| Saturday, June 21 |
|
| |
|
| 1:00
PM – 5:00 PM |
EDUCATION
COURSE
(separate registration required) |
Integration
of Human and Animal Data in Understanding Mechanisms
and Risk for Human Birth Defects
Organized by the Education Committee; Dana Shuey, Chairperson
Sponsored by Endo Pharmaceuticals, Inc.
Coursebooks provided by CTBR
Refreshments sponsored by Covance and DuPont Haskell
Laboratory for Health and Environmental Sciences
Session I: Integration of Animal and Human Data
in Drug Development and Pregnancy Labeling: The Statins
as a Case Example
|
- 1:05
PM – 1:15 PM Welcome
|
William
Slikker, Jr., President, Teratology Society |
- 1:15
PM – 1:30 PM Introduction
|
Dana
Shuey, Endo Pharmaceuticals, Inc. |
- 1:30
PM – 2:20 PM Cholesterol and morphogenesis — Animal models
|
Speaker:
Max Muenke, NIH |
-
2:20 PM – 3:05 PM Cholesterol and morphogenesis — Human evidence.
|
Speaker: Richard Kelley, Johns Hopkins
University |
|
|
- 3:25
PM – 4:10 PM Preclinical developmental toxicity studies with statins.
|
Speaker: L. David Wise, Merck Research
Laboratories |
-
4:15 PM – 5:00 PM Integration of animal and human data in pregnancy labeling.
|
Speaker: Jeanne Manson, The Children’s
Hospital of Philadelphia |
|
|
| 8:15
AM - 11:30 AM |
EDUCATION
COURSE (CONTINUED FROM SATURDAY) |
Session
II: Animal Models in the Advancement of Understanding Mechanisms
and Risk of Human Defects |
-
8:00 AM – 8:45 AM Human neural tube defects — Current understanding of epidemiology,
genetics and risk factors.
|
Speaker: Cynthia Moore, Centers for
Disease Control
and Prevention |
-
8:45 AM – 9:30 AM Advances in animal models for understanding the role of folates
in neural tube defects.
|
Speaker: Richard Finnell, Texas A&M
University System Health Science Center |
|
|
|
-
9:45 AM – 10:30 AM Interspecies comparison of mechanisms of neurulation, implications
for interpretation of neural tube defects in developmental
toxicity studies.
|
Speaker: John DeSesso, Mitretek Systems
|
-
10:30 AM – 11:45 AM Autism — Clinical aspects, epidemiology, and advances in animal
models for understanding mechanisms and risk factors.
|
Speaker: Patricia Rodier, University
of Rochester |
| 1:00
PM - 4:40 PM |
MARCH
OF DIMES SYMPOSIUM |
|
Assisted
Reproductive Technology (ART) and Reproductive Problems:
What Are the Facts and Issues?
Organized by Barbara Struthers,
B.J. Struthers, Ltd. and Stephen Harris, Stephen B. Harris
Group.
Sponsored by March of Dimes Birth
Defects Foundation Grant No. 4-FY02-262, and by TAP Pharmaceutical
Products, Inc.
|
-
1:00 PM – 1:40 PM S1 A clinical introduction to ART.
|
Speaker: Anthony Scialli, Georgetown
University |
-
1:40 PM – 2:20 PM S2 Congenital anomalies in ART.
|
Speaker: David Adamson, Advanced Reproductive
Care, Inc. |
|
|
|
-
2:40 PM – 3:20 PM S3 High birth weights in IVF and cloned calves.
|
Speaker: Gary Anderson, UC Davis
|
-
3:20 PM – 4:00 PM S4 Methodologic issues in examining the incidence of birth defects
in infants born to ART patients.
|
Speaker: Jim Mills, NICHD
|
-
4:00 PM – 4:40 PM S5 Off-label use of drugs in ART — A curse or a blessing? An
industry perspective.
|
Speaker: Ashraf Youssef, TAP Pharmaceutical
Products, Inc. |
| 5:00
PM - 6:00 PM |
ISSUES
FORUM |
|
Meet the Editors; Meeting with Other
Organizations in 2007. |
William
Slikker, Jr., President, Teratology Society |
| 5:00
PM - 7:30 PM |
EXHIBITS
OPEN |
| 6:00
PM - 7:30 PM |
WELCOMING
RECEPTION |
|
|
| 8:00
AM - 9:00 AM |
THE
JOSEF WARKANY LECTURE:
Autism as a Birth Defect.
Speaker:
Patricia Rodier, Department of
Obstetrics/Gynecology, University of Rochester |
| 9:00
AM - 9:50 AM |
The
James G. Wilson Publication Award Presentation and Address
Mitochondrial
Transduction of Ocular Teratogenesis During Methylmercury
Exposure.
Michael F. O'Hara, Covance Laboratories,
Inc.
|
| 10:00
AM – 11:00 AM |
Decade
of Behavior DISTINGUISHED LECTURER
30-Year Perspective on Fetal Alcohol
Syndrome Research.
Sponsored
by NBTS/TS/BTS/OTIS
Ann Streissguth, Ph.D., Professor,
Department of Psychiatry and Behavioral Sciences; Director,
Fetal Alcohol and Drug Unit, University of Washington
School of Medicine
|
| 11:00
AM – 12:30 PM |
Student
Plenary Session and Platform Award Competition
Organized
by Jack Bishop, Chair, Student Affairs Committee, Teratology
Society |
| 1:00
PM 9:00 PM |
PUBLIC
AFFAIRS COMMITTEE WORKSHOP (joint session with NBTS/ OTIS/
TS) |
| Communicating
Risks for Pregnancy Exposures: A Workshop on Appropriate
Incorporation of Animal Developmental Toxicity Data in
Drug Labels.
Sponsored
by Centers for Disease Control, Eli Lilly and Company,
FDA-Office of Women’s Health, March of Dimes,
Merck, and Pfizer, Inc.
Organized by Judy Buelke-Sam,
Toxicology Services, Christina Chambers, California
Teratogen Information Service, Jan Friedman, University
of British Columbia, Carole Kimmel, ORD/U.S. EPA, Janine
Polifka, University of Washington, Anthony Scialli,
Georgetown University Hospital and Melissa Tassinari,
Pfizer, Inc.
A one-day, multi-disciplinary
workshop will be convened with participants who represent
clinicians, pharmacists, teratologists, epidemiologists,
and risk communication specialists. The objective of
theworkshop will be to develop a set of recommedations
for improvement of the pregnancy label with a particular
focus on the incorporation of animal data in a clinically
relevant fashion that will support improved risk assessment
and risk communication.
|
|
1:00 PM – 1:10 PM Overview of the workshop background and goals
|
Speaker: Anthony Scialli, Georgetown
University |
|
1:10 PM – 1:30 PM Improving the pregnancy label; thoughts from an industry perspective.
|
Speaker: Melissa Tassinari, Pfizer
|
|
1:30 PM – 1:50 PM Developing the pregnancy label from the regulatory perspective.
|
Speaker: Sandra Kweder, U.S. FDA
|
1:50 PM – 2:10 PM Interpreting animal reproductive toxicity studies as they are presented
in the pregnancy label when developing risk assessments.
|
Speaker: Jan Friedman, University
of British Columbia |
2:10 PM – 2:30 PM Health risk communication under terms of uncertainty.
|
Speaker: Katherine Lyon Daniel, CDC
|
| 2:30
PM – 3:15 PM Panel Discussion I: |
Should animal reproductive toxicity studies be conducted prior to
marketing of a new drug, and if so why? What kinds of data
should be incorporated explicitly in the label text? |
| 3:15
PM – 3:30 PM Public comment |
|
| 3:30
PM – 3:45 PM Break |
|
| 3:45
PM – 5:30 PM Panel Discussion II: |
Should data in the label be presented in raw form or in summary
form with or without interpretation? In what format should
data or summary information be presented in the label to
make it most informative and useful to the clinician? Should
a risk/benefit statement be included?
|
|
5:30 PM – 6:00 PM Public comment
|
|
| 6:00
PM – 7:30 PM Dinner break |
|
| 7:30
PM – 8:30 PM Panel Discussion III: |
Are there ways in which the quality of information in the label
could be improved? Are there ways in which broader access
to information could improve the clinician's ability to
more effectively utilize information in the label?
|
8:30 PM – 8:45 PM Public comment
|
|
8:45 PM – 9:00 PM Summary
|
|
| |
|
| 5:00
PM - 7:30 PM |
Joint
TS/NBTS/OTIS Poster Session I |
| 7:30
PM - 10:30 PM |
MARTA/MTA
STUDENT CAREER EVENT |
|
|
| 7:00
AM - 8:15 AM |
Mini
course: The Placenta and Developmental
Toxicity/Teratogenicity |
|
Chaired by Dana Shuey, Endo Pharmaceuticals,
Inc.
Coursebooks provided by CTBR |
-
7:00 AM – 7:45 AM The placenta as a target for toxicity and human health risk assessment.
|
Speaker: Richard Miller, University
of Rochester
Medical Center |
-
7:45 AM – 8:30 AM Interspecies comparison of placental metabolism and transport, implications
for developmental toxicity testing and human health
risk assessment.
|
Speaker: William Slikker, Jr., NCTR/U.S.
FDA |
| 9:00
AM – 12:00 PM |
WILEY-LISS
SYMPOSIUM |
Gene-Environment
Interactions in Susceptibility: Human Studies and Animal
Models.
Organized and Co-chaired by Barbara Abbott, U.S. EPA
and Martha Werler, Boston University
|
-
9:00 AM – 9:45 AM S6 Interactions between host susceptibilities and exogenous exposures
in birth defects research: An epidemiologic perspective.
|
Speaker: Gary M. Shaw, California
Birth Defects Monitoring Program |
-
9:45 AM – 10:30 AM S7 Gene variants influencing susceptibility to neural tube defects.
|
Speaker: Richard H. Finnell, Texas
A & M University System Health Science Center
|
-
10:30 AM – 10:40 AM Break
|
|
-
10:40 AM – 11:25 AM S8
Pancreatic transcription factors in sacral agenesis models related
to currarino syndrome.
|
Speaker: J. Michael Salbaum, Center
for Human Molecular Genetics, University Nebraska Medical
Center |
-
11:25 AM – 12:00 PM S9
Gene-environment interactions and susceptibility to childhood asthma.
|
Speaker: Stephen R. Kleeberger, NIEHS,
Laboratory of Pulmonary Pathobiology |
| 12:30
PM – 7:30 PM |
Posters
and Exhibits Open |
| 1:00
PM - 4:00 PM |
Concurrent
Symposium I (NBTS/TS/JOINT SYMPOSIUM) |
An
Update on Animal Juvenile Toxicity Testing: Pharmaceutical
Use and Environmental Exposures in Children.
Co-organized by Judy Buelke-Sam,
Toxicology Services and J. Edward Fisher,
U.S. FDA |
-
1:00 PM – 1:10 PM Introduction
|
J. Edward Fisher, U.S. FDA
|
-
1:10 PM – 1:40 PM S10 Juvenile animal studies: Species selection and comparative organ
system developmental schedules.
|
Speaker: Mark Hurtt, Pfizer, Inc.
|
-
1:40 PM – 2:10 PM S11 Overview of U.S. FDA guidance for juvenile toxicity studies.
|
Speaker: Kenneth Hastings, U.S. FDA
|
|
|
-
2:20 PM – 2:50 PM S12 Current U.S. EPA approach to assessing hazards of childhood exposures
to pesticides.
|
Speaker: Susan Makris, U.S. EPA
|
-
2:50 PM – 3:20 PM S13 Design considerations in juvenile toxicity studies.
|
Speaker: Judy Buelke-Sam, Toxicology
Services |
-
3:20 PM – 4:00 PM Discussion Period
|
| 1:00
PM - 4:30 PM |
Concurrent
Symposium II (TS/OTIS JOINT SESSION) |
Teratogen
Update
Organized by Robert Brent, Alfred
I. DuPont Hospital for Children
|
-
1:00 PM – 1:45 PM S14 Update on the reproductive risks associated with lead exposure.
|
Speaker: David C. Bellinger, Children’s
Hospital Boston and Harvard Medical School |
-
1:45 PM – 2:30 PM S15 Vertical transmission of HIV: AIDS in the newborn.
|
Speaker: Richard Miller, University
of Rochester School of Medicine and Dentistry |
| |
|
-
2:45 PM – 3:30 PM S16 Update of advances in environmentally-relevant endocrine disruptors.
|
Speaker: Shelley Tyl, RTI International
|
-
3:30 PM – 4:00 PM S17 Update on non-genital malformations from exposure to progestational
agents.
|
Speaker: Robert Brent, Alfred I. DuPont
Hospital for Children |
-
4:00 PM – 4:30 PM Discussion Period
|
| 5:00
PM - 7:30 PM |
Joint
Teratology/NBTS Poster Session II |
| 7:30
PM – 9:30 PM |
MÜTTER
MUSEUM TOUR (ticket required) |
|
Concurrent
Sessions |
| 8:30
AM - 11:30 AM |
Childhood
Obesity: Impact on Children’s Health and Possible
Developmental Etiologies.
Organizers and Co-chairs William
Slikker, Jr., NCTR/U.S. FDA and Bernard Schwetz, U.S.
FDA |
-
8:00 AM – 8:40 AM S18 Impact of childhood obesity on children’s health.
|
Speaker: Rear Admiral Ken Moritsugu,
Deputy Surgeon General |
-
8:40 AM – 9:15 AM S19 The fetal programming hypothesis: Possible role in childhood obesity.
|
Speaker: William Slikker, Jr., NCTR/U.S.
FDA |
-
9:15 AM – 9:45 AM Warkany
Tea
|
|
-
9:45 AM – 10:25 AM S20
Maternal smoking during pregnancy and association with childhood
obesity.
|
Speaker: Michael Toschke, Ludwig-Maximilians-University,
Munich, Germany |
-
10:25 AM – 11:05 AM S21
Animal models of developmental nicotine exposure: Possible mechanisms
of childhood obesity.
|
Speaker: Edward Levin, Duke University
|
| 8:30
AM - 11:30 AM |
Occupational Exposures and
Reproductive Health.
Organized by the National Institute
for Occupational Safety and Health (NIOSH), National Occupational
Research Agenda Reproductive Team |
-
8:00 AM – 8:30 AM S22 Overview: Impact and extent of reproductive hazards in the workplace.
|
Speaker: Barbara Grajewski, National
Institute for Occupational Safety and Health, CDC
|
-
8:30 AM – 9:15 AM S23 Conducting workplace exposure assessments for reproductive hazards.
|
Speaker: Joseph Coble, National Cancer
Institute |
-
9:15 AM – 9:45 AM Warkany
Tea
|
|
-
9:45 AM – 10:25 AM S24
Clinical tools and strategies for occupational reproductive workplace
hazards.
|
Speaker: Deborah Cory-Slechta, University
of Rochester Medical School |
10:25 AM – 11:05 AM S25 Considerations for making alternative duty recommendations.
|
Speaker: Melissa McDiarmid, University
of Maryland School of Medicine |
| 8:30
AM - 11:30 AM |
The Fetal Basis of Adult
Disease: Role of the Environment.
Sponsored by The National Institute
of Environmental Health Sciences, NIH, DHHS
Organized by Jerry Heindel, NIH/NIEHS
|
-
8:15 AM – 8:20 AM Introduction and opening remarks.
|
Speaker: Jerry Heindel, NIH/NIEHS
|
-
8:20 AM – 8:40 AM S26 Gene imprinting during development: A systems biology approach to
Teratology.
|
Speaker: John McLachlan, Center for
Bioenvironmental Research at Tulane and Xavier Universities
|
-
8:40 AM – 9:15 AM S27 DES exposure in utero: A paradigm for mechanisms leading to adult disease.
|
Speaker: David Sassoon, Mt. Sinai
Medical School |
-
9:15 AM – 9:45 AM Warkany
Tea
|
|
-
9:45 AM – 10:20 AM S28 Developmental pesticide exposure and the Parkinson’s Disease
phenotype.
|
Speaker: Deborah Cory-Slechta, University
of Rochester Medical School |
-
10:20 AM – 10:55 AM S29 Interaction of diet and in utero chemical exposures on adult disease.
|
Speaker: Fred vom Saal, University
of Missouri |
-
10:55 AM – 11:30 AM S30 The fetal basis of adult disease: Epigenetic mechanism.
|
Speaker: Miguel Constancia, The Babraham
Institute, UK |
| 1:00
PM - 5:00 PM |
PLATFORM
SESSIONS (3 Concurrent Sessions) Selected from submitted
abstracts
Clinical
Teratology and Epidemiology
Mechanisms
of Abnormal Development
Mechanisms
Genomics and Risk Assessment |
| 5:00
PM - 6:00 PM |
BUSINESS
MEETING |
| 7:00
PM - 8:00 PM |
BANQUET
RECEPTION
Sponsored by Covance |
| 8:00
PM |
BANQUET
AND DANCING
Band supported by WIL Research
Laboratories, Inc. |
|
|
| 8:30
AM - 11:30 AM |
CONCURRENT
SYMPOSIUM I |
|
A
Detective Story: Is the Prenatal Toxicity of a Therapeutic
in Rats Relevant to Human Risk?
Co–Chaired by Joseph F. Holson,
WIL Research Laboratories, Inc. and L. Bruce Pearce, BioPure
Corporation
|
-
8:30 AM – 8:50 AM S31 Overview of issues concerning false positive findings in reproductive
toxicology and introduction of a case study of an oxygen
therapeutic.
|
Speaker: Joseph F. Holson, WIL Research
Laboratories, Inc. |
-
8:50 AM – 9:15 AM S32 Review of clinical indication, manufacture and general toxicology
of an oxygen therapeutic (HBOC–201).
|
Speaker: Craig Harris, University
of Michigan |
-
9:50 AM – 10:20 AM S34
Finding of developmental toxicity studies of HBOC–201 in rodent
and canine models.
|
Speakers: Donald G. Stump and Joseph
F. Holson,
WIL Research Laboratories, Inc. |
-
10:20 AM – 11:00 AM S35
An analysis and review of the relative morphology of extraembryonic
membranes in mammals and their roles in histiotrophic
nutrition and as possible sites of development insult.
|
Speakers: John DeSesso, Mitretek Systems
Inc. and
Joseph F. Holson, WIL Research Laboratories, Inc.
|
Meetings
PDF of Final Program
Mutter
Museum Tour