Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics.
Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics.
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DOI：
10.3389/fonc.2017.00273
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发表时间：
2017
影响因子：
4.7
通讯作者：
Molinski SV
中科院分区：
文献类型：
--
作者：
Hernandez JJ;Pryszlak M;Smith L;Yanchus C;Kurji N;Shahani VM;Molinski SV
将现有疗法重新定位或“再利用”以用于替代疾病适应症是一种有吸引力的方法，可以在药物开发期间节省大量的时间和金钱投资。对于癌症适应症，重新利用的治疗的主要目标是疗效，由于需要立即治疗该患者人群，因此对安全性的限制较少。本报告提供了一个高层次的概述，说明药物开发商如何追求重新利用资产，以前导航的资金努力，监管事务和知识产权法，以商业化这些“新”药物在肿瘤学。本文提供了对资助计划的深入了解（例如，政府赠款和慈善组织），学术和企业倡议可以利用这些资金来重新利用癌症药物。此外，我们强调了先前的例子，其中现有的、食品和药物管理局或欧洲药物管理局批准的疗法的二次使用已经在计算机中预测并在体外和/或体内成功验证（即，动物模型和人类临床试验）用于某些肿瘤学适应症。最后，我们描述了制药行业以前采用的策略，以导航监管的考虑，并成功地商业化他们的药品。在重新利用现有的癌症药物以使患者和药物开发人员受益时，必须仔细考虑这些因素。
The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.
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