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  1. Science & Research (NCTR)

Azra Dad Ph.D.

Staff Fellow — Division of Genetic and Molecular Toxicology

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Azra Dad, Ph.D.
(870) 543-7121
NCTRResearch@fda.hhs.gov  

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Education & Training

Dr. Azra Dad earned her Bachelor of Science degree in Genetics from the University of Peshawar, Pakistan, where she established a strong foundation in molecular genetics and biological sciences. She subsequently pursued graduate training in the United States at the University of Illinois Urbana-Champaign (UIUC), one of the nation’s leading research institutions, where she received her Ph.D. in Toxicology.

During her doctoral studies, Dr. Dad was supported by two highly competitive fellowships: a Faculty Development Scholarship from the Government of Pakistan and the National Institute of Environmental Health Sciences (NIEHS) Interdisciplinary Environmental Toxicology Scholarship, a joint UIUC/NIEHS training award that recognized the interdisciplinary and environmental relevance of her research.

Following completion of her doctorate, Dr. Dad joined the U.S. Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) as an Oak Ridge Institute for Science and Education (ORISE) Postdoctoral Fellow in the Division of Genetic and Molecular Toxicology (DGMT). The ORISE fellowship program provides advanced scientific training within federal research laboratories and prepares early-career investigators for independent regulatory science research. During this period, Dr. Dad received specialized training in genetic toxicology, including the in vivo Pig-a gene mutation assay and advanced flow cytometry methodologies, which established the foundation for her independent research career at FDA. 

Professional Appointments

In 2021, Dr. Dad transitioned from her ORISE fellowship to an FDA Staff Fellow position within DGMT at NCTR, reflecting formal recognition of her scientific accomplishments and independent research leadership. As a Staff Fellow and Principal Investigator, she leads the DGMT in vitro inhalation toxicology laboratory and oversees all aspects of laboratory operations, including experimental design, scientific strategy, laboratory management, and personnel supervision.

Dr. Dad directs two specialized research units: the Smoke Laboratory, responsible for the generation and characterization of combustible cigarette smoke and electronic nicotine delivery system (ENDS) aerosols, and the Air-Liquid Interface (ALI) Laboratory, dedicated to the culture, maintenance, and exposure of differentiated human airway organotypic models. Her responsibilities also include coordination with multidisciplinary collaborators, including analytical chemists, pathologists, and international robotics manufacturers, as well as ongoing scientific engagement with FDA’s Center for Tobacco Products (CTP), for which she serves as the primary scientific representative for her research program.

Research Interests & Laboratory Focus

Dr. Azra Dad serves as a Principal Investigator and smoke/inhalation toxicology laboratory lead in the Division of Genetic and Molecular Toxicology (DGMT) at FDA’s National Center for Toxicological Research (NCTR). Her research program focuses on regulatory toxicology, with expertise spanning inhalation toxicology, genetic toxicology, and environmental toxicology.

1. In Vitro Inhalation Toxicology of Tobacco Products

Dr. Dad directs the DGMT in vitro inhalation toxicology laboratory, which investigates the comparative toxicological and genotoxic effects of conventional combustible cigarettes and electronic nicotine delivery systems (ENDS), including e-cigarettes and JUUL products. Her laboratory employs differentiated primary human airway organotypic cultures exposed at the air-liquid interface (ALI), a physiologically relevant in vitro model that closely mimics the human respiratory epithelium.

Aerosols and smoke are generated using specialized robotic exposure systems under controlled and reproducible conditions. Studies conducted in her laboratory integrate multiple toxicological endpoints, including:

  • Functional assessments, such as ciliary beating frequency (CBF) and transepithelial electrical resistance (TEER)
  • Cytotoxicity and cellular metabolic analyses
  • Genotoxicity evaluations, including the Comet assay for DNA strand-break analysis and error-corrected next-generation sequencing for mutation profiling
  • Histopathological and structural assessments using immunohistochemistry (IHC)

This work directly supports FDA/CTP regulatory evaluation of tobacco and nicotine-containing products.

2. Genetic Toxicology & the Pig-a Gene Mutation Assay

Dr. Dad has made significant contributions to the development and regulatory validation of the in vivo Pig-a gene mutation assay. Her research includes development of the Pig-a assay in neutrophils and granulocytes, isolation and characterization of rat bone marrow granulocyte populations, identification of Pig-a mutant cells using flow cytometry, and molecular characterization of mutations through next-generation sequencing.

Her work contributed directly to the development and approval of OECD Test Guideline No. 470 for the in vivo erythrocyte Pig-a gene mutation assay, now recognized internationally as a regulatory genetic toxicology standard. Dr. Dad has also conducted comprehensive molecular analyses of genes involved in the glycosylphosphatidylinositol (GPI)-anchor biosynthesis pathway.

3. Environmental Toxicology

Earlier in her career, Dr. Dad investigated the toxicological effects of haloacetic acid drinking water disinfection byproducts on mammalian cellular metabolism. Her research focused on disruption of glycolytic pathways and mitochondrial enzyme function, including pyruvate dehydrogenase activity.

Current Research Protocol

Dr. Dad currently serves as Principal Investigator on a CTP-funded research protocol titled:

“Comparative Toxicity and Genotoxicity of Electronic Nicotine Delivery Systems and Conventional Cigarettes Evaluated in Differentiated Human Airway In Vitro Cell Models Exposed at the Air-Liquid Interface.”

Ongoing and planned studies include:

  • Comparative assessment of inhalation toxicity and genotoxicity associated with ENDS/JUUL aerosols and conventional cigarette smoke in differentiated human airway ALI cultures
  • Evaluation of combustible cigarettes and JUUL products using HCI/CORESTA Reference Method No. 81 and ISO puffing regimens
  • Integration of multi-endpoint datasets for statistical analysis, regulatory reporting, and peer-reviewed publication

Honors & Awards 

  • FDA Honor Award – Crosscutting: OECD Pig-a Test Guideline Development and Publication Team— for developing OECD Test Guideline No. 470 for the in vivo erythrocyte Pig-a gene mutation assay-2023
  • FDA Group Recognition Award: Smoking and Vaping Robot Validation Team — for validating smoking and vaping robots for in vitro toxicology studies on tobacco products-2024
  • FDA Commissioner’s Special Citation Group Award (Commissioner Dr. Scott Gottlieb)-2019
  • Special Act or Service Award / Cash Award for outstanding creativity and problem-solving in repair of the Vitrocell smoking robot-2023
  • Outstanding Service Award, FDA/NCTR
  • ORISE Postdoctoral Fellowship, FDA/NCTR
  • NIEHS Interdisciplinary Environmental Toxicology Scholarship, UIUC/NIEHS/NIH- 2014
  • Government of Pakistan Faculty Development Fellowship for Ph.D. studies at UIUC

Professional Memberships

  • Environmental Mutagenesis and Genomics Society (EMGS)- Since 2013
  • Society of Toxicology (SOT)- Since 2018
  • Institute of In Vitro Sciences (IIVS), Evaluation of Tobacco Products Workgroup- Since 2023

Selected Publications

  1. Miranda, J. A., Dad, A., Qu, X., et al. (2025). Background Mutation Frequencies in TK6 and L5178Y Cells: Implications for Error-Corrected Sequencing. Environmental and Molecular Mutagenesis, 66(6–7), 367–376.
  2. Dad, A., Revollo, J. R., Pearce, M. G., McKinzie, P. B., Heflich, R. H., & Dobrovolsky, V. N. (2021). Pig-a Gene Mutations in Bone Marrow Granulocytes of Procarbazine-Treated F344 Rats. Environmental and Molecular Mutagenesis, 62(4), 265–272.
  3. Dad, A., Dobrovolsky, V. N., Heflich, R. H., & Revollo, J. R. (2020). Molecular Analysis of GPI-Anchor Biosynthesis Pathway Genes in Rat Strains Used for the Pig-a Gene Mutation Assay. Mutation Research/Genetic Toxicology and Environmental Mutagenesis, 858–860, 503256.
  4. Dad, A., Jeong, C. H., Wagner, E. D., & Plewa, M. J. (2018). Haloacetic Acid Water Disinfection Byproducts Affect Pyruvate Dehydrogenase Activity and Disrupt Cellular Metabolism. Environmental Science & Technology, 52(3), 1525–1532.

Lab Members

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

Mason Pearce
Biologist/Support Scientist

Rebecca Wynne
Biologist/Support Scientist

Contact Information
Azra Dad
(870) 543-7121
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