Associate Director of Regulatory Activities — Office of the Center Director

Donna L. Mendrick, Ph.D.
(301) 796-8892
donna.mendrick@fda.hhs.gov

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About  |  Publications

Background

Donna L. Mendrick received a Ph.D. in microbiology—in the field of immunopathology—from the State University of New York at Buffalo. She continued training as a postdoctoral fellow in the Department of Pathology at Harvard Medical School and Brigham and Women’s Hospital where she became assistant professor. Dr. Mendrick joined the biotechnology company Human Genome Sciences (HGS) where she examined the efficacy and safety of recombinant human proteins in numerous animal models and participated in writing HGS’s first Investigational New Drug application. She then joined Gene Logic where she was a scientific fellow and Vice President of Pharmacogenomics and ran a consortium of pharmaceutical companies that examined the usefulness of gene expression as a signal of toxicity in both animals and in vitro systems. She began at FDA as Director of the Division of Systems Biology at National Center for Toxicological Research (NCTR). Dr. Mendrick then became the Associate Director of Regulatory Activities and relocated to FDA’s White Oak campus where she serves as liaison between NCTR and FDA’s regulatory product centers. Her FDA-wide committee assignments include membership in the Senior Science Council, chairing the Artificial Intelligence Working Group, chairing the Emerging Sciences Working Group, and co-chairing the Alternative Methods Working Group. She is also the Designated Federal Officer for NCTR’s Science Advisory Board.

Dr. Mendrick has received multiple FDA Group Awards. While at Harvard Medical School and Brigham and Women’s Hospital, she was presented the Joseph A. Shankman Award from the National Kidney Foundation (NKF) of Massachusetts before serving on NKF’s board. She is an inventor on 10 issued patents, was a member of a study section for the U.S. National Institutes of Health, and was profiled in the Washington Post. She has participated in many groups associated with the Society of Toxicology, including past Chair of the Clinical and Translational Toxicology Specialty Section, and has organized several Contemporary Concepts in Toxicology meetings.

Research Interests

Dr. Mendrick has over 25 years of experience in the fields of in vitro biology, computational modeling, pathology, pharmacogenomics, pharmacology, toxicology—in vitro and in vivo assays using small molecules, toxicogenomics, immunology, in vivo efficacy, and safety assessment of recombinant therapeutic proteins and disease modeling. She is now focused on examining the usefulness of new alternate methodologies in research and regulatory settings and artificial intelligence.

Professional Societies/National and International Groups

European Organ-on-Chip Society
Member
2019 – Present

Interagency Coordinating Committee on the Validation of Alternative Methods
Member
2009 – Present

International Microphysiological Society
Incoming Chair, Membership Committee
2023

Renal Pathology Society
Member
1999 – Present

Scientific Liaison Coalition 
Animal Models Working Group Chair, member, past Chair
2011 – Present

Society of Toxicology
Member, past Chair of the National Area Chapter, past member of the Membership Committee
1998 – Present

Tox21 Collaboration
FDA Co-lead
2017 – Present

Selected Publications

Perspectives on the Evaluation and Adoption of Complex in vitro Models in Drug Development: Workshop with the FDA and the Pharmaceutical Industry (IQ MPS Affiliate).
Baran S.W., Brown P.C., Baudy A.R., Fitzpatrick S.C., Frantz C., Fullerton A., Gan J., Hardwick R.N., Hillgren K.M., Kopec A.K., Liras J.L., Mendrick D.L., Nagao R., Proctor W.R., Ramsden D., Ribeiro A.J.S., Stresser D., Sung K.E., Sura R., Tetsuka K., Tomlinson L., Van Vleet T., Wagoner M.P., Wang Q., Arslan S.Y., Yoder G., and Ekert J.E.
ALTEX. 2022, 39(2). doi: 10.14573/altex.2112203.

FutureTox IV Workshop Summary: Predictive Toxicology for Healthy Children.
Knudsen T.B., Fitzpatrick S.C., De Abrew K.N., Birnbaum L.S., Chappelle A., Daston G.P., Dolinoy D.C., Elder A., Euling S., Faustman E.M., Fedinick K.P., Franzosa J.A., Haggard D.E., Haws L., Kleinstreuer N.C., Buck Louis G.M., Mendrick D.L., Rudel R., Saili K.S., Schug T.T., Tanguay R.L., Turley A.E., Wetmore B.A., White K.W., and Zurlinden T.J.
Toxicol Sci. 2021, 180(2):198-211. doi: 10.1093/toxsci/kfab013.

An FDA/CDER Perspective on Nonclinical Testing Strategies: Classical Toxicology Approaches and New Approach Methodologies (NAMs).
Avila A.M., Bebenek I., Bonzo J.A., Bourcier T., Davis Bruno K.L., Carlson D.B., Dubinion J., Elayan I., Harrouk W., Lee S.L., Mendrick D.L., Merrill J.C., Peretz J., Place E., Saulnier M., Wange R.L., Yao J., Zhao D., and Brown P.C.
Regul Toxicol Pharmacol. 2020, 114:104662. doi: 10.1016/j.yrtph.2020.104662. 

"Natural" is Not Synonymous With "Safe": Toxicity of Natural Products Alone and in Combination with Pharmaceutical Agents.
Gaston T.E., Mendrick D.L., Paine M.F., Roe A.L., and Yeung C.K.
Regul Toxicol Pharmacol. 2020, 113:104642. doi: 10.1016/j.yrtph.2020.104642.

Biology-Inspired Microphysiological Systems to Advance Patient Benefit and Animal Welfare in Drug Development.
Marx U., Akabane T., Andersson T.B., Baker E., Beilmann M., Beken S., Brendler-Schwaab S., Cirit M., David R., Dehne E.M., Durieux I., Ewart L., Fitzpatrick S.C., Frey O., Fuchs F., Griffith L.G., Hamilton G.A., Hartung T., Hoeng J., Hogberg H., Hughes D.J., Ingber D.E., Iskandar A., Kanamori T., Kojima H., Kuehnl J., Leist M., Li B., Loskill P., Mendrick D.L., Neumann T., Pallocca G., Rusyn I., Smirnova L., Steger-Hartmann T., Tagle D.A., Tonevitsky A., Tsyb S., Trapecar M., Van de Water B., Van den Eijnden-van Raaij J., Vulto P., Watanabe K., Wolf A., Zhou X., and Roth A.
ALTEX. 2020, 37(3):365-394. doi: 10.14573/altex.2001241.

The US Federal Tox21 Program: A Strategic and Operational Plan for Continued Leadership.
Thomas R.S., Paules R.S., Simeonov A., Fitzpatrick S.C., Crofton K.M., Casey W.M., and Mendrick D.L.
ALTEX. 2018, 35(2):163-168. doi: 10.14573/altex.1803011.

A Hybrid Gene Selection Approach to Create the S1500+ Targeted Gene Sets for Use in High-Throughput Transcriptomics.
Mav D., Shah R.R., Howard B.E., Auerbach S.S., Bushel P.R., Collins J.B., Gerhold D.L., Judson R.S., Karmaus A.L., Maull E.A., Mendrick D.L., Merrick B.A., Sipes N.S., Svoboda D., and Paules R.S.
PLoS One. 2018, 13(2):e0191105. doi: 10.1371/journal.pone.0191105. eCollection 2018.

Metabolic Syndrome and Associated Diseases: From the Bench to the Clinic.
Mendrick D.L., Diehl A.M., Topor L.S., Dietert R.R., Will Y., La Merrill M.A., Bouret S., Varma V., Hastings K.L., Schug T.T., Emeigh Hart S.G., and Burleson F.G.
Toxicol Sci. 2018, 162(1):36-42. doi: 10.1093/toxsci/kfx233.

FutureTox III: Bridges for Translation.
Juberg D.R., Knudsen T.B., Sander M., Beck N.B., Faustman E.M., Mendrick D.L., Fowle J.R. 3rd, Hartung T., Tice R.R., Lemazurier E., Becker R.A., Fitzpatrick S.C., Daston G.P., Harrill A., Hines R.N., Keller D.A., Lipscomb J.C., Watson D., Bahadori T., and Crofton K.M.
Toxicol Sci. 2017, 155(1):22-31. doi: 10.1093/toxsci/kfw194. 

Molecular Docking for Identification of Potential Targets for Drug Repurposing.
Luo H., Mattes W., Mendrick D.L., and Hong H.
Curr Top Med Chem. 2016, 16(30):3636-3645. doi: 10.2174/1568026616666160530181149.

Adverse Outcome Pathways: From Research to Regulation Scientific Workshop Report.
Kleinstreuer N.C., Sullivan K., Allen D., Edwards S., Mendrick D.L., Embry M., Matheson J., Rowlands J.C., Munn S., Maull E., and Casey W.
Regul Toxicol Pharmacol. 2016, 76:39-50. doi: 10.1016/j.yrtph.2016.01.007. 

Machine Learning Methods for Predicting HLA-Peptide Binding Activity.
Luo H., Ye H., Ng H.W., Shi L., Tong W., Mendrick D.L., and Hong H.
Bioinform Biol Insights. 2015, 9(Suppl 3):21-9. doi: 10.4137/BBI.S29466.

Translating Extracellular microRNA into Clinical Biomarkers for Drug-Induced Toxicity: From High-Throughput Profiling to Validation.
Wang W., Shi Q., Mattes W.B., Mendrick D.L., and Yang X.
Biomark Med. 2015, 9(11):1177-88. doi: 10.2217/bmm.15.86.

HLADR: a Database System for Enhancing the Discovery of Biomarkers for Predicting Human Leukocyte Antigen-Mediated Idiosyncratic Adverse Drug Reactions.
Du T., Yang L., Luo H., Zhou P., Mei H., Xuan J., Xing Q., Ning B., Mendrick D.L., and Shi L.
Biomark Med. 2015, 9(11):1079-93. doi: 10.2217/bmm.15.98. Epub 2015 Oct 26.

Molecular Docking to Identify Associations Between Drugs and Class I Human Leukocyte Antigens for Predicting Idiosyncratic Drug Reactions.
Luo H., Du T., Zhou P., Yang L., Mei H., Ng H., Zhang W., Shu M., Tong W., Shi L., Mendrick D.L., and Hong H.
Comb Chem High Throughput Screen. 2015, 18(3):296-304. doi: 10.2174/1386207318666150305144015.

FutureTox II: In Vitro Data and In Silico Models for Predictive Toxicology.
Knudsen T.B., Keller D.A., Sander M., Carney E.W., Doerrer N.G., Eaton D.L., Fitzpatrick S.C., Hastings K.L., Mendrick D.L., Tice R.R., Watkins P.B., and Whelan M.
Toxicol Sci. 2015, 143(2):256-67. doi: 10.1093/toxsci/kfu234.

Biomarkers of Tobacco Smoke Exposure.
Mattes W., Yang X., Orr M.S., Richter P., and Mendrick D.L.
Adv Clin Chem. 2014, 67:1-45. doi: 10.1016/bs.acc.2014.09.001. 

Correlating In Vitro Data to In Vivo Findings for Risk Assessment.
Bale A.S., Kenyon E., Flynn T.J., Lipscomb J.C., Mendrick D.L., Hartung T., and Patton G.W.
ALTEX. 2014, 31(1):79-90. doi: 10.14573/altex.1310011.

Transcriptional Profiling to Identify Biomarkers of Disease and Drug Response.
Mendrick D.L.
Pharmacogenomics. 2011, 12(2):235-49. doi: 10.2217/pgs.10.184.

Translational Medicine and the Value of Biomarker Qualification.
Goodsaid F.M. and Mendrick D.L.
Sci Transl Med. 2010, 2(47):47ps44. doi: 10.1126/scitranslmed.3001040.