E: Agendas and Participants in Committee Workshops

Workshop on Contraceptive Research and Development and the Frontiers of Contemporary Science

December 8-9, 1994

Room 130, Cecil and Ida Green Building

2001 Wisconsin Avenue, NW

Washington, DC 20015

Thursday , December 8 , 1994

8:45 a.m

WELCOME

Allan Rosenfield, chair

Polly Harrison

9:00 a.m.

OPENING REMARKS

Kenneth Shine

Mahmoud Fathalla

9:30 a.m.

MALE CONTRACEPTION

William Bremner, overview

Frank French

David Hamilton

Geoffrey Waites

10:15 a.m.

MENSES INDUCERS

Paul Van Look, overview

Horacio Croxatto

11:00 a.m.

BARRIERS AGAINST STD/HIV AND HIV ATTACHMENT-PREVENTION

Nancy Alexander, overview

Lourens Zaneveld



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--> E: Agendas and Participants in Committee Workshops Workshop on Contraceptive Research and Development and the Frontiers of Contemporary Science December 8-9, 1994 Room 130, Cecil and Ida Green Building 2001 Wisconsin Avenue, NW Washington, DC 20015 Thursday , December 8 , 1994 8:45 a.m WELCOME Allan Rosenfield, chair Polly Harrison 9:00 a.m. OPENING REMARKS Kenneth Shine Mahmoud Fathalla 9:30 a.m. MALE CONTRACEPTION William Bremner, overview Frank French David Hamilton Geoffrey Waites 10:15 a.m. MENSES INDUCERS Paul Van Look, overview Horacio Croxatto 11:00 a.m. BARRIERS AGAINST STD/HIV AND HIV ATTACHMENT-PREVENTION Nancy Alexander, overview Lourens Zaneveld

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--> 11:45 a.m. VACCINES Paul Primakoff, overview John Herr 12:30 p.m. LUNCH 1:30 p.m. New Thoughts About Old Ideas Henry Gabelnick 2:00 p.m. AREA 1—BASIC GENETICS Genetic screening and mapping, gene expression, and transcription factors Moderator: Bert O'Malley Principals: Walter Gilbert Donald McDonnell David Page Allen Spradling 3:30 p.m. AREA 2—CONTROL/ACTION Signal transduction, releasing factors, RAFT proteins, ion channels, peptide receptors, and steroid hormone synthesis Moderator: Jerome Strauss Principals: Bertil Hille Andrés Negro-Vilar Neena Schwartz Roy Smith Robert Stein 5:00 p.m. ADJOURN 6:00 p.m. Reception/Buffet

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--> Friday , December 9 , 1994 9:00 a.m. AREA 3-PRE-FERTILIZATION TO FERTILIZATION Apoptosis, ovulation and the ovaries, meiotic and mitotic cell cycles, mammalian fertilization, molecular basis of gamete interaction, and signalling pathways Moderator: David Garbers Principals: Aaron Hsueh William Lennarz JoAnne Richards Patricia Saling Debra Wolgemuth 10:30 a.m. AREA 4-POST-FERTILIZATION TO IMPLANTATION Angiogenesis, apoptosis, and implantation (cytokine function, integrin biology, and trophoblast invasion) Moderator: Susan Fisher Principals: Mina Bissell Michael Harper Judah Folkman Bruce Lessey 12:00 p.m. LUNCH 1:00 p.m. AREA 5-METHODOLOGIES Combinatorial chemistry, appropriate modelling Walter Moos Jeffrey Harris 1:30 p.m. AREA 6-INFECTIOUS DISEASES AND IMMUNOLOGY Deborah Anderson Jiri Mestecky 3:00 p.m. REVIEW PANEL Horacio Croxatto Egon Diczfalusy Bert O'Malley 4:00 p.m. ADJOURN

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--> Saturday , December 9 , 1994 8:30 a.m. Executive Session of the Committee 12:00 p.m. ADJOURN Workshop Participants Nancy J. Alexander Chief, Contraceptive Development Branch Center for Population Research National Institute for Child Health and Human Development National Institutes of Health Deborah J. Anderson Associate Professor Harvard Medical School Fearing Research Laboratory Felice M. Apter Center for Population, Health, and Nutrition Bureau for Global Programs U.S. Agency for International Development Hedia Belhadj El Ghouayel Technical and Evaluation Division United Nations Population Fund Balbir Bhogal Director of Immunology Zonagen, Inc. Gabriel Bialy Acting Deputy Director Center for Population Research National Institute for Child Health and Human Development National Institutes of Health Mina J. Bissell Director Life Sciences Division Lawrence Berkeley Laboratory William J. Bremner Professor and Vice Chairman Department of Medicine University of Washington Donald D. Brown Director Department of Embryology Carnegie Institute of Washington Nancy L. Buc Partner Buc and Beardsley Washington, DC Peter F. Carpenter Founder/Director Mission and Values Institute Stanford University Willard Cates, Jr. Director, Division of Training Centers for Disease Control and Prevention Rebecca J. Cook Associate Professor Faculty of Law University of Toronto

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--> Horacio B. Croxatto Professor Instituto Chileno de Medicina Egon Diczfalusy Professor Emeritus Karolinska Hospital Laneta Dorflinger Director Clinical Trials Division Family Health International Richard H. Douglas Vice President for Corporate Development Genzyme Corporation Mahmoud F. Fathalla Senior Advisor for Biomedical and Reproductive Health Research The Rockefeller Foundation, and Professor of Obstetrics and Gynaecology Assiut University Susan J. Fisher Professor and Chair Division of Oral Biology University of California at San Francisco Jonathan J. Fleming General Partner Matrushka Venture Capital (MVC) Judah M. Folkman Professor of Pediatrics Harvard Medical School Frank S. French Director Laboratories for Reproductive Biology Department of Pediatrics School of Medicine University of North Carolina at Chapel Hill Henry L. Gabelnick Director and Principal Investigator Contraceptive Research and Development (CONRAD) Program Professor, Department of Obstetrics and Gynecology Eastern Virginia Medical School David L. Garbers Professor of Pharmacology Howard Hughes Medical Institute University of Texas Southwestern Medical Center Walter Gilbert Professor Harvard University The Biological Laboratories Allan Goldhammer Director for Research Activities Biotechnology Industry Organization (BIO) David W. Hamilton Professor and Head Department of Cell Biology and Neuroanatomy University of Minnesota Michael J.K. Harper Professor Department of Obstetrics and Gynecology Baylor College of Medicine

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--> Jeffrey D. Harris Director of Molecular Biology Zonagen, Inc. Polly F. Harrison Study Director Division of Health Sciences Policy Institute of Medicine John M. Herr, Jr. Professor of Cell Biology Director, Center for Recombinant Gamete Vaccinology University of Virginia Medical School Bertil Hille Professor Department of Physiology University of Washington Gregory F. Hollis Director Cellular and Molecular Biology Merck Research Laboratories Aaron J.W. Hsueh Professor Department of Obstetrics and Gynecology Stanford University Medical Center Timothy Kanaley Research Assistant Division of Health Sciences Policy Institute of Medicine William J. Lennarz Department of Biochemistry and Cell Biology State University of New York Bruce A. Lessey Department of Obstetrics and Gynecology University of North Carolina Dennis W. Lincoln Director Reproductive Unit, Edinburgh Medical Research Council Carolyn Makinson Program Officer Population Program Andrew W. Mellon Foundation Donald P. McDonnell Associate Professor of Pharmacology Duke University Medical Center Jiri Mestecky Professor Department of Microbiology University of Alabama Walter H. Moos Chemical Therapeutics Research Chiron Corporation David C. Mowery Associate Professor of Business and Public Policy University of California at Berkeley Andrés F. Negro-Vilar Director Women's Health Research Institute, and Vice President Wyeth-Ayerst Research

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--> Bert W. O'Malley Professor and Chair Department of Cell Biology Baylor College of Medicine David Page Whitehead Institute for Biomedical Research Massachusetts Institute of Technology Sandra Panem President Vector Fund Management Gordon W. Perkin President Program for Appropriate Technology in Health (PATH) Joseph S. Podolski President and Chief Executive Officer Zonagen, Inc. Paul Primakoff Department of Molecular and Cell Biology University of California at Davis JoAnne S. Richards Professor Department of Cell Biology Baylor College of Medicine Allan Rosenfield (Committee Chair) Dean, and DeLamar Professor of Public Health, and Professor of Obstetrics and Gynecology Columbia University School of Public Health Patricia M. Saling Associate Professor Department of Obstetrics and Gynecology Duke University Medical Center Neena B. Schwartz Professor Department of Neurobiology Northwestern University Bennett M. Shapiro Executive Vice President Worldwide Basic Research Merck Research Laboratories Valerie Setlow Director Division of Health Sciences Policy Institute of Medicine Kenneth I. Shine President Institute of Medicine Steven W. Sinding Director Population Sciences The Rockefeller Foundation Roy P. Smith Department of Biochemistry Merck Research Laboratories Jeffrey Spieler Senior Biomedical Research Advisor Center for Population, Health, and Nutrition Bureau for Global Programs United States Agency for International Development

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--> Allan C. Spradling Staff Member Howard Hughes Medical Institute Carnegie Institute of Washington Jacqueline Sherris Editor, Outlook Program for Appropriate Technology in Health (PATH) Robert Stein Senior Vice President, and Chief Scientific Officer Ligand Pharmaceuticals Jerome F. Strauss, III Professor and Director Center for Research on Women's Health University of Pennsylvania Laura Tangley Science Writer for the Institute of Medicine Paul Van Look Associate Director Special Programme of Research, Development, and Research Training in Human Reproduction World Health Organization Geoffrey M.H. Waites President, International Society for Andrology Kevin J. Whaley Research Scientist Department of Biophysics Johns Hopkins University Debra J. Wolgemuth Professor of Human Genetics and Development College of Physicians and Surgeons Columbia University Lourens J. D. Zaneveld Research Director Women's Health Research Center Professor Department of Obstetrics and Gynecology, and Department of Biochemistry Rush University, St. Luke's Medical Center Bai-ge Zhao Director Shanghai Institute of Planned Parenthood Research

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--> Agenda Workshop on Private Sector Participation in Contraceptive Research and Development: Opportunities, Challenges, Strategies May 11-12, 1995 Room 130, Cecil and Ida Green Building 2001 Wisconsin Avenue, NW Washington, DC 20015 Thursday , May 11 , 1995 8:45 a.m. Welcome Introduction of Participants Adoption of Agenda and Timetable Allan Rosenfield, Chair (All presentations on the rest of Day I will be of a length that will permit ample time for discussion.) Session 1: What We Have Done So Far 9:15 a.m. Thoughts and Conclusions from Bellagio Conference, April 10-14, 1995, on Public- and Private Sector Collaboration in Contraceptive Research and Development Mahmoud Fathalla 10:00 a.m. Findings from IOM Workshop on Contraceptive Research and Development and the Frontiers of Science, December 8-9, 1994 The Farther Frontier David Garbers The Middle Ground Andrés Negro-Vilar 11:00 a.m. Break

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--> Session 2: Challenges and Questions 11:15 a.m. Defining the Market: What Are the Needs? Jacqueline Forrest What Is the Market?—Measures and Calculations William Sheldon 12:15 p.m. Lunch 1:30 p.m. The Legal and Regulatory Scene: Changes and Perspectives at the FDA Philip Corfman Tort Reform Update Ellen Flannery 2:30 p.m. Industry Perspectives: A Panel Discussion Robert Essner Michael Kafrissen Hans Vemer Guenter Stock 3:45 p.m. Break 4:00 p.m. Instructions to Working Groups: Objectives and Framework for Discussions Allan Rosenfield/Polly Harrison (The composition of each Working Group will be balanced among the expertises and backgrounds of the participant group as a whole. A set of draft questions for the Groups is attached to this agenda.) 4:30 p.m. What Are the Most Important Political Perspectives in the United States and How Might These Be Taken into Account? The Honorable Nita M. Lowey The Honorable Constance A. Morella

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--> 5:30 p.m. Adjourn Buffet Reception 7:30 p.m. Brief Meeting of Each Working Group to Organize Itself and Marshal Initial Thoughts Friday , May 12 , 1995 8:45 a.m. Reconvene Briefly in Room 130 for trouble-shooting, questions, clarifications, et cetera. 9:00 a.m. Working Groups (continued) and Preparation of Working Group Reports 12:00 p.m. Lunch 1:00 p.m. Working Group Presentations by Rapporteurs Response Panel and Discussion Conclusions, Recommendations, Followup [A panel of individuals with expertise in the areas addressed on Day 1 will react to the conclusions and recommendations reported by each group , and moderate comments from the workshop audience as a whole.] 4:00 p.m. Adjournment 4:15 p.m. Meeting of Committee and Sponsors 5:15 p.m. Full Adjournment

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--> Workshop Participants Nancy J. Alexander** Chief, Contraceptive Development Center for Population Research National Institute for Child Health and Human Development National Institutes of Health Hedia Belhadj-El Ghouayel* Technical and Evaluation Division United Nations Population Fund Willem Bergink Program Manager for Reproductive Medicine Organon International B.V. Seth Berkley** Acting Director for Health Sciences The Rockefeller Foundation Enriqueta C. Bond President The Burroughs Wellcome Fund Lance Bronnenkant President and Chief Executive Officer Finishing Enterprises, USA Donald D. Brown* Director Department of Embryology Carnegie Institute of Washington Barbara Brummer Advanced Care Products Nancy L. Buc* Partner Buc, Levitt, and Beardsley Stephanie Burns Manager, FDA and Women's Health Dow Corning Corporation Peter F. Carpenter* Founder/Director, Mission and Values Institute Visiting Scholar, Center for Biomedical Ethics Stanford University Willard Cates, Jr.* Director Division of Training Epidemiology Program Office Centers for Disease Control and Prevention James Cavanaugh President HealthCare Investment Corporation Scott Chappel Senior Scientific Advisor Ares-Serono Michael Cohen Scientific Director Applied Medical Research, Ltd. Philip A. Corfman Supervisory Medical Officer for Fertility and Maternal Health U.S. Food and Drug Administration Rebecca J. Cook* Associate Professor, Faculty of Law University of Toronto *   Committee Member **   Sponsor Representative

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--> Horacio B. Croxatto* Professor Instituto Chileno de Medicina Reproductiva Bernard M. Dickens Professor, Faculty of Law, Faculty of Medicine Centre of Criminology and Centre for Bioethics University of Toronto Laneta Dorflinger Family Health International Richard H. Douglas* Vice President, Corporate Development Genzyme Corporation Robert Essner President Wyeth-Ayerst Laboratories Mahmoud F. Fathalla** Senior Advisor for Biomedical and Reproductive Health Research The Rockefeller Foundation, and Professor of Obstetrics and Gynaecology Assiut University Diane Feldman Vice President for Over-the-Counter Business Syntex Corporation Alan Ferguson Atlas Venture Mary Flack Parke-Davis Pharmaceutical Research Warner-Lambert Co. Ellen Flannery Partner Covington and Burling Jonathan Fleming Matrushka Venture Capital (MVC) Jacqueline D. Forrest Director of Research The Alan Guttmacher Institute Adrian Fugh-Berman** Contraceptive Development Branch National Institute for Child Health and Human Development National Institutes of Health Henry L. Gabelnick** Director Contraceptive Research and Development (CONRAD) Program Professor, Department of Obstetrics and Gynecology Eastern Virginia Medical School David L. Garbers Patrick E. Haggerty Distinguished Chair in Basic Biomedical Science Howard Hughes Medical Institute University of Texas Southwestern Medical Center at Dallas Philip Gevas President and Chief Executive Officer Aphton Pharmaceuticals Michael J.K. Harper* Professor, Department of Obstetrics and Gynecology Baylor College of Medicine

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--> Polly F. Harrison Study Director Division of Health Sciences Policy Institute of Medicine Robert Howells Director, Population Initiative The Wellcome Trust Leonard Jacob Executive Vice President and Chief Operating Officer Magainin Pharmaceuticals Michael Kafrissen Vice President for Clinical Affairs Ortho-McNeil Timothy Kanaley Research Assistant Division of Health Sciences Policy Institute of Medicine David H. Katz Chief Executive Officer and President Lidak Pharmaceuticals Walter Klemann Head, Strategic Business Unit, Fertility Control and Hormone Therapy Schering AG Susan Lambert Vice-President J&J Development Corporation Ortho-McNeil Pharmaceutical Samuel Lin Assistant Surgeon General (Ret.), US Public Health Service, and Executive Director, Federal Medical Affairs The Upjohn Company Ernest Loumaye Corporate Ob/Gyn Director Medical Affairs Department Serono Corporation Carolyn Makinson** Program Officer Population Program Andrew W. Mellon Foundation Donald Patrick McDonnell* Associate Professor of Pharmacology Department of Pharmacology Duke University Medical Center Jonathan Miles Brown Director of Technical Marketing Martek Biosciences Jonathan Missner Vice President, Operations Applied Medical Research, Ltd. David C. Mowery* Professor of Business and Public Policy Walter A. Haas School of Business University of California at Berkeley Andrés Negro-Vilar Director, Women's Health Research Institute, and Vice President Wyeth-Ayerst Research

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--> Mark J. Newman Vice President, Research and Development Vaxcel, Inc. Judy Norsigian* Codirector Boston Women's Health Book Collective Robert O'Neill Vice-President J&J Development Corporation Ortho-McNeil Pharmaceuticals Sandra Panem* President Vector Fund Management Audrey Phillips Research Manager Department of Reproductive Research R. W. Johnson Pharmaceutical Research Institute Jonathan Rosen Director, Transcription Research Ligand Pharmaceuticals Allan Rosenfield (Committee Chair)* Dean, and DeLamar Professor of Public Health, and Professor of Obstetrics and Gynecology Columbia University School of Public Health Jean Rowan Director, Clinical Programs Parke-Davis Pharmaceutical Research Warner-Lambert Co. Ekkehard Schillinger Head of Research Schering AG Sheldon Segal Distinguished Scientist The Population Council Valerie Setlow Director Division of Health Sciences Policy Institute of Medicine Bennett M. Shapiro* Executive Vice President Worldwide Basic Research Merck Research Laboratories William C. Sheldon President and Chief Executive Officer Applied Medical Research, Ltd. Kenneth I. Shine President Institute of Medicine Steven Sinding** Director, Population Sciences The Rockefeller Foundation Jeffrey Spieler** Senior Biomedical Research Advisor, Office of Population Center for Population, Health, and Nutrition Bureau for Global Programs United States Agency for International Development

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--> Felicia Stewart Deputy Assistant Secretary for Population Affairs Department of Health and Human Services, Public Health Service Pamela Stratton** Special Assistant in Gynecology and Clinical Research Contraceptive Development Branch National Institute of Child Health and Human Development National Institutes of Health Laura Tangley Science Writer for the Institute of Medicine Wylie Vale* Professor The Clayton Foundation Laboratories for Peptide Biology The Salk Institute Hans M. Vemer Director of Research and Medical Director Organon International B.V. David Woo President and Chief Scientific Officer Immunotherapy Corporation Craig Wright Vice President of Research and Development Novovax Lourens J. D. Zaneveld Research Director Women's Health Research Center Professor, Department of Obstetrics and Gynecology, and Department of Biochemistry Rush University, Rush-St. Luke's Medical Center Bai-ge Zhao* Director Shanghai Institute of Planned Parenthood Research