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  8. Jessica Hawes Oliphant
  1. Science & Research (NCTR)

Jessica J. Hawes Oliphant Ph.D.

Deputy Director – Division of Systems Biology

Headshot of Dr. Jessica Hawes Oliphant

Jessica J. Hawes Oliphant, Ph.D.
(870) 543-7121
NCTRResearch@fda.hhs.gov

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About  |  Publications

Background

Dr. Jessica Oliphant is deputy director of the Division of Systems Biology at FDA’s National Center for Toxicological Research (NCTR) where she leads regulatory research and assists the Division with strategic directions, internal and external collaborations, initiatives, management, budget, and contracts. Dr. Oliphant has ten years of experience conducting pharmacology/toxicology drug review and risk assessments for investigative new drugs (INDs) and market new drug applications (NDAs) within the Office of New Drugs at the Center for Drug Evaluation and Research (CDER). This work includes safety margin determinations, translation of risk, clinical dose/dosing recommendations, clinical trial safety monitoring, and drug labeling. During her tenure at FDA, Dr. Oliphant has worked with diverse regulators and research scientists on regulatory projects involving therapeutics, health indications, safety concerns, and FDA-regulated products—including areas of medical product safety, food safety, personalized medicine, innovative technologies, systems biology, bioinformatics, software tool development, and analytical method development and qualification.

Dr. Oliphant is an active member of many scientific subcommittees and working groups (WGs) across the Agency, including co-chair of the FDA Biomarker WG and founder/leader of the Montelukast WG. She 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 the recipient of the 2023 NCTR Director’s Award and 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 FDA, Dr. Oliphant 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 organizations such as 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 received the Graduate of the Year Award.

 

Research Interests

Dr. Oliphant’s research interests cover the broad spectrum of scientific topics studied within the Division of Systems Biology, with a focus on identifying scientific needs and knowledge gaps pertaining to FDA-regulated products and Regulatory Science. Current research areas of interest include neuropsychiatric risks of montelukast, oligonucleotide therapeutics, perinatal health, alternative methods, biomarker discovery/validation, cannabinoids, and rare diseases.

 

Professional Societies/National and International Groups

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

Society of Toxicology
Member, Former Speaker
2019 – Present

 

Selected Publications

Decoding Complexity in Synthetic Oligonucleotides: Unraveling Coeluting Isobaric Impurities by High Resolution Mass Spectrometry.
Abdullah A.M., Sommers C., Rodriguez J.D., Zhang D., Kozak D., Hawes J., Sapru M., and Yang K.
Analytical Chemistry. 2024, 96(2): 904–909. doi: 10.1021/acs.analchem.3c05016.  PMID: 38158374; PMCID: PMC10794994.

U.S. FDA Public Meeting: Identification of Concepts and Terminology for Multicomponent Biomarkers.
Abena S. Agyeman, Bandukwala A., Bouri K., Hawes J., Krainak D.M., Lababidi S., Mishina E.V., Thekkudan T., Turfle P., and Wang S.J. on behalf of the U.S. Food and Drug Administration Biomarker Working Group.
Biomarkers in Medicine. 2023, 17(11):523-531. doi:10.2217/bmm-2023-0351. PMID: 37713233.

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., Ronxhi J.
Current Protocols. 2022, 2(7):e478. doi: 10.1002/cpz1.478. PMID: 35790095.

Tandem Mass Spectrometric Sequence Characterization of Synthetic Thymidine-Rich Oligonucleotides.
Abdullah A.M., Hawes J., Sommers C., Rodriguez J.D., and Yang K.
Journal of Mass Spectrometry. 2022, 57(4): e4819. doi: 10.1002/jms.4819. PMID: 35347805; PMCID: PMC9287059.

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.

Contact Information
Jessica J. Hawes Oliphant
(870) 543-7121
Expertise
Expertise
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