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  1. Advancing Regulatory Science

Comprehensive Assessment of Sex-Differential Smoking-related Effects in Publicly Available Gene Expression Data

CERSI Collaborator:  Emily Flynn, BA; Russ Altman, MD, PhD (Stanford)

FDA Collaborators:    Bridget Nugent, PhD; Jonathan Kwan, MS, CDR, USPHS

Project Start Date: October 2019

Regulatory Science Challenge

Many diseases and drugs affect men and women differently. Historically, women have been underrepresented in biomedical research or analyses of sex differences have been left out of research studies. This has led to gaps in knowledge about the effects of many FDA-regulated products in women, which in some instances has led to serious health consequences. Sex differences in smoking behaviors and health-related effects have been reported in research, but the biology underlying these differences is not well understood. Gene expression studies can be used to examine molecular-level changes in smokers, and the resulting data can provide a unique opportunity for examining dynamic biological responses to smoking. While many public datasets have examined these biological-level changes in response to smoking to better understand how it leads to cancer and other health risks, the majority of these studies have missing or incorrect sex labels, preventing researchers from thoroughly examining whether men and women have biological differences in smoking response.

Project Description & Goals

In this study, we propose to add sex labels to gene expression studies using an automated computer program that imputes sex-related information from the biological data. We will use this labeled data to examine whether there are biological sex differences in responses to smoking. To enable us to distinguish between differences due to sex versus other factors, we will catalog all existing gene expression data related to smoking, and then combine data from multiple studies for each tissue (e.g., airway, lung, blood) to determine whether consistent sex differences exist for any of the tissues. These findings may facilitate biomarker 1  identification and the development of targeted strategies for treating smoking-related diseases in men and women. This analytical approach has the potential to be used as a template to examine sex differences also for pharmaceutical drug responses. Overall, our work will lead to a better understanding of how smoking affects men and women differently on a biological level.


  • 1A biomarker is any substance, structure, or process that can be measured in the body or its products that can be used as a signal of a normal or disease condition, can predict disease progress, or influence or predict the outcome of a treatment.
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