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APPENDIX B Agenclas and Parlicipants in Committee Workshops International Symposium on New Frontiers in Contraceptive Research The National Academies 2101 Constitution Avenue Washington, DC TUESDAY, JULY 15, 2003 8:00 AM WELCOME REMARKS Jerome Strauss, M.D., Ph.D., University of Pennsylvania INTRODUCTION TO SYMPOSIUM Allan Rosenfield, M.D., Columbia University 8:30 AM DISCOVERY APPROACH TO TARGET SELECTION AND VALIDATION Moderator: Robert Braun, Ph.D., University of Washington Moderator: Martin Matzuk, M.D., Ph.D., Baylor College of Medicine Insights from the testicular transcriptome: Michael Griswold, Ph.D., Washington State University Proteomics and the discovery of contraceptive drug and vaccine targets: John C. Herr, Ph.D., University of Virginia Toward a comprehensive analysis of the genetic control of male fertility: Barbara Wakimoto, Ph.D., University of Washington 202

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APPENDIX B 10:00 AM BREAK 203 10:15 AM Toward the genetics of mammalian reproduction: Induction and mapping of gametogenesis mutants in mice: John Schimenti, Ph.D., The Jackson Laboratory Model organisms: The use of Xenopus Levis as a potential model for contraceptive research: Laurence D. Etkin, Ph.D., MD Anderson Cancer Center Trapping participants of the oocyte-granulosa cell regula- tory loop as potential contraceptive targets: John Eppig, Ph.D., The Jackson Laboratory 11:45 AM FROM TARGET SELECTION TO PRODUCT DEVELOPMENT Moderator: Gregory S. Kopf, Ph.D., Wyeth Research Charles Grudzinskas, Ph.D., Drug Development Consultant 12:15 PM LUNCH 1:15 PM FUNCTIONAL TARGETS FOR CONTRACEPTION Moderator: Linda Giudice, M.D., Ph.D., Stanford University Moderator: Gregory S. Kopf, Ph.D., Wyeth Research Leptin peptide antagonists: Down-regulation of leptin actions in embryo implantation: Ruben Gonzalez, Ph.D., Boston Biomedical Research Institute Gamete membrane fusion: A genetic approach: Diana Myles, Ph.D., University of California, Davis Using chemical genetics to study regulators of fertility: Caroline Shamu, Ph.D., Harvard Medical School 2:45 PM BREAK 3:00 PM SMALL GROUP DISCUSSIONS STD Prevention and Contraception: Should research be pursued jointly or separately? Moderator: Nancy Padian, Ph.D., University of California, San Francisco Target Selection: What criteria should be used to select promising targets? Moderator: Jerome Strauss, M.D., Ph.D., University of Penn- sylvania

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204 NEW FRONTIERS IN CONTRACEPTIVE RESEARCH Adoption of Contraceptives: What are the challenges associ- ated with adopting contraceptives and how can they be overcome? Moderator: Jacqueline Darroch, Ph.D., Alan Guttmacher Institute Immunological Approaches and Contraceptive Research: What is the future outlook? Moderator: Michael Harper, Ph.D., Sc.D., CONRAD Evaluation of Contraceptives: What are the obstacles to preclinical evaluation and proof of concept in contra- ceptive development and how can they be overcome? Moderators: Marlene Cohen, Ph.D., Independent Consultant; Ruth Merkatz, Ph.D., R.N., Pfizer 5:00 PM ADJOURN WEDNESDAY, JULY 16, 2003 8:00 AM ADVANCES IN MATERIALS SCIENCE Moderator: Lisa Brannon-Peppas, Ph.D., University of Texas, Austin Overview of controlled release: Thomas Tice, Ph.D., Southern Research Institute An overview of controlled release technology in contracep- tive devices: Camilla Santos, Ph.D., Spherics, Inc. Development of injectable, biodegradable microsphere products for sustained drug delivery: Mark Tracy, Ph.D., Alkermes, Inc. 9:30 AM BREAK 9:45 AM CASE STUDIES IN CONTRACEPTIVE DEVELOPMENT Moderator: Anna Glasier, M.D., University of Edinburgh Contraceptive microbicide development: Lessons from mucosal ecology: Kevin Whaley, Ph.D., Epicyte Pharma- ceutical, Inc.; Johns Hopkins University; ReProtect, Inc.; Mapp Pharmaceutical, Inc. Male hormonal contraception: William Bremner, M.D., Ph.D., University of Washington Biosyn/C31G: Anne Marie Corner, M.B.A., Biosyn; Daniel Malamud, Ph.D., University of Pennsylvania; Kurt Barnhart, M.D., University of Pennsylvania

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APPENDIX B 11:45 AM LUNCH 205 12:45 PM CHALLENGES AND SOLUTIONS IN CONTRACEPTIVE PRODUCT DEVELOPMENT AND EVALUATION Moderator: Regine Sitruk-Ware, M.D., Population Council Challenges and solutions in contraceptive product develop- ment and evaluation: A U.S. regulatory perspective: Lisa Rarick, M.D. Giving choices in family planning: Paul F.A. Van Look, M.D., Ph.D., World Health Organization Applicability of contraceptive research to the need of women in developing countries: Ellen Elizabeth Hardy, Ph.D., Universidade Estadul de Campinas, Brazil Exploring user issues that affect contraceptive development and introduction: Kim E. Dickson, M.D., Reproductive Health Research Unit, South Africa 2:45 PM BREAK 3:00 PM PANEL DISCUSSION Moderator: Nancy Padian, Ph.D., University of California, San Francisco Diana Blithe, Ph.D., National Institute of Child Health and Human Development, National Institutes of Health Laneta Dorflinger, Ph.D., Family Health International Henry Gabelnick, Ph.D., CONRAD Maurizio Macaluso, M.D., Dr.PH, Centers for Disease Control and Prevention Jeffrey Spieler, U.S. Agency for International Development 4:30 PM SUMMARY Jerome Strauss, M.D., Ph.D., University of Pennsylvania 5:00 PM ADJOURN

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206 Nancy Alexander Organon Pharmaceuticals USA Inc. Amy Allina National Women's Health Network Suresh Arya National Institutes of Health **Kurt Barnhart University of Pennsylvania Wendy Barr University of Pennsylvania Margaret Battin University of Utah Gabriel Bialy National Institute of Child Health and Human Development, National Institutes of Health Holly Blanchard Planned Parenthood of Metropolitan Washington, DC **Diana Blithe National Institute of Child Health and Human Development, National Institutes of Health Lisa Brannon-Peppas The University of Texas at Austin *Committee Member **Workshop Speaker *** Sponsor Representative NEW FRONTIERS IN CONTRACEPTIVE RESEARCH WORKSHOP PARTICIPANTS Robert E. Braun University of Washington **William Bremner University of Washington Carolyn Brown Private Practice-Physician Arkansas Stephanie Brown Wyeth Pharmaceuticals Erika Check Nature Marlene L. Cohen Creative Pharmacology Solutions, LLC Doug Colvard CONRAD Program Carmela Cordero Engend er He al th **Anne Marie Corner Biosyn ~Vanessa E. Cullins Planned Parenthood Foundation of America Jacqueline E. Darroch Alan Guttmacher Institute Louis Depaolo NICHD, NIH

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APPENDIX B **Kim E. Dickson Reproductive Health Research Unit, South Africa **Laneta Dorflinger Family Health International Regine Douthard USAID Allison Doyle Johns Hopkins University Charlotte Ellertson Ibis Reproductive Health Collette Eccleston National Academy of Sciences Eugenia Eckard Office of Population Affairs Edward Eddy NIEHS, NIH **John Eppig The Jackson Laboratory **Laurence D Etkin MD Anderson Cancer Center **Henry Gabelnick CONRAD **Ruben Gonzalez Boston Biomedical Research Institute **Mike Griswold Washington State University ** Charles V. Grudzinskas Drug Development Consultant 207 ~Mahmoud Fathalla Assiut University, Egypt Mary Feeney National Academy of Sciences Shira Fischer Institute of Medicine Karin French Takoma Park, MD Linda C. Giudice Stanford University Medical Center Anna Glasier Lothian Primary Care NHS Trust Phyllis Greenberger Society for Women's Health Research Gary Grubb Wyeth Research **Ellen Elizabeth Hardy Universi da de E s ta dul de Campinas, Brazil Michael Harper Eastern Virginia Medical School Florence Haseltine National Institute of Child Health and Human Development, National Institutes of Health Joanne Hawana The Blue Sheet **John C. Herr University of Virginia

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208 Maria Herrero University of Virginia Laura Hessburg National Family Planning and Reproductive Health Association Mai Hijazi USAID Tom Hollon The Scientist Judith Johnson Library of Congress Michael Kafrissen Ortho-McNeil Pharmaceutical Mihira Karra USAID Sarah Kieweg Duke University Hyun K. Kim National Institutes of Health Dreg Kopf Discovery Women's Health Research Institute, Wyeth Research Trisha Lamphear Alliance for Microbicide Development *Committee Member **Workshop Speaker *** Sponsor Representative NEW FRONTIERS IN CONTRACEPTIVE RESEARCH rune Lee National Institutes of Health Phyllis Leppert National Institute of Child Health and Human Development, National Institutes of Health Yi-Nan Lin Baylor College of Medicine Kim Lundberg George Washington University Joanne Luoto National Institutes of Health **Maurizio Macaluso Centers for Disease Control and Prevention Trent Mackay CPR/NICHD/NIH **Daniel Malamud University of Pennsylvania Judy Manning U.S. Agency for International Development Steve Marcus Newton, MA Danica Marinac-Dabic Center for Devices and Radiological Health

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APPENDIX B Martin Matzuk Baylor College of Medicine Elizabeth McCarthy Institute of Medicine Janice Mehler The National Academies Ruth Merkatz Pfizer, Inc. Nigel Mcwilliam CONRAD Kate Miller Ibis Reproductive Health Marjorie Miller Wyeth Shirine Mohagheghpour Planned Parenthood Federation of America Kirsten Moore Reproductive Health Technologies Project rohanna Morfesis Planned Parenthood Federation of America, Inc Tamarah Moss Advocates for Youth **Diana Myles University of California, Davis Sharyl Nass Institute of Medicine 209 Deborah O'Brien University of North Carolina School of Medicine Ann O'Hanlon National Partnership for Women & Families Nancy Padian University of California, San Francisco Gordon Perkin Bill and Melinda Gates Foundation Tracy Rankin National Institutes of Child Health and Human Development **Lisa Rarick Formerly, U.S. Food and Drug Administration Neelakanta Ravindranath Georgetown University Medical Center Pat Reichelderfer NICHD Ericka Reid National Academy of Engineering **Allen Rosenfield Columbia University **Camille Santos Spherics, Inc.

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210 Kate Schaffer Ibis Reproductive Health Gerald Schatten Pittsburgh Development Center **John Schimenti The Jackson Laboratory **Caroline Shamu Harvard Medical School Karen Shea Planned Parenthood Federation of America Emily Shen Wyeth Pharmaceuticals Wayne Shields Association of Reproductive Health Professionals Viviana Simon Society for Women's Health Research Ashley Simons-Rudolph The George Washington University Engine Sitruk-Ware Population Council Harris Solomon USAID Jeff Solomon Wyeth Pharmaceutical *Committee Member **Workshop Speaker *** Sponsor Representative NEW FRONTIERS IN CONTRACEPTIVE RESEARCH **Jeffrey Spieler U.S. Agency for International Development Robert Spirtas National Institute of Child Health and Human Development, National Institutes of Health Felicia Stewart University of California, San Francisco Jerome Strauss III University of Pennsylvania Medical Center Gretchen Stuart UT Southwestern Medical Center Amy Swann Association of Reproductive Health Professionals Sheila Talafous Wyeth Pharmaceuticals Joseph Tash University of Kansas Medical Center John Townsend Population Council **Mark Tracy Alkermes, Inc. s

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APPENDIX B Theresa Van Der Vlugt Food and Drug Administration **Paul F.A. Van Look World Health Organization Ulyana Vjugiua Johns Hopkins University Kirsten Vogelsong World Health Organization **Barbara Wakimoto University of Washington 211 Tracy Weitz UCSF Center for Reproductive Health Research & Policy **Kevin Whaley Epicyte Merrick Wright Johns Hopkins School of Public Health Wei Yan Baylor College of Medicine Koji Yoshinaga NICHD, NIH