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U.S. Food and Drug Administration

The Office of Women's Health Scientific Research Program

Appendix I


OWH/CDER Funded Research

1994
Carol B. Trapnell, MD: An open-label, randomized, cross-over, feasibility study to quantify the retention of vaginally administered nonoxynol-9 (N-9) foam in premenopausal women

Women in Clinical Trials:
Lou Cantillina, MD: Terfenadine/Oral contraceptive study
David Flockhart, MD, PhD: Comparison of the beta-adrenergic antagonist actions of propranolol in men and women
Raymond L. Woosley, MD, PhD: Comparison of the potassium channel blocking actions of quinidine in men and women

1995
Carol B. Trapnell, MD: The effect of Thalidomide on the pharmacokinetics of ethinyl estradiol and norethindrone

Bruce V. Stadel, MD: Hormone replacement therapy in women with a previous diagnosis of endometrial cancer

Brenda Vaughan, MD: Thalidomide: Are there gender disparities in treatment outcome and non-teratogenic adverse effects?

Edwin J. Matthews, PhD: Estimation of reproductive toxicity of pharmaceuticals using QSAR software programs

Ellen R. Tabak, PhD: Gender differences in perception of risks communicated by prescription and over-the-counter drug labels, Phase I

Sheila Weiss, PhD: Profile of drug use in pregnancy

1996
Donna A. Volpe, PhD: In vitro prediction of time to neutropenic nadir: anti-neoplastic alkylating agents as prototype drugs

1997
John Strong, PhD: Contribution of estrogen components to the efficacy of conjugated estrogens-preliminary analytical chemistry

Ana Szarfman, MD, PhD: Visualization tools for studying gender differences

Ellen R. Tabak, PhD: Gender differences in perception of risks communicated by prescription and over-the-counter drug labels, Phase II

1998
Ana Szarfman, MD, PhD: Data mining techniques for identifying potential serious drug interactions in women

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

Shiew Mei Huang, PhD, Robert Branch, PhD: Gender differences in P450 activities and their implications (co-funded by NIH ORWH)

Carolyn McCloskey, M.D., MPH: Teratogen Surveillance

Thomas Layloff: Chemical characteristics of conjugated estrogens

John Strong, PhD: Contribution of estrogen components to the efficacy of conjugated estrogens-preliminary analytical chemistry (continuation of FY 97 project)

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

Ralph Lillie, RPh: Adverse Events Reporting System (AERS): Risk assessment, Compliance & Management

1999
Chandra Sahajwalla, PhD: Evaluation of in-vitro mechanistic basis for gender dependant differences in pharmacokinetics

2000
Debra Birnkrant, M.D., Ajaz Hussain, Ph.D., "Vaginal Volume: Optimizing vaginal deployment of topcial microbicides"

Ronald Honchel, Ph.D., Frank Sistare, Ph.D., "Evaluation of the Tg.AC transgenic mouse as a model for predicting the photocarcinogenicity of pharmaceuticals and cosmeceuticals"

Ann Farrell, M.D., Lilia Talarico, M.D., "Women's participation in clinical drug trials for unstable angina and myocardial infarction


OWH/CFSAN Funded Projects

1994
John E. Bailey: Cosmetics initiatives: Alpha hydroxy acids (AHAs)

John E. Bailey: AHA literature search

Sara B. Fein, PhD: Infant feeding practices study

1995
Kenneth T. Durham: CFSAN's women's health Internet initiative - Phase I

Mary L. Tortorello, PhD: Rapid method for detection and enumeration of Listeria monocytogenes in foods

Ruth Welch: Osteoporosis prevention in adolescent girls

1996
Kenneth T. Durham: CFSAN's women's health Internet initiative: Phase II

Ruth A. Welch, MS, RD: Women's health information line

Thomas J. Sobotka, PhD: Screening for nervous system dysfunction in offspring of dams exposed to natural food contaminates during pregnancy

1997
Thomas J. Sobotka, Phd: Screening for nervous system dysfunction in offspring of dams exposed to natural food contaminates during pregnancy (con't of FY 96)

Mona S. Calvo, PhD: 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

Shirley R. Blakely, PhD: Obesity: Its effect on antioxidant and estrogen metabolism

1998
Shirley R. Blakely, PhD: Obesity: Its effect on antioxidant and estrogen metabolism

Nancy Slifman, MD, MPH: Contaminants in dietary supplements frequently used in women

Kenneth T. Durham: CFSAN's Internet initiative: infra-structure support

1999
Robert Bronaugh: Potential exposure of women to estrogens, phytoestrogens and Xenoestrogens through cosmetic products

2000
Jeffrey Yourick, Ph.D., "Teratogenic potential of cosmetic products containing Retinol (Vitamin A) and Retinyl Palmitate-Phase I"


OWH/CVM Research Projects

1999
John Leighton, Ph.D. "A novel molecular approach to risk assessment of hormonally Active compounds"

2000
Jurgen von Bredow, Ph.D., "Use of a unique animal model to study placental milk transfer of ciprofloxicin from the dam to the offspring during the perinatal period"


OWH/NCTR Funded Projects

1994
Dan Sheehan, Ph.D.: Effects of Toremifene and ICI 182,780 on rat uterine growth

1995
Randal Streck, PhD: Mechanism of tamoxifen development toxicity and neoplasia: tamoxifen effects on the rat uterine insulin like growth factor system

S. Jill James, PhD: Mechanism of immunotoxicity and carcinogenicity associated with silicone breast implants

1996
Darnell Jackson: Development of an estrogen knowledge base for research and regulation

Daniel M. Sheehan, PhD: Experimental assessment of environmental estrogens

Frederick A. Beland, PhD: DNA adducts of tamoxifen

1997
Christine B. Ambrosone, PhD: Breast cancer in African-American women: Metabolic modification of dietary and hormonal risk factors

S. Jill James, Ph.D.: Molecular and metabolic determinants of maternal risk and progression of Down's syndrome: Potential for nutritional intervention

William H. Tolleson, PhD: Development of in vitro human cell culture systems to screen compounds suspected to have estrogenic or anti-estrogen activity

1998
Patricia Thompson, PhD: In-vivo modeling of steroid-mediated gender effects in drug metabolism

1999
Dean Roberts, PhD: Antigenic biomarkers of estrogen catechol metabolism for post-market surveillance of oral contraceptives and HRT's

Patricia Thompson, PhD: Part II of in-vivo modeling of steroid-mediated gender effects on cytochrome P450 3A4 and 2D6

2000
Anane Aidoo, Ph.D., "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., "Evaluation of the Tk knockout mouse as a model of systemic lupus erythematosus,"


CBER Funded Projects

1994
Frederick W. Miller, MD, PhD: Immunogenetic risk factors for silicone-associated multiple myeloma and monoclonal gammopathy of undetermined significance

Michael A. Norcross, MD: Women and AIDS transmission

1995
Basil Golding, MD: Induction of mucosal immunity to protect females from HIV-1

David S. Finbloom, MD: 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

Dennis Klinman, MD, PhD: Hormonal regulation of cytokine producing cells in women with systemic lupus erythematosus

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

1996
Basil Golding, MD: Induction of mucosal immunity to protect females from HIV-1

Dennis Klinman, MD, PhD: A novel approach to the treatment of lupus nephritis

Emily B. Shachter, PhD: Administration of thrombolytic therapy to women with acute myocardial infarction. Is it too late?

Giovanna Tosato, MD: IP-10: A potential new therapeutic for breast cancer

Penelope Robbins, PhD: Human cytotoxic T lymphocyte recognition of Papilloma virus

1997
Hana Golding, PhD: 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

Margaret Bash, MD, MPH: Antigenic characteristics and immungenicity of synthetic peptide vaccines for the pathogenic Neisseria: Neisseria meningitides and Neisseria gonorrhea

1998
Margaret Bash, MD, MPH: Antigenic characteristics and immungenicity of synthetic peptide vaccines for the pathogenic Neisseria: Neisseria meningitides and Neisseria gonorrhea

Emily Shachter, PhD: Improve the efficacy of chemotherapeutic drugs for the treatment of breast cancer

Hana Golding, PhD: The role of HIV-1 co-receptors in sexual and mother-to-infant transmission

Frederick Miller, MD, PhD: Silicone gel-filled breast implant capsules: A molecular histologic and immunophenotypic study (continuation of FY 94 funding)

1999
Carolyn Deal, PhD: Hormone effects on pathogenesis & host cell interactions of N. Gonnorrhea

Vance Berger, PhD: Improving the evaluation of ovarian cancer treatment

Margaret Bash, MD, MPH: Antigenic characteristics and immungenicity of synthetic peptide vaccines for the pathogenic Neisseria: Neisseria meningitides and Neisseria gonorrhea (continuation of FY 98 award)


CDRH Funded Projects

1994
Carol Sierka: Consumer brochure on mammography

Carol Sierka: Development of MQSA Speaker Kits

Langone/Jacobs: Silicone Gel Alternatives Workshop

1995
Danica Marinac-Dabic, MD: Gender differences in early and long-term results of coronary angioplasty with Palmaz/Schatz stent

K. Myers, PhD: Non-invasive assessment of silicone migration from gel-filled breast implants

Keith A. Wear, PhD: Application of ultrasonic tissue characterization to diagnosis of bone disease

Paula G. Silberberg, MD: Contraceptive efficacy table for uniform contraceptive labeling-- a consumer focus group study - Part I

1996
Marwood N. Ediger, PhD: Development of a safe, economical assay for silicone containment in blood and tissue

Matthew R. Myers, PhD: A computer model for simulating virus transport through barriers

Paula Silberberg, MD: Reactions of women to contraceptive efficacy tables for uniform contraceptive labeling -- a consumer focus group study--Part II

Melvyn Greberman, MD, MPH: The transfer of defense, intelligence and space technologies for the early detection and control of cancers in women (conference)

1997
IOM study: A study of safety of silicone breast implants

S. Lori Brown, MD: Protocol for a study of breast implant rupture (co-funded by FDA-OC)

Robert Jennings, PhD: Optimization of mammography

Rosalie Bright, ScD: Mammography breast cancer screening rates among disadvantaged women within a pre-paid health care system

Danica Marinac-Dabic, MD: Gender differences in early and long-term results of coronary angioplasty with the Palmaz/Schatz stent

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

Danica Marinac-Dabic, MD: Epidemiology of medical devices in women (conference)

1998
Keith Wear, PhD: Development and validation of ultrasonic backscatter measurement for bone density assessment

Patricia Dubill, PhD: Abrasion testing of breast implants

James Karanian, PhD: Ovarian steroids and cardiovascular disease: the role of gender in the effectiveness of interventional medical devices

S. Lori Brown, M.D.: Protocol for a study of breast implant rupture (continuation from FY 97 funding)

Roselie Bright, ScD: Presentation of findings at the 14th International Conference on Pharmacoepidemiology (in conjunction with funded FY 97 project)

Danica Marinac-Dabic, MD: Conference on Epidemiology of medical devices in women

(publication of presentations from FY 97 project)

Harvey Rudolph, PhD: Accerlated aging studies of condoms/condom materials

Harvey Rudolph, PhD: Flow studies and the use of a waveguide in cardiovascular devices

1999
Rosalie Bright, ScD: Active Postmarketing surveillance methods: A Hospital pilot

Robert Navazio, Ph.D "Assessment of consumer understanding of barrier contraception and tampon labeling: Focus Group Studies"

2000
Brad Astor, Ph.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"



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