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U.S. Department of Health and Human Services

Science & Research

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List of Research Science Program Awards - by Therapeutic Categories

 

Since 1994, the FDA Office of Women's Health has funded approximately 290 studies in the following areas:

Autoimmune Diseases, Bioinformatics, Breast Implants, Breast Cancer/Mammography, Cancer, Cardiovascular Diseases, Cosmetic, Device Safety, Diet/Obesity, Dietary Supplement, Feminine Hygiene, HIV/STD, Hormone, Infant Feeding, Osteoporosis, Pregnancy, Sex Differences, Women in Clinical Trials, Other

 

Autoimmune Diseases

Clinical and Biological Significance of Three Identified Targets in Systemic Lupus Erythematosus Patient PBMCs: IL-18, TNFSF13B, and FOXP3 - Beverly Lyn-Cook, PhD, NCTR (13) 

Use of innate immune response modulators in women: The perfect storm to trigger autoimmune disease?
 - Daniela Verthelyi, MD, PhD, CDER (13)

Sex Disparities in Autoimmune Treatment Response - Lanyan Fang, PhD, CDER (12)

A Mechanistic Study of the Capacity of Silicone to Present (Self) Antigens to the Immune System - Jack Ragheb, PhD, CDER (12)

Lupus Workshop – Shashi Amur, Special funding/CDER (11)

Sex and ethnic differences in expression of Toll-like receptors (TLR-3, TLR-7, and TLR-9) in systemic lupus erythematous (SLE): new targets for emerging therapeutics – Beverly Lyn-Cook, PhD, NCTR (11)

The Role of Vaccine Adjuvant Mediated TACI Upregulation in SLE - Mustafa Akkoyunlu, PhD, CBER (08)

Gender, Ethnicity and Pharmacogenomics in Systemic Lupus Erythematosus (SLE) - Shashi Amur, PhD, CDER (07)

Sex differences in Systemic Lupus Erythematosus (SLE):  Effects of a single nucleotide polymorphism (SNP) in the prolactin (PRL) gene on individual response to prasterone therapy - Neera Gopee, PhD, NCTR (07)

Evaluation of the Tk knockout (TkKO) mouse as a model of systemic lupus erythematosus - Vasily Dobrovolsky, PhD, NCTR (00)

Postmarketing drug risk assessment using the ARAMIS database in RA patients – Mary Willy, PhD, CDER (99)

A novel approach to the treatment of lupus nephritis - Dennis Klinman, MD, PhD, CBER (96)

Cytokine induced activation of the Jak kinase/STAT transcription factor pathway in immune cells (monocytes and lymphocytes) of patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) - David S. Finbloom, MD, CBER (95)

Hormonal regulation of cytokine producing cells in women with systemic lupus erythematosus - Dennis Klinman, MD, PhD, CBER (95)

 

Bioinformatics/ Data mining/ Safety

Population-Based Computational Framework for Assessing Xenobiotic Disposition and Interaction Effects in Pregnant Women-Pilot Study - Annie Lumen, PhD, NCTR (13) 
 

Continuation of a pilot study on performing sex analysis on a vaccine database – Jingyee Kou, PhD, Special funding/CBER (11)

A pilot study on performing sex analysis on a vaccine database – Jingyee Kou, PhD, Special funding/CBER (10)

Development of an FDA resource for sex difference-related pharmacogenomics data review-Phase II - Weida Tong, PhD, NCTR (09)

Detection and Confirmation of Gender Related Safety Signals Using the Electronic Healthcare Data from the Department of Defense - Ana Szarfman, MD PhD, CDER (08)

Development of a FDA Resource for Improved Efficiency of Sex Difference Related Pharmacogenomic Data Analysis and review - Weida Tong, PhD, NCTR (07)

Adverse Events Reporting System (AERS):  Risk assessment, compliance, and management - Ralph Lillie, RPh, CDER, (98)

Data mining techniques for identifying potential serious drug interactions in women - Ana Szarfman, MD PhD, CDER (98)

Visualization tools for studying gender differences - Ana Szarfman, MD PhD, CDER (97)

 

Breast Implants

MRI Safety Testing of Breast Tissue Expanders used in Mastectomy Patients - Sunder Rajan, PhD, CDRH (13)

MRI and Ultrasound imaging of silicone filled breast implants – Rajan Sunder, PhD, CDRH (11)

Abrasion testing of breast implants - Patricia Dubill, PhD, CDRH (98)

Protocol for a study of breast implant rupture - S. Lori Brown, MD, CDRH (97)

A study of safety of silicone breast implants - IOM study, Institute of Medicine/S. Lori Brown, MD, CDRH (97)

Development of a safe, economical assay for silicone containment in blood and tissue - Marwood N. Ediger, PhD, CDRH (96)

Mechanism of immunotoxicity and carcinogenicity associated with silicone breast implants - S. Jill James, PhD, NCTR (95)

Noninvasive assessment of silicone migration from gel-filled breast implants - Kyle Myers, PhD, CDRH (95)

Silicone Gel Alternatives Workshop - John Langone, PhD, CDRH (94)

Immunogenetic risk factors for silicone-associated multiple myeloma and monoclonal gammopathy of undetermined significance - Frederick Miller, MD, PhD, CBER (94,98)

 

Breast Cancer/Mammography

 

Phantom-based evaluation of photoacoustic imaging systems for breast tumor vasculature quantification - Brian Garra, MD, CDRH (14)

Calcium and material characterization in women using dual-energy computed tomography - Nicholas Petrick, PhD, CDRH (14)

Incremental Values of Sequential Procedures for Diagnosing Breast Cancer - Zhiwei Zhang, PhD, CDRH (13)

Safety and Efficacy of Iron Oxide Nanoparticles Used as MRI Contrast Agents for Breast Cancer Imaging - Peter Goering, PhD, CDRH (12)

Quantitative oncomutation profile of triple negative breast cancer - Meagan Myers, PhD, NCTR (12)

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 - Andreu Badal-Soler, PhD, CDRH (12)

Development of a targeted microRNA-based epigenetic therapeutic approach for breast cancer treatment – Igor Pogribny, PhD, NCTR (11)

Integrated analysis of single nucleotide polymorphism and copy number variation in genome association of breast cancer - Ching-Wei Chang, PhD, NCTR(11)

Evaluating radiation risks and benefits of breast CT for diagnosing breast cancer – Robert Jennings, PhD, CDRH (11)

Reproducibility in the quantitative assessment of multiple tissue-based biomarkers for breast cancer using light and digital microscopy – Nicholas Petrick, PhD, CDRH (11) 

Safety and efficacy of biomarkers using gene expression data for breast cancer patient treatment and care - Subok Park, PhD, CDRH (10)

Dose and image quality optimizations in various full-field digital mammography systems - Kish Chakrabarti, PhD, CDRH (10)

Development of standard color management methods for assessment of immunohistochemical HER2 expression in breast cancer using digital microscopy, Aldo Badano, PhD, CDRH (10)

Inactivation of UDP-Glucuronosyltransferases (UGTs) in human breast tissues: Accessing cancer risk, tamoxifen safety and toxicity - Athena Starlard-Davenport, PhD, NCTR (09)

Women’s radiation dose and excess cancer risk associated with x-ray computed tomography scans: quantification and risk-mitigation strategies, Iacovos S. Kyprianou, Ph.D., CDRH (09)

Development of a tissue-mimicking physical phantom and quantitative, assessment tools for standardizations, optimization, and NSF risk reduction in dynamic contrast-enhanced MRI of the breast, Aldo Badano, Ph.D., CDRH (09)

Effects of Proposed Revisions to the Regulations Implementing the Mammography Quality Standards Act - Steven Tucker, OC (08)

Dose and Image Quality in Full Field mammography - Kish Chakrabarti, PhD, CDRH (08)

Qualifying Imaging Biomarkers to Monitor Neoadjuvant Chemotherapy in Breast Cancer Patients to Identify Responders Using Positron Emission Tomography (PET), Christy John, PhD, CDER (08)

Patient Safety and Imaging Performance of Three-Dimensional (3D) X-Rays Systems for Detection of Breast Cancer - Subok Park, PhD, CDRH (08)

Implications of Gender-based Differences in Cardiovascular Disease on Imaging for Treatment and Diagnosis - Iacovos Kyprianou, PhD, CDRH (05)

Discovery and evaluation of interspecies biomarkers to identify and characterize the cardiotoxic effects of Transtuzumab (Herceptin), a novel antibody used in the treatment of breast cancer - Eugene Herman, PhD, CDER (01)

Improve the efficacy of chemotherapeutic drugs for the treatment of breast cancer - Emily Shacter, PhD, CBER (98)

Mammography breast cancer screening rates among disadvantaged women within a prepaid health care system - Rosalie Bright, ScD, CDRH (97)

Optimization of mammography - Robert Jennings, PhD, CDRH (97)

IP-10: A potential new therapeutic for breast cancer - Giovanna Tosato, MD, CBER (96)

DNA adducts of tamoxifen - Frederick A. Beland, PhD, NCTR (96, 99)

Mammography quality standards act facilities workshop - Barbara Ward-Groves, MPH, ORA (95)

Development of Mammography Quality Standards Act (MQSA) Speaker Kits - Carol Sierka, CDRH (94)

 

Cancer

Nuclear Uptake of Transcription Co-Activator JTV1 Induces p53-Meadiated Apoptosis of Ovarian Cancer (OC) Cells – Implications for the Development of New Ovarian  Cancer Biomarkers and Therapeutic Targets – Liu Juhong, PhD, CDER (11)

Genotyping of  Transporter Genes Associated with Gender Differences and Promoter Methylation Profile of UGT1A1 in Human Liver: A Mean of Assessing Safety and Toxicity of Chemotherapeutic Drugs - Beverly Lyn-Cook, PhD, NCTR (08)

Sex differences in chemotherapeutic toxicity: profiling of transporter genes in human - Beverly Lyn-Cook, PhD, NCTR (06)
 

Quantitative Tumor Size- Survival relationship in Oncology clinical trials - Jogarao Gobburu, PhD, CDER (06)

Improving the evaluation of ovarian cancer treatment - Vance Berger, PhD, CBER (99)

In Vitro Prediction of Time to Neutropenic Nadir: Anti-neoplastic Alkylating Agents as Prototype Drugs, Donna A. Volpe, Ph.D., CDER (96)

Development of a Safe, Economical Assay for Silicone Containment in Blood and Tissue, Marwood N. Ediger, Ph.D., CDRH (96)

The Transfer of Defense, Intelligence and Space Technologies for the Early Detection and Control of Cancers in Women (conference), Melvyn Greberman, M.D., MPH, CDRH (96)

 

Cardiovascular Diseases

 

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 - Li Pang, MD, NCTR (14)

 Blood pressure threshold for cardiovascular disease risk: an assessment of sex-based criterion - Ching Wei Chang, PhD, NCTR (14)

 Novel therapeutic approaches to prevent drug-induced torsade de pointes - Norman Stockbridge, MD, PhD, CDER (14)

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 - Wen Jin Wu, MD, PhD, CDER (14)

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” – David Strauss, MD, PhD, Special Funding/CDRH (13)

Gender-Specific Predictors of Heart Failure Hospitalization and Death in Cardiac Resynchronization Therapy - David Strauss, MD, PhD, CDRH (12)

Novel Electrocardiographic Device Algorithms to Assess Cardiac Safety of Investigational Drugs - David Strauss, MD, PhD, CDRH (12)

Investigate the mechanisms of trastuzumab-induced cardiotoxicity and cardiotoxicity and cardio protective role of antioxidants in trastuzumab-mediated cardiac dysfunction - Wen Jin Wu, MD, PhD, CDER (12)

Abdominal Aortic Aneurysms: analysis of patient Characteristics and Anatomy Related to EVAR treatment and outcomes- AAA CARE - Tina Morrison, PhD, CDRH (12)

Sex-Specific Left Bundle Branch Block Criteria and ECG Scar Quantification to Predict Benefit from Cardiac Resynchronization Therapy (CRT) – David Strauss, MD, Special funding/CDRH (11)

Addressing the unmet medical needs for cardioproctection in women receiving chemotherapy – Rao, Ashutosh, CDER (11)

Preclinical Test Methods for Percutaneously Implanted Heart Valves: Effect of Non-Circular Valve Configuration After Implantation On Valve Leaflet Dynamics – Terry Woods, NCTR (11)

Genetic and epigenetic mechanisms for sex differences in the kidney of a rat model system: developing safety biomarkers for FDA regulated products – James Fuscoe, PhD, NCTR (11)

Atrial Fibrillation Ablation Registry Study  (SAFARI) - Ellen Pinnow, MPH, CDRH (10)

Assessment of outcomes and bleeding complications following implantation of drug eluting stents (DES) and dual anti-platelet therapy (DAPT) - Hesha Duggirala, Ph.D, CDRH (10)

The swan-ganz balloon flotation pulmonary artery catheter: possible racial and sex discrepancies - Daniel Canos, Ph.D,, CDRH (10)

Sex- and age- related differences in baseline QT, QT prolongation, and TdP risk - Christine Garnett, PharmD, CDER (10)

Risk of Adverse Events Following Cardiac Catheterization by Hemostasis Device Use – Phase III - Dale Tavris, MD, MPH, CDRH (10)

Analysis of sex-differences in cardiac resynchronization therapy devices: inclusion, adverse events, and outcomes - Kathryn O'Callaghan, CDRH (09)

Workshop: Guidance for the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Devices - Kathryn O’Callaghan, CDRH (08)

Gender-Related Differences in QT Effects and Torsade de Pointes Potential of Drugs - Christine Garnett, PharmD/ Phillip Dinh, PhD, CDER (08)

Factors Accelerating the Progression of Heart Failure (HF) in Women: Implications for Drug Interactions with Medical Devices - Soma Kalb, PhD, CDRH (07)

Drug Eluting Stent (DES)/Thrombosis - Bram Zukerman;  Norman Stockbridge, Duke Clinical Research Institute (07)

Real-World Outcomes of Drug-Eluting Stents - Art Sedrakyan, MD, PhD, CDRH/AHRQ (07)

The Impact of Sex-Based Differences in Atherosclerotic Plaque on the Response to Drug Eluting Stent Implantation - Dinesh Patwardhan, PhD, CDRH (07)

ECG Warehouse - Mortara Instruments Inc., Justin Mortara, PhD, Mortara Instruments Inc., (06)

ECG Warehouse - Duke Clinical Research Institute and Duke University - Christopher Cabell, M.D., MHS, Duke Clinical Research Institute (DCRI) (06)

Assessment of the Accuracy of the Troponin Assay and the Diagnosis of Myocardial Infarction by Gender - Azadeh Shoaibi, PhD/ Dale Tavris, MD, MPh, CDRH (05)

Systems Biology Approach to Evaluate Sex Differences in Heart of a Rat Model - James C. Fuscoe, Ph.D., NCTR (05)

Use and Outcomes of Coronary Stents in Women: Use of a National Medicare Database - Karen Freund, MD, Boston Univ (05)

Transmission Attenuation Correction for Female Patients Undergoing Myocardial Perfusion Imaging: Correction for Confounding Breast Tissue Artifact - Michelle Dew, MD, Univ. of Arizona, (04)

Pilot Study:  Combined Beta1 Arg 389 and Alpha 2c Del 322-325 Adrenergic Receptor Polymorphisms and Heart Failure with Preserved Left Ventricular Ejection Fraction in African American Women - Thierry LeJemtel, MD, Tulane Univ (04)

Are Women at Higher risk from Proarrhythmic Drugs? - Jogarao Gobburu, PhD, CDER (03)

Discovery and Evaluation of Interspecies Biomarkers to Monitor the Early Onset and the Progression of Cardiovascular Toxicity Associated with Thiazolidinedione Compounds Used in the Treatment of Type 2 Diabetes - Eugene Herman, PhD, CDER (03)

Cardiovascular Effects Of Ultrasound Contrast Agents in Intact and Ovariectomized Female Animals - Melvin Stratmeyer, PhD, CDRH (03)

Project Title:  Electrophysiological Characterization of Several Torsadogenic Drugs in Isolated Rabbit Hearts - John Koerner, PhD, CDER (03)

Incidence and attributable risk of serious adverse events and death associated with the use of homeostasis devices by gender - Dale Tavris, MD, MPH, CDRH (02)

Women's participation in clinical drug trials for unstable angina and myocardial infarction - Ann Farrell, MD, CDER (00)

Flow studies and the use of a waveguide in cardiovascular devices - Harvey Rudolf, PhD, CDRH (98)

Ovarian steroids and cardiovascular disease: The role of gender in the effectiveness of interventional medical devices - James Karanian, PhD, CDRH (98)

Variations in the drug-induced QT interval prolongation during the menstrual cycle - Ana Szarfman, MD, PhD, Raymond L. Woosley, MD, PhD, CDER (co-funded by NIH ORWH, 98)

A comparison of gender specific utilization of implantable cardioverter defibrillator therapy and post-implantation survivability - Steven Lascher, DVM, MPH, CDRH (97)

Administration of thrombolytic therapy to women with acute myocardial infarction. Is it too late? - Emily B. Shacter, PhD, CBER (96)

Gender differences in early and long-term results of coronary angioplasty with the Palmaz/Schatz stent - Danica Marinac-Dabic, MD, CDRH (95, 96, 97)

Comparison of the beta-adrenergic antagonist actions of propranolol in men and women - David Flockhart, MD, PhD, CDER (94)

Comparison of the potassium channel blocking actions of quinidine in men and women - Raymond L. Woosley, MD, PhD, CDER (94)

Terfenadine/Oral contraceptive study - Lou Cantillina, MD, CDER (94)

 

Cosmetics/ Skin

Effect of Injection Techniques, Materials Chemistry and Physical Properties of Dermal Fillers on Potential for Bacterial Colonization and Infection - Kenneth Phillips. PhD, CDRH (13)

Risk Assessment of Human Skin Microflora Metabolism of Synthetic Azo Colorants used in Women’s Cosmetics - Huizhong Chen, PhD, NCTR (08)

Optimization of UV exposure patterns:  Maximizing perceived benefits while minimizing photocarcinogenic and photoaging effects, Sharon Miller, MS, CDRH (01)

Latex allergy genomics study:  Developing a diagnostic gene expression microarray for Type 1 latex allergy using transcriptome profiling - Rosalie Elespuru, PhD, CDRH (01)

Birth defect potential of cosmetic products containing retinol (vitamin A) and retinyl palmitate - Jeffrey Yourick, PhD, CFSAN (00)

Evaluation of the Tg.Ac transgenic mouse as a model for predicting the photocarcinogenicity of pharmaceuticals and cosmeceuticals - Ronald Honchel, PhD, CDER (99)

Potential Exposure of Women to Estrogens, Phytoestrogens and Xenoestrogens through Cosmetic Products, Robert Bronaugh, PhD, CFSAN (99)

Cosmetics Initiatives Alpha Hydroxy Acids (AHAs), John E. Bailey, Ph.D., CFSAN (94)

AHA Literature Search, John E. Bailey, PhD, CFSAN (94)
                                                                               

Device Safety

Follicle-stimulating hormone (FSH) may exacerbate local and systemic effects of wear particles released from metal-on-metal hip implants: Implications for women - Steven C. Wood, PhD, CDRH (14)

Mechanical causes of higher hip implant failure rates in women - James Coburn, MS, CDRH (13)

Photo-Thermal Safety in Laser-based Devices for Detection and Treatment of Breast Cancer: Effect of Endogenous Absorbers and Gold Nano-Particles - Do-Hyun Kim, PhD, CDRH (13)

TREAT Registry: Women's Health Safe PCI Study: Bleeding Risk and Transradial Catheterization - Bram Zuckerman, MD, Katie O’Callaghan, Special funding/CDRH (11)

Sex-based differences in the molecular mechanisms of polymer degradation in drug eluting stents (DES) -  Rallabhandi, Prasad, PhD, CDRH (11)

Evaluation of safety and effectiveness of mesh implantation in surgical interventions for the treatment of pelvic floor disorders, Phase III – Cara Krulewitch, CNM, PhD, CDRH (11)

Evaluation of Safety and Effectiveness of Mesh Implantation in Surgical Interventions for the Treatment of Pelvic Floor Disorders, PHASE II and PHASE III - Cara Krulewitch, CNM, PhD, CDRH (10)

Sex-based differences in the safety of drug-eluting stents containing bioresorbable materials - Dinesh Patwardhan, PhD, CDRH (09)

Quality of life and significant symptoms after LASIK - Malvina Eydelman, MD, CDRH (09)

The Safety and Effectiveness of Surgical Mesh Implant Use in Uro-Gynecologic Surgery for Soft Tissue Augmentation - Cara Krulewitch, CNM, PhD, CDRH (08)

Gender Differential in National Estimates for Medical Device-Associated Adverse Events (MDAEs) from Emergency Departments - Cunlin Wang, MD, PhD, CDRH (08)

Active postmarketing surveillance methods:  hospital pilot - Roselie Bright, ScD, CDRH (99)

Epidemiology of medical devices in women - Danica Marinac-Dabic, MD, CDRH (97)

 

Diet/Obesity

Review of herbal weight loss product experiences and adverse events - Sara Warber, MD, Univ. of Michigan (00)

Breast cancer in African-American women:  Metabolic modification of dietary and hormonal risk factors - Christine Ambrosone, PhD, NCTR (97)

Obesity:  Its effect on antioxicant and estrogen metabolism - Shirley Blakely, PhD, CFSAN (97)

 

Dietary Supplement/Safety

 

Detection of synthetic drugs as adulterants in natural and herbal slimming products by UPLC-mass spectrometry - Phyllis Wilson, PhD, ORA (14)

Effects of phytoestrogens on gene expression responses of vaginal epithelial cells after contact with candida albicans - R. Doug Wagner, PhD, NCTR (10)

Computational human health effects study to assess the safety of botanical extracts widely used by women in the United States for treatment of menopausal symptoms - Luis Valerio, PhD, CDER (09)

Understanding Consumer Behavior Associated with Changing Messages on Listeria monocytogenes and Food Safety - Elizabeth Calvey, PhD/ Marjorie Davidson, PhD, CFSAN (07)

Phytoestrogens: Drug interaction potential in women - Gail Anderson, PhD, Univ. of Washington (00)

Use and interaction of dietary supplements in the SEA Trial - Mara Vitolins, DrPH, Wake Forest Univ. (00)

The effects of St Johns Wort on the efficacy of oral contraception - Stephen Hall, PhD, Indiana University (00)

Effects of dietary soy and calcium supplementation on lipid levels, brachial artery function, biochemcial markers of bone turnover, inflammatory markers of atherosclerosis and menopuasal symptioms in postmenopausal women - Francine Welty, MD PhD, Beth Israel Deaconess Medical Center and Harvard Univ. (00)

Pattern of botanical dietary supplement usage in menopausal women - Gail Mahady, PhD, Univ. of Illinois at Chicago (00)

Contaminants in dietary supplements frequently used in women - Nancy Slifman, MD, MPH, CFSAN (98)

Vitamin K status of non-Hispanic balck and white girls and young adult women:  direct measure of serum phylloquinone levels and measurement of a new functional endpoint in serum samples from NHANES II - Mona Calvo, PhD, CFSAN (97)

Women's Health Information Line, Ruth Welch, MS, CFSAN (96)

CFSAN's Women's Health Internet Initiative: Phase II, Kenneth T. Durham, CFSAN (96)

CFSAN's Women's Health Internet Initiative - Phase I, Kenneth T. Durham, CFSAN (95)

 

Feminine Hygiene

Evaluation of methods used to measure growth of staphylococcus aureus and the production of toxic shock syndrome toxin-1 as influenced by menstrual tampons - Mark E. Hart, PhD, NCTR (14)

Nanoparticle Effects on Induction of Pro-inflammatory Responses to Candida albicans by Cultured Vaginal Epithelial Cells - Robert Wagner, PhD, NCTR (13)

Detection of Nanoscale Materials in Products Targeted to Women: Feminine Hygiene Products and Dietary Supplements - Linder Sean, PhD, ORA (11)

Application of co-culture and simulated vaginal models to elucidate the inhibitory properties of naturally occurring and bioengineered strains of lactobacillus toward toxic shock syndrome toxin-1 producing strains of staphylococcus aureus - Mark Hart, PhD, NCTR (09)

Development of a Rapid Version of the Tampon Test Method Based on 21CFR801.430 - Lesley Kerr, ORA (07)

Protective effect of vaginal Lactobacillus species against Staphylococcus Aureus-mediated toxic shock syndrome - Christopher Elkins, PhD, NCTR (06)

Analysis of Dioxins/Furnas Levels in Tampons - Jeff Archer, PhD, ORA (00)

Vaginal volume: optimizing vaginal deployment of topical microbicides - Debra Birnkrant, MD, CDER (00)

 

HIV/ Sexually Transmitted Disease

Evaluation of HSV-2 co-infection and hormonal contraceptive use on HIV acquisition and pathogenesis using patient-derived clinical specimens - Indira Hewlett, PhD, CBER (13)
 

Women in HIV trials: a comprehensive review and meta-analysis for safety - Guoxing Soon, PhD, CDER (10)

In vitro studies to assess impact of gender and co-infection with Herpes Simplex virus type 2 on the replication and transmissibility of major emerging HIV-1 variants - Indira Hewlett, PhD, CBER (09)

Effects of B-Estradiol, on the Safety of Anti-HIV Drugs - Andrew Dayton, PhD, CBER (08)

Evaluation of gender differences in detection, replication and transmissibility of emerging HIV-1 Variants - Indira Hewlett, PhD, CBER (07)

Molecular mechanisms underlying gender-associated differences in the adverse reactions to the anti-retroviral agent, zidovudine (AZT): Role of mitochondrial toxicity - Varsha Desai, PhD, NCTR (06)

HIV SELECTEST: A novel assay for diagnosis of HIV infections in the presence of antibodies induced by candidate HIV vaccines: Evaluation of gender bias in sensitivity and specificity - Hana Golding, Ph.D.  and Surender Khurana, Ph.D, CBER (06)

Sex difference dependent drug-drug interactions of anti-HIV therapeutics - Hyojong Kwon, PhD, CDER (05)

Gender Dimorphism in HIV Infection in Primary Macrophages and T-Lymphocytes: Kinetics of HIV Replication and Efficacy of Antiretroviral Agents - Andrew Dayton, PhD, CBER (04)

Thymic regeneration and immune reconstitution:  Development of animal models to study the role of cytokines and hormonal contributions - Hana Golding, PhD, CBER (01)

Vaginal volume: optimizing vaginal deployment of topical microbicides-- Debra Birnkrant, MD, CDER (00)

Effect of reproductive hormones on the pathogenesis and host cell interactions of Neisseria gonorrhoeae - Carolyn Deal, PhD, CBER (99) 
                                                                                                                                                                                                                                         
Antigenic characteristics and immunogenicity of synthetic peptide vaccines for the pathogenic Neisseria: Neisseria meningitides and Neisseria gonorrhea - Margaret Bash, MD, MPH, CBER (97, 98, 99)

The role of HIV-1 co-receptors in sexual and mother-to-infant transmission - Hana Golding, PhD, CBER (97, 98)

A computer model for simulating virus transport through barriers - Matthew R. Myers, PhD, CDRH (96)

Human cytotoxic T lymphocyte recognition of Papilloma virus - Penelope Robbins, PhD, CBER (96)

Induction of mucosal immunity to protect females from HIV-1 - Basil Golding, MD, CBER (95)

Development of a method to evaluate the effect of vaccines and antiviral therapy on latent viral burden in an animal model of genital herpes - Philip R. Krause, MD, CBER (95)

Conference on STD clinical trials workshop - NIH/OEA (94)

Prevention of sexual transmission of HIV- Michael Norcross, MD, CBER (94)

 

Hormone/ Endocrine Disruptors

Investigation of Drug-Drug Interactions with Hormonal Contraceptives - Chongwoo Yu, PhD, CDER (12)

Quantification of drug retained in the skin after removal of estradiol transdermal drug delivery systems used in hormone replacement therapy - Sri Rama Krishnaiah Yellela, PhD, CDER (12)

An investigation of sexual dysfunction in depressive trials – Peiling Yang, PhD, CDER (11)

Effects of body mass index (BMI)/body weight (BW) on effectiveness of hormonal contraceptive products for women – Chongwoo Yu, PhD, CDER (11)

The Role of Estrogen in Controlling Hepatitis C Virus Replication – Deborah Taylor, CBER (11)

Quantum mechanical and NMR spectral approaches for the rapid prediction of estrogen activity of FDA regulated chemicals - Jon Wilkes, PhD, NCTR (10)

Genome wide methylation arrays for detecting markers of increased susceptibility to mammary cancer caused by in utero exposures to endocrine disruptors - Cecilia Aguila, DVM, CVM (09)

The role of estrogen in enhancing innate immunity during viral infection - Deborah Taylor, PhD, CBER (09)

Gene Expression Responses of Estrogen-Primed Vaginal Epithelial Cells After Contact With Candida albicans and Probiotic Lactobacilli - R. Doug Wagner, PhD, NCTR (08)

Evaluation of Inflammation and Sex Hormones as Biological Factors that May Contribute to Gender Differences in Susceptibility to Chemical-Induced Liver Injury – Studies Using Human Liver Cells in Culture - Thomas Flynn, PhD, CFSAN (08)

Evaluating the Effects of Over-the-Counter Skin Products, such as Sunscreen, on the Absorption of Dermally Applied Estradiol, in an In- Vitro and an In-Vivo Model - Nakissa Sadrieh, PhD, CDER (08)

Development and Validation of an HPLC method for the Simultaneous Determination of Estradiol, Estriol, Estrone and Progesterone in Pharmaceutical Preparations - Phyllis Wilson, ORA (07)

The Role of Estrogen in Enhancing Innate Immunity During Viral Infection - Deborah Taylor, PhD, CBER (07)

Modulating effects of estrogen in food allergen induced lung inflammation in a highly sensitive rat model for postmenopausal women(Do Phytoestrogens Modify Asthmatic Response to Food Allergens in  Newly Validated, highly sensitive, in-bred asthmatic rat mouse - Mona Calvo, PhD, Maria Lorenzo, DVM, CFSAN (04)

Gender Based Differences in the Vascular Response to Anthrax Toxin: Investigation of the Role of Hormones in an In Vitro Human Endothelial Cell Culture System - Felice D'Agnillo, PhD, CBER (04)

Effect of Sex Hormones on the Immune response of CpG ODN - Daniela Verthelyi, PhD, CBER (02)

Evaluation of the effects of daidzein and genistein (hormone replacement agents) on the genotoxic and carcinogenic activity of the model mammary carcinogen 7,12-dimethylbenz(a)anthracene (DMBA) in ovarectomized transgenic Big Blue rats - Anane Aidoo, PhD, NCTR (00)

Chemical characteristis of conjugated estrogens - Thomas Layloff, PhD, CDER (98)

In-vivo modeling of steroid-mediated gender effects in drug metabolism, Phase I and II - Patricia Thompson, PhD, NCTR (98)

Contribution of estrogen components to the efficacy of conjugated estrogens-preliminary analytical chemistry - John Strong, PhD, Mei-Ling Chen, PhD, CDER (97)

Development of in vitro human cell culture systems to screen compounds suspected to have estrogenic or anti-estrogen activity - William Tolleson, PhD, NCTR (97)

Experimental assessment of environmental estrogens - Dan Sheehan, PhD, NCTR (96)

Development of an estrogen knowledge base for research and regulation - Darnell Carlton Jackson, PhD, NCTR (96)

Hormone replacement therapy in women with a previous diagnosis of endometrial cancer - Bruce  V. Stadel, MD, MPH, CDER (95)

Mechanism of tamoxifen development toxicity and neoplasia:  Tamoxifen effects on the rat uterine insulin like growth factor system, Randal Streck, PhD/ Dan Sheehan, PhD, NCTR (95)

A novel molecular approach to risk assessment of hormonally active compounds, John Leighton, PhD, CVM (95)

Estimation of reproductive toxicity of pharmaceuticals using QSAR software programs, Edwin Matthews, PhD, CDER (95)

Effects of toremifene and ICI 182,780 on rat uterine growth and differentiation, Dan Sheehan, PhD, NCTR (94)

 

Infant Feeding

Ciprofloxacin and Doxycycline in lactating women and in the elderly - Raymond Galinsky, PharmD, Indiana School of Medicine (02)

Development of a general approach for the investigation of drug transfer in breast milk:  In vitro assessment of drug distribution into breast milk - Patrick McNamara PhD/ Gerald Fetterly, PhD, CDER (01)

Infant Feeding Practices Study - Sara Fein, PhD, CFSAN (94)

 

Osteoporosis and Bone Health

 

Disease systems analysis: towards a generic framework for characterizing disease progression and treatment effects in osteoporosis - Li Li, PhD, CDER (14)

Exploring Potential Safety Issues of PPIs on Osteoporosis in Elderly Women Using the PPI Legacy Database - Zhongjun Luo, MD, PhD, CDER (12)

Assessment of Risk Factors Associated with Exposure to Proton Pump inhibitors and Fracture and CV outcomes in post-menopausal osteoporosis women - Antonio Paredes, PhD, CDER (10)

Do vertebroplasty procedures increase the risk of adjacent level vertebral fractures in osteoporotic women - Srinidhi Nagaraja, PhD, CDRH (09)

Development and Guidelines for Evaluating the Appropriateness of Vertebroplasty Surgery for Patients with Osteoporosis - Jove Graham, PhD, CDRH (04)

A study to evaluate the consistency of T-scores among ultrasound bone measurement devices and the usefulness of these devices for monitoring bone status - Richard Kotz, PhD, CDRH (00)

Development and validation of ultrasonic backscatter measurement for bone density assessment - Keith Wear, PhD, CDRH (98)

Application of ultrasonic tissue characterization to diagnosis of bone disease, Keith Wear, PhD, CDRH (95)

Osteoporosis Prevention in Adolescent Girls, Ruth Welch, MS, RD and Carole Schiffman, CFSAN (95)

 

Pregnancy/ Prevention/ Exposure

 

Bayesian assessment of safety profiles for pregnant women-From animal study to human clinical trial - Judy X. Li, PhD, CBER (14)

Evaluation of pharmacokinetics of thrombogenic impurity following different routes of immune globulin administration during pregnancy - Mikhail Ovanesov, PhD, CBER (14)

Assessing Passive Prophylaxis of Infection at Different Stages during Gestation in a Pregnant Animal Model
 - Evi Struble, PhD, CBER (13)

Applications of Clinical Pharmacology Principles in Pharcotherapy of Diseases in Pregnancy - Srikanth Nallani, Ph.D CDER (12)

Improving safety of blood products administered during pregnancy - Mikhail Ovanesov, PhD, CBER (12)

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 - Zhiping Ye, PhD / Xie Hang, PhD, CBER (12)
 

A Comparitive Analysis of Adverse Events Between Conventional Tube Ligation and Transcervical Occlusive Devices of the Fallopian Tube for Female Sterilization: A Cohort Study - Colin Anderson-Smits, MPH, CDRH (12)

MRI in pregnant patients: A systematic analysis of Radio-frequency heating with multi-transmit technology - Leonardo Angelone, PhD, CDRH (12)
 

Prophylaxis of HBV infection with HBIGIV in a pregnant animal model – Pei Zhang, MD, CBER (11)

Treatment of progressive vaccinia in a pregnant immunocompromised mouse model - Dorothy Scott, MD, CBER (10)

An analysis of safety signal detection methods for pregnancy exposure registries - Paul Schuette, PhD, CDER (10)

Applications of clinical pharmacology principles in pharmacotherapy of diseases in pregnancy - Shrikant Nallani, Ph.D, CDER (10)

Ethics roundtable: the ethics of studying drugs and biologics in pregnant women - Karen Feibus, MD, CDER (09)

The Asthma and Allergy Medications in Pregnancy Surveillance System (AAMPSS) Demonstration Project - Sandra Kweder, MD, CDER (08)

Pharmacokinetics and Pharmacodynamics of Selected Antibiotics during Pregnancy - Gloria Sarto, MD, PhD, Univ. of Wisconsin (06)

Research on the Effects of Drug Exposure in Pregnancy - Anne Trontell, MD, MPH, CDER/AHRQ (06)

Drug Use in Pregnancy - Mary Willy, PhD, CDER (06)

Phase I -II Mental Modeling Research of how best to communicate to health care providers about the risks and benefits of prescription drug use for pregnant or Lactating Women with Chronic Conditions - Kara Morgan, PhD, OC (06)

Drug Metabolism in Women - Stephen Hall, PhD, Indiana Univ. (04)

Pharmacokinetics of Atenolol in Lactating Women - Mary Hebert, PharmD, Univ. of Washington (04)

Developmental  Toxicity of Androstenedione in Rats - Robert Sprando, PhD, CFSAN (04)

Assessment of Maternal Effects & Infant Outcomes Using Large Automated Healthcare Data Systems in Women Exposed to Prescription Medications During Pregnancy - William Cooper, MD MPH, Vanderbilt Univ. (03)

Characterization of the effect of androstenedione exposure on female reproductive health, fertility and the development of the F1 generation - Robert Sprando, PhD, CFSAN (02)

Pharmacokinetics and Pharmacodynamics (PK/PD) of Atenolol in Pregnancy - Mary Hebert, PharmD, Univ. of Washington (02)

Labetalol and Hypertension in Pregnancy:  Pharmacokinetics and Pharmacodynamics - James Fischer, PharmD, Univ. of Illinios, Chicago (01)

The PK of Amoxicillin during Pregnancy and Postpartum - Mary Hebert, PharmD, Univ. of Washington (01)

The effects of Echinacea on cytochrome P450 enzymes and oral contraceptives - Stephan Hall, PhD/ Shiew-Mei Huang PhD, CDER (01)

Use of a Unique Animal Model to Study Placental and Milk Transfer of Enrofloxacin from the Dam to the Offspring During the Perinatal Period - Jurgen von Bredow, PhD, CVM (00)

Focus group testing of labing for tampons and barrier contraceptives - Robert Navario/S. Lori Brown, CDRH (99)

Determination of antigenic biomarkers of estrogen catechol metabolism for post-market surveillance of oral contraceptives and hormone replacement therapy - Dean W. Roberts, PhD, NCTR (99)

Teratogen Surveillance - Carolyn McCloskey, MD, CDER (98)

Accelerated aging studies of condoms/condom materials - Harvey Rudolf, PhD, CDRH (98)

Pregnancy Labeling Taskforce: Focus Group testing - Kathryn Aiken, PhD, CDER, (98, co-funded by NIH ORWH)

Development and validation of a universal water leak test method for barrier contraceptives - Leslie Kerr (Neunaber), ORA (98)

Molecular and metabolic determinants of maternal risk and progression of Down Syndrome:  potential for nutritional intervention - S. Jill James, PhD, NCTR (97)

Optimization of mammography - Robert Jennings, PhD, CDRH, (97)

Screening for nervous system dysfunction in offspring of dams exposed to natural food contaminates during pregnancy - Thomas Sobotka, PhD, CFSAN (96)

Contraceptive efficacy table for uniform contraceptive label-a consumer focus group study-Part I and Part II- Paula G. Silberberg, MD, CDRH (95, 96)

The effect of Thalidomide on the pharmacokinetics of ethinyl estradiol and norethindrone - Carol B. Trapnell, MD, CBER (95)

Thalidomide:  Are there gender disparities in treatment outcome and non-teratogenic adverse effects? Benda Vaughan, MD, CDER (95)

Rapid method for detection and enumeration of Listeria monocytogenes in foods - Mary L. Tortorello, PhD, CFSAN (95)

Profile of drug use in pregnancy - Sheila Weiss, PhD, CDER (95)

An open-label, randomized, crossover, feasibility study to quantify the retention of vaginally administered nonoxynol-9 (N-9) foam in premenopausal women - Carol Trapnell, MD, CDER (94)

FDA-Regulalted Products and Pregnant Women: Workshop, OWH (94)
 

 

Sex Differences

The Effects of Gender Differences in Revision Rates for Spinal Total Disc Replacement Procedures
 - Srinidhi Nagaraja, PhD, CDRH (13)

Sex differences in biomarkers of kidney injury in patients with metal-on-metal hip implants - Ronald Brown, MS, CDRH (13)

Gender differences in neuronal reward circuit activation by nicotine and tobacco smoke using magnetic resonance spectroscopy - Serguei Liachenko, PhD, NCTR (12)

Sex differences in kidney biomarker response following exposure to an orthopedic alloy: Implications for the safety assessment of metal-on-metal hip implants - Ronald Brown, MS, CDRH (12)

Gender effect on PK/PD of hypnotic drug: Driving impairment and dosing recommendations - Jagan Mohan Parepally, PhD, CDER (12)

Pharmacokinetics (PK) and biomarkers of the medications used to treat multiple sclerosis (MS) – any gender difference? - Wu Ta-Chen, PhD, CDER (11)

A pilot study on performing sex analysis on a vaccine database - Jingyee Kou, PhD, CBER (10)

“Sex Differences in FDA Regulated Products: Research for the Future” seminar series - Beverly Lyn-Cook, PhD, NCTR (09)

Mechanisms of Gender Differences in Aspirin Effects: Metabolizing Enzymes and Therapeutic Targets - Baitang Ning, PhD, NCTR (07)

CYP2B6 Genotype-Phenotype and the Influence of Sex and Ethnicity - Erin G. Schuetz, PhD, St. Jude’s Research Hospital (05)

Gender Differences in the Willingness to Read and Follow Patient Information - Ellen Tabak, PhD, CDER (04)

Gender effect on the assessment of bioavailability and bioequivalence in bioequalence trials - Mei Ling Chen, PhD, CDER (01)

Development and characterization of conditionally immortalized human primary hepatocyte cell lines from female and male donors- Phase I - Angela Harris, PhD, NCTR (02)

Mechanistic basis for gender-dependent differences in pharmacokinetics - Chandra Sahajwalla, PhD, CDER (99)

Gender differences in P450 activities and their implications - Shiew Mei Huang, PhD, Robert Branch, PhD, CDER (98)

Gender differences in perception of risks communicated by prescription and over-the-counter drug labels, Phase I and II - Ellen Tabak, PhD, CDER (95)

 

Women in Clinical Trials

Evaluation of gender-related clinical pharmacology information in the labelings on adverse events and outcomes - Lei Zhang, PhD, CDER (10)

Identification of Sex Differences in Adverse Outcomes for New Molecular Entities (NMEs) Approved from 2000-2002 - Yongsheng Yang, PhD, CDER (07)

Participation of Women in Clinical Trials and Gender Analysis in Original NDAs Approved 2000-2002 - Yongsheng Yang, PhD, CDER (06)

Women in HIV Trials: A comprehensive Review and Meta-analysis - Greg Soon, PhD, CDER (06)

Gender Differences and Impact of Pharmacogenomics in Rheumatoid Arthritis, Shashi Amur, PhD, CDER (06)

Impact of Gender Analysis and Pharmacogenomics on Clinical Efficacy, Safety, and Pharmacokinetics of Drugs Used for the Treatment of Alzheimer's Disease - Angela Men, PhD, CDER (06)

Statistical analysis of gender specific data from New Drug Application (NDA) submissions - Ohidul Siddiqui, PhD, CDER (06)

Evaluation of Availability and Quality of Information Available on Females Included in Mechanical device Implant Trials - Kathryn O'Callaghan, CDRH (06)

Women's participation in clinical drug trials for unstable angina and myocardial infarction - Ann Farrell, MD, CDER (00)

FDA Scholarship in Women's Health Program: Participation of Females in Clinical Trials and Gender Analysis of Data in Biologic Product Applications. Marion Gruber, PhD, CBER (2000)

Development and expansion of a pilot tracking system for monitoring the barriers to the enrollment of women in clinical trials, Toigo, Teresa, OC/OEA (95)

 

Other

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 - Qiang Shi, PhD, NCTR (12)

The Molecular Assays and Targeted Therapies (MATT) Consortium - Ray Woosley, MD, PhD, Critical Path Institute (06)

Self-Monitoring of Blood Glucose with Finger-Tip versus AST: Effect on Long term Glycemic Control - Caroline Apovian, MD, Boston Univ (03)

Drug update in human mammary gland epithelia - Shinya Ito, MD/ Gerald Fetterly, PhD, CDER (01)

CFSAN's Internet Initiative:  Infra-structure support - Kenneth T. Durham, CFSAN (98)

Research involving human subject committee (RIHSC) - Peter Rheinstein, MD, JD, OC/OEA (95)