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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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