Building a roadmap to biomarker qualification: challenges and opportunities
Building a roadmap to biomarker qualification: challenges and opportunities
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DOI：
10.2217/bmm.15.90
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发表时间：
2015-01-01
影响因子：
2.2
通讯作者：
Buckman-Garner, ShaAvhree Y.
中科院分区：
文献类型：
--
作者：
Amur, Shashi G.;Sanyal, Sarmistha;Buckman-Garner, ShaAvhree Y.
药物开发中生物标志物的监管接受的传统途径是在单一药物开发计划的背景下，通过在药物批准提交中提交生物标志物数据。美国FDA的关键路径倡议（Critical Path Initiative）呼吁建立生物标志物资格认证流程，以推动药物开发范式的进展。为此，药物评价和研究中心（CDER）建立了生物标志物鉴定程序（BQP），对特定使用环境（COU）的生物标志物进行鉴定。然后，合格的生物标志物可以用于该COU的多种药物开发项目，而无需重新审查。在这里，我们描述了BQP的一些特征和两个新的倡议，它们有可能通过与FDA的早期互动来帮助生物标志物的开发。最后，我们讨论了FDA从提交者那里收到的一些反馈以及BQP为加强该计划所采取的行动。
The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program.