Delivering the power of nanomedicine to patients today
Delivering the power of nanomedicine to patients today
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DOI：
10.1016/j.jconrel.2020.07.007
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发表时间：
2020-10-10
影响因子：
10.8
通讯作者：
Schmid, Ruth
中科院分区：
文献类型：
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作者：
Germain, Matthieu;Caputo, Fanny;Schmid, Ruth
COVID-19大流行的形势提醒我们，我们永远需要高价值的灵活解决方案来满足迫切的临床需求，包括适用于现场使用和提供靶向治疗的简化诊断技术。从我们的角度来看，纳米技术作为解决复杂医疗挑战的技术解决方案的通用平台，是一种至关重要的资源。正是从这个角度出发，我们对帕克斯教授最近发表在《控制释放杂志》上的社论提出了质疑。Park教授认为，在过去的15年里，纳米医学未能向患者提供承诺的创新临床解决方案（Park， K.）。这是纳米医学炒作结束的开始。控释学报，2019；305,221 -222 b[1]。我们，ETPN（欧洲纳米医学技术平台）b[2]，恭敬地表示不同意。事实上，目前市场上超过50种配方，以及最近批准的3种关键纳米药物产品（例如Onpattro， Hensify和Vyxeos）已经证明，纳米医学领域能够以独特的方式设计产品，克服传统医学中的关键障碍，而且还可以通过使用纯物理作用模式在细胞内提供新的无药物治疗效果，从而改变患者的生活。此外，目前正在进行临床试验的bbbb400纳米药物配方有望单独或与其他关键使能技术结合，为市场带来新的临床解决方案（例如核酸递送平台），包括生物技术、微流体、先进材料、生物材料、智能系统、光子学、机器人、纺织、大数据和ICT（信息与通信技术）。然而，我们同意朴教授的观点，“现在是时候检查纳米医学临床转化的困难来源并向前迈进了”。但是为了实现这一目标，支持有前景的纳米药物配方临床转化的投资应该增加，而不是减少。正如EMA最近在其2025年路线图中所鼓励的那样，我们应该通过一个连接学术界、工业界、医疗保健提供者和政策制定者的共同知识中心来创造更多的统一，以减少目前标准化和监管机构景观的碎片化。推进跨技术创新战略，支持纳米医学作为一种高价值、低成本的解决方案发展，以解决未被满足的医疗需求，并帮助该领域最有前景的创新项目更好、更快地进入临床。这种全球视野是ETPN在过去15年中选择鼓励的。所有的行动都应该以清晰的临床观点为出发点，“不做任何宣传”，关注“现实生活中最重要的事情”，也就是病人和他/她的生活质量。这份关于纳米医学成就的ETPN概述有助于加强我们的动力，进一步扩大和发展纳米医学在全球医疗保健领域的成熟度，加快将其巨大潜力转化为切实的医学突破的步伐。
The situation of the COVID-19 pandemic reminds us that we permanently need high-value flexible solutions to urgent clinical needs including simplified diagnostic technologies suitable for use in the field and for delivering targeted therapeutics. From our perspective nanotechnology is revealed as a vital resource for this, as a generic platform of technical solutions to tackle complex medical challenges. It is towards this perspective and focusing on nanomedicine that we take issue with Prof Parks recent editorial published in the Journal of Controlled Release. Prof. Park argued that in the last 15 years nanomedicine failed to deliver the promised innovative clinical solutions to the patients (Park, K. The beginning of the end of the nanomedicine hype. Journal of Controlled Release, 2019; 305, 221-222 [1]. We, the ETPN (European Technology Platform on Nanomedicine) [2], respectfully disagree. In fact, the more than 50 formulations currently in the market, and the recent approval of 3 key nanomedicine products (e. g. Onpattro, Hensify and Vyxeos), have demonstrated that the nanomedicine field is concretely able to design products that overcome critical barriers in conventional medicine in a unique manner, but also to deliver within the cells new drug-free therapeutic effects by using pure physical modes of action, and therefore make a difference in patients lives. Furthermore, the > 400 nanomedicine formulations currently in clinical trials are expecting to bring novel clinical solutions (e.g. platforms for nucleic acid delivery), alone or in combination with other key enabling technologies to the market, including biotechnologies, microfluidics, advanced materials, biomaterials, smart systems, photonics, robotics, textiles, Big Data and ICT (information & communication technologies) more generally. However, we agree with Prof. Park that " it is time to examine the sources of difficulty in clinical translation of nanomedicine and move forward ". But for reaching this goal, the investments to support clinical translation of promising nanomedicine formulations should increase, not decrease. As recently encouraged by EMA in its roadmap to 2025, we should create more unity through a common knowledge hub linking academia, industry, healthcare providers and hopefully policy makers to reduce the current fragmentation of the standardization and regulatory body landscape. We should also promote a strategy of cross-technology innovation, support nanomedicine development as a high value and low-cost solution to answer unmet medical needs and help the most promising innovative projects of the field to get better and faster to the clinic. This global vision is the one that the ETPN chose to encourage for the last fifteen years. All actions should be taken with a clear clinical view in mind, " without any fanfare", to focus "on what matters in real life", which is the patient and his/her quality of life.This ETPN overview of achievements in nanomedicine serves to reinforce our drive towards further expanding and growing the maturity of nanomedicine for global healthcare, accelerating the pace of transformation of its great potential into tangible medical breakthroughs.