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Commercial Licensing of HIV-1 Protease: Applications of the NIH Research Tools Policy. HIV-1蛋白酶的商业许可:NIH研究工具政策的应用。
The journal of biolaw & business Pub Date : 2009-01-01
George H Keller, Steven M Ferguson
{"title":"Commercial Licensing of HIV-1 Protease: Applications of the NIH Research Tools Policy.","authors":"George H Keller,&nbsp;Steven M Ferguson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Licensing of the HIV-1 protease gene by the NIH Office of Technology Transfer (OTT) provides an example of the effective use of the principles of the NIH Research Tools Policy, which was designed to provide broad access to important biomedical technologies. The OTT licensing experience is presented in detail as it was applied to research reagents, diagnostics and drug development to thus enhance the overall development process for a wide variety of medical products.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"12 4","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2009-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3013055/pdf/nihms160153.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"29568335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Research examines the minimal risk standard for pediatric research. 研究检查了儿科研究的最低风险标准。
The journal of biolaw & business Pub Date : 2006-01-01
Arlene D Luu
{"title":"Research examines the minimal risk standard for pediatric research.","authors":"Arlene D Luu","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The \"minimal\" risk standard for protection of pediatric research subjects often fails due to unclear definitions and uneven IRB application, requiring an alternative standard to better assist pediatric research assessment.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 1","pages":"52-3"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26370359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Stem cell research debate shifting to the courts. 干细胞研究之争转向法庭。
The journal of biolaw & business Pub Date : 2006-01-01
Katherine R Vick
{"title":"Stem cell research debate shifting to the courts.","authors":"Katherine R Vick","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>California stem cell initiative faces legal challenges from groups opposing embryonic research and abortion opponents.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 1","pages":"56-7"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26370362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The bounds of science and ethics. 科学和伦理的界限。
The journal of biolaw & business Pub Date : 2006-01-01
Bryan A Liang
{"title":"The bounds of science and ethics.","authors":"Bryan A Liang","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 1","pages":"44-5"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26370356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
National Institutes of Health enacts final ethics regulations. 国家卫生研究院颁布最终的道德规范。
The journal of biolaw & business Pub Date : 2006-01-01
April C Ness
{"title":"National Institutes of Health enacts final ethics regulations.","authors":"April C Ness","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>NIH new ethics regulations limit its employees activities, investments, and receipt of awards of NIH employees.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 1","pages":"50-1"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26370358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Face transplants and the difficulties of obtaining research approval. 面部移植和获得研究批准的困难。
The journal of biolaw & business Pub Date : 2006-01-01
Aline Gaba
{"title":"Face transplants and the difficulties of obtaining research approval.","authors":"Aline Gaba","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>After over one year of consideration, the world's first face transplant has obtained research approval despite ethical and safety concerns.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 1","pages":"54-5"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26370361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The legal status of embryos and implications for reproductive technologies and biotechnology research. 胚胎的法律地位及其对生殖技术和生物技术研究的影响。
The journal of biolaw & business Pub Date : 2006-01-01
Krietta Kai Bowens
{"title":"The legal status of embryos and implications for reproductive technologies and biotechnology research.","authors":"Krietta Kai Bowens","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The legal status of embryos in American law is changing. At present, most states do not afford embryos the same protections as a born person, but some states are attempting to change this standard. Granting embryos the same legal status as born human beings poses a significant problem for industries that work with embryos, especially fertility treatment facilities and scientists researching stem cell and gene therapy technologies. This paper describes the methods of defining embryos in American law, and discusses the implications of granting embryos the same rights as born persons for the reproductive technology and scientific research industries.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 1","pages":"17-25"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26370354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Financial conflicts of interest in biomedical human subject research. 生物医学人类受试者研究中的经济利益冲突。
The journal of biolaw & business Pub Date : 2006-01-01
Nathan Goldstein
{"title":"Financial conflicts of interest in biomedical human subject research.","authors":"Nathan Goldstein","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The purpose of this paper is to examine the past, present and future of financial conflict of interest regulation in biomedical human subject testing. Part I will briefly review the forces giving rise to the current controversy. Part II will examine the more influential ethical codes on human subject testing and argue that they are inconclusive on the subject of financial conflicts of interest. Part III will examine the various regulations now in place and identify their serious flaws. Part IV will critique the leading proposals for reform. The Conclusion will synthesize the best features of the various proposals for reform and suggest improvements left unaddressed by these proposals.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 1","pages":"26-37"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26370355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Beyond Patents and Royalties: Perception and Reality of Doing Business with the NIH. 超越专利和版税:与美国国立卫生研究院做生意的感知和现实。
The journal of biolaw & business Pub Date : 2006-01-01 DOI: 10.1038/bioent895
Gil Ben-Menachem, Steven M Ferguson, Krishna Balakrishnan
{"title":"Beyond Patents and Royalties: Perception and Reality of Doing Business with the NIH.","authors":"Gil Ben-Menachem,&nbsp;Steven M Ferguson,&nbsp;Krishna Balakrishnan","doi":"10.1038/bioent895","DOIUrl":"https://doi.org/10.1038/bioent895","url":null,"abstract":"<p><p>Young, and mid size biotech companies can benefit hugely from the US National Institutes of Health (NIH), not least because of the agency's non-dilutive funding, guidance, and opportunities for collaboration. Increasingly, however, there is a fair bit of misunderstanding about what the NIH can and cannot do for a biotech entrepreneur.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"24 1","pages":"17-20"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1038/bioent895","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40035614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Audits of clinical trials in India: a step in the right direction. 印度临床试验审计:朝着正确方向迈出的一步。
The journal of biolaw & business Pub Date : 2006-01-01
Viveka Roychowdhury
{"title":"Audits of clinical trials in India: a step in the right direction.","authors":"Viveka Roychowdhury","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Random audits of clinical trial sites in India are due to start any time now. These regulatory measures come at a very crucial time when India's relatively young clinical research industry is poised for exponential growth. Can the industry scale up fast enough? Viveka Roychowdhury spoke to a cross section of industry experts to get their views.</p>","PeriodicalId":83088,"journal":{"name":"The journal of biolaw & business","volume":"9 3","pages":"26-8"},"PeriodicalIF":0.0,"publicationDate":"2006-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"26428517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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