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. Qiang Shi
  1. Science & Research (NCTR)

Qiang Shi Ph.D.

Senior Staff Fellow — Division of Systems Biology

Qiang Shi

Qiang Shi, Ph.D.
(870) 543-7121
NCTRResearch@fda.hhs.gov

Back to NCTR Principal Investigators page


About  |  Publications  |  Lab Members


Background

Dr. Qiang Shi obtained a Ph.D. in pharmacology from Zhejiang University (China). His Ph.D. dissertation was on mouse liver protein modifications in drug induced liver injury (DILI). After completion of his postdoctoral training in DILI at FDA’s National Center for Toxicological Research (NCTR), he was converted to a visiting scientist and then a senior staff fellow. He received the "FDA Outstanding Junior Investigator Award" in 2011, the FDA "Outstanding Intercenter Scientific Collaboration Award (Group)" in 2011 and 2016, and the FDA “Group Recognition Award” in 2021. Dr. Shi’s organ-on-a-chip research was presented at the invitation-only event “American Possibilities: A White House Demo Day” hosted by the White House Office of Science and Technology Policy, in which President Biden toured the more than 40 demonstrations.

Research Interests

Dr. Shi’s main research focus is mechanisms and biomarkers for DILI. He has more than 20 years of experience in the culture of primary hepatocytes from multiple species with a mechanistic focus on drug-induced mitochondrial damage and metabolism-mediated hepatocyte injury. For biomarker studies, he uses in vitro systems and human clinical samples to explore novel translational DILI biomarkers, focusing on circulating micro-ribonucleic acids (microRNAs) in urine and blood. He has published more than 60 peer-reviewed articles and book chapters. Dr. Shi’s most recent work involves the study of DILI induced by FDA-approved small-molecule kinase inhibitors and antisense oligonucleotide drugs, and the evaluation of using commercial liver-on-a-chip models to predict DILI and food product-associated liver injury. Long-term research goals include:

  • Developing non-invasive translational biomarkers to predict DILI susceptibility, regeneration, and severity.
  • Exploring new alternative models—particularly novel in vitro models such as organs-on-a-chip—to aid in the prediction of liver risks associated with drugs, chemicals, or food products.
  • Enhancing the understanding of mechanisms for liver injury.

Professional Societies/National and International Groups

International MPS Society
Member
2021 – Present

Society of Toxicology
Member
2013 – Present

 

Selected Publications

Co-Culture of Human Primary Hepatocytes and Nonparenchymal Liver Cells in the Emulate® Liver-Chip for the Study of Drug-Induced Liver Injury.
Shi Q., Arefin A., Ren L., Papineau K.S., Barnette D.A., Schnackenberg L.K., Hawes J.J., Avigan M., Mendrick D.L., Ewart L., and Ronxhi J. 
Curr Protoc. 2022, 2(7):e478. doi: 10.1002/cpz1.478.

Hepatic Transcript Profiles of Cytochrome P450 Genes Predict Sex Differences in Drug Metabolism.
Fuscoe J.C., Vijay V., Hanig J.P., Han T., Ren L., Greenhaw J.J., Beger R.D., Pence L.M., and Shi Q.
Drug Metab Dispos. 2020, 48(6):447-458. doi: 10.1124/dmd.119.089367.

Performance of High-Throughput CometChip Assay Using Primary Human Hepatocytes: A Comparison of DNA Damage Responses with In vitro Human Hepatoma Cell Lines.
Seo J.E., Wu Q., Bryant M., Ren L., Shi Q., Robison T.W., Mei N., Manjanatha M.G., and Guo X.
Arch Toxicol. 2020, 94(6):2207-2224. doi: 10.1007/s00204-020-02736-z.

Recent Advances in Understanding the Hepatotoxicity Associated with Protein Kinase Inhibitors.
Shi Q., Yang X., Ren L., and Mattes W.B.
Expert Opin Drug Metab Toxicol. 2020, 16(3):217-226.

Cytotoxicity of 34 FDA Approved Small-Molecule Kinase Inhibitors in Primary Rat and Human Hepatocytes.
Zhang J., Ren L., Yang X., White M., Greenhaw J., Harris T., Wu Q., Bryant M., Papoian T., Mattes W., and Shi Q.
Toxicol Lett. 2018, 291:138-148.

Drug-Induced Liver Injury in Children: Clinical Observations, Animal Models, and Regulatory Status.
Shi Q., Yang X., Greenhaw J.J., Salminen A.T., Russotti G.M., and Salminen WF.
Int J Toxicol. 2017, 36(5):365-379.

Effects of 31 FDA Approved Small-Molecule Kinase Inhibitors on Isolated Rat Liver Mitochondria.
Zhang J., Salminen A., Yang X., Luo Y., Wu Q., White M., Greenhaw J., Ren L., Bryant M., Salminen W., Papoian T., Mattes W., and Shi Q.
Arch Toxicol. 2017, 91(8):2921-2938.

The Cytochrome P450 Inhibitor SKF-525A Disrupts Autophagy in Primary Rat Hepatocytes.
Luo Y., Yang X., and Shi Q.
Chem Biol Interact. 2016, 255:55-62.

Circulating MicroRNA and Long Noncoding RNA as Biomarkers of Cardiovascular Diseases.
Shi Q. and Yang X.
J Cell Physiol. 2016, 231(4):751-5.

A Comprehensive Study of the Association Between Drug Hepatotoxicity and Daily Dose, Liver Metabolism, and Lipophilicity using 975 Oral Medications.
Weng Z., Wang K., Li H., and Shi Q.
Oncotarget. 2015, 6(19):17031-8.

Regorafenib Impairs Mitochondrial Functions, Activates AMP-Activated Protein Kinase, Induces Autophagy, and Causes Rat Hepatocyte Necrosis.
Weng Z., Luo Y., Yang X., Greenhaw J.J., Li H., Xie L., Mattes W.B., and Shi Q.
Toxicology. 2015, 327:10-21.

Drugs and Diseases Interacting with Cigarette Smoking in US Prescription Drug Labelling.
Li H. and Shi Q.
Clin Pharmacokinet. 2015, 54(5):493-501.

Circulating Mitochondrial Biomarkers for Drug-Induced Liver Injury.
Shi Q., Yang X., Mattes W.B., Mendrick D.L., Harrill A.H., and Beger R.D.
Biomark Med. 2015, 9(11):1215-23.

Inhibition of Cytochrome P450s Enhances (+)-Usnic Acid Cytotoxicity in Primary Cultured Rat Hepatocytes.
Shi Q., Greenhaw J., and Salminen W.F.
J Appl Toxicol. 2014, 34(8):835-40.

Circulating Extracellular Vesicles as a Potential Source of New Biomarkers of Drug-Induced Liver Injury.
Yang X., Weng Z., Mendrick D.L., and Shi Q.
Toxicol Lett. 2014, 225(3):401-6.

Green Tea Epigallocatechin Gallate Binds to and Inhibits Respiratory Complexes in Swelling but not Normal Rat Hepatic Mitochondria.
Weng Z., Zhou P., Salminen W.F., Yang X., Harrill A.H., Cao Z., Mattes W.B., Mendrick D.L., and Shi Q.
Biochem Biophys Res Commun. 2014, 443(3):1097-104.

Hopes and Challenges in Using miRNAs as Translational Biomarkers for Drug-Induced Liver Injury.
Shi Q., Yang X., and Mendrick D.L.
Biomark Med. 2013, 7(2):307-15.

Mechanisms for Epigallocatechin Gallate Induced Inhibition of Drug Metabolizing Enzymes in Rat Liver Microsomes.
Weng Z., Greenhaw J., Salminen W.F., and Shi Q.
Toxicol Lett. 2012, 214(3):328-38.

Hepatic Cytochrome P450s Attenuate the Cytotoxicity Induced by Leflunomide and its Active Metabolite A77 1726 in Primary Cultured Rat Hepatocytes.
Shi Q., Yang X., Greenhaw J., and Salminen W.F.
Toxicol Sci. 2011, 122(2):579-86.

Biomarkers for Drug-Induced Liver Injury.
Shi Q., Hong H., Senior J., and Tong W.
Expert Rev Gastroenterol Hepatol. 2010, 4(2):225-34.

 

Lab Members

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

Daniel Yeisley, Ph.D.
ORISE Fellow

Lijun Ren
Staff Fellow


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