Science & Research
List of Research Science Program Awards - by Year
List of intramural, extramural and special funding awarded by year
2013
Indira Hewlett, PhD, CBER
Evaluation of HSV-2 co-infection and hormonal contraceptive use on HIV acquisition and pathogenesis using patient-derived clinical specimens
Evi Struble, PhD, CBER
Assessing Passive Prophylaxis of Infection at Different Stages during Gestation in a Pregnant Animal Model
Daniela Verthelyi, MD, PhD, CDER
Use of innate immune response modulators in women: The perfect storm to trigger autoimmune disease?
Sunder Rajan, PhD, CDRH
MRI Safety Testing of Breast Tissue Expanders used in Mastectomy Patients
Ronald Brown, MS, CDRH
Sex differences in biomarkers of kidney injury in patients with metal-on-metal hip implants
Srinidhi Nagaraja, PhD, CDRH
The Effects of Gender Differences in Revision Rates for Spinal Total Disc Replacement Procedures
Zhiwei Zhang, PhD, CDRH
Incremental Values of Sequential Procedures for Diagnosing Breast Cancer
Kenneth Phillips. PhD, CDRH
Effect of Injection Techniques, Materials Chemistry and Physical Properties of Dermal Fillers on Potential for Bacterial Colonization and Infection
James Coburn, MS, CDRH
Mechanical causes of higher hip implant failure rates in women
Do-Hyun Kim, PhD, CDRH
Photo-Thermal Safety in Laser-based Devices for Detection and Treatment of Breast Cancer: Effect of Endogenous Absorbers and Gold Nano-Particles
Robert Wagner, PhD, NCTR
Nanoparticle Effects on Induction of Pro-inflammatory Responses to Candida albicans by Cultured Vaginal Epithelial Cells
2012
David Strauss, MD, PhD, CDRH
Gender-Specific Predictors of Heart Failure Hospitalization and Death in Cardiac Resynchronization Therapy
Peter Goering, PhD, CDRH
Safety and Efficacy of Iron Oxide Nanoparticles Used as MRI Contrast Agents for Breast Cancer Imaging
David Strauss, MD, PhD, CDRH
Novel Electrocardiographic Device Algorithms to Assess Cardiac Safety of Investigational Drugs
Tina Morrison, PhD, CDRH
Abdominal Aortic Aneurysms: analysis of patient Characteristics and Anatomy Related to EVAR treatment and outcomes- AAA CARE
Ronald Brown, MS, CDRH
Sex differences in kidney biomarker response following exposure to an orthopedic alloy: Implications for the safety assessment of metal-on-metal hip implants
Andreu Badal-Soler, PhD, 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
Leonardo Angelone, PhD, CDRH
MRI in pregnant patients: A systematic analysis of Radio-frequency heating with multi-transmit technology
Colin Anderson-Smits, MPH, CDRH,
A Comparitive Analysis of Adverse Events Between Conventional Tube Ligation and Transcervical Occlusive Devices of the Fallopian Tube for Female Sterilization: A Cohort Study
Meagan Myers, PhD, NCTR
Quantitative oncomutation profile of triple negative breast cancer
Qiang Shi, PhD, 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.
Serguei Liachenko, PhD, NCTR
Gender differences in neuronal reward circuit activation by nicotine and tobacco smoke using magnetic resonance spectroscopy
Mikhail Ovanesov, PhD, CBER
Improving safety of blood products administered during pregnancy
Zhiping Ye, PhD / Xie Hang, PhD, 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
Wen Jin Wu, MD, PhD, CDER
Investigate the mechanisms of trastuzumab-induced cardiotoxicity and cardiotoxicity and cardio protective role of antioxidants in trastuzumab-mediated cardiac dysfunction
Chongwoo Yu, PhD, CDER
Investigation of Drug-Drug Interactions with Hormonal Contraceptives
Jagan Mohan Parepally, PhD, CDER
Gender effect on PK/PD of hypnotic drug: Driving impairment and dosing recommendations
Zhongjun Luo, MD, PhD, CDER
Exploring Potential Safety Issues of PPIs on Osteoporosis in Elderly Women Using the PPI Legacy Database
Sri Rama Krishnaiah Yellela, PhD, CDER
Quantification of drug retained in the skin after removal of estradiol transdermal drug delivery systems used in hormone replacement therapy
Srikanth Nallani, Ph.D CDER
Applications of Clinical Pharmacology Principles in Pharcotherapy of Diseases in Pregnancy
Lanyan Fang, PhD, CDER
Sex Disparities in Autoimmune Treatment Response
Jack Ragheb, PhD, CDER
A Mechanistic Study of the Capacity of Silicone to Present (Self) Antigens to the Immune System
2011
Pei Zhang, MD, CBER
Prophylaxis of HBV infection with HBIGIV in a pregnant animal model
Deborah Taylor, CBER
The Role of Estrogen in Controlling Hepatitis C Virus Replication
Peiling Yang, PhD, CDER
An investigation of sexual dysfunction in depressive trials
Chongwoo Yu, PhD, CDER
Effects of body mass index (BMI)/body weight (BW) on effectiveness of hormonal contraceptive products for women
Juhong Liu, PhD, CDER
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
Rao, Ashutosh, CDER
Addressing the unmet medical needs for cardioproctection in women receiving chemotherapy
Ta-Chen Wu, PhD, CDER
Pharmacokinetics (PK) and biomarkers of the medications used to treat multiple sclerosis (MS) – any gender difference?
Cara Krulewitch, CNM, PhD, CDRH
Evaluation of safety and effectiveness of mesh implantation in surgical interventions for the treatment of pelvic floor disorders, Phase III
Robert Jennings, PhD, CDRH
Evaluating radiation risks and benefits of breast CT for diagnosing breast cancer
Nicholas Petrick, PhD, CDRH
Reproducibility in the quantitative assessment of multiple tissue-based biomarkers for breast cancer using light and digital microscopy
Dinesh Patwardhan, PhD, CDRH
Sex-based differences in the molecular mechanisms of polymer degradation in drug eluting stents (DES)
Terry Woods, CDRH
Preclinical Test Methods for Percutaneously Implanted Heart Valves: Effect of Non-Circular Valve Configuration After Implantation On Valve Leaflet Dynamics
Rajan Sunder, PhD, CDRH
MRI and Ultrasound imaging of silicone filled breast implants
Ching-Wei Chang, PhD, NCTR
Integrated analysis of single nucleotide polymorphism and copy number variation in genome association of breast cancer
Beverly Lyn-Cook, PhD, NCTR
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
Igor Pogribny, PhD, NCTR
Development of a targeted microRNA-based epigenetic therapeutic approach for breast cancer treatment
James Fuscoe, PhD, NCTR
Genetic and epigenetic mechanisms for sex differences in the kidney of a rat model system: developing safety biomarkers for FDA regulated products
Sean Linder, PhD, ORA
Detection of Nanoscale Materials in Products Targeted to Women: Feminine Hygiene Products and Dietary Supplements
Rallabhandi, Prasad, PhD, CFSAN
Studies of gluten-mediated cell signaling and immune modulation in Caco-2 intestinal epithelial cells: impact on women’s health and celiac disease
Shashi Amur, Special funding/CDER
Lupus Workshop
Katie O'Callaghan, Special funding/CDRH
Prospective assessment of clinical and health status outcomes for female patients undergoing Percutaneous Coronary Intervention (PCI) procedures via femoral and radial access
David Strauss, MD, Special funding/CDRH
Sex-Specific Left Bundle Branch Block Criteria and ECG Scar Quantification to Predict Benefit from Cardiac Resynchronization Therapy (CRT)
Jingyee Kou, PhD, Special funding/CBER
Continuation of a pilot study on performing sex analysis on a vaccine database
2010
Dorothy Scott, M.D. (CBER)
Treatment of progressive vaccinia in a pregnant immunocompromised mouse model
Cara Krulewitch, PhD (CBER)
Evaluation of Safety and Effectiveness of Mesh Implantation in Surgical Interventions for the Treatment of Pelvic Floor Disorders, PHASE II and PHASE III
Ellen Pinnow, PhD (CBER)
Atrial Fibrillation Ablation Registry Study (SAFARI)
Jingyee Kou, PhD (CBER)
A pilot study on on performing sex analysis on a vaccine database
Antonio Paredes, PhD (CDER)
Assessment of Risk Factors Associated with Exposure to Proton Pump inhibitors and Fracture and CV outcomes in post-menopausal osteoporosis woman
Srikanth Nallani, PhD (CDER)
Applications of clinical pharmacology principles in pharmacotherapy of diseases in pregnancy
Christine Garnett, Pharm D (CDER)
Sex and age related differences in baseline QT, QT prolongation, and TdP risk
Guoxing (Greg) Soon, Ph.D (CDER)
Women in HIV trials: a comprehensive review and meta-analysis for safety
Lei Zhang, PhD (CDER)
Evaluation of gender-related clinical pharmacology information in the labelings on adverse events and outcomes
Paul Schuette, PhD (CDER)
An analysis of safety signal detection methods for pregnancy exposure registries
Aldo Badano, PhD (CDRH)
Development of standard color management methods for assessment of immunohistochemical HER2 expression in breast cancer using digital microscopy
Daniel Canos, PhD (CDRH)
The swan-ganz balloon flotation pulmonary artery catheter: possible racial and sex discrepancies
Hesha Duggirala, PhD (CDRH)
Assessment of outcomes and bleeding complications following implantation of drug eluting stents (DES) and dual anti-platelet therapy (DAPT)
Kish Chakrabarti, PhD (CDRH)
Dose and image quality optimizations in various full-field digital mammography systems
Subok Park, PhD (CDRH)
Safety and efficacy of biomarkers using gene expression data for breast cancer patient treatment and care
Dale Tavris, PhD (CDRH)
Risk of Adverse Events following Cardiac Catheterization by Hemostasis Device Use – Phase III
Jon Wilkes, PhD (NCTR)
Quantum mechanical and NMR spectral approaches for the rapid prediction of estrogen activity or new drugs and environmental documents
Doug Wagner, PhD (NCTR)
Effects of phytoestrogens on gene expression responses of vaginal epithelial cells afgter contact with candida albicans
2009
Indira Hewlett, Ph.D. (CBER)
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
Deborah Taylor, Ph.D. (CBER)
The role of estrogen in enhancing innate immunity during viral infection
Luis Valerio, Ph.D. (CDER)
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
Karen Feibus, M.D. (CDER)
Ethics roundtable: the ethics of studying drugs and biologics in pregnant women
Srinidhi Nagaraja, Ph.D. (CDRH)
Do vertebroplasty procedures increase the risk of adjacent level vertebral fractures in osteoporotic women
Malvina Eydelman, M.D. (CDRH)
Quality of life and significant symptoms after LASIK
Katie O’Callaghan, MS. (CDRH)
Analysis of sex-differences in cardiac resynchronization therapy devices: inclusion, adverse events, and outcomes
Dinesh V. Patwardhan, Ph.D. (CDRH)
Sex-based differences in the safety of drug-eluting stents containing bioresorbable materials
Aldo Badano, Ph.D. (CDRH)
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
Iacovos S. Kyprianou, Ph.D. (CDRH)
Women’s radiation dose and excess cancer risk associated with x-ray computed tomography scans: quantification and risk-mitigation strategies
Mark Hart, Ph.D. (NCTR)
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
Weida Tong, Ph.D. (NCTR)
Development of an FDA resource for sex difference-related pharmacogenomics data review-Phase II
Beverly Lyn-Cook, Ph.D. (NCTR)
Women’s health initiative seminar series and workshop at NCTR
Beverly Lyn-Cook, Ph.D. & Athena Davenport, Ph.D. (NCTR)
Inactivation of UDP-Glucuronosyltransferases (UGTs) in human breast and endometrial tissues: accessing cancer risk, tamoxifen safety and toxicity
Cecilia Aguila D.V.M. (CVM)
Genome wide methylation arrays for detecting markers of increased susceptibility to mammary cancer caused by in utero exposures to endocrine disruptors
2008
Mustafa Akkoyunlu Ph.D. (CBER)
The Role of Vaccine Adjuvant Mediated TACI Up regulation in SLE
Andrew Dayton, Ph.D. (CBER)
Effects of B-Estradiol on the Safety of Anti-HIV Drugs
Christine Garnett, Ph.D., Philip Dinh, Ph.D. (CDER)
Gender-Related Differences in QT Effects and Torsade de Pointes Potential of Drugs
Christy John, Ph.D. (CDER)
Qualifying Imaging Biomarkers to Monitor Neoadjuvant Chemotherapy in Breast Cancer Patients to Identify Responders Using Positron Emission Tomography (PET)
Sandra Kweder, M.D. (CDER)
The Asthma and Allergy Medications in Pregnancy Surveillance System (AAMPSS) Demonstration Project
Nakissa Sadrieh, Ph.D. (CDER)
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
Ana Szarfman, Ph.D. (CDER)
Detection and Confirmation of Gender Related Safety Signals Using the Electronic Healthcare Data from the Department of Defense
Lei Zhang Ph.D. (CDER)
Safer use of Narcotics in Pregnant and Lactating Women
Kish Chakrabarti, Ph.D. (CDRH)
Dose and Image Quality Optimization in Full Field Digital Mammography
Cara Krulewitch, CNM, Ph.D. (CDRH)
The Safety and Effectiveness of Surgical Mesh Implant Use in Uro-Gynecologic Surgery for Soft Tissue Augmentation
Kathryn M. O’Callaghan, B.S. (CDRH)
Workshop: Guidance for the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Devices
Subok Park, Ph.D. (CDRH)
Patient Safety and Imaging Performance of Three-Dimensional (3D) X-Rays Systems for Detection of Breast Cancer
Cunlin Wang, M.D., Ph.D. (CDRH)
Gender Differential in National Estimates for Medical Device-Associated Adverse Events (MDAEs) from Emergency Departments
Thomas Flynn, Ph.D. (CFSAN)
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
Huizhong Chen, Ph.D. (NCTR)
Risk Assessment of Human Skin Microflora Metabolism of Synthetic Azo Colorants used in Women’s Cosmetics
Beverly Lyn-Cook, Ph.D. (NCTR)
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
Doug Wagner, Ph.D. (NCTR)
Gene Expression Responses of Estrogen-Primed Vaginal Epithelial Cells After Contact With Candida albicans and Probiotic Lactobacilli
Steven Tucker, Ph.D, (OC)
Effects of Proposed Revisions to the Regulations Implementing the Mammography Quality Standards Act
2007
Indira Hewlett, Ph.D. (CBER)
Evaluation of Gender Differences in Detection, Replication and Transmissibility of Emerging HIV-1 Variants
Deborah Taylor, Ph.D. (CBER)
The Role of Estrogen in Enhancing Innate Immunity During Viral Infection
Shashi Amur, Ph.D. (CDER)
Gender, Ethnicity and Pharmacogenomics in Systemic Lupus Erythematosus (SLE)
Audrey Gassman, M.D. (CDER)
Workshop: Drugs in Pregnancy
Yongsheng Yang, Ph.D. (CDER)
Identification of Sex Differences in Adverse Outcomes for New Molecular Entities (NMEs) Approved from 2000-2002
Soma Kalb, Ph.D. (CDRH)
Factors Accelerating the Progression of Heart Failure (HF) in Women: Implications for Drug Interactions with Medical Devices
Dinesh Patwardhan, Ph.D. (CDRH)
The Impact of Sex-Based Differences in Atherosclerotic Plaque on the Response to Drug Eluting Stent Implantation
Art Sedrakyan, MD, Ph.D. (CDRH/AHRQ)
Real-World Outcomes of Drug-Eluting Stents
Elizabeth Calvey Ph.D., Marjorie Davidson, Ph.D. (CFSAN)
Understanding Consumer Behavior Associated with Changing Messages on Listeria monocytogenes and Food Safety
Neera Gopee, Ph.D. (NCTR)
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
Baitang Ning, Ph.D. (NCTR)
Mechanisms of Gender Differences in Aspirin Effects: Metabolizing Enzymes and Therapeutic Targets
Weida Tong, Ph.D. (NCTR)
Development of a FDA Resource for Improved Efficiency of Sex Difference Related Pharmacogenomic Data Analysis and review
Lesley Kerr, Ph.D. (ORA)
Development of a Rapid Version of the Tampon Test Method Based on 21CFR801.430
Phyllis Wilson, Ph.D. (ORA)
Development and Validation of an HPLC Method for the Simultaneous Determination of Estradiol, Estriol, Estrone and Progesterone in Pharmaceutical Preparations
Extramural studies:
Bram Zukerman PhD, Norman Stockbridge, PhD, Duke Clinical Research Institute
Drug Eluting Stent (DES)/Thrombosis
2006
Hana Golding, Ph.D., Surender Khurana, Ph.D. (CBER)
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
Shashi Amur, Ph.D. (CDER)
Gender Differences and Impact of Pharmacogenomics in Rheumatoid Arthritis
Angela Men, Ph.D., Shashi Amur, Ph.D. (CDER)
Impact of Gender Analysis and Pharmacogenomics on Clinical Efficacy, Safety, and Pharmacokinetics of Drugs Used for the Treatment of Alzheimer’s Disease.
Jogarao Gobbura, PhD. (CDER)
Quantitative Tumor Size- Survival Relationship in Oncology Clinical Trials
Ohidul Siddiqui, Ph.D. (CDER)
Statistical Analysis of Gender Specific Data from New Drug Application (NDA) Submissions
Guoxing (Greg) Soon, Ph.D. (CDER)
Women in HIV Trials: A Comprehensive Review and Meta-Analysis
Mary Willy, Ph.D. (CDER)
Drug Use in Pregnancy
Anne Trontell, MD, MPH., (CDER/AHRQ)
Research on the Effects of Drug Exposure in Pregnancy
Yongsheng Yang, Ph.D. (CDER)
Participation of Women in Clinical Trials and Gender Analysis of Data in Original NDAs Approved 2000-2002
Jove Graham, Ph.D. (CDRH)
Evaluating the Effectiveness of Vertebroplasty for Improving the Mechanical Properties of the Spine in Patients with Osteoporosis.
Kathryn O’Callaghan B.S. (CDRH)
Evaluation of Availability and Quality of Information Available on Females Included in Mechanical Device Implant Trials.
Varsha Desai, Ph.D. (NCTR)
Molecular Mechanisms Underlying Gender-associated Differences in the Adverse Reactions to the Anti-retroviral Agent, Zidovudine (AZT) Role of Mitochondrial Toxicity
Christopher Elkins, Ph.D., Mark Hart, Ph.D. (NCTR)
Protective Effect of Vaginal Lactobacillus Species Against Staphylococcus Aureus-mediated Toxic Shock Syndrome
Beverly Lyn-Cook, Ph.D. (NCTR)
Sex Differences in Chemotherapeutic Toxicity: Profiling of Transporter Genes in Human Liver
Extramural studies:
Kara Morgan, Ph.D. (OC)
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
Christopher Cabell, M.D., MHS, Duke Clinical Research Institute (DCRI)
ECG Warehouse - Duke Clinical Research Institute and Duke University
Justin Mortara, Mortara Instrument Inc.
ECG Warehouse - Mortara Instruments Inc.
Ray Woosley, MD, Ph.D., The Critical Path Institute
The Molecular Assays and Targeted Therapies (MATT) Consortium
Gloria Sarto, MD., University of Wisconsin
Pharmacokinetics and Pharmacodynamics of Selected Antibiotics during Pregnancy
2005
Hyojong Kwon, Ph.D., Robert Lionberger, Ph.D. (CDER)
Sex Difference Dependent Drug-drug Interactions of Anti-HIV Therapeutics
Iacovos Kyprianou, Ph.D., Kyle Myers, Ph.D. (CDRH)
Implications of Gender-based Differences in Cardiovascular Disease on Imaging for Treatment and Diagnosis
Azadeh Shoaibi, M.S., MPH, Dale Tavris M.D. MPH (CDRH)
Assessment of the Accuracy of the Troponin Assay and the Diagnosis of Myocardial Infarction by Gender/ How Gender Influences Treatment
James Fuscoe, Ph.D. (NCTR)
Systems Biology Approach to Evaluate Sex Differences in the Heart of a Rat Model
Extramural studies:
Karen Freund, MD, Boston University
Use and Outcomes of Coronary Stents in Women: Use of a National Medicare Database
Erin G. Schuetz, Ph.D.
CYP2B6 Genotype-Phenotype and the Influence of Sex and Ethnicity
2004
Felice D’Agnillo, Ph.D. (CBER)
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
Andrew Dayton, Ph.D. (CBER)
Gender Dimorphism in HIV Infection in Primary Macrophages and T-Lymphocytes Kinetics of HIV Replication and Efficacy of Anti-Retroviral Agents
Ellen Tabak, Ph.D, Leslie Wheelock, Ph.D. (CDER)
Gender Differences in the Willingness to Read and Follow Patient Information
Jove Graham, Ph.D. (CDRH)
Development of Guidelines for Evaluating the Appropriateness of Vertebroplasty Surgery for Patients with Osteoporosis
Maria Lorenzo, DVM, Mona S. Calvo, Ph.D. (CFSAN)
Do Phytoestrogens Modify the Allergic Response to Food Allergens in the Newly Validated, Highly Sensitive, In-Bred Asthmatic Rat Model?
Robert Sprando, Ph.D. (CFSAN)
Developmental Toxicity of Androstenedione in Rats
Extramural studies:
Mary Hebert, Pharm D, University of Washington
Pharmacokinetics and Pharmacodynamics (PK/PD) of Atenolol in Lactating Women
Stephen Hall, PhD, Indiana University
Drug Metabolism in Women
Michelle Dew, MD, University of Arizona
Transmission Attenuation Correction for Female Patients Undergoing Myocardial Perfusion Imaging: Correction for Confounding Breast Tissue Artifact
Thierry LeJemtel, MD, Tulane University
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
2003
Jogarao Gobburu, Ph.D. (CDER)
Are Women at Higher Risk from Proarrhythmic Drugs?
Eugene Herman, Ph.D. (CDER)
Discovery and Evaluation of Interspecies Biomarkers to Monitor the Early Onset and the Progression of Cardiovascular Toxicity Associated with Tiazolidinedione Compounds Used in the Treatment of Type 2 Diabetes
John. Koerner, Ph.D. (CDER)
Electrophysiological Characterization of Several Torsadogenic Drugs in Isolated Rabbit Hearts
Melvin Stratmeyer, Ph.D. (CDRH)
Cardiovascular Effects of Ultrasound Contrast Agents in Intact and Ovariectomized Female Animals
Extramural studies:
William Cooper, MD MPH, Vanderbilt University
Assessment of Maternal Effects & Infant Outcomes Using Large Automated Healthcare Data Systems in Women Exposed to Prescription Medications During Pregnancy
Caroline Apovian, MD, Boston University
Self-Monitoring of Blood Glucose with Finger-Tip versus AST: Effect on Long term Glycemic Control
Marlene Freeman, MD, Arizona Health Science Center
Maternal Antidepressent Drug Research and Evaluation (Madre): Pharmacokinetics and Pharmacodynamics of Sertraline in Pregnant and Postpartum
2002
Daniela Verthelyi, Ph.D. (CBER)
Effect of Sex Hormones on the Immune Response to CpG ODN
Mei Ling Chen, Ph.D. (CDER)
Gender Effect on the Assessment of Bioavailability and Bioequivalence Gender Differences in Intestinal Levels of CYP3A4, CYP 3A5, P-gP and MRP
Dale Tavris, M.D. MPH (CDRH)
Incidence and Attributable Risk of Serious Adverse Events and Death Associated with the Use of Homeostasis Devices by Gender
Robert Sprando, Ph.D. (CFSAN)
Characterization of the Effect of Pre-pubertal and Pubertal Exposure of Androstenedione on Female Reproductive Health
Angela Harris, Ph.D. (NCTR)
Development and Characterization of Conditionally Immortalized Human Primary Hepatocyte Cell Lines From Female And Male Donors -- Phase I
Extramural studies:
Mary Hebert, Pharm D, University of Washington
Pharmacokinetics and Pharmacodynamics (PK/PD) of Atenolol in Pregnancy
Raymond Galinsky, Indiana School of Medicine
Ciprofloxacin and Doxycycline in lactating women and in the elderly
2001
Hana Golding, Ph.D., Marina Zaitseva, Ph.D. (CBER)
Thymic Regeneration and Immune Function Reconstitution in Babies Born to HIV-infected Mothers
Eugene A. Herman, Ph.D., Frank Sistare Ph.D. (CDER)
Discovery and Evaluation of Interspecies Biomarkers to Identify and Characterize the Cardiotoxic Effects of Herceptin, a Novel Antibody Used in the Treatment of Breast Cancer
Shew-Mei Huang, Ph.D., Steven Hall Ph.D. (CDER)
The Effects of Echinacea on Cytochrome P450 Enzymes and Oral Contraceptives
Shinya Ito, M.D., Gerald Fetterly, Ph.D. (CDER)
Drug Update in Human Mammary Gland Epithelia
Patrick J. McNamara, Ph.D., Gerald Fetterly, Ph.D. (CDER)
Development of a General Approach for the Investigation of Drug Transfer in Breast Milk: In Vitro Assessment of Drug Distribution into Breast Milk
Rosalie Elespuru, Ph.D., Roselie Bright, Sc.D. (CDRH)
Developing a Diagnostic Gene Expression Profile for Latex Sensitivity Using Microarrays
Sharon Miller M.S., Janusz Beer, Ph.D. (CDRH)
Optimization of UV Exposure Patterns Maximizing Perceived Benefits While Minimizing Photocarcinogenic/photo-aging Effects
Extramural studies:
James Fischer, Pharm D, University of Illinios
Labetalol and Hypertension in Pregnancy: Pharmacokinetics and Pharmacodynamics
Mary Hebert, Pharm D, University of Washington
The PK of Amoxicillin during Pregnancy and Postpartum
2000
Debra Birnkrant, M.D., Ajaz Hussain, Ph.D. (CDER)
Vaginal Volume: Optimizing Vaginal Deployment of Topical Microbicides
Ann Farrell, M.D., Lilia Talarico, M.D. (CDER)
Women's Participation in Clinical Drug Trials for Unstable Angina and Myocardial Infarction
Ronald Honchel, Ph.D., Frank Sistare, Ph.D. (CDER)
Evaluation of the Tg.AC Transgenic Mouse as a Model for Predicting the Photocarcinogenicity of Pharmaceuticals and Cosmeceuticals
Ronald Kaczmarek, M.D. (CDRH)
Surveillance of Sex-specific Utilization, Morbidity, and Mortality Associated with Transmyocardial Revascularization
Richard Kotz, Ph.D. (CDRH)
A Study to Evaluate the Consistency of T-scores Among Ultrasound Bone Measurement Devices and the Usefulness of these Devices for Monitoring Bone Status
Jeffrey Yourick, Ph.D. (CFSAN)
Teratogenic Potential of Cosmetic Products Containing Retinol (Vitamin A) and Retinyl Palmitate-Phase I
Jurgen von Bredow, Ph.D. (CVM)
Use of a Unique Animal Model to Study Placental Milk Transfer of Ciprofloxicin from the Dam to the Offspring During the Perinatal Period
Anane Aidoo, Ph.D. (NCTR)
Evaluation of the Effects of Daidzein And Genistein on The Genotoxic and Carcinogenic Activity of the Model Mammary Carcinogen 7,12-Dimethylbenz(A) Anthracene (DBMA) in Ovariectomized Transgenic Big Blue Rats
Vasily Dobrolovsky, Ph.D. (NCTR)
Evaluation of the Tk Knockout Mouse as a Model of Systemic Lupus Erythematosus
Jeffery Archer, M.S. (ORA)
Analysis of Dioxins/Furnas (17 congeners) Levels in Tampons
Extramural studies:
Gail Mahady, PhD, University of Illinois at Chicago
Pattern of botanical dietary supplement usage in menopausal women
Francine Welty, MD PhD, Beth Israel Deaconess Medical Center and Harvard U
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
Stephen Hall, PhD, Indiana University
The effects of St Johns Wort on the efficacy of oral contraception
Sara Warber, MD, University of Michigan
Review of herbal weight loss product experiences and adverse events.
Mara Vitolins, DrPH, Wake Forest University
Use and interaction of dietary supplements in the SEA Trial.
Gail Anderson, PhD, University of Washington
Phytoestrogens: Drug interaction potential in women
1999
Vance Berger, Ph.D. (CBER)
Improving the Evaluation of Ovarian Cancer Treatment
Carolyn Deal, Ph.D. (CBER)
Hormone Effects on Pathogenesis & Host Cell Interactions of N. Gonnorrhea
Chandra Sahajwalla, Ph.D. (CDER)
Evaluation of In-vitro Mechanistic Basis for Gender Dependant Differences in Pharmacokinetics
Mary Willy, Ph.D. (CDER)
Post-marketing Drug Risk Assessment Using the ARAMIS Database in RA Patients
Rosalie Bright, Sc.D. (CDRH)
Active Postmarketing Surveillance Methods: A Hospital Pilot
Robert Navario, Ph.D, S.L.Brown, M.D. (CDRH)
Assessment of Consumer Understanding of Barrier Contraception and Tampon Labeling: Focus Group Studies
Robert Bronaugh, Ph.D. (CFSAN)
Potential Exposure of Women to Estrogens, Phytoestrogens and Xenoestrogens through Cosmetic Products
Dean Roberts, Ph.D. (NCTR)
Antigenic Biomarkers of Estrogen Catechol Metabolism for Post-Market Surveillance of Oral Contraceptives and HRT's
1998
Frederick Miller, M.D., Ph.D. (CBER)
Silicone Gel-filled Breast Implant Capsules: A Molecular Histologic and Immunophenotypic Study
Emily Shachter, Ph.D. (CBER)
Improve the Efficacy of Chemotherapeutic Drugs for the Treatment of Breast Cancer
Kathryn Aiken, Ph.D. (CDER)
Pregnancy Labeling Taskforce Focus Group testing (co-funded by NIH ORWH)
Shiew Mei Huang, Ph.D., Robert Branch, Ph.D. (CDER)
Gender Differences in P450 Activities and their Implications (co-funded by NIH ORWH)
Thomas Layloff, Ph.D. (CDER)
Chemical Characteristics of Conjugated Estrogens
Ralph Lillie, RPh (CDER)
Adverse Events Reporting System (AERS): Risk assessment, Compliance & Management
Carolyn McCloskey, M.D., MPH (CDER)
Teratogen Surveillance
Ana Szarfman, M.D., Ph.D. (CDER)
Data Mining Techniques for Identifying Potential Serious Drug Interactions in Women
Ana Szarfman, M.D., Ph.D., Raymond L. Woosley, M.D., Ph.D. (CDER)
Variations in the Drug-induced QT Interval Prolongation During the Menstrual Cycle (Co-funded by NIH ORWH)
Kenneth T. Durham, Ph.D. (CFSAN)
CFSAN's Internet Initiative: Infra-structure Support
Nancy Slifman, M.D., MPH (CFSAN)
Contaminants in Dietary Supplements Frequently Used in Women
Patricia Dubill, Ph.D. (CDRH)
Abrasion Testing of Breast Implants
James Karanian, Ph.D. (CDRH)
Ovarian Steroids and Cardiovascular Disease the Role of Gender in the Effectiveness of Interventional Medical Devices
Harvey Rudolph, Ph.D. (CDRH)
Accelerated Aging Studies of Condoms/condom Materials
Harvey Rudolph, Ph.D. (CDRH)
Flow Studies and the Use of a Waveguide in Cardiovascular Devices
Keith Wear, Ph.D. (CDRH)
Development and Validation of Ultrasonic Backscatter Measurement for Bone Density Assessment
Patricia Thompson, Ph.D. (NCTR)
In-Vivo Modeling Of Steroid-Mediated Gender Effects in Drug Metabolism (Phase I and II)
Lesley Kerr, Ph.D. (ORA)
Development and Validation of a Universal Water Leak Test Method for Barrier Contraceptives
1997
Margaret Bash, M.D., MPH (CBER)
Antigenic Characteristics and Immunogenicity of Synthetic Peptide Vaccines for the Pathogenic Neisseria: Neisseria meningitides and Neisseria gonorrhea
Hana Golding, Ph.D. (CBER)
Sexual transmission of HIV-1 in Women and Mother to Infant Transmission: The Importance of HIV-1 Co-receptor Expression on Cerviovaginal Cells and on Cord Blood Cell Subsets
John Strong, Ph.D. (CDER)
Contribution of Estrogen Components to the Efficacy of Conjugated Estrogens - Preliminary Analytical Chemistry
Ana Szarfman, M.D., Ph.D. (CDER)
Visualization Tools for Studying Gender Differences
S. Lori Brown M.D. (IOM/CDRH)Institute of Medicine Study: A Study of Safety of Silicone Breast Implants
S. Lori Brown, M.D. (CDRH)
Protocol for a Study of Breast implant rupture
Rosalie Bright, Sc.D. (CDRH)
Mammography Breast Cancer Screening Rates Among Disadvantaged Women within a Pre-Paid Health Care System
Robert Jennings, Ph.D. (CDRH)
Optimization of mammography
Steven Lascher, DVM, MPH (CDRH)
A Comparison of Gender Specific Utilization of Implantable Cardioverter Defibrillator Therapy and Post-implantation Survivability
Danica Marinac-Dabic, M.D. (CDRH)
Epidemiology of Medical Devices in Women (conference)
Shirley R. Blakely, Ph.D. (CFSAN)
Obesity: Its Effect on Antioxidant and Estrogen Metabolism
Mona S. Calvo, Ph.D. (CFSAN)
Vitamin K Status of Non-Hispanic Black 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 III
Christine B. Ambrosone, Ph.D. (NCTR)
Breast Cancer in African-American Women: Metabolic Modification of Dietary and Hormonal Risk Factors
S. Jill James, Ph.D. (NCTR)
Molecular and Metabolic Determinants of Maternal Risk and Progression of Down's Syndrome Potential for Nutritional Intervention
William H. Tolleson, Ph.D. (NCTR)
Development Of In Vitro Human Cell Culture Systems to Screen Compounds Suspected To Have Estrogenic or Anti-Estrogen Activity
1996
Dennis Klinman, M.D., Ph.D. (CBER)
A Novel Approach to the Treatment of Lupus Nephritis
Penelope Robbins, Ph.D. (CBER)
Human Cytotoxic T Lymphocyte Recognition of Papilloma Virus
Emily B. Shachter, Ph.D. (CBER)
Administration of Thrombolytic Therapy to Women with Acute Myocardial Infarction: Is It Too Late?
Giovanna Tosato, M.D. (CBER)
IP-10: A Potential New Therapeutic for Breast Cancer
Donna A. Volpe, Ph.D. (CDER)
In Vitro Prediction of Time to Neutropenic Nadir: Anti-neoplastic Alkylating Agents as Prototype Drugs
Marwood N. Ediger, Ph.D. (CDRH)
Development of a Safe, Economical Assay for Silicone Containment in Blood and Tissue
Melvyn Greberman, M.D., MPH (CDRH)
The Transfer of Defense, Intelligence and Space Technologies for the Early Detection and Control of Cancers in Women (conference)
Matthew R. Myers, Ph.D. (CDRH)
A Computer Model for Simulating Virus Transport through Barriers
Kenneth T. Durham, Ph.D. (CFSAN)
CFSAN's Women's Health Internet Initiative- Phase II
Thomas J. Sobotka, Ph.D. (CFSAN)
Screening for Nervous System Dysfunction in Offspring of Dams Exposed to Natural Food Contaminates During Pregnancy
Ruth A. Welch, Ph.D. (CFSAN)
Women's Health Information Line
Frederick A. Beland, Ph.D. (NCTR)
DNA Adducts of Tamoxifen
Darnell Carlton Jackson, Ph.D. (NCTR)
Development of an Estrogen Knowledge Base for Research and Regulation
Daniel M. Sheehan, Ph.D. (NCTR)
Experimental Assessment of Environmental Estrogens
1995
David S. Finbloom, M.D. (CBER)
Cytokine Induced Activation of the Jak Kinase/STAT Transcription Factor Pathway in Immune Cells (Monocytes and Lymphocytes) of Patients with Rheumatoid Arthritis and Systemic Lupus Erythematosus
Basil Golding, M.D. (CBER)
Induction of Mucosal Immunity to Protect Females from HIV-1
Dennis Klinman, M.D., Ph.D. (CBER)
Hormonal Regulation of Cytokine-producing Cells in Women with Systemic Lupus Erythematosus
Philip R. Krause, M.D. (CBER)
Development of a Method to Evaluate the Effect of Vaccines and Antiviral Therapy on Latent Viral Burden in an Animal Model of Genital Herpes
Carol B. Trapnell, M.D. (CDER)
The Effect of Thalidomide on the Pharmacokinetics of Ethinyl Estradiol and Norethindrone
Edwin J. Matthews, Ph.D. (CDER)
Estimation of Reproductive Toxicity of Pharmaceuticals Using QSAR Software Programs
Bruce V. Stadel, M.D. (CDER)
Hormone Replacement Therapy in Women with a Previous Diagnosis of Endometrial Cancer
Ellen R. Tabak, Ph.D. (CDER)
Gender Differences in Perception of Risks Communicated by Prescription and Over-the-counter Drug Labels, Phase I and II
Brenda Vaughan, M.D. (CDER)
Thalidomide: Are There Gender Disparities in Treatment Outcome and Non-teratogenic Adverse Effects?
Sheila Weiss, Ph.D. (CDER)
Profile of Drug Use in Pregnancy
Danica Marinac-Dabic, M.D. (CDRH)
Gender Differences in Early and Long-term Results of Coronary Angioplasty with Palmaz/Schatz Stent
Kyle Myers, Ph.D. (CDRH)
Non-invasive Assessment of Silicone Migration from Gel-filled Breast Implants
Paula G. Silberberg, M.D. (CDRH)
Contraceptive Efficacy Table for Uniform Contraceptive Labeling-- a Consumer Focus Group Study - Part I and II
Keith A. Wear, Ph.D. (CDRH)
Application of Ultrasonic Tissue Characterization to Diagnosis of Bone Disease
Kenneth T. Durham, Ph.D. (CFSAN)
CFSAN's Women's Health Internet Initiative - Phase I
Mary L. Tortorello, Ph.D. (CFSAN)
Rapid Method for Detection and Enumeration of Listeria Monocytogenes in Foods
Ruth Welch Ph.D., Carole Schiffman Ph.D. (CFSAN)
Osteoporosis Prevention in Adolescent Girls
John Leighton, Ph.D. (CVM)
A Novel Molecular Approach to Risk Assessment of Hormonally Active Compounds
Peter Rheinstein, M.D., JD (OEA)
Research Involving Human Subject Committee (RIHSC)
Teresa Toigo, RPh, MBA (OEA)
Development and Expansion of a Pilot Tracking System for Monitoring the Barriers to the Enrollment of Women in Clinical Trials
S. Jill James, Ph.D. (NCTR)
Mechanism of Immunotoxicity and Carcinogenicity Associated With Silicone Breast Implants
Randal Streck, Ph.D. (NCTR)
Mechanism of Tamoxifen Development Toxicity and Neoplasia Tamoxifen Effects on the Rat Uterine Insulin Like Growth Factor System
Barbara Ward-Groves, MPH (ORA)
Mammography Quality Standards Act Facilities Workshop
1994
Frederick W. Miller, M.D., Ph.D. (CBER)
Immunogenetic Risk Factors for Silicone-associated Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance
Michael A. Norcross, M.D. (CBER)
Women and AIDS Transmission
Carol B. Trapnell, M.D. (CDER)
An Open-label, Randomized, Cross-over, Feasibility Study to Quantify the Retention of Vaginally Administered Nonoxynol-9 (N-9) Foam in Premenopausal Women
Lou Cantillina, M.D. (CDER)
Women in Clinical Trials Terfenadine/Oral Contraceptive Study
David Flockhart, M.D., Ph.D. (CDER)
Comparison of the Beta-adrenergic Antagonist Actions of Propranolol in Men and Women
Raymond L. Woosley, M.D., Ph.D. (CDER)
Comparison of the Potassium Channel Blocking Actions of Quinidine in Men and Women
John Langone, Ph.D. (CDRH)
Silicone Gel Alternatives Workshop
Carol Sierka, B.S. (CDRH)
Consumer Brochure on Mammography Development of MQSA Speaker Kits
John E. Bailey, Ph.D. (CFSAN)
Cosmetics Initiatives Alpha Hydroxy Acids (AHAs)
John E. Bailey, Ph.D. (CFSAN)
AHA Literature Search
Sara B. Fein, Ph.D. (CFSAN)
Infant Feeding Practices Study
Dan Sheehan, Ph.D. (NCTR)
Effects of Toremifene and ICI 182,780 on Rat Uterine Growth and Differentiation
Conference on STD Clinical Trials Workshop (NIH and OEA)
April 6-8 1994
OWH Small Grants Program (OC)
Workshop: FDA-regulated Products and Pregnant Women
