构建生物标志物鉴定路线图：挑战与机遇
Building a roadmap to biomarker qualification: challenges and opportunities.
作者信息
Amur Shashi G, Sanyal Sarmistha, Chakravarty Aloka G, Noone Marianne H, Kaiser James, McCune Susan, Buckman-Garner ShaAvhree Y
机构信息
Office of Translational Sciences, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, Maryland, MD 20993-0002, USA.
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, MD 20993-0002, USA.
出版信息
Biomark Med. 2015;9(11):1095-105. doi: 10.2217/bmm.15.90. Epub 2015 Nov 3.
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.
生物标志物在药物研发中获得监管认可的传统途径是，在单一药物研发项目的背景下，于药物批准申报材料中提交生物标志物数据。美国食品药品监督管理局（FDA）的关键路径计划呼吁建立生物标志物资格认定程序，以推动药物研发模式取得进展。对此，药物评价与研究中心（CDER）设立了生物标志物资格认定项目（BQP），为特定的使用背景（COU）鉴定一种生物标志物。然后，这种经鉴定合格的生物标志物可用于针对该使用背景的多个药物研发项目，而无需重新审评。在此，我们描述了BQP的一些特点以及两项新举措，这两项新举措有可能通过与FDA的早期互动来助力生物标志物的研发。最后，我们讨论了FDA从申报者那里收到的一些反馈以及BQP为加强该项目所采取的行动。
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