| 2024 |
Intramural |
CAMACHO, LUISA |
NCTR |
Systematic evaluation of reconstructed human skin models to predict the percutaneous absorption of cosmetic ingredients and other FDA-regulated products |
Cosmetics, Dermatology |
| 2024 |
Intramural |
WILLETT, ROSE |
NCTR |
Sex-comparative cancer modeling: Determining the sex differences in lorcaserin-induced non-genotoxic mechanisms associated with increased female lung cancer prevalence |
Oncology/cancer, Biomarkers |
| 2024 |
Intramural |
YU, LI-RONG |
NCTR |
Informed prediction of anthracycline-induced cardiotoxicity (IMPACT): A multicenter biomarker qualification study |
Oncology/cancer, Toxicology, Biomarkers |
| 2024 |
Intramural |
GUO, WENJING |
NCTR |
Identify sex disparities in opioid drug safety signals in FDA adverse events report system (FAERS) and social media Twitter to improve women’s health |
Pharmaceuticals, Opioids |
| 2024 |
Intramural |
FAIRMAN, KIARA |
NCTR |
Pregnancy Pharmacokinetic Database |
Obstetrics/Gynecology, Pharmacology |
| 2024 |
Intramural |
MAZOR, RONIT |
CBER |
Investigation of sex difference in immunogenicity and efficacy of AAV mediated gene therapy |
Immunology, Gene therapy |
| 2023 |
Intramural |
AYYOUB, AMAL |
CDER |
Evaluation of the Impact of Dose Interruptions and Reductions on the Clinical Efficacy of Targeted Breast Cancer Drugs |
Oncology/cancer, Pharmacology |
| 2023 |
Intramural |
WU, WEN JIN |
CDER |
Identify therapeutic biomarkers, characterize bispecific antibodies (BsAbs) to treat ovarian cancer (OC), and support the reviews of FDA-regulated BsAbs |
Oncology/cancer, Biologics |
| 2023 |
Intramural |
PINTO, CAROLINE |
CDRH |
Application of in vitro and in silico models to predict the total estrogenicity of chemicals released from cardiovascular medical devices |
Oncology/cancer, Medical device |
| 2023 |
Intramural |
SAMALA, RAVI |
CDRH |
Tackling sex bias in AI for severity assessment of COVID-19 |
Infectious diseases, Medical device, Artificial Intelligence |
| 2023 |
Intramural |
CAI, CHENGZHONG |
NCTR |
Potential Context of Use for a Human-Based Engineered Heart Tissue System to Detect Sex Disparities of Chemotherapy Drugs (Special Funding) |
Oncology/cancer, Pharmaceuticals |
| 2023 |
Intramural |
CHEN, MINJUN |
NCTR |
Identify genetic and nongenetic factors with increasing susceptibility to herbal dietary supplement (HDS)-induced liver injury in women |
Dietary supplements, Pharmacogenomics, Toxicology |
| 2023 |
Intramural |
LI, DONGYING |
NCTR |
Sex-biased safety profiles in IND submissions and its manifestation in NDA approval and post-marketing surveillance |
Pharmaceuticals |
| 2022 |
Intramural |
XIE, HANG |
CBER |
Investigating the impact of SARS-CoV-2 infection on female fertility and assessing vaccination-induced immunity in protecting pregnant K18-ACE2 transgenic mice against emerging SARS-CoV-2 variants |
Infectious diseases |
| 2022 |
Extramural (CERSI) |
SON, MOEUN |
Yale-Mayo |
Evaluate the application of machine learning algorithms to the management of postpartum hemorrhage |
Obstetrics/Gynecology, Cardiovascular |
| 2022 |
Extramural (CERSI) |
SHAH, SAMIT |
Yale-Mayo |
Improving the Diagnosis and Treatment of Women with Myocardial Ischemia and No Obstructive Coronary Artery Disease |
Cardiovascular |
| 2022 |
Extramural (CERSI) |
STINCHCOMB, AUDRA |
University of Maryland |
Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products |
Obstetrics/Gynecology, Pharmacology, Pharmaceuticals |
| 2021 |
Intramural |
KAMAL, NAHID |
CDER |
Affordable generics for menopausal women: Mechanistic evaluation of forumulation design and performance of estradiol intravaginal ring products |
Obstetrics/Gynecology, Medical device |
| 2021 |
Intramural |
TOLNAY, MATE |
CDER |
Define a biomarker of decidual inflammation to predict recurrent pregnancy loss |
Obstetrics/Gynecology, Immunology, Biomarkers |
| 2021 |
Intramural |
ZIDAN, AHMED |
CDER |
Developing quality standards for an innovative personalized 3D printed intravaginal ring for menopausal women |
Obstetrics/Gynecology, Medical device |
| 2021 |
Extramural (CERSI) |
IWASAKI, AKIKO |
Yale-Mayo |
Sex differences in immune profiles of PASC before and after vaccination |
Infectious diseases, Immunology |
| 2021 |
Intramural |
BIGHAMIAN, RAMIN |
CDRH |
Next generation sex-specific ventilator systems enabled by neural activity |
Pulmonary, Medical device |
| 2021 |
Extramural (CERSI) |
KLEIN, SABRA |
Johns Hopkins |
Defining SARS-CoV2 vaccine-induced immunity in pregnant and lactating people |
Infectious diseases, Immunology, Obstetrics/Gynecology |
| 2021 |
Intramural |
CHANDRASEKAR, VAISHNAVI |
CDRH |
Effect Of Sex Differences on the Drug Absorption, Biological Responses and Adverse Events Elicited by Paclitaxel Containing Medical Devices |
Cardiovascular, Medical device |
| 2021 |
Intramural |
GALLAS, BRANDON |
CDRH |
Dataset to validate digital-pathology algorithms that quantify tumor-infiltrating lymphocytes in breast cancer |
Oncology/cancer, Diagnostics, Artificial Intelligence |
| 2021 |
Intramural |
SAHINER, BERKMAN |
CDRH |
Prediction of response to therapy for advanced/metastatic breast cancer: Joint analysis of radiologic and genomic data using machine learning |
Oncology/cancer, Artificial Intelligence |
| 2021 |
Extramural (CERSI) |
VASHISHT, ROHIT |
UCSF-Stanford |
Learning Real-World Sex-Specific Clinical Factors Influencing the Susceptibility to Infection, Immune Response, Treatment Utilization and Outcomes Among Individuals Infected with SARS-CoV-2 Infection |
Infectious diseases |
| 2021 |
Intramural |
SHIN, HAINSWORTH |
CDRH |
Identifying the cellular impact of surface textures in relation to breast implant associated anaplastic large-cell lymphoma |
Oncology/cancer, Medical device |
| 2021 |
Intramural |
YU, LI-RONG |
NCTR |
Verification of novel predictive biomarkers of doxorubicin-induced cardiotoxcity in breast cancer patients |
Oncology/cancer, Toxicology |
| 2020 |
Intramural |
DEVADAS, KRISHNAKUMAR |
CBER |
Impact of sex-based differences in the expression of host non-coding RNA biomarkers that can diagnose early HIV-1 infection |
Infectious diseases
|
| 2020 |
Intramural |
XIE, HANG |
CBER |
Identify unique antibody characteristics for prediction of effective influenza vaccination in pregnant and lactating women |
Infectious diseases, Immunology, Obstetrics/Gynecology |
| 2020 |
Intramural |
BENT, ROBYN |
CDER |
Qualitative Development of Patient Preference Survey Tool for Contraception Products (Special Funding) |
Obstetrics/Gynecology |
| 2020 |
Intramural |
DINATALE, MIRIAM |
CDER |
Pregnancy and Lactation Labeling Rule (PLLR): Health Care Provider Testing to Improve Health Communications Related to Lactation |
Obstetrics/Gynecology, Public Health |
| 2020 |
Intramural |
STONE, HEATHER |
CDER |
CURE Pregnancy Treatment Repository |
Obstetrics/Gynecology, Pharmaceuticals |
| 2020 |
Intramural |
XU, XIAOMING |
CDER |
An innovative alternative approach for assessing drug release from levonorgestrel intrauterine systems (IUSs) for supporting bioequivalence: in vitro drug release model in combination with advanced morphological characterization with micro-imaging (Special Funding) |
Obstetrics/Gynecology, Medical device |
| 2020 |
Extramural (CERSI) |
LADD-ACOSTA, CHRISTINE |
Johns Hopkins |
Assessing real-world use of pharmaceuticals among pregnant women |
Obstetrics/Gynecology, Pharmaceuticals |
| 2020 |
Intramural |
ELESPURU, ROSALIE |
CDRH |
Development of an integrated database for gender-based toxicological assessments (Special Funding) |
Toxicology, Medical device |
| 2020 |
Intramural |
WEIJIE, CHEN |
CDRH |
Predicting the response to hormonal treatment of women with atypical endometrial hyperplasia using artificial intelligence/machine learning (AI/ML) algorithms |
Oncology/cancer, Biomarkers, Artificial Intelligence |
| 2020 |
Extramural (BAA) |
TAO, ZHANG |
Husson University |
Predicting the transfer of breast cancer resistant milk using IN VITRO to IN VIVO Extrapolation (IVIVE) |
Oncology/cancer, Pharmaceuticals |
| 2020 |
Intramural |
CUEVAS-MARTINEZ, ELVIS-YANE |
NCTR |
Sex differences in Alzheimer’s disease associated with blood-brain barrier and immunological responses: Basis for emerging technologies for discovery of potential biomarkers and new therapies in women |
Neurology, Biomarkers |
| 2020 |
Intramural |
FAHMI, TARIQ |
NCTR |
Determination of Sex Differences in Immune Responses to Nanoparticles |
Immunology, Toxicology |
| 2020 |
Intramural |
MEI, NAN |
NCTR |
Mechanistic evaluation of genotoxic potential of black cohosh, a dietary supplement widely marketed for relief of gynecologic disorders and menopausal symptoms |
Obstetrics/Gynecology, Toxicology, Dietary supplements |
| 2019 |
Intramural |
CRAVEN, BRENT |
CDRH |
Evaluating inferior vena cava filter performance in women using patient-specific computational modeling |
Cardiovascular, Medical device |
| 2019 |
Intramural |
GARCIA, MONICA |
CDRH |
Computational models to evaluate the safety and effectiveness of vaginal heating devices |
Obstetrics/Gynecology, Medical device |
| 2019 |
Intramural |
DU, DONGYI (TONY) |
CDRH |
Evaluating the clinical comparibility of US vs. non-US clinical trial data for FDA-regulated medical devices for obesity treatment (co-funding with OMH) |
Endocrine/Metabolic, Medical device |
| 2019 |
Intramural |
FAIRMAN, KIARA |
NCTR |
Development of an artificially intelligent virtual pregnant woman modeling suite to support regulatory decisions |
Obstetrics/Gynecology, Pharmacology, Artificial Intelligence |
| 2019 |
Extramural (CERSI) |
FLYNN, EMILY |
UCSF-Stanford |
Comprehensive Assessment of Sex-Differential Smoking-related Effects in Publicly Available Gene Expression Data |
Pulmonary, Gene expression |
| 2019 |
Extramural (CERSI) |
HARGRAVES, IAN
|
Yale-Mayo
|
Methods to capture post-market patient preference information |
Medical device |
| 2019 |
Intramural |
LYN-COOK, BEVERLY |
NCTR |
Validation of Nuclear, Cytoplasmic and Cell Surface Receptors Expression in Triple Negative Breast Cancer Subtypes Treated with Vorinostat (Special Funding) |
Oncology/cancer, Biomarkers |
| 2019 |
Extramural (BAA) |
MULLINS, DANIELS |
University of Maryland |
Health Communications |
Public Health, Pharmaceuticals, Biologics |
| 2019 |
Intramural |
PETRICK, NICHOLAS |
CDRH |
Digital and 3D printed methods for quantitative CT-based bone texture and microarchitecture analysis for fracture risk (Special Funding) |
Musculoskeletal |
| 2019 |
Intramural |
TARTERA, CARMEN |
CFSAN |
Evaluation of women’s targeted dietary supplements for labeling complicance and potential contamination, containing live microbes in the US market with special emphasis on pregnant and lactating women, and infants |
Dietary supplements, Obstetrics/Gynecology, Metagenomics |
| 2019 |
Intramural |
TONG, WEIDA |
NCTR |
Develop a Database of Herbal/ Dietary Supplements (HDS) Hepatotoxicity to Support the Agency’s New Efforts to Strengthen Regulation of HDS Products (extension of FY16 project) (Special Funding) |
Hepatic, Dietary supplements |
| 2019 |
Extramural (BAA) |
WebMD |
WebMD |
Survey- Lupus Patient Perspective on Clinical Trials |
Autoimmune, Clinical Trials |
| 2019 |
Extramural (BAA) |
WebMD |
WebMD |
Survey- Lupus Prescriber Referral Bias |
Autoimmune, Clinical Trials |
| 2019 |
Extramural (BAA) |
WebMD |
WebMD |
Survey-Women’s Health Special Populations |
Obstetrics/Gynecology, Pharmaceuticals |
| 2019 |
Extramural (BAA) |
WU, JOSEPH |
UCSF-Stanford |
Identifying genetic mechanisms of doxorubicin-induced cardiotoxcity |
Oncology/cancer, Toxicology |
| 2019 |
Intramural |
WU, WEN JIN |
CDER |
Develop novel bispecific antibodies to improve the safety and efficacy of FDA-regulated products for the treatment of triple negative breast cancers (Special Funding) |
Oncology/cancer, Biologics |
| 2019 |
Intramural |
YU, LI-RONG |
NCTR |
Verification of Novel Predictive Biomarkers of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients |
Oncology/cancer, Toxicology |
| 2019 |
Intramural |
ZHUANG, LUNING |
CDER |
Application of model-informed approaches to facilicate dose selection for antimalarial drugs in pregnant women to support efficient drug development |
Infectious disease |
| 2019 |
Intramural |
ZIRKELBACH, JEANNE FOURIE |
CDER |
Patient reported outcomes (PRO) symptom data to complement traditional exposure-response (ER) analysis to optimize dose selection and dose reduction strategies during adjuvant breast cancer treatment drug development |
Oncology/cancer, Patient-reported outcomes |
| 2018 |
Intramural |
GUERRIERI, GIOIA |
CDER |
Plasma biomarkers in perimenopause-onset depression |
Psychiatry, Biomarkers, Obstetrics/Gynecology |
| 2018 |
Intramural |
JU, JING |
CDER |
Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products |
Public Health |
| 2018 |
Intramural |
PANG, LI |
NCTR |
Sex differences in drug-induced QT prolongation and Torsades de pointes establishing an in vitro model for high-throughput screening and risk assessment of torsadogenic drugs (special funding) |
Cardiovascular, Gene expression |
| 2018 |
Intramural |
RAJAN, SUNDER |
CDRH |
Development of a Standardized Protocol for Screening and Detection of ALCL and implant rupture through High Resolution 3D MRI imaging of silicone breast implants QC title – Standardizing the protocol for High-resolution 3D MRI for imaging silicone breast implants for screening and detection of ALCL |
Oncology/cancer, Medical device |
| 2018 |
Intramural |
SAHA, ANINDITA |
CDRH |
Analysis of Sex Specific Differences in Quality of Life Measures for Heart Failure |
Cardiovascular, Patient-reported outcomes |
| 2018 |
Intramural |
SHIN, HAINSWORTH |
CDRH |
Identifying the impact of surface-texturing on the differential pathogenesis of Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) |
Oncology/cancer, Medical device |
| 2018 |
Intramural |
ZUSTERZEEL, ROBBERT |
CDER |
Evaluation of the Safety and Effectiveness of Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) for Atrial Fibrillation in Underrepresented Subgroups in Premarket Clinical Trials Using Combined Clinical and Statistical Modeling Approaches. (special funding) |
Cardiovascular, Medical device, Pharmaceuticals |
| 2017 |
Intramural |
ELEKAWACHI, OLUCHI |
CBER |
Evaluation of the extent and impact of gender sensitive advertising and promotional labeling of Health Products (Special Funding) |
Public health |
| 2017 |
Intramural |
FERGUSON, SHERRY |
NCTR |
Gender differences related to Alzheimer’s disease as revealed by Exome sequencing and RNA Seq (Special Funding) |
Neurology, Biomarkers, Gene expression |
| 2017 |
Intramural |
FUSCOE, JAMES |
NCTR |
Evaluation of transcriptomics-based predictions of sex- and age-related susceptibilities to treatment-induced adverse effects in F344 rats (Special Funding) |
Endocrine/Metabolic, Gene expression, Pharmaceuticals |
| 2017 |
Intramural |
JIANG, HELEN |
CDRH |
Sex-specific analysis of percutaneous left atrial appendage (LAA) closure device for stroke prevention in patients with atrial fibrillation |
Cardiovascular |
| 2017 |
Intramural |
LUMEN, ANNIE |
NCTR |
Population-Based computational framework for assessing xenobiotic disposition and interaction effects in pregnant women |
Obstetrics/Gynecology, Pharmacology, Endocrine/Metabolic |
| 2017 |
Intramural |
LYN-COOK, BEVERLY |
NCTR |
Stimulate innovation in clinical evaluations and personalized medicine to improve patient outcomes with triple negative breast cancer |
Oncology/cancer |
| 2017 |
Intramural |
RAJAN, SUNDER; ANGELONE, LEONARDO |
CDRH |
Virtual model of a female human subject with large body habitus for use in MR Radio frequency safety assessments |
Medical device |
| 2017 |
Intramural |
STRAUSS, DAVID |
CDER |
Translational regulatory science to advance drug safety in women combining in silico modeling and clinical approaches |
Cardiovascular |
| 2017 |
Intramural |
TOROSYAN, YELIZAVETA |
CDRH |
In silico research on sex differences in the biological responses and adverse events elicited by implantable devices/ biomaterials (Special funding) |
Medical device, Biomarkers |
| 2017 |
Intramural |
YU, LI-RONG |
NCTR |
Predictive clinical biomarkers for chemotherapy induced cardiotoxicity (Special Funding) |
Oncology/cancer, Toxicology, Biomarkers |
| 2016 |
Intramural |
BUEHLER, PAUL |
CBER |
Evaluation of thromboembolic events following C1-inhibitor therapy |
Rare Diseases, Pharmaceuticals |
| 2016 |
Intramural |
DAS, SRILEKHA |
CDRH |
Bacteria and virus migration through latex condoms in the presence of personal lubricants |
Obstetrics/Gynecology, Infectious disease, Medical device |
| 2016 |
Intramural |
DU, DONGYI |
CDRH |
Sex and racial difference in prosthetic aortic valve selection and risk factors for patient outcome—an observational study of Medicare beneficiaries |
Cardiovascular, Medical device |
| 2016 |
Intramural |
GARRA, BRIAN |
CDRH |
Spectral Photoacoustic Tomography (PAT) for Breast Tumor Oximetry: Test Method Development, In Vivo Validation, and Computational Modeling |
Oncology/cancer, Medical device |
| 2016 |
Intramural |
LEE, LAI MING |
CDER |
Cardiovascular Risk of Testosterone Treatment in Women |
Cardiovascular, Obstetrics/Gynecology |
| 2016 |
Intramural |
LYN-COOK, BEVERLY |
NCTR |
The role of epigenetic mechanisms in re-expression of ER, PR, and HER receptors in triple negative breast cancer: effects of FDA approved epigenetic drugs and dietary agents |
Oncology/cancer, Pharmaceuticals |
| 2016 |
Intramural |
MYERS, MATTHEW |
CDRH |
Development of test methods to evaluate the risk of cancer-cell permeation through tissue containment bags during laparoscopic power morcellation of uterine fibroids |
Oncology/cancer, Medical device |
| 2016 |
Intramural |
NAGARAJA, SRINIDHI BAUMANN, ANDREW |
CDRH |
Improving assessment of spinal device subsidence by incorporating female anatomy and density |
Musculoskeletal, Medical device |
| 2016 |
Intramural |
PATRI, ANIL |
NCTR |
Evaluating the migration and toxic potential of silver nanoparticles in feminine hygiene products into vaginal tissue: In vivo rodent and human in vitro 3D mucosal models |
Obstetrics/Gynecology, Toxicology |
| 2016 |
Intramural |
PETRICK, NICHOLAS |
CDRH |
Calcium and material characterization in women using dual-energy CT: Phase II |
Cardiovascular, Medical device |
| 2016 |
Intramural |
PEZESHK, ARIA |
CDRH |
Preservation of relevant clinical information in lossy compressed digital mammograms using objective image quality metrics |
Oncology/cancer, Medical device |
| 2016 |
Intramural |
SADRIEH, NAKISSA |
CFSAN |
Non-clinical mechanistic studies in addressing ovarian cancer risk from talc use in cosmetics (Special funding) |
Oncology/cancer, Cosmetics |
| 2016 |
Intramural |
SAHINER, BERKMAN |
CDRH |
Mammographic CAD device testing using computationally inserted microcalcification clusters and masses |
Oncology/cancer, Medical device, Method development & validation |
| 2016 |
Intramural |
STRUBLE, EVI |
CBER |
Assessment of Placental Transmission of Zika Virus Glycoprotein E Immunogen |
Obstetrics/Gynecology, Infectious diseases |
| 2016 |
Intramural |
TONG, WEIDA |
NCTR |
Hepatotoxicity database for herbal/dietary supplements |
Hepatic, Toxicology, Dietary Supplements |
| 2016 |
Intramural |
WAGNER, DOUG |
NCTR |
Drug-delivery nanoparticle immunological effects on induction of pro-inflammatory responses to Candida albicans in mice |
Immunology, Obstetrics/Gynecology |
| 2016 |
Intramural |
WEAR, KEITH |
CDRH |
Advancing Methods for Assessment and Prediction of Clinical Performance of High Intensity Therapeutic Ultrasound Systems (special funding) |
Medical device, Method development & validation |
| 2016 |
Intramural |
WU, WEN JIN |
CDER |
Development of biomarkers for trastuzumab-induced toxicity |
Oncology/cancer, Toxicology, Biomarkers |
| 2016 |
Intramural |
WU, WENDY |
CDER |
Optimization of an in silico cardiac cell model for predicting sex differences in drug-induced proarrhythmia risk |
Cardiovascular |
| 2016 |
Intramural |
YU, JINGYU |
CDER |
Tool development of modeling and simulations for metastatic breast cancer |
Oncology/cancer |
| 2015 |
Intramural |
CANOS, DANIEL |
CDRH |
Sex-specific outcomes with cardiac resynchronization therapy |
Cardiovascular, Medical device |
| 2015 |
Intramural |
CANOS, DANIEL |
CDRH |
Individual patient-data meta-analysis and post-market analysis as a method for improving data quality in demographic subgroups |
Cardiovascular, Medical device, Clinical Trials |
| 2015 |
Intramural |
COBURN, JAMES |
CDRH |
Sex-specific modeling and analysis of ACL injury susceptibility |
Musculoskeletal, Medical device |
| 2015 |
Intramural |
LI, XIANG |
CBER |
Bayesian demographic subgroup analyses for pregnant women |
Obstetrics/Gynecology, Clinical trials |
| 2015 |
Intramural |
LIACHENKO, SERGUEI |
NCTR |
Gender differences in neuronal reward circuit activation by nicotine and tobacco smoke using magnetic resonance spectroscopy |
Neurology |
| 2015 |
Intramural |
LUMEN, ANNIE |
NCTR |
Population-based computational framework for assessing xenobiotic disposition and interaction effects in pregnant women (Supplementary funds) |
Obstetrics/Gynecology, Endocrine/Metabolic |
| 2015 |
Intramural |
MARINAC, DANICA |
CDRH |
Capturing Sex-Specific Data in Regulatory Submissions and National Vascular Quality Initiative Registry |
Cardiovascular, Medical device |
| 2015 |
Intramural |
MYERS, MEAGAN |
NCTR |
Oncomutation profile of triple negative breast cancer: Additional studies in African American women |
Oncology/cancer, Biomarkers |
| 2015 |
Intramural |
NAGARAJA, SRINIDHI |
CDRH |
The effects of gender differences in adverse events for integrated fixation spinal implants |
Muscoloskeletal, Medical device |
| 2015 |
Intramural |
OVANESOV, MIKHAIL |
CBER |
Effect of procoagulant impurity on coagulation in plasma from pregnant women |
Hematologic, Obstetrics/Gynecology |
| 2015 |
Intramural |
PANG, LI |
NCTR |
A pilot study for evaluating genetic influences on sex differences of drug-induced proarrhythmia |
Cardiovascular, Pharmaceuticals |
| 2015 |
Intramural |
PHILLIPS, KENNETH |
CDRH |
Bacterial colonization and biofilm formation in dermal fillers implants: An in vivo model to confirm in vitro findings and pathogenesis leading to adverse events |
Dermatology, Medical device |
| 2015 |
Intramural |
RAO, V ASHUTOSH |
CDER |
Addressing the unmet medical needs for cardioprotection in women receiving chemotherapy |
Oncology/cancer, Toxicology |
| 2015 |
Intramural |
RONK, CHRISTOPHER |
CDRH |
Inclusion of Minority Racial/Ethnic Subjects in OB-GYN Device Applications and Device Labeling, 2005-2015 (Special Funding) |
Obstetrics/Gynecology, Medical device |
| 2015 |
Intramural |
STRAUSS, DAVID |
CDER |
Ensuring Accessible Supply of Safe and Effective Drugs: Quantifying Women-Specific Pro-Arrhythmia Risk of Drug Therapies (Special Funding) |
Cardiovascular, Pharmaceuticals |
| 2015 |
Intramural |
STRUBLE, EVI |
CBER |
Treating the pregnant patient: pharmacokinetic and mechanistic studies of antiviral IGIV preparations at different stages of gestation in an animal model of pregnancy |
Obstetrics/Gynecology, Pharmacology, Infectious diseases |
| 2015 |
Intramural |
WOODS, TERRY |
CDRH |
Identifying and characterizing key mechanical characteristics of surgical meshes used for pelvic organ prolapse repair and treatment of stress |
Obstetrics/Gynecology, Medical device |
| 2015 |
Intramural |
WOODS, TERRY |
CDRH |
Preclinical test methods for percutaneously implanted heart valves – Effect of non-circular valve configuration after implantation on valve leaflet dynamics |
Cardiovascular, Medical device |
| 2015 |
Intramural |
XIE, HANG |
CBER |
Modulatory effects of progesterone on maternal immunity and their implications in pregnancy-associated susceptibility to avian influenza infections |
Infectious diseases, Obstetrics/Gynecology, Immunology |
| 2014 |
Intramural |
CHANG, CHING-WEI |
NCTR |
Blood pressure threshold for cardiovascular disease risk: an assessment of sex-based criterion |
Cardiovascular, Diagnostics |
| 2014 |
Intramural |
GARRA, BRIAN |
CDRH |
Phantom-based evaluation of photoacoustic imaging systems for breast tumor vasculature quantification |
Oncology/cancer, Medical device, Method development & validation |
| 2014 |
Intramural |
GELPERIN, KATE |
CDER |
Evaluation and Improvement of Post-Market Pregnancy Registries |
Obstetrics/Gynecology |
| 2014 |
Intramural |
HART, MARK |
NCTR |
Evaluation of methods used to measure growth of staphylococcus aureus and the production of toxic shock syndrome toxin-1 as influenced by menstrual tampons |
Infectious diseases, Medical device, Obstetrics/Gynecology |
| 2014 |
Intramural |
LI, LI |
CDER |
Disease systems analysis: towards a generic framework for characterizing disease progression and treatment effects in osteoporosis |
Musculoskeletal, Pharmaceuticals |
| 2014 |
Intramural |
LI, XIANG (JUDY) |
CBER |
Bayesian assessment of safety profiles for pregnant women-From animal study to human clinical trial |
Obstetrics/Gynecology |
| 2014 |
Intramural |
OVANESOV, MIKHAIL |
CBER |
Evaluation of pharmacokinetics of thrombogenic impurity following different routes of immune globulin administration during pregnancy |
Obstetrics/Gynecology, Immunology |
| 2014 |
Intramural |
PANG, LI |
NCTR |
Sex differences in drug-induced QT prolongation and torsade de pointes: establishing an in vitro model for high-throughput screening and risk assessment of torsadogenic drugs |
Cardiovascular, Gene expression |
| 2014 |
Intramural |
PARISER, ANNE |
CDER |
Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products (Special Funding) |
Pharmaceuticals, Biologics |
| 2014 |
Intramural |
PETRICK, NICHOLAS |
CDRH |
Calcium and material characterization in women using dual-energy computed tomography |
Cardiovascular, Medical device |
| 2014 |
Intramural |
SAHINER, BERKMAN |
CDRH |
Simulation of realistic masses on mammograms and digital breast tomosynthesis images for system assessment and CAD development/testing |
Oncology/cancer, Medical device |
| 2014 |
Intramural |
STOCKBRIDGE, NORMAN |
CDER |
Novel therapeutic approaches to prevent drug-induced torsade de pointes |
Cardiovascular, Pharmacology, Pharmaceuticals |
| 2014 |
Intramural |
WILSON, PHYLLIS |
ORA |
Detection of synthetic drugs as adulterants in natural and herbal slimming products by UPLC-mass spectrometry |
Dietary supplements, Method development & validation |
| 2014 |
Intramural |
WOOD, STEVEN |
CDRH |
Follicle-stimulating hormone (FSH) may exacerbate local and systemic effects of wear particles released from metal-on-metal hip implants: Implications for women |
Obstetrics/Gynecology, Medical device, Immunology |
| 2014 |
Intramural |
WU, WEN JIN |
CDER |
Develop animal and cellular models to investigate the mechanisms of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine to support post-marketing surveillance of these antibody-based HER2-targeted therapies, and characterize novel serum biomarker of cardiotoxicity induced by trastuzumab, trastuzumab/pertuzumab, and ado-trastuzumab emtansine |
Oncology/cancer, Toxicology, Biomarkers |
| 2013 |
Intramural |
BROWN, RONALD |
CDRH |
Sex differences in biomarkers of kidney injury in patients with metal-on-metal hip implants |
Renal, Medical device, Biomarkers |
| 2013 |
Intramural |
COBURN, JAMES |
CDER |
Mechanical causes of higher hip implant failure rates in women |
Musculoskeletal, Medical device |
| 2013 |
Intramural |
GELPERIN, KATE |
CDER |
Evaluation and Improvement of Post-Market Pregnancy Registries |
Obstetrics/Gynecology, Pharmaceuticals |
| 2013 |
Intramural |
HEWLETT, INDIRA |
CBER |
Evaluation of HSV-2 co-infection and hormonal contraceptive use on HIV acquisition and pathogenesis using patient-derived clinical specimens |
Infectious diseases, Obstetrics/Gynecology, Biomarkers |
| 2013 |
Extramural (CERSI) |
INGBER, DONALD |
Harvard |
Tissue on a Chip |
Organ chip models, Oncology/cancer, Pharmaceuticals |
| 2013 |
Intramural |
KIM, DO-HYUN |
CDRH |
Photo-Thermal Safety in Laser-based Devices for Detection and Treatment of Breast Cancer: Effect of Endogenous Absorbers and Gold Nano-Particles |
Oncology/cancer, Medical device |
| 2013 |
Intramural |
LUMEN, ANNIE |
NCTR |
Population-Based Computational Framework for Assessing Xenobiotic Disposition and Interaction Effects in Pregnant Women-Pilot Study |
Endocrine/Metabolic, Obstetrics/Gynecology |
| 2013 |
Intramural |
LYN-COOK, BEVERLY |
NCTR |
Clinical and Biological Significance of Three Identified Targets in Systemic Lupus Erythematosus Patient PBMCs: IL-18, TNFSF13B, and FOXP3 |
Autoimmune, Biomarkers |
| 2013 |
Intramural |
NAGARAJA, SRINIDHI |
CDRH |
The Effects of Gender Differences in Revision Rates for Spinal Total Disc Replacement Procedures |
Musculoskeletal, Medical device |
| 2013 |
Intramural |
PHILLIPS, KENNETH |
CDRH |
Effect of Injection Techniques, Materials Chemistry and Physical Properties of Dermal Fillers on Potential for Bacterial Colonization and Infection |
Infectious diseases, Medical device, Cosmetics |
| 2013 |
Intramural |
RAJAN, SUNDER |
CDRH |
MRI Safety Testing of Breast Tissue Expanders used in Mastectomy Patients |
Medical device |
| 2013 |
Intramural |
STOCKBRIDGE, NORMAN; STRAUSS, DAVID |
CDRH |
PK analysis of the samples for a study funded by CDER Critical Pathways titled, “A double-blind, randomized, placebo-controlled single-dose, five-period crossover study of the electrocardiographic effects of ranolazine, dofetilide, verapamil and quinidine in healthy subjects” |
Cardiovascular, Pharmacology, Pharmaceuticals |
| 2013 |
Intramural |
STRUBLE, EVI |
CBER |
Assessing Passive Prophylaxis of Infection at Different Stages during Gestation in a Pregnant Animal Model |
Immunology, Obstetrics/Gynecology, Infectious diseases |
| 2013 |
Intramural |
VERTHELYI, DANIELA |
CDER |
Use of innate immune response modulators in women: The perfect storm to trigger autoimmune disease? |
Immunology, Autoimmune |
| 2013 |
Intramural |
WAGNER, ROBERT |
NCTR |
Nanoparticle Effects on Induction of Pro-inflammatory Responses to Candida albicans by Cultured Vaginal Epithelial Cells |
Obstetrics/Gynecology, Pharmaceuticals |
| 2013 |
Intramural |
ZHANG, ZHIWEI |
CDRH |
Incremental Values of Sequential Procedures for Diagnosing Breast Cancer |
Oncology/cancer, Medical device, Method development & validation |
| 2012 |
Intramural |
ANDERSON-SMITS, COLIN |
CDRH |
A Comparative Analysis of Adverse Events Between Conventional Tubal Ligation and Transcervical Occlusive Devices of the Fallopian Tube for Female Sterilization: A Cohort Study |
Obstetrics/Gynecology, Medical device |
| 2012 |
Intramural |
ANGELONE, LEONARDO |
CDRH |
MRI in pregnant patients: A systematic analysis of Radio-frequency heating with multi-transmit technology |
Obstetrics/Gynecology, Medical device |
| 2012 |
Intramural |
BADAL-SOLER, ANDREU |
CDRH |
Development, validation and dissemination of computational modeling tools to estimate radiation dose and image quality of emerging imaging technologies for the diagnosis and staging of breast cancer |
Oncology/cancer, Medical device |
| 2012 |
Intramural |
BROWN, RONALD |
CDRH |
Sex differences in kidney biomarker response following exposure to an orthopedic alloy: Implications for the safety assessment of metal-on-metal hip implants |
Toxicology, Medical device, Biomarkers |
| 2012 |
Intramural |
FANG, LANYAN |
CDER |
Sex Disparities in Autoimmune Treatment Response |
Autoimmune |
| 2012 |
Intramural |
GOERING, PETER |
CDRH |
Safety and Efficacy of Iron Oxide Nanoparticles Used as MRI Contrast Agents for Breast Cancer Imaging |
Oncology/cancer, Medical device |
| 2012 |
Intramural |
LIACHENKO, SERGUEI |
NCTR |
Gender differences in neuronal reward circuit activation by nicotine and tobacco smoke using magnetic resonance spectroscopy |
Neurology |
| 2012 |
Intramural |
LUO, ZHONGJUN |
CFSAN |
Exploring Potential Safety Issues of PPIs on Osteoporosis in Elderly Women Using the PPI Legacy Database |
Pharmaceuticals, Musculoskeletal |
| 2012 |
Intramural |
MORRISON, TINA |
CDRH |
Abdominal Aortic Aneurysms: analysis of patient Characteristics and Anatomy Related to EVAR treatment and outcomes- AAA CARE |
Cardiovascular, Medical device |
| 2012 |
Intramural |
MYERS, MEAGAN |
NCTR |
Quantitative oncomutation profile of triple negative breast cancer |
Oncology/cancer, Gene expression |
| 2012 |
Intramural |
NALLANI, SRIKANTH |
CDER |
Applications of Clinical Pharmacology Principles in Pharmacotherapy of Diseases in Pregnancy |
Obstetrics/Gynecology, Pharmacology |
| 2012 |
Intramural |
OVANESOV, MIKHAIL |
CBER |
Improving safety of blood products administered during pregnancy |
Hematologic, Obstetrics/Gynecology, Immunology |
| 2012 |
Intramural |
PAREPALLY, JAGAN MOHAN |
CDER |
Gender effect on PK/PD of hypnotic drug: Driving impairment and dosing recommendations |
Neurology, Pharmacology, Pharmaceuticals |
| 2012 |
Intramural |
RAGHEB, JACK |
CDER |
A Mechanistic Study of the Capacity of Silicone to Present (Self) Antigens to the Immune System |
Autoimmune, Medical device |
| 2012 |
Intramural |
SHI, QIANG |
NCTR |
Identifying drugs that cause women-biased hepatotoxicity by reviewing FDA drug approcal packages/labels and FDA maintained databases and conducting comparitive studies in primary hepatocytes of rats, mice, and humans |
Hepatic, Pharmaceuticals |
| 2012 |
Intramural |
STRAUSS, DAVID |
CDRH |
Novel Electrocardiographic Biomarkers to Assess Cardiac Safety of Investigational Drugs |
Cardiovascular, Biomarkers |
| 2012 |
Intramural |
STRAUSS, DAVID |
CDRH |
Gender-Specific Predictors of Heart Failure Hospitalization and Death in Cardiac Resynchronization Therapy |
Cardiovascular, Medical device |
| 2012 |
Intramural |
WU, WEN JIN |
CDER |
Investigating the molecular mechanisms of trastuzumab-induced cardiotoxicity and explore the cardioprotective role of antioxidants in the trastuzumab-mediated cardiac dysfunction |
Oncology/cancer, Toxicology |
| 2012 |
Intramural |
XIE, HANG |
CBER |
Development of a mouse model to mimic the response of female and pregnant human subjects to avian influenza infections and to evaluate the protective efficacy of pandemic H5N1 vaccines against highly pathogenic avian influenza |
Infectious disease, Obstetrics/Gynecology, Immunology |
| 2012 |
Intramural |
YELLELA, SRI RAMA KRISHNAIAH |
CDER |
Quantification of drug retained in the skin after removal of estradiol transdermal drug delivery systems used in hormone replacement therapy |
Obstetrics/Gynecology, Medical device, Pharmaceuticals, Dermatology |
| 2012 |
Intramural |
YU, CHONGWOO |
CDER |
Investigation of Drug-Drug Interactions with Hormonal Contraceptives |
Obstetrics/Gynecology, Pharmacology |
