U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of the Commissioner
  5. Office of the Chief Scientist
  6. National Center for Toxicological Research
  7. Science & Research (NCTR)
  8. Kelly Harris
  1. Science & Research (NCTR)

Kelly Harris Ph.D.

Senior Staff Fellow — Division of Biochemical Toxicology

Headshot of Dr. Kelly Harris

Kelly Harris, Ph.D.
(870) 543-7121
NCTRResearch@fda.hhs.gov  

Back to NCTR Principal Investigators page


About  |  Publications  |  Lab Members


Background

Dr. Harris is a senior staff fellow in the Division of Biochemical Toxicology at FDA’s National Center for Toxicological Research (NCTR). Dr. Harris graduated from the University of Tennessee at Martin with a B.S. degree in biological sciences and from Middle Tennessee State University (MTSU) with a M.S. in biological sciences. Following graduation from MTSU, Dr. Harris was accepted into the Biomedical Sciences Program at Meharry Medical College in the Department of Biochemistry and Cancer Biology, where she graduated with a Ph.D. During her doctoral research, Dr. Harris studied the mechanisms involved in the causation of colorectal cancers by benzo(a)pyrene—a polycyclic aromatic hydrocarbon compound—and how Western diet potentiates this process. A solid background in chemical carcinogenesis, pharmacology, and toxicology helped her to pursue research on the toxicant-induced pathophysiological changes in biological systems at the cellular and molecular level.

In 2016, Dr. Harris joined the Division of Genetic and Molecular Toxicology (DGMT) at NCTR as a postdoctoral fellow. During postdoctoral training in Dr. Barbara Parsons’s laboratory, Dr. Harris helped determine the sensitivity of high-throughput next-generation sequencing and helped develop a method capable of detecting a panel of the most prevalent human cancer driver mutations. This work was recognized with an NCTR Outstanding Service Award. In 2019, Dr. Harris became a staff fellow with DGMT as a member of FDA’s Center for Drug Evaluation and Research Over-the-Counter Monograph team. This position provided Dr. Harris with the opportunity to continue her laboratory studies, as well as to work as a reviewer to help identify potentially harmful toxicants present in foods and drugs. During her tenure at NCTR, Dr. Harris has developed and validated next-generation sequencing-based protocols for the detection and quantification of rare somatic mutations in both normal and tumor tissues. Her work has resulted in the creation of cancer biomarker panels that correlate to hot spot cancer mutations. Dr. Harris and other members of the laboratory conducting this research were awarded an NCTR Group Recognition Award for their efforts to develop human cancer driver biomarker panels using next-generation sequencing. She was also the recipient of a New Investigator Merit Award from the Environmental Mutagenesis and Genomics Society.

 

Research Interests

Dr. Harris’s current research focuses on the use of FDA-approved epigenetic drugs to treat triple-negative breast cancer (TNBC), an aggressive form of cancer with many subtypes that respond to few current drug regimens. She is evaluating the anti-cancer effect of suberoylanilide hydroxamic acid, a histone deacetylase inhibitor approved by FDA for the treatment of patients with cutaneous T-cell lymphoma. Dr. Harris received funding from FDA’s Office of Women’s Health to study the effects of this drug on TNBC cell lines and tissues with regard to target gene expression, enzyme activity and inhibition, RNA sequencing, signaling pathways, receptor interaction pathways, and differentiation pathways. Dr. Harris is also the principal investigator of a study that utilizes a targeted, error-corrected next generation sequencing panel to:

  • quantify differences in cancer driver mutations (CDMs) in African American and European American women to provide useful information in personalized cancer treatment
  • validate CarcSeq breast-specific panel of hotspot CDM-containing targets as a composite biomarker of breast cancer risk

This will be achieved by relating variations in normal breast DNA mutant fractions—as a surrogate of clonal expansion—with age, which is a major determinant of cancer risk.

 

Professional Societies/National and International Groups

American Association for Cancer Research
Member
2023 – Present

Environmental Mutagenesis and Genomics Society        
Member
2016 – Present
Council Member
2019 – 2024
Session chairperson
2019, 2022
Diversity, Equity, and Inclusion Committee Chair
2018 – 2022
Diversity, Equity, and Inclusion Committee Co-Chair
2022 – 2024


Health and Environmental Sciences Institute
Member 
2019 – Present
Genetic Toxicology Technical Committee
2019 – Present

 

Selected Publications

Assessment of Clonal Expansion Using CarcSeq Measurement of Lung Cancer Driver Mutations and Correlation with Mouse Strain- and Sex-Related Incidence of Spontaneous Lung Neoplasia.
Harris K.L., McKim K.L., Myers M.B., Gong B., Xu J., and Parsons B.L.
Toxicological Sciences. 2021, 184(1):1-14.
 
CarcSeq Measurement of Rat Mammary Cancer Driver Mutations and Relation to Spontaneous Mammary Neoplasia.
McKim K.L., Myers M.B., Harris K.L., Gong B., Xu J., and Parsons B.L.
Toxicol Sci. 2021, 182(1):142-158.

Benzo(a)pyrene-Induced Cytotoxicity, Cell Proliferation, DNA Damage and Altered Gene Expression Profiles in HT-29 Human Colon Cancer Cells.
Myers J., Harris K.L., Devi R.P.V., Pratap S., and Ramesh A.
Cell Biol Toxicol. 2021, 37(6):891-913.

Quantification of Cancer Driver Mutations in Human Breast and Lung DNA Using Targeted, Error-Corrected CarcSeq.
Harris K.L., Walia V., Gong B., McKim K.L., Myers M.B., Xu J., and Parsons B.L.
Environ and Mol Mutagen. 2020, 61(9):872-889.

Rationale and Roadmap for Developing Panels of Hotspot Cancer Driver Gene Mutations as Biomarkers of Cancer Risk.
Harris K.L., Myers M.B., McKim K.L., Elespuru R.K., and Parsons B.L.
Environ Mol Mutagen. 2019, 61(1):152-175.

Western Diet Enhances Benzo(a)pyrene-Induced Colon Tumorigenesis in a Polyposis in Rat Coli (PIRC) Rat Model of Colon Cancer.
Harris K.L., Pulliam S.R., Niaz M.S., Okoro E., Guo Z., Washington M.K., Adunyah S.E., Amos-Landgraf J., and Ramesh A.
Oncotarget. 2016, 7(20):28947-60.

Absorption of Food Toxicants: An Overview on Polycyclic Aromatic Hydrocarbons.
Harris K.L., Banks L.D., Harris K.J., Archibong A.E., Hood D.B., and Ramesh A.
In: Bagchi D. and Swaroop A. (Eds.) Food Toxicology. 2016, CRC Press.

Metabolism of the Environmental Toxicant, Benzo(a)pyrene by Subcellular Fractions of Human Ovary.
Rekhadevi P.V., Diggs D.L., Huderson A.C., Harris K.L., Archibong A.E., and Ramesh A.
Hum Exp Toxicol. 2014, 33(2):196-202.

Polycyclic Aromatic Hydrocarbons.
Banks L.D., Harris K.L., Mantey J.A., Hood D.B., Archibong A.E., and Ramesh A.
In: Gupta R. (Ed.) Biomarkers. 2014, Elsevier Publishers.

Bioaccessibility of Polycyclic Aromatic Hydrocarbons: Relevance to Toxicity and Carcinogenesis.
Harris K.L., Banks L.D., Mantey J.A., Huderson A.C., and Ramesh A.
Expert Opin Drug Metab Toxicol. 2013, 9(11):1465-80.

Benzo(a)pyrene Modulates Fluoranthene-Induced Cellular Responses in HT-29 Colon Cells in a Dual Exposure System.
Harris K.L., Myers J.N., and Ramesh A.
Environ Toxicol Pharmacol. 2013, 36(2):358-367.

Tumor Microsomal Metabolism of the Toxicant Benzo(a)pyrene in ApcMin Mouse Model of Colon Cancer.
Diggs D.L., Harris K.L., Rekhadevi P.V., and Ramesh A.
Tumour Biol. 2012, 33(4):1255-60.

Polycyclic Aromatic Hydrocarbons and Digestive Tract Cancers: A Perspective.
Diggs D.L., Huderson A.C., Harris K.L., Myers J.N., Banks L.D., Rehkadevi P.V., Niaz M.S., and Ramesh A.
J Environ Sci Health C Environ Carcinog Ecotoxicol Rev. 2011, 29(4):324-57.

Lab Members

Contact information for all lab members:
(870) 543-7121
NCTRResearch@fda.hhs.gov

Beverly Lyn-Cook, Ph.D.
Interdisciplinary Research Biologist

Beverly Word, B.S.
Lab Manager


Contact Information
Kelly Harris
(870) 543-7121
Expertise
Expertise
Approach
Domain
Technology & Discipline
Toxicology
Back to Top