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Anticipating the clinical adoption of regenerative medicine: building institutional readiness in the UK.展望再生医学的临床应用:在英国建立机构准备状态。
Regen Med. 2018 Jan;13(1):29-39. doi: 10.2217/rme-2017-0121. Epub 2018 Jan 23.
2
[Big Biology : Supersizing Wissenschaft zu Beginn des 21. Jahrhunderts].[大生物学:21世纪初科学的规模化发展]
NTM. 2016 Jun;24(2):195-223. doi: 10.1007/s00048-016-0141-8.
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REIMBURSEMENT OF CELL-BASED REGENERATIVE THERAPY IN THE UK AND FRANCE.英国和法国基于细胞的再生疗法的报销情况。
Med Law Rev. 2016 Spring;24(2):234-58. doi: 10.1093/medlaw/fww009. Epub 2016 Apr 15.
4
CRISPR: taking the shortcut to a healthy genome editing enterprise.CRISPR:通往健康基因组编辑事业的捷径。
Regen Med. 2016 Apr;11(3):229-34. doi: 10.2217/rme-2016-0012. Epub 2016 Mar 11.
5
Are there specific translational challenges in regenerative medicine? Lessons from other fields.再生医学中是否存在特定的转化挑战?来自其他领域的经验教训。
Regen Med. 2015;10(7):885-95. doi: 10.2217/rme.15.50. Epub 2015 Nov 6.
6
Reproducibility in science: improving the standard for basic and preclinical research.科学可重复性:提高基础和临床前研究的标准。
Circ Res. 2015 Jan 2;116(1):116-26. doi: 10.1161/CIRCRESAHA.114.303819.

加速创新:复杂性、监管与时间性

Accelerating Innovation: Complexity, Regulation, and Temporality.

作者信息

Webster Andrew

机构信息

Science and Technology Studies Unit, University of York, York, United Kingdom.

出版信息

Front Sociol. 2019 Mar 12;4:13. doi: 10.3389/fsoc.2019.00013. eCollection 2019.

DOI:10.3389/fsoc.2019.00013
PMID:33869340
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8022755/
Abstract

This Perspective paper explores recent moves seen in many countries toward accelerating the speed at which biomedical innovation can be delivered to the clinic. It discusses the drivers behind this and the rationale for it, illustrating this briefly in the field of regenerative medicine. It argues that the process reconfigures present/future relations, especially in terms of the relationship between different forms of evidence and risk calculations. The regulatory/innovation relationship is, as a result, being rewritten. Paradoxically, the moves toward acceleration are less to do with the arrival of a more streamlined evaluation system that selects for scientifically robust technologies ready for "the market." In contrast, it reflects the growing complexity of innovation itself: whereas Latour (1987) had argued that "science-in the-making" was backstage in contrast to "ready-made science," the former is now very visible. This in turn has generated two other parallel processes-"regulation-in-the-making" and "risk-in-the-making." Such shifts can be seen in the field of regenerative medicine. The paper asks how best to engage with the move toward acceleration and thereby the future oversight of innovation.

摘要

这篇观点文章探讨了许多国家近期为加快生物医学创新成果应用于临床的速度而采取的举措。文章讨论了其背后的驱动因素及原理,并以再生医学领域为例进行简要说明。文章认为,这一过程重塑了当下与未来的关系,尤其是在不同形式的证据与风险计算之间的关系方面。因此,监管与创新的关系正在被重新改写。矛盾的是,加速的举措并非源于出现了一个更精简的评估体系,该体系能筛选出科学上可靠且准备好进入“市场”的技术。相反,它反映了创新本身日益增长的复杂性:拉图尔(1987年)曾提出,“正在形成的科学”与“现成的科学”相比处于幕后,而如今前者已十分显著。这进而又产生了另外两个并行的过程——“正在形成的监管”和“正在形成的风险”。此类转变在再生医学领域可见一斑。文章探讨了如何最好地应对加速的趋势以及对创新的未来监管。