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美国国立卫生研究院对纳米药物产品和器械投资的临床转化

Clinical Translation of the National Institutes of Health's Investments in Nanodrug Products and Devices.

作者信息

Henderson Lori A, Shankar Lalitha K

机构信息

Diagnostic Imaging Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, Maryland, 20850, USA.

出版信息

AAPS J. 2017 Mar;19(2):343-359. doi: 10.1208/s12248-016-9995-x. Epub 2016 Dec 19.

DOI:10.1208/s12248-016-9995-x
PMID:27995455
Abstract

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting biomedical research. The NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability. In support of this mission, NIH has invested about $4.4 billion since 2001 in nanotechnology (NT) research. This investment is leading to fundamental changes in understanding biological processes in health and disease, as well as enabling novel diagnostics and interventions for treating disease. NIH scientists are developing molecular agents and methods for earlier and more accurate diagnosis and therapies aimed directly and selectively at diseased cells, and are exploring root causes of common and rare diseases at the nanoscale. Work is also underway to move these research tools and devices into clinical practice. This particular investigative review examines the NIH NT portfolio linked to clinical trials from FY2008 to FY2015 to assess the progress of clinical translation. Among the subset of trials identified, 70% target drug or combination drug-device products used in treating cancer, AIDS, and other various diseases. The review also provides insight into trends observed from studying the clinical research portfolio.

摘要

美国国立卫生研究院(NIH)是美国卫生与公众服务部的一部分,是开展和支持生物医学研究的主要联邦机构。NIH的使命是寻求有关生命系统本质和行为的基础知识,并应用这些知识来增进健康、延长寿命以及减少疾病和残疾。为支持这一使命,自2001年以来,NIH已在纳米技术(NT)研究方面投入了约44亿美元。这项投资正在导致对健康和疾病中生物过程的理解发生根本性变化,同时也为疾病治疗带来了新颖的诊断方法和干预措施。NIH的科学家们正在开发分子试剂和方法,以实现更早期、更准确的诊断,并研发直接且有选择性地针对病变细胞的治疗方法,同时正在纳米尺度上探索常见和罕见疾病的根本原因。将这些研究工具和设备转化为临床实践的工作也在进行中。本次专项调查审查研究了2008财年至2015财年与临床试验相关的NIH纳米技术项目组合,以评估临床转化的进展情况。在所确定的试验子集中,70%的目标是用于治疗癌症、艾滋病和其他各种疾病的药物或药物与设备的组合产品。该审查还深入分析了研究临床研究项目组合时观察到的趋势。

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本文引用的文献

1
Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date.基于纳米颗粒的药物:对美国食品药品监督管理局(FDA)批准的材料及迄今临床试验的综述。
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2
Nanoliposome is a Promising Carrier of Protein and Peptide Biomolecule for the Treatment of Cancer.纳米脂质体是用于癌症治疗的蛋白质和肽生物分子的一种有前景的载体。
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Cancer nanotherapeutics in clinical trials.
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Product quality for nanomaterials: current U.S. experience and perspective.纳米材料的产品质量:美国当前的经验与展望
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Nanotechnologies in cancer treatment and diagnosis.癌症治疗和诊断中的纳米技术。
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NCI investment in nanotechnology: achievements and challenges for the future.NCI 对纳米技术的投资:未来的成就与挑战。
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Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.药品中纳米材料PQRI研讨会总结报告:当前经验与潜在风险管理
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Nanotherapeutics in the EU: an overview on current state and future directions.欧盟的纳米疗法:现状与未来方向概述
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