Deputy Director – Division of Systems Biology

Jessica Hawes, Ph.D.
(870) 543-7121
[email protected]

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About  |  Publications

Background

Dr. Jessica Hawes is Deputy Director of the Division of Systems Biology at FDA’s National Center for Toxicological Research (NCTR) where she leads research direction, management, internal and external collaborations, initiatives, budgetary allocations, and procurement. Dr. Hawes has over ten years of experience conducting drug review and risk assessments for Investigative New Drugs and market New Drug Applications (NDAs) within the Office of New Drugs at the Center for Drug Evaluation and Research (CDER), including safety margin determinations, translation of risk, clinical dose/dosing recommendations, clinical trial safety monitoring, and drug labeling.

Dr. Hawes is an active member of numerous scientific subcommittees and working groups across the Agency, and has been invited to chair and/or give dozens of lectures at academic, government, and scientific forums at both national and international levels. She is also a graduate of the competitive FDA Leadership Development Program, with certification in Executive Leadership from the FDA and the American University School of Public Affairs. Prior to joining the FDA, Dr. Hawes received a Ph.D. in pharmacology from Yale University, conducted brain cancer research as a postdoctoral fellow at the National Cancer Institute, and received numerous scientific Young Investigator Awards from multiple organizations, including the National Research Council. She received a Bachelor of Science degree from Weber State University, majoring in chemistry with a minor in physics, where she was recipient of the Graduate of the Year Award.

Research Interests

Dr. Hawes’s research interests cover the broad spectrum of scientific topics studied within the Division of Systems Biology, including identifying scientific needs and knowledge gaps pertaining to FDA-regulated products and Regulatory Science through research and collaboration. Current research areas of interest include elucidating risks for special populations exposed to viral pathogens and therapeutics, vaccines, cannabinoids, immune responses, and rare diseases.

Professional Societies/National and International Groups

American College of Toxicology
Program Committee, Symposia Co-Chair, Speaker, Member
2016 – Present

Drug Information Association
Symposia Co-Chair, Member
2019 – Present

FDA-DruSafe-Biosafe
Speaker
2017

Gordon Research Conference
Symposia Co-Chair, Speaker, Member
2021 – Present

International Society for the Study of Xenobiotics
Symposia Co-Chair, Speaker
2019 – Present

Simulations Model-Informed Drug Development Conference
Speaker
2021

Society of Toxicologic Pathologists
Continuing Education Course Speaker
2021

Society of Toxicology
Speaker, Member
2019 – Present

Selected Publications

Tandem Mass Spectrometric Sequence Characterization of Synthetic Oligonucleotides.
Abdullah A.M., Zhang D., Pang E., Hawes J., Sommers C., Kozak D., Rodriguez J., and Yang K.
Submitted to Journal of Mass Spectrometry. 2021, (Under Review).

Development and Regulatory Challenges for Peptide Therapeutics.
Zane D., Feldman P.L., Sawyer T., Sobol Z., and Hawes J. 
Int J Toxicol. 2021, 40(2):108-124. doi: 10.1177/1091581820977846. Epub 2020 Dec 17. PMID: 33327828.

Elucidating Interactions Between SARS-CoV-2 Trimeric Spike Protein and ACE2 Using Homology Modeling and Molecular Dynamics Simulations.
Sakkiah S., Guo W., Pan B., Ji Z., Yavas G., Azevedo M., Hawes J., Patterson T.A., and Hong H.
Front Chem. 2021, 8:622632. doi: 10.3389/fchem.2020.622632. PMID: 33469527; PMCID: PMC7813797.

NDA 209803 Steglatro (Ertugliflozin) Pharmacology/Toxicology Review and Evaluation.
Hawes J.
Internal FDA Review: Division of Metabolic and Endocrine Products, CDER, FDA. 2016.  

NDA 209805 Steglujan (Ertugliflozin; Sitagliptin Phosphate) Pharmacology/Toxicology Review and Evaluation.
Hawes J.
Internal FDA Review: Division of Metabolic and Endocrine Products, CDER, FDA. 2016.  

NDA 209806 Segluromet (Ertugliflozin; Metformin Hydrochloride) Pharmacology/Toxicology Review and Evaluation.
Hawes J.
Internal FDA Review: Division of Metabolic and Endocrine Products, CDER, FDA. 2016.  

U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma.
Herndon T.M., Deisseroth A., Kaminskas E., Kane R.C., Koti K.M., Rothmann M.D., Habtemariam B., Bullock J., Bray J.D., Hawes J., Palmby T.R., Jee J., Adams W., Mahayni H., Brown J., Dorantes A., Sridhara R., Farrell A.T., and Pazdur R.
Clin Cancer Res. 2013, 19(17):4559-63. doi: 10.1158/1078-0432.CCR-13-0755. Epub 2013 Jun 17. PMID: 23775332.

NDA 202714 Kyprolis (Carfilzomib) Pharmacology/Toxicology Review and Evaluation.
Bray J. and Hawes J.
Internal FDA Review: Division of Hematology Oncology Products, CDER, FDA.  2011.

Control of Proliferation in Astrocytoma Cells by the Receptor Tyrosine Kinase/PI3K/AKT Signaling Axis and the Use of PI-103 and TCN as Potential Anti-Astrocytoma Therapies.
Gürsel D.B., Connell-Albert Y.S., Tuskan R.G., Anastassiadis T., Walrath J.C., Hawes J.J., Amlin-Van Schaick J.C., and Reilly K.M.
Neuro Oncol. 2011, 13(6):610-21. doi: 10.1093/neuonc/nor035. PMID: 21636709; PMCID: PMC3107099.

Genetically Engineered Mouse Models in Cancer Research.
Walrath J.C., Hawes J.J., Van Dyke T., and Reilly K.M.
Adv Cancer Res. 2010, 106:113-64. doi: 10.1016/S0065-230X(10)06004-5. PMID: 20399958; PMCID: PMC3533445.

Bioluminescent Approaches for Measuring Tumor Growth in a Mouse Model of Neurofibromatosis.
Hawes J.J. and Reilly K.M.
Toxicol Pathol. 2010, 38(1):123-30. doi: 10.1177/0192623309357075. PMID: 20176786; PMCID: PMC6348901.

Novel Dual-Reporter Preclinical Screen for Anti-Astrocytoma Agents Identifies Cytostatic and Cytotoxic Compounds.
Hawes J.J., Nerva J.D., and Reilly K.M.
J Biomol Screen. 2008, 13(8):795-803. doi: 10.1177/1087057108321085. Epub 2008 Jul 29. PMID: 18664715; PMCID: PMC2693415.

Galanin Protects Against Behavioral and Neurochemical Correlates of Opiate Reward.
Hawes J.J., Brunzell D.H., Narasimhaiah R., Langel U., Wynick D., and Picciotto M.R.
Neuropsychopharmacology. 2008, 33(8):1864-73. doi: 10.1038/sj.npp.1301579. Epub 2007 Oct 24. PMID: 17957220; PMCID: PMC2504505.

Nf1 Expression is Dependent on Strain Background: Implications for Tumor Suppressor Haploinsufficiency Studies.
Hawes J.J., Tuskan R.G., and Reilly K.M.
Neurogenetics. 2007, 8(2):121-30. doi: 10.1007/s10048-006-0078-5. Epub 2007 Jan 11. PMID: 17216419; PMCID: PMC6687394.

Galanin and Galanin-Like Peptide Modulate Neurite Outgrowth via Protein Kinase C-Mediated Activation of Extracellular Signal-Related Kinase.
Hawes J.J., Narasimhaiah R., and Picciotto M.R.
Eur J Neurosci. 2006, 23(11):2937-46. doi: 10.1111/j.1460-9568.2006.04828.x. PMID: 16819983.

Galanin Attenuates Cyclic AMP Regulatory Element-Binding Protein (CREB) Phosphorylation Induced by Chronic Morphine and Naloxone Challenge in Cath.a Cells and Primary Striatal Cultures.
Hawes J.J., Narasimhaiah R., and Picciotto M.R.
J Neurochem. 2006, 96(4):1160-8. doi: 10.1111/j.1471-4159.2005.03613.x. Epub 2006 Jan 17. PMID: 16417577.

Galanin Can Attenuate Opiate Reinforcement and Withdrawal.
Picciotto M.R., Hawes J.J., Brunzell D.H., and Zachariou V.
Neuropeptides. 2005, 39(3):313-5. doi: 10.1016/j.npep.2004.12.001. Epub 2005 Jan 28. PMID: 15944028.

GalR1, but not GalR2 or GalR3, Levels are Regulated by Galanin Signaling in the Locus Coeruleus Through a Cyclic AMP-Dependent Mechanism.
Hawes J.J., Brunzell D.H., Wynick D., Zachariou V., and Picciotto M.R.
J Neurochem. 2005, 93(5):1168-76. doi: 10.1111/j.1471-4159.2005.03105.x. PMID: 15934937; PMCID: PMC1352153.

Characterization of GalR1, GalR2, and GalR3 Immunoreactivity in Catecholaminergic Nuclei of the Mouse Brain.
Hawes J.J. and Picciotto M.R.
J Comp Neurol. 2004, 479(4):410-23. doi: 10.1002/cne.20329. Erratum in: J Comp Neurol. 2005 Sep 12;490(1):98-100. PMID: 15514977.

The Neuropeptide Galanin Modulates Behavioral and Neurochemical Signs of Opiate Withdrawal.
Zachariou V., Brunzell D.H., Hawes J., Stedman D.R., Bartfai T., Steiner R.A., Wynick D., Langel U., Picciotto M.R.
Proc Natl Acad Sci U S A. 2003, 100(15):9028-33. doi: 10.1073/pnas.1533224100. Epub 2003 Jul 9. PMID: 12853567; PMCID: PMC166432.

The Docking Protein FRS2alpha Controls a MAP Kinase-Mediated Negative Feedback Mechanism for Signaling by FGF Receptors.
Lax I., Wong A., Lamothe B., Lee A., Frost A., Hawes J., and Schlessinger J.
Mol Cell. 2002, 10(4):709-19. doi: 10.1016/s1097-2765(02)00689-5. PMID: 12419216.