Office of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, MD.
Department of Psychiatry, Tobacco Research Programs, University of Minnesota, Minneapolis, MN.
Nicotine Tob Res. 2019 Jan 1;21(1):3-13. doi: 10.1093/ntr/ntx273.
Since 2009, the United States (US) Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has had the authority to regulate the manufacture, distribution, and marketing of tobacco products in order to reduce the death and disease caused by tobacco use. Biomarkers could play an important role across a number of FDA regulatory activities, including assessing new and modified risk tobacco products and identifying and evaluating potential product standards.
On April 4-5, 2016, FDA/CTP hosted a public workshop focused on biomarkers of potential harm (BOPH) with participants from government, industry, academia, and other organizations. The workshop was divided into five sessions focused on: (1) overview of BOPH; (2) cardiovascular disease (CVD); (3) chronic obstructive pulmonary disease (COPD); (4) cancer; and (5) new areas of research.
The deliberations from the workshop noted some promising BOPH but also highlighted the lack of systematic effort to identify BOPH that would have utility and validity for evaluating tobacco products. Research areas that could further strengthen the applicability of BOPH to tobacco regulatory science include the exploration of composite biomarkers as predictors of disease risk, "omics" biomarkers, and examining biomarkers using existing cohorts, surveys, and experimental studies.
This paper synthesizes the main findings from the 2016 FDA-sponsored workshop focused on BOPH and highlights research areas that could further strengthen the science around BOPH and their applicability to tobacco regulatory science.
自 2009 年以来，美国（美国）食品和药物管理局（FDA）烟草产品中心（CTP）有权监管烟草产品的制造、分销和营销，以减少烟草使用造成的死亡和疾病。生物标志物可以在 FDA 的许多监管活动中发挥重要作用，包括评估新的和改良的风险烟草产品以及确定和评估潜在的产品标准。
2016 年 4 月 4 日至 5 日，FDA/CTP 举办了一次关于潜在危害生物标志物（BOPH）的公开研讨会，参与者来自政府、工业界、学术界和其他组织。研讨会分为五个部分，重点关注：（1）BOPH 概述；（2）心血管疾病（CVD）；（3）慢性阻塞性肺疾病（COPD）；（4）癌症；（5）新的研究领域。
研讨会的讨论指出了一些有前途的 BOPH，但也强调缺乏系统地识别 BOPH 的工作，这些 BOPH 将对评估烟草产品具有实用性和有效性。可以进一步加强 BOPH 对烟草监管科学适用性的研究领域包括探索作为疾病风险预测指标的复合生物标志物、“组学”生物标志物，以及使用现有队列、调查和实验研究来检验生物标志物。
本文综合了 2016 年 FDA 主办的关于 BOPH 的研讨会的主要发现，并强调了可以进一步加强 BOPH 及其对烟草监管科学适用性的科学研究领域。
