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.

U.S. Food and Drug Administration
  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. Amy Inselman
  1. Science & Research (NCTR)

Amy Inselman Ph.D.

Staff Fellow — Division of Systems Biology

Dr. Amy Inselman
Amy Inselman, Ph.D.
(870) 543-7121
NCTRResearch@fda.hhs.gov  

Back to NCTR Principal Investigators page

About  |  Publications  |  Lab Members

Background

Dr. Amy Inselman received her B.S. degree in biology from Southeast Missouri State University in 1998 and her Ph.D. from the University of Tennessee in 2003. Following completion of her degree, she completed postdoctoral training at the National Institute for Environmental Health Sciences (NIEHS) in the Laboratory of Reproductive and Developmental Toxicology, Gamete Biology Section. She joined the FDA in 2009 as an ORISE fellow and currently is a research biologist in the Division of Systems Biology, Biomarkers and Alternative Models Branch. Her research has primarily focused on reproductive and developmental biology and more recently has expanded to include the development and evaluation of alternative in vitro model systems for use in developmental toxicity testing. In addition, Dr. Inselman has served as the principal investigator on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) developmental and reproductive guideline studies for the NIEHS/National Toxicology Program investigating oxybenzone, a sunscreen component. She has also received funding from the FDA’s Perinatal Health Center of Excellence (PHCE) to investigate opioid exposure during pregnancy on development of neural tube defects. Dr. Inselman represents the agency on multiple Health and Environmental Sciences Institute (HESI) committees related to Developmental and Reproductive Toxicity (DART) and co-chairs the FDA DART intra-agency interest group.

Research Interests

The Biomarkers and Alternative Models Branch within the Division of Systems Biology at NCTR develops and evaluates cell-culture models to examine various types of toxicity and investigates whether such models could reduce or replace animals in safety testing of FDA-regulated products. Dr. Inselman’s current research interests are focused on human induced pluripotent stem cell (hiPSC)  models that may serve as alternatives to whole-animal studies for predicting developmental toxicity, including developmental neurotoxicity. Dr. Inselman established the mouse embryonic stem cell test (mEST) within the FDA and investigated whether additional differentiation endpoints (e.g. osteoblasts) could improve the predictive nature of the assay. Her present work is focused on developmental neurotoxicity and she leads a group investigating the effects of early opioid exposure on neural development using both in vitro and in vivo models.

Professional Societies/National and International Groups

Society of Toxicology
Member
2012 – Present

South Central Chapter of the Society of Toxicology (SCCSOT)
Member
2012 – Present

Stem Cell Specialty Section of the Society for Toxicology
Member
2012 – Present

Teratology Society
Member
2012 – Present

Education Committee
2014 – Present

Constitution and Bylaws Committee
2018 – Present; Chair - 2020
 

 

Selected Publications

Dr. Daniel Acosta and In Vitro Toxicology at the U.S. Food and Drug Administration’s National Center for Toxicological Research.
Inselman A.L., Liu F., Wang C., Shi Q., Pang L., Mattes W., White M., Lyn-Cook B., Rosas-Hernandez H., Cuevas E., Lantz S., Imam S., Ali S., Petibone D.M., Shemansky J.M., Xiong R., Wang Y., Tripathi P., Cao X., Heflich R.H., and Slikker W. Jr.
Toxicol In Vitro. 2020, 64:104471.

Potential Mechanisms for Phencyclidine/Ketamine-Induced Brain Structural Alterations and Behavioral Consequences.
Wang, C., Inselman, A., Liu, S., and Liu, F.
Neurotoxicology. 2020, 76:213-219.

Transcript Profiling in the Testes and Prostrates of Postnatal Day 30 Sprague-Dawley Rats Exposed Prenatally and Lactationally to 2-Hydroxy-4-Methoxybenzophenone.
Nakamura, N., Vijay, V., Desai, V.G., Hansen, D.K., Han, T., Chang, C.W., Chen, Y.C., Harrouk, W., McIntyre, B., Foster, P.M., Fuscoe, J.C., and Inselman, A.L.
Reprod Toxicol. 2018, 82:111-123.

Transcriptomics Analysis of Early Embryonic Stem Cell Differentiation Under Osteoblast Culture Conditions: Applications for Detection of Developmental Toxicity.
Chen, X., Han, T., Fisher, J.E., Harrouk, W., Tassinari, M.S., Merry, G.E., Sloper, D., Fuscoe, J.C., Hansen, D.K. and Inselman, A.L.
Reprod Toxicol. 2017, 69:75-83.

Evaluation of Culture Time and Media in an In Vitro Testis Organ Culture System.
Nakamura, N., Merry, G.E., Inselman, A.L., Sloper, D.T., Del Valle P.L., Sato, T., Ogawa, T., and Hansen, D.K.
Birth Defects Res. 2017, 109(7):465-474.

Disrupting Cyclin Dependent Kinase 1 in Spermatocytes Causes Late Meiotic Arrest and Infertility in Mice.
Clement T.M.*, Inselman A.L.*, Goulding E.H., Willis W.D., and Eddy E.M.
Biol Reprod. 2015, 93(6):137.
*indicates equal contribution by authors

Developing Osteoblasts as an Endpoint for the Mouse Embryonic Stem Cell Test.
Chen X., Hansen D.K., Merry G., DeJarnette C., Nolen G., Sloper D., Fisher J.E., Harrouk W., Tassinari M.S., and Inselman A.L.
Reprod Toxicol. 2015, 53:131-40.

Effects of Silver Nanoparticles on Human and Rat Embryonic Neural Stem Cells.
Liu F., Mahmood M., Xu Y., Watanabe F., Biris A.S., Hansen D.K., Inselman A., Casciano D., Patterson T.A., Paule M.G., Slikker W. Jr., and Wang C.
Front Neurosci. 2015, 9:115.

Effects of Maternal and Lactational Exposure to 2-Hydroxy-4-Methoxybenzone on Development and Reproductive Organs in Male and Female Rat Offspring.
Nakamura N., Inselman A.L., White G.A., Chang C.W., Trbojevich R.A., Sephr E., Voris K.L., Patton R.E., Bryant M.S., Harrouk W., McIntyre B.S., Foster P.M., and Hansen D.K.
Birth Defects Res B Dev Reprod Toxicol. 2015, 104(1):35-51.

Reevaluation of the Embryonic Stem Cell Test. disclaimer icon
Inselman A.L., Nolen G.T., Chang C.W., Harrouk W., Fisher J.E., Tassinari M.S., and Hansen D.K.
Journal of Regulatory Science. 2013, 1(1):32-49.

Alternative Models in Developmental Toxicology.
Lee H.Y., Inselman A.L., Kanungo J., and Hansen D.K.
Syst Biol Reprod Med. 2012, 58(1):10-22.

Assessment of Research Models for Testing Gene-Environment Interactions.
Inselman A.L., Hansen D.K., Lee H.Y., Nakamura N., Ning B., Monteiro J.P., Varma V., and Kaput J.
Eur J Pharmacol. 2011, 668 Suppl 1:S108-16.

Heat Shock Protein 2 Promoter Drives Cre Expression in Spermatocytes of Transgenic Mice.
Inselman A.L., Nakamura N., Brown P.R., Willis W.D., Goulding E.H., and Eddy E.M.
Genesis. 2010, 48(2):114-20.

A Missense Mutation in the Capza3 Gene and Disruption of F-Actin Organization in Spermatids of Repro32 Infertile Male Mice.
Geyer C.B., Inselman A.L., Sunman J.A., Bornstein S., Handel M.A., and Eddy E.M.
Dev Biol. 2009, 330(1):142-52.

 

Lab Members

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

Chengzhong Cai, Ph.D.
Visiting Scientist

Pravin R. Kaldhone, Ph.D.
ORISE Postdoctoral Fellow

 

Contact Information
Amy Inselman
(870) 543-7121
Back to Top