações Farmacêuticas/administração & dosagem
[Mh] Termos MeSH secundário: Controle de Medicamentos e Entorpecentes
União Europeia
Seres Humanos
Propriedade Intelectual
Saúde Pública
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Pharmaceutical Preparations)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170922
[Lr] Data última revisão:
170922
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170704
[St] Status:MEDLINE
[do] DOI:10.1080/13543776.2017.1350648


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[PMID]:28246248
[Au] Autor:Webster P
[Ad] Endereço:Toronto, Ontario.
[Ti] Título:TRIPS drug amendment a start.
[So] Source:CMAJ;189(7):E289, 2017 02 21.
[Is] ISSN:1488-2329
[Cp] País de publicação:Canada
[La] Idioma:eng
[Mh] Termos MeSH primário: Países em Desenvolvimento
Custos de Medicamentos
Medicamentos Genéricos/economia
Propriedade Intelectual
Direito Internacional
[Mh] Termos MeSH secundário: Fármacos Anti-HIV/economia
Antimaláricos/economia
Antituberculosos/economia
Seres Humanos
[Pt] Tipo de publicação:NEWS
[Nm] Nome de substância:
0 (Anti-HIV Agents); 0 (Antimalarials); 0 (Antitubercular Agents); 0 (Drugs, Generic)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171016
[Lr] Data última revisão:
171016
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170302
[St] Status:MEDLINE
[do] DOI:10.1503/cmaj.1095391



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