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APPENDIX C Commidee Biographies Jerome F. Strauss III, M.D., Ph.D., is the Luigi Mastroianni, fr. Professor and director of the Center for Research on Reproduction and Women's Health at the University of Pennsylvania Medical Center, and associate chairman, Department of Obstetrics and Gynecology. Dr. Strauss's labo- ratory has three primary interests: (1) the regulation of steroid hormone synthesis in ovary and placenta, (2) polycystic ovary syndrome, (3) the biology of fetal membranes, and (4) the molecular basis of sperm motility. Dr. Strauss is a member of the Institute of Medicine, the National Advi- sory Child Health and Human Development Council, and is the current president of the Society for Gynecologic Investigation. He also serves as the U.S. chair of the Indo-U.S. Joint Working Group on Contraceptive Development and Reproductive Health. Lisa Brannon-Peppas, Ph.D., is a research professor in the Department of Biomedical Engineering at the University of Texas, Austin. With degrees in chemical engineering, her research efforts focus on finding ways to expand the utility of biodegradable microparticles and nanoparticles to more effectively treat and prevent disease through the targeted delivery of drugs. Formerly, Dr. Brannon-Peppas was president and founder of Biogel Technology, Inc. (Indianapolis, IN). The company, created in 1991, was a research-driven enterprise that specialized in applying the tech- nologies of polymer science to controlled delivery, separations, bio- materials, bioadhesives, and other areas. The company was active in research, development, and preparation of polymeric materials in biotech- nology, bioengineering, medical sciences, and industrial pharmacy. 212

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APPENDIX C 213 Robert E. Braun, Ph.D., is an associate professor in the Department of Genome Sciences at the University of Washington, Seattle. His laboratory studies a variety of topics related to mammalian germ cell differentiation. One focus of his work is to understand the mechanism and the impor- tance of posttranscriptional gene regulation in germ cells. A second research interest is the mechanism of androgen regulation of mammalian spermatogenesis. A third area of interest is the genetic control of germ line stem cell self-renewal. Dr. Braun has served as a standing member on the Reproductive Biology Study Section of the National Institutes of Health (NIH) and an ad hoc member on several special study sections. He organized the NIH Workshop on New Approaches to Male Contraception as well as a Keystone Meeting on Germ Cell Differentiation and is cur- rently on the editorial board of the Biology of Reproduction. Marlene L. Cohen, Ph.D., is vice president of Creative Pharmacology Solutions LLC. She is also adjunct professor of pharmacology at the Indiana University School of Medicine. She recently retired as a Lilly Research Fellow from the Lilly Research Laboratories, Eli Lilly & Com- pany, where she worked for more than 25 years in drug development and was involved in all stages of product development, from target validation to clinical testing. Her work at Lilly covered a broad array of targets, including anxiety, depression, migraines, and obesity. She holds more than 25 patents and has published more than 200 publications in peer- reviewed journals while at Lilly. Vanessa E. Cullins, M.D., M.P.H., M.B.A., is vice president for medical affairs, Planned Parenthood Federation of America, Inc. (PPFA), New York, NY. In this capacity, she oversees clinical services, clinical business development, the PPFA Nurse Practitioners Program in Women's Health, the newly established PPFA Multi-Center Trial Network, and Affiliate Evaluation Department. Her administrative interests center around im- proving the quality of reproductive health service delivery through data analysis, interdisciplinary problem identification, problem solving, project planning, and project implementation. She currently serves on the New York State Department of Health Committee for the Care of Women with HIV Infection and is a member of the boards of directors of the Contraception Foundation and the Association of Reproductive Health Professionals. Jacqueline E. Darroch, Ph.D., is senior vice president and vice president for science at The Alan Guttmacher Institute, New York, NY. She has expertise in demography and sociology, with a specialization in repro-

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214 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH ductive health behavior. She has a long-standing interest in sexual and reproductive health and rights, especially in relation to public policy and public education, including topics such as family planning, contraception, sexually transmitted diseases, and maternal health. She has also studied contraceptive service delivery and financing and method use effectiveness. Mahmoud Fathalla, M.D., is the professor of obstetrics and gynecology and former dean of the Medical School at Assiut University, Egypt, and is current chairman of the World Health Organization (WHO) Global Advi- sory Committee on Health Research. Former positions include director of the United Nations Development Program/United Nations Population Fund/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction; senior adviser, Bio- medical and Reproductive Health Research, the Rockefeller Foundation; president of the International Federation of Gynaecology and Obstetrics; and chairman of the International Medical Advisory Panel of the Inter- national Planned Parenthood Federation. Linda C. Giudice, M.D., Ph.D., is the Stanley McCormick Memorial Professor of Obstetrics and Gynecology, chief of Reproductive Endocri- nology and Infertility, and director of Women's Health at Stanford at the Stanford University Medical Center. Her scientific and clinical interests focus on women's reproductive health, with a major interest in disorders of ovulation, infertility, endometriosis, embryo implantation, in vitro fertilization, contraception, endometrial biology, and stem cell research. She is currently coordinating a collaborative National Institutes of Health consortium for the genome-wide investigation of gene expression in the human endometrium relative to fertility and endometriosis. Anna Glasier, M.D., is the director, Family Planning & Well Women Services, Lothian Primary Care National Health Service Trust, Edinburgh, Scotland. She is also senior lecturer, University of Edinburgh Department of Obstetrics and Gynecology. Her clinical research has focused on hor- monal interventions for contraception, with a particular focus on emer- gency contraception. She has served on many committees of the World Health Organization that deal with contraception and family planning. Noted publications include Contraception Past and Future, which was published in Nature Medicine in 2002. Michael Harper, Ph.D., Sc.D, M.B.A., is professor of obstetrics and gyne- cology, Eastern Virginia Medical School, director of the Consortium for Individual Collaboration in Contraceptive Research, and director of the Global Microbicide Project of CONRAD. CONRAD seeks to develop

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APPENDIX C 215 better, safer, and more acceptable methods of fertility regulation, with an emphasis on suitability for use in developing countries. Priority is given to moving promising lead compounds through phase I and II clinical trials. Dr. Harper's previous experience as technical officer at ICI Pharma- ceuticals involved research on antihormonal agents for contraception and cancer therapy and the discovery of tamoxifen. Dr. Harper worked for the World Health Organization/Reproductive Health and Research program from 1972 to 1975 and has consulted for the World Health Organization, the U.S. Agency for International Development, the National Institute of Child Health and Human Development, the National Science Founda- tion, and the Andrew W. Mellon Foundation. Gregory S. Kopf, Ph.D., is the assistant vice president for contraception, Women's Health Research Institute at Wyeth Research in Collegeville, PA, and adjunct professor of obstetrics and gynecology at the University of Pennsylvania School of Medicine. His academic research interests focused on signal transduction in gamete activation, fertilization, and preimplan- tation embryo development. At Wyeth, his group is mining genomic da- tabases in search of potential novel targets for contraception and is also working with a number of academic scientists who are using new tech- nologies to identify potential targets. Martin M. Matzuk, M.D., Ph.D., is the Stuart A. Wallace Chair and pro- fessor of the Departments of Pathology, Molecular and Cellular Biology, and Molecular and Human Genetics at Baylor College of Medicine. His research focuses on generating and studying transgenic mice with im- paired fertility and ovarian and testicular cancer with the goal of identify- ing and characterizing novel genes and pathways that are critical for reproduction and that thus represent targets for contraception in humans. He has received multiple honors, including awards from the Endocrine Society, the Society for the Study of Reproduction, and the American Society for Investigative Pathology. In 2001, he received a prestigious MERIT Award from the National Institutes of Health. Dr. Matzuk has published more than 160 papers and holds several patents for modified forms of reproduction-related hormones and transgenic models. Ruth Merkatz, R.N., Ph.D., is Director, Team Leader for Women's Health, including the contraceptive product line, at Pfizer Inc. Previously, she was the first director of the Food and Drug Administration's (FDA's) Of- fice of Women's Health, where she worked on regulation of breast im- plants, contraceptives, and other issues of particular importance to women, such as breast cancer, sexually transmitted diseases, and os- teoporosis. She took the lead with FDA's Center for Drug Evaluation and

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216 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH Research to change FDA policy to allow women of childbearing potential to participate in early-phase drug trials and to ensure sex and gender analyses as part of drug development. Before joining FDA, Dr. Merkatz served as assistant director of nursing and director of Clinical Programs for Women and Children at the lack D. Weller Hospital of the Albert Einstein College of Medicine (AECOM), Montefiore Medical Center. She holds an appointment as associate clinical professor of obstetrics, gyne- cology, and women's health at AECOM. Nancy Padian, M.P.H., Ph.D., is professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco (UCSF), and the Department of Epidemiology and Biostatistics at UCSF and at the School of Public Health, University of California Berkeley. She is director of the UCSF Women's Global Health Institute and of inter- national research at the UCSF AIDS Research Institute, as well as co- director of the Center for Reproductive Health Research and Policy. She also served as vice chair of the University of California Task Force on AIDS. Padian has served as principal investigator on numerous federally and privately funded research projects with high-risk populations. Her domestic research currently addresses adolescent reproductive health among teenagers in immigrant and minority communities. The major objective of her international research program is to reduce the risk of HIV infection among young women primarily through the use of female- controlled methods of prevention, such as microbicides or barrier contra- ceptives, and through the development of programs that foster economic independence and thus reduce reliance on male sexual partners. In col- laboration with colleagues at the University of Zimbabwe (UZ) 8 years ago, she founded the UZ-UCSF Collaborative Research Program in Women's Health located in Zimbabwe, where she currently has eight research projects, and more recently she was awarded two grants on HIV prevention among women in India and one grant on HIV prevention among women in Mexico. Dr. Padian is a frequent participant in annual National Institutes of Health (NIH) Office of AIDS Research planning workshops and in 2003 was asked to chair the workshop on international research. She sits on the NIH AIDS Epidemiology Study Section and is an elected member to the American Epidemiology Society. Regine L. Sitruk-Ware, M.D., is a reproductive endocrinologist and holds the position of executive director of product research and development at the Population Council's Center of Biomedical Research. She organizes preclinical research and clinical development of new molecules designed for reproductive health care in men and women suitable for use in devel- oping countries. She is a program director for a cooperative contraceptive

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APPENDIX C 217 research center of the NICHD. Prior to joining the Council, Sitruk-Ware had successively an academic career and then a career in industry in research and development. She taught and conducted clinical research in reproductive endocrinology at the University of Paris for 10 years. She was a member of the International Committee for Contraceptive Research, which was established by the Population Council in 1970. She is a member of several national and international medical societies. Sitruk-Ware has written eight books and over 200 articles and reviews, mostly dealing with women's health care issues. She served as adviser on several ad hoc com- mittees of the World Health Organization and the National Institutes of Health. She received her medical doctorate at the University of Paris and is currently an adjunct professor at Rockefeller University.

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218 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH Antisense RNA A complementary strand of RNA that blocks the tran- scription of a naturally occurring (sense) messenger RNA molecule by binding to it. Autocrine signaling Secretion of a substance, such as a growth factor, that stimulates the secretory cell itself. Azoospermia Absence of living sperm in semen. Barrier method A contraceptive method that establishes a physical or chemical barrier between the sperm and ovum, e.g., condom, dia- phragm, foam, sponge, cervical cap. Some of the barrier contracep- tives are used in conjunction with a spermicidal agent. Bioavailability The degree to which a drug (or other substance) becomes available to the target tissue after administration. Biotechnology The collection of industrial processes that involve the use of biological systems. For some industries, the processes involve the use of genetically engineered organisms. Capacitation A process that takes place in the female reproductive tract by which sperm acquire the ability to fertilize an egg. cDNA see Complementary DNA cDNA subtraction hybridization methods A technique used to identify genes expressed differentially between two tissue samples. A large excess of mRNA from one sample is hybridized to cDNA from the other, and the double-stranded hybrids are removed by physical means. The remaining cDNAs are those that are not represented as RNA in the first sample and, thus, that are presumably expressed uniquely in the second sample. To improve specificity, the process is often repeated several times. Cervical cap Small latex or plastic cap that covers the cervix. Users of this barrier method of birth control must spread spermicidal cream or jelly inside the cap. Cervix Literally, "neck"; the constricted part of an organ; the cervix of the uterus is the lower and narrow end of the uterus that opens into the vagina. For pregnancy to occur, sperm must pass through the cervix into the uterus. Chemotaxis The attraction or repulsion of a cell by a chemical gradient. Chemotaxis affects the direction of motion only. Chorionic gonadotropin A glycoprotein produced by the primate placenta that plays a role in stimulating ovarian secretion of estrogen and progesterone during the first trimester of pregnancy. Clinical testing Trials to determine the safety and efficacy of a drug or device in humans. Complementary DNA (cDNA) DNA that is synthesized from a messen- ger RNA template by the enzyme reverse transcriptase. The single- stranded form of cDNA can be used as a probe to find a gene.