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  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

 

DateTitleJournal
2024Repeat Treatment of Organotypic Airway Cultures with Ethyl Methanesulfonate Causes Accumulation of Somatic Cell Mutations Without Expansion of Bronchial-Carcinoma-Specific Cancer Driven MutationsGenetic Toxicology and Environmental Mutagenesis
2024Utility of Life Stage-Specific Chemical Risk Assessments Based on New Approach Methodologies Food and Chemical Toxicology
2024Sustained Antigen Delivery Improves Germinal Center Reaction and Increases Antibody Responses in Neonatal MiceNPJ Vaccines
2024Evaluating 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
2024Evaluation of a Microphysiological Human Placental Barrier Model for Studying Placental Drug TransferReproductive Toxicology
20232368. SARS-CoV-2 mRNA Vaccination Induces B Cell Immunity in the Tonsils and Adenoids of ChildrenOpen Forum Infectious Diseases
2023Application of Quantitative Systems Pharmacology to Pediatric Drug Safety Assessment Clinical Pharmacology & Therapeutics
2023Bench Testing Performance of Deep Learning-Based CT Image Denoising Methods: Influence of Object Background on Image Sharpness and Noise Texture SPIE Medical Imaging
2023An FDA Guide on Indications for Use and Device Reporting of Artificial Intelligence-Enabled Devices: Significance for Pediatric UseJournal of the American College of Radiology
2023Gene Expression Analyses Reveal Potential Mechanism of Inorganic Arsenic-Induced Apoptosis in ZebrafishJournal of Applied Toxicology
2023IL6 Suppresses Vaccine Responses in Neonates by Enhancing IL2 Activity on T Follicular Helper Cellsnpj Vaccines
2023Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for SotalolJournal of Clinical Pharmacology
2023Inorganic Arsenic Alters the Development of Dopaminergic Neurons But Not Serotonergic Neurons and Induces Motor Neuron Development via Sonic Hedgehog Pathway in ZebrafishNeuroscience Letters
2023Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy Journal of Clinical Pharmacology
2023Multi-omics Analysis of Mucosal and Systemic Immunity to SARS-CoV-2 After BirthCell
2023Nanoluciferase Reporter Zika Viruses as Tools for Assessing Infection Kinetics and Antibody PotencyViruses
2023Neonatal Outcomes and Indirect Consequences Following Maternal SARS-CoV-2 Infection in Pregnancy: A Systematic Review BMJ Open
2023Neutralization 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
2023Pediatric-Specific Evaluations for Deep Learning CT DenoisingZenodo
2023Pharmacokinetics of Antibodies During Pregnancy: General Pharmacokinetics and Pregnancy Related Physiological Changes (Part 1) International Immunopharmacology
2023Pharmacokinetics of Antibodies During Pregnancy: Impact of Pregnancy on the Pharmacokinetics of Antibodies (Part 2) International Immunopharmacology
2023Physiologically Based Pharmacokinetic Modeling of Nilotinib for Drug-Drug Interactions, Pediatric Patients, and Pregnancy and LactationJournal of Clinical Pharmacology
2023Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug PharmacokineticsPharmaceutics
2022Adaptive Immune Responses to SARS-CoV-2 Persist in the Pharyngeal Lymphoid Tissue of ChildrenNature Immunology
2022An Antibody from Single Human VH-Rearranging Mouse Neutralizes All SARS-CoV-2 Variants Through BA.5 by Inhibiting Membrane FusionScience Immunology
2022BSL2-compliant Lethal Mouse Model of SARS-CoV-2 and Variants of Concern to Evaluate Therapeutics Targeting the Spike ProteinFrontiers in Immunology
2022Comprehensive Profiling of the Human Viral Exposome in Households Containing an At-Risk Child with Mitochondrial Disease During the 2020–2021 COVID-19 PandemicClinical and Translational Medicine
2022Cross-Reactive Immunity Against the SARS-CoV-2 Omicron Variant is Low in Pediatric Patients with Prior COVID-19 or MIS-CNature Communications
2022Developing an In Vitro to In Vivo Extrapolation (IVIVE) Model to Predict Human Milk-to-Plasma Drug Concentration RatiosMolecular Pharmaceutics
2022Durability 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 BiologicsGastroentorology
2022Evaluation of the Robustness of Cerebral Oximetry to Variations in Skin Pigmentation Using a Tissue-Stimulating PhantomBiomedical Optics Express
2022Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology PerspectiveThe Journal of Clinical Pharmacology
2022Exploring Maternal-Fetal Pharmacology Through PBPK Modeling ApproachesFrontiers in Pediatrics
2022Fetal Clinical Pharmacology: A New Frontier of Drug Safety and TherapeuticsThe Journal of Clinical Pharmacology
2022Improving Development of Drug Treatments for Pregnant Women and the FetusTherapeutic Innovation & Regulatory Science
2022In Vivo Pharmacokinetic Analyses of Placental Transfer of Three Drugs of Different Physicochemical Properties in Pregnant RatsReproductive Toxicology
2022Knowledge, Attitude, and Beliefs of Medication Use in Pregnancy in an Urban Tertiary Care Center The Journal of Clinical Pharmacology
2022Neutralization of Severe Acute Respiratory Syndrome Coronavirus 2 Omicron and Other Variants in Serum From Children With Vaccination-Induced MyocarditisClinical Infectious Diseases
2022SARS-CoV-2 mRNA Vaccine Induced Higher Antibody Affinity and IgG Titers Against Variants of Concern in Post-Partum vs Non-Post-Partum WomeneBioMedicine
2022Systemic and Lower Respiratory Tract Immunity to SARS-CoV-2 Omicron and Variants in Pediatric Severe COVID-19 and Mis-CVaccines
2022Zika Virus Infection and Antibody Neutralization in FcRn Expressing Placenta and Engineered Cell LinesVaccines
2021Entry and Disposition of Zika Virus Immune Complexes in a Tissue Culture Model of the Maternal-Fetal InterfaceVaccines
2021Genetic Toxicity Testing Using Human In Vitro Organotypic Airway Cultures: Assessing DNA Damage With the CometChip and Mutagenesis by Duplex SequencingEnvironmental and Molecular Mutagenesis
2021Immune Responses and Therapeutic Challenges in Paediatric Patients with New-Onset Acute Myeloid Leukaemia and Concomitant COVID-19British Journal of Haematology
2021Infant Ear Canal ModelingJournal of the Acoustical Society of America
2021Mechanistic 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
2021Methodologic Approaches in Studies Using Real-World Data (RWD) to Measure Pediatric Safety and Effectiveness of Vaccines Administered to Pregnant Women: A Scoping ReviewVaccine
2021Pharmacoethics and Pregnancy: Overcoming the Therapeutic Orphan StigmaBritish Journal of Clinical Pharmacology
2021Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and RaltegravirClinical Pharmacokinetics
2021Physiologically Based Pharmacokinetic (PBPK) Modeling of RNAi Therapeutics: Opportunities and ChallengesBiochemical Pharmacology
2021Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology ModelingFrontiers in Pediatrics
2021SARS-CoV-2 Immune Repertoire in MIS-C and Pediatric COVID-19Nature Immunology
2021Survey of Acoustic Output in Neonatal Brain ProtocolsJournal of Magnetic Resonance Imaging
2020Acoustic Noise Measurements During Neonatal Magnetic Resonance ScansJournal of the Acoustical Society of America
2020Antibody Signature Induced by SARS-CoV-2 Spike Protein Immunogens in RabbitsScience Translational Medicine
2020Characterizing Biopersistence Potential of the Metabolite 5:3 Fluorotelomer Carboxylic Acid After Repeated Oral Exposure to the 6:2 Fluorotelomer AlcoholToxicology and Applied Pharmacology
2020Comparison of 3D-printed Phantoms for Testing Cerebral Oximeter PerformanceSPIE
2020Considerations for Pharmacokinetic Assessment of Immunoglobulins: Gammagard in Very Low Birth Weight Neonates with and without Baseline-CorrectionInternational Immunopharmacology
2020Methodologic Approaches in Studies Using Real-World Data to Measure Pediatric Safety and Effectiveness of Vaccines Administered to Pregnant Women: A Scoping Review ProtocolJBI Evidence Synthesis
2020Physiologically Based Pharmacokinetic Modeling: A Promising Tool for Translational Research and Regulatory ToxicologyCurrent Opinion in Toxicology
2020Population Pharmacokinetics of Immunoglobulin Intravenous Preparation in Very Low Birth Weight NeonatesInternational Immunopharmacology
2019Skin Pigmentation Impact on Cerebral Oximetry: Development and Implementation of a Phantom-Based Test Method (Conference Presentation)SPIE BiOS
2018Internal Exposure-Based Pharmacokinetic Evaluation of Potential for Biopersistence of 6:2 Fluorotelomer Alcohol (FTOH) and its MetabolitesFood and Chemical Toxicology
2018IL-6 Impairs Vaccine Responses in Neonatal MiceFrontiers in Immunology

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