Impact of BREXIT on UK Gene and Cell Therapy: The Need for Continued Pan-European Collaboration.
Impact of BREXIT on UK Gene and Cell Therapy: The Need for Continued Pan-European Collaboration.
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英国脱欧对英国基因和细胞治疗的影响：需要持续的泛欧合作。
DOI：
10.1089/hum.2016.29033.ahb
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发表时间：
2016
影响因子：
4.2
通讯作者：
Baker AH
中科院分区：
文献类型：
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作者：
Baker AH
2016年6月23日，英国举行全民公投，决定退出欧盟。这就是所谓的Brexit。英国政府尚未启动第50条，1在正式退出之前，有两年的时间来谈判接触条款，但英国脱欧机制已经开始加速。在最初的冲击波在英国及其他地区引起反响之后，许多人现在正在考虑英国研究的未来，欧盟的互动以及与科学界更广泛的合作。显然，这其中的大部分是任何类型的科学研究的共性，并已在一些科学期刊中得到阐述。那么，英国退欧对基因和细胞疗法意味着什么呢？因为英国是这些先进疗法的基础科学和临床转化的领先力量。这项研究现在得到了政府、慈善机构和商业部门的大力支持和投资，并正在成为英国国家医疗保健、创新和产业化战略的重要组成部分。从监管的角度来看，欧洲药品管理局（目前总部设在伦敦）目前负责在欧洲范围内批准新药，并促进多中心试验的实施。因此，如果不想对英国和其他欧盟成员国产生不利影响，就需要在许多领域找到谈判解决方案。当然，目前我们处于一个相对未知和难以预测的局面。基因和细胞治疗的开发和应用在欧盟的资助议程上已经有十多年了。欧盟对致力于这些人类健康方法的财团的投资已在专业期刊中有详细记载。2-4这些财团中有许多涉及总部设在英国的研究实验室，这些研究实验室为英国和欧盟成员国带来了巨大的利益。该领域的增长在一定程度上可以归功于这些联盟，这些联盟提供了证明新方法的安全性，有效性和可翻译性所需的临床前研究的广度。当需要最大限度地招募涉及罕见和超罕见遗传病的临床试验受试者时，联合体方法尤为重要。随着这些技术进入临床实践并在临床实践中确立，患者进入试验中心和专业干预变得更加重要。迄今为止，欧盟积极推动医疗流动性，通过互惠协议使患者能够在成员国接受治疗（从而获得临床试验）。英国科学家可以通过各种机制申请研究资金。其中包括地平线2020（H2020-当前的框架计划，以前是框架7，6等），其中包括奖学金（对内和对外）以及通过各种资助工具解决特定相关科学问题的联盟。此外，备受追捧的欧洲研究机构（ERC）赠款为个人提供了有声望的资金，根据申请人的职业状况，可以是启动者，巩固者或高级机制。英国受益
ON JUNE 23RD, 2016, the United Kingdom in a referendum voted to exit the European Union (EU). This is the so-called Brexit. The government is yet to activate Article 50, 1 after which there are 2 years to negotiate terms of engagement before the official exit, but the Brexit machinery is already picking up momentum. After the initial shockwaves that reverberated across the United Kingdom and beyond, many are now considering what the future holds for research based in the United Kingdom, for EU interactions, and for wider collaborations with the scientific community. Clearly much of this is generic to any type of scientific research, and has been articulated in a number of scientific journals. So what might Brexit mean for gene and cell therapy, given that the United Kingdom is a leading force in both basic science and clinical translation of these advanced therapeutics? This research is now gaining substantial support and investment from government, charitable and commercial sectors and is becoming a significant part of the UK national healthcare, innovation, and industrialization strategy. From the regulatory standpoint, the European Medicines Agency (currently headquartered in London) is now responsible for licensing new medicines across Europe and facilitates the implementation of multicenter trials. So there are a significant number of areas for which negotiated solutions need to be found if there is not to be a detrimental effect on the United Kingdom and indeed other EU member states. At present, of course, we are in a situation that is relatively unknown and difficult to predict. The development and application of gene and cell therapy have been very high on the EU funding agenda for more than decade. The investment by the EU in consortia working on these approaches to human health has been well documented in the pages of specialist journals. 2–4 Many of these consortia involve UK-based research laboratories and these have provided substantial benefit to both the United Kingdom and to EU member states. The growth in the field can be credited, to some extent through such consortia that have provided the breadth of preclinical research required to prove safety, efficacy, and translatability of new approaches. Consortium approaches have been particularly important when there has been a need to maximize the recruitment of subjects for clinical trials involving rare and ultrarare genetic conditions. As these technologies enter and become established in clinical practice, patient access to trial sites and specialized interventions becomes even more important. To date, the EU has actively promoted healthcare mobility, enabling patients to receive treatment (and therefore access to clinical trials) in member states through reciprocal agreements.There are various mechanisms through which UK scientists can apply for research funding. These include Horizon 2020 (H2020—the current framework program, previously these were Frameworks 7, 6, and so forth) that includes fellowships (inward and outward) as well as consortia to tackle specific pertinent scientific issues through a variety of funding tools. In addition, the much sought after European Research Agency (ERC) grants provide prestigious funding for individuals, based on either starter, consolidator, or advanced mechanisms, depending on the career status of the applicant. The United Kingdom has benefited
简介：欧盟第七期研究与技术发展框架计划基因治疗和基因转移项目（第二部分）。
影响因子：
--
作者：
David Gancberg;A. Hoeveler;R. Draghia‐Akli
通讯作者：
R. Draghia‐Akli
简介：第七个框架计划的基因和细胞治疗项目。
DOI：
--
发表时间：
2014
期刊：
影响因子：
--
作者：
GancbergDavid;NorstedtIrene;Draghia
通讯作者：
Draghia