Fairness in Manufacturing Cellular Therapies.
Fairness in Manufacturing Cellular Therapies.
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DOI：
10.1080/15265161.2018.1445792
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发表时间：
2018-04
期刊：
影响因子：
--
通讯作者：
Ossorio PN
中科院分区：
文献类型：
--
作者：
Das A;Saha K;Ossorio PN
细胞免疫疗法，特别是嵌合抗原受体 T (CAR T) 细胞产品的最新成功，引起了患者、研究人员和投资者的兴奋。目前有数百项免疫疗法临床试验正在进行中，并且计划进行更多试验（Hartmann 等人，2017）。不幸的是，没有足够的专业制造能力来满足早期临床试验对患者特异性工程细胞的需求（Levine et al. 2017）。联邦政府资助的细胞制造计划正在推动制造的改进（NSF 细胞制造技术工程研究中心 2018），但用于试验的免疫治疗产品仍然是稀缺资源。在本期中，Jecker 及其同事（2018）将免疫治疗生产设施（制造商）确定为免疫治疗临床试验基础设施中重要的、理论不足的组成部分，这些组成部分具有以前未被认识到的生物伦理意义。他们概述了一个新的框架，用于将稀缺的制造资源分配给临床试验，使用四个标准和一个三阶段过程来确定哪些免疫治疗试验将获得资源。杰克尔和同事发现了一个超越免疫治疗产品的问题。例如，病毒基因疗法同样难以制造——它们的制造过程有时产生的病毒足以治疗一名患者（美国食品和药物管理局 [FDA] 2017）。分配制造资源的框架可以适用于多种类型的基因和细胞治疗试验。Jecker 及其同事为试验分配制造资源的四个标准是机会均等、医疗效益的大小、所需的资源和随机选择。选择这些标准是因为它们有经验数据的支持，并且可以公平、透明地实施。然而，我们质疑目前设想的框架是否会产生公平的结果
Recent successes of cellular immunotherapies, specifically chimeric antigen receptor T (CAR T) cell products, have generated excitement among patients, researchers, and investors. There are now hundreds of immunotherapy clinical trials underway, and many more are planned (Hartmann etal. 2017). Unfortunately, there is not enough specialized manufacturing capacity to meet the demand for patient-specific, engineered cells for early-stage clinical trials (Levine et al. 2017). Federally funded cell manufacturing initiatives are driving improvements in manufacturing (NSF Engineering Research Center for Cell Manufacturing Technologies 2018), but immunotherapy products for trials are still scarce resources. In this issue, Jecker and colleagues (2018) identify immunotherapy production facilities (manufacturers) as important, undertheorized components of the immunotherapy clinical trials infrastructure, components with previously unappreciated bioethical significance. They outline a novel framework for allocating scarce manufacturing resources to clinical trials, using four criteria and a three-stage process for determining which immunotherapy trials would receive resources. Jecker and colleagues identify an issue that transcends immunotherapy products. For instance, viral gene therapies are similarly difficult to manufacture—their manufacturing runs sometimes produce virus sufficient to treat only one patient (US Food and Drug Administration [FDA] 2017). A framework for allocating manufacturing resources could be applicable to many types of gene and cell therapy trials.Jecker and colleagues’ four criteria for allocating manufacturing resources to trials are equal opportunity, magnitude of medical benefit, resources required, and random selection. These criteria were chosen because they can be backed by empirical data and could be fairly and transparently implemented. However, we question whether the framework as currently envisioned would produce a fair
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影响因子：
11.1
作者：
Hartmann J;Schüßler-Lenz M;Bondanza A;Buchholz CJ
通讯作者：
Buchholz CJ
影响因子：
13.4
作者：
Jecker, Nancy S.;Wightman, Aaron G.;Diekema, Douglas S.
通讯作者：
Diekema, Douglas S.
影响因子：
10.1
作者：
Maus, Marcela V.;Haas, Andrew R.;June, Carl H.
通讯作者：
June, Carl H.
DOI：
10.1016/j.omtm.2016.12.006
发表时间：
2017-03-17
期刊：
Molecular therapy. Methods & clinical development
影响因子：
--
作者：
Levine BL;Miskin J;Wonnacott K;Keir C
通讯作者：
Keir C
影响因子：
4
作者：
Barnard, Katharine D.;Dent, Louise;Cook, Andrew
通讯作者：
Cook, Andrew