Biomarkers of potential harm

Summary of an FDA-sponsored public workshop

Cindy M. Chang, Yu Ching Cheng, Taehyeon M. Cho, Elena V. Mishina, Arseima Y. Del Valle-Pinero, Dana M. Van Bemmel, Dorothy K Hatsukami

Research output: Contribution to journalReview article

2 Citations (Scopus)

Abstract

Introduction: 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. Methods: 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. Results and Conclusions: 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. Implications: 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.

Original languageEnglish (US)
Pages (from-to)3-13
Number of pages11
JournalNicotine and Tobacco Research
Volume21
Issue number1
DOIs
StatePublished - Jan 1 2019

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United States Food and Drug Administration
Biomarkers
Education
Tobacco Products
Tobacco
Research
Tobacco Use
Marketing
Chronic Obstructive Pulmonary Disease
Industry
Cardiovascular Diseases
Organizations

PubMed: MeSH publication types

  • Journal Article

Cite this

Chang, C. M., Cheng, Y. C., Cho, T. M., Mishina, E. V., Del Valle-Pinero, A. Y., Van Bemmel, D. M., & Hatsukami, D. K. (2019). Biomarkers of potential harm: Summary of an FDA-sponsored public workshop. Nicotine and Tobacco Research, 21(1), 3-13. https://doi.org/10.1093/ntr/ntx273

Biomarkers of potential harm : Summary of an FDA-sponsored public workshop. / Chang, Cindy M.; Cheng, Yu Ching; Cho, Taehyeon M.; Mishina, Elena V.; Del Valle-Pinero, Arseima Y.; Van Bemmel, Dana M.; Hatsukami, Dorothy K.

In: Nicotine and Tobacco Research, Vol. 21, No. 1, 01.01.2019, p. 3-13.

Research output: Contribution to journalReview article

Chang, CM, Cheng, YC, Cho, TM, Mishina, EV, Del Valle-Pinero, AY, Van Bemmel, DM & Hatsukami, DK 2019, 'Biomarkers of potential harm: Summary of an FDA-sponsored public workshop', Nicotine and Tobacco Research, vol. 21, no. 1, pp. 3-13. https://doi.org/10.1093/ntr/ntx273
Chang CM, Cheng YC, Cho TM, Mishina EV, Del Valle-Pinero AY, Van Bemmel DM et al. Biomarkers of potential harm: Summary of an FDA-sponsored public workshop. Nicotine and Tobacco Research. 2019 Jan 1;21(1):3-13. https://doi.org/10.1093/ntr/ntx273
Chang, Cindy M. ; Cheng, Yu Ching ; Cho, Taehyeon M. ; Mishina, Elena V. ; Del Valle-Pinero, Arseima Y. ; Van Bemmel, Dana M. ; Hatsukami, Dorothy K. / Biomarkers of potential harm : Summary of an FDA-sponsored public workshop. In: Nicotine and Tobacco Research. 2019 ; Vol. 21, No. 1. pp. 3-13.
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