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. NCTR Research Focus Areas
  9. Perinatal and Maternal Research
  1. NCTR Research Focus Areas

Perinatal and Maternal Research

Perinatal and Maternal Health Info | PHCE Topics | PHCE Publications
Picture of a mother with a sleeping baby

Perinatal and Maternal Research

Perinatal (i.e., the periods of time including pregnancy, childbirth, and infant/child development) and maternal health have been cornerstones of NCTR regulatory science research for over 40 years. 

Many drugs and other medical products provided to pregnant women, neonates, and infants are used off-label due to ethical concerns performing clinical trials in these understudied populations.  In addition, environmental exposure through foods represents another knowledge gap; infants consume more food per kilogram of body weight than any other age group, which could result in higher dietary exposures to chemicals. Often there is little to no available data to assess potential risks with these exposures; thus, safety and risk assessments for foodborne chemicals, biological-, and/or chemical-threat agents rely upon data obtained from animal models and in vitro cellular toxicology studies. 

Congress directed NCTR to lead efforts to create and manage the FDA virtual Perinatal Health Center of Excellence (PHCE). The PHCE was established in 2018 as an FDA-wide collaborative effort to review and fund research related to perinatal populations on an annual basis. 

With the support of collaborating product centers, NCTR coordinates the activities of the PHCE to conduct studies that address important perinatal regulatory-science needs. PHCE-funded research falls into the following categories: new alternative models, traditional toxicology studies, translational and clinical studies, computational modeling, bioanalytical chemistry, exposure science, and bioinformatics targeting. The highest priority during the selection process is given to projects with a potential for wide regulatory impact, including policy changes and realigning industry standards, thereby improving clinical practice and research approaches.

PHCE Research Topics

Current PHCE projects include (but are not limited to) research in the following areas:

  • Non-Immune biomarkers for Zika virus 
  • Simulation tools to reform the dosing strategy of therapeutic antibodies in pregnancy and young pediatric patient population
  • Perinatal CBD central nervous system (CNS) activity and toxicity
  • Immunogenicity of mRNA vaccines in early age
  • Impact of emerging SARS-CoV-2 variants on placental functions and neonatal outcomes
  • Advancing the application of lactation physiologically-based pharmacokinetic models
  • Predictive toxicology models of drug placental permeability using 3D-fingerprints and AI 
  • New alternative models of folliculogenesis (maturation of fertilizable egg) for assessing drug/chemical toxicity
  • Development of a pharmacology model for fetal cardiac safety
  • Blood clots in pregnant patients with sickle cell disease: the role and regulation of Von Willebrand Factor
  • Effect of obesity on the pharmacokinetics and pharmacodynamics of monoclonal antibodies in pediatric patients

Selected PHCE Publications

 

Date Title Journal
2024 Repeat Treatment of Organotypic Airway Cultures with Ethyl Methanesulfonate Causes Accumulation of Somatic Cell Mutations Without Expansion of Bronchial-Carcinoma-Specific Cancer Driven Mutations Genetic Toxicology and Environmental Mutagenesis
2024 Utility of Life Stage-Specific Chemical Risk Assessments Based on New Approach Methodologies  Food and Chemical Toxicology
2024 Sustained Antigen Delivery Improves Germinal Center Reaction and Increases Antibody Responses in Neonatal Mice NPJ Vaccines
2024 Evaluating the Toxicokinetics of Some Metabolites of a C6 Polyfluorinated Compound, 6:2 Fluorotelomer Alcohol in Pregnant and Nonpregnant Rats After Oral Exposure to the Parent Compound  Food and Chemical Toxicology
2024 Evaluation of a Microphysiological Human Placental Barrier Model for Studying Placental Drug Transfer Reproductive Toxicology
2023 2368. SARS-CoV-2 mRNA Vaccination Induces B Cell Immunity in the Tonsils and Adenoids of Children Open Forum Infectious Diseases
2023 Application of Quantitative Systems Pharmacology to Pediatric Drug Safety Assessment  Clinical Pharmacology & Therapeutics
2023 Bench Testing Performance of Deep Learning-Based CT Image Denoising Methods: Influence of Object Background on Image Sharpness and Noise Texture  SPIE Medical Imaging
2023 An FDA Guide on Indications for Use and Device Reporting of Artificial Intelligence-Enabled Devices: Significance for Pediatric Use Journal of the American College of Radiology
2023 Gene Expression Analyses Reveal Potential Mechanism of Inorganic Arsenic-Induced Apoptosis in Zebrafish Journal of Applied Toxicology
2023 IL6 Suppresses Vaccine Responses in Neonates by Enhancing IL2 Activity on T Follicular Helper Cells npj Vaccines
2023 Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol Journal of Clinical Pharmacology
2023 Inorganic Arsenic Alters the Development of Dopaminergic Neurons But Not Serotonergic Neurons and Induces Motor Neuron Development via Sonic Hedgehog Pathway in Zebrafish Neuroscience Letters
2023 Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy  Journal of Clinical Pharmacology
2023 Multi-omics Analysis of Mucosal and Systemic Immunity to SARS-CoV-2 After Birth Cell
2023 Nanoluciferase Reporter Zika Viruses as Tools for Assessing Infection Kinetics and Antibody Potency Viruses
2023 Neonatal Outcomes and Indirect Consequences Following Maternal SARS-CoV-2 Infection in Pregnancy: A Systematic Review  BMJ Open
2023 Neutralization of SARS-CoV-2 Omicron BQ.1, BQ.1.1 and XBB.1 Variants Following SARS-CoV-2 Infection or Vaccination in Children  Nature Communications
2023 Pediatric-Specific Evaluations for Deep Learning CT Denoising Zenodo
2023 Pharmacokinetics of Antibodies During Pregnancy: General Pharmacokinetics and Pregnancy Related Physiological Changes (Part 1)  International Immunopharmacology
2023 Pharmacokinetics of Antibodies During Pregnancy: Impact of Pregnancy on the Pharmacokinetics of Antibodies (Part 2)  International Immunopharmacology
2023 Physiologically Based Pharmacokinetic Modeling of Nilotinib for Drug-Drug Interactions, Pediatric Patients, and Pregnancy and Lactation Journal of Clinical Pharmacology
2023 Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug Pharmacokinetics Pharmaceutics
2022 Adaptive Immune Responses to SARS-CoV-2 Persist in the Pharyngeal Lymphoid Tissue of Children Nature Immunology
2022 An Antibody from Single Human VH-Rearranging Mouse Neutralizes All SARS-CoV-2 Variants Through BA.5 by Inhibiting Membrane Fusion Science Immunology
2022 BSL2-compliant Lethal Mouse Model of SARS-CoV-2 and Variants of Concern to Evaluate Therapeutics Targeting the Spike Protein Frontiers in Immunology
2022 Comprehensive Profiling of the Human Viral Exposome in Households Containing an At-Risk Child with Mitochondrial Disease During the 2020–2021 COVID-19 Pandemic Clinical and Translational Medicine
2022 Cross-Reactive Immunity Against the SARS-CoV-2 Omicron Variant is Low in Pediatric Patients with Prior COVID-19 or MIS-C Nature Communications
2022 Developing an In Vitro to In Vivo Extrapolation (IVIVE) Model to Predict Human Milk-to-Plasma Drug Concentration Ratios Molecular Pharmaceutics
2022 Durability of Immunity Is Low Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA.1, BA.2, and BA.3 Variants After Second and Third Vaccinations in Children and Young Adults With Inflammatory Bowel Disease Receiving Biologics Gastroentorology
2022 Evaluation of the Robustness of Cerebral Oximetry to Variations in Skin Pigmentation Using a Tissue-Stimulating Phantom Biomedical Optics Express
2022 Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective The Journal of Clinical Pharmacology
2022 Exploring Maternal-Fetal Pharmacology Through PBPK Modeling Approaches Frontiers in Pediatrics
2022 Fetal Clinical Pharmacology: A New Frontier of Drug Safety and Therapeutics The Journal of Clinical Pharmacology
2022 Improving Development of Drug Treatments for Pregnant Women and the Fetus Therapeutic Innovation & Regulatory Science
2022 In Vivo Pharmacokinetic Analyses of Placental Transfer of Three Drugs of Different Physicochemical Properties in Pregnant Rats Reproductive Toxicology
2022 Knowledge, Attitude, and Beliefs of Medication Use in Pregnancy in an Urban Tertiary Care Center  The Journal of Clinical Pharmacology
2022 Neutralization of Severe Acute Respiratory Syndrome Coronavirus 2 Omicron and Other Variants in Serum From Children With Vaccination-Induced Myocarditis Clinical Infectious Diseases
2022 SARS-CoV-2 mRNA Vaccine Induced Higher Antibody Affinity and IgG Titers Against Variants of Concern in Post-Partum vs Non-Post-Partum Women eBioMedicine
2022 Systemic and Lower Respiratory Tract Immunity to SARS-CoV-2 Omicron and Variants in Pediatric Severe COVID-19 and Mis-C Vaccines
2022 Zika Virus Infection and Antibody Neutralization in FcRn Expressing Placenta and Engineered Cell Lines Vaccines
2021 Genetic Toxicity Testing Using Human In Vitro Organotypic Airway Cultures: Assessing DNA Damage With the CometChip and Mutagenesis by Duplex Sequencing Environmental and Molecular Mutagenesis
2021 Immune Responses and Therapeutic Challenges in Paediatric Patients with New-Onset Acute Myeloid Leukaemia and Concomitant COVID-19 British Journal of Haematology
2021 Infant Ear Canal Modeling Journal of the Acoustical Society of America
2021 Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pharmacokinetics? Frontiers in Pediatrics
2021 Methodologic Approaches in Studies Using Real-World Data (RWD) to Measure Pediatric Safety and Effectiveness of Vaccines Administered to Pregnant Women: A Scoping Review Vaccine
2021 Pharmacoethics and Pregnancy: Overcoming the Therapeutic Orphan Stigma British Journal of Clinical Pharmacology
2021 Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir Clinical Pharmacokinetics
2021 Physiologically Based Pharmacokinetic (PBPK) Modeling of RNAi Therapeutics: Opportunities and Challenges Biochemical Pharmacology
2021 Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling Frontiers in Pediatrics
2021 SARS-CoV-2 Immune Repertoire in MIS-C and Pediatric COVID-19 Nature Immunology
2021 Survey of Acoustic Output in Neonatal Brain Protocols Journal of Magnetic Resonance Imaging
2020 Acoustic Noise Measurements During Neonatal Magnetic Resonance Scans Journal of the Acoustical Society of America
2020 Antibody Signature Induced by SARS-CoV-2 Spike Protein Immunogens in Rabbits Science Translational Medicine
2020 Characterizing Biopersistence Potential of the Metabolite 5:3 Fluorotelomer Carboxylic Acid After Repeated Oral Exposure to the 6:2 Fluorotelomer Alcohol Toxicology and Applied Pharmacology
2020 Comparison of 3D-printed Phantoms for Testing Cerebral Oximeter Performance SPIE
2020 Considerations for Pharmacokinetic Assessment of Immunoglobulins: Gammagard in Very Low Birth Weight Neonates with and without Baseline-Correction International Immunopharmacology
2020 Methodologic Approaches in Studies Using Real-World Data to Measure Pediatric Safety and Effectiveness of Vaccines Administered to Pregnant Women: A Scoping Review Protocol JBI Evidence Synthesis
2020 Physiologically Based Pharmacokinetic Modeling: A Promising Tool for Translational Research and Regulatory Toxicology Current Opinion in Toxicology
2020 Population Pharmacokinetics of Immunoglobulin Intravenous Preparation in Very Low Birth Weight Neonates International Immunopharmacology
2019 Skin Pigmentation Impact on Cerebral Oximetry: Development and Implementation of a Phantom-Based Test Method (Conference Presentation) SPIE BiOS
2018 Internal Exposure-Based Pharmacokinetic Evaluation of Potential for Biopersistence of 6:2 Fluorotelomer Alcohol (FTOH) and its Metabolites Food and Chemical Toxicology

Subscribe to NCTR Research Highlights Newsletter

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top