Strategic Planning Meeting Results

Christina Chambers and Melissa Tassinari

The Teratology Society’s third Strategic Planning
Session was held in San Diego, California, on April 18-
20, 2007. Following a pre-conference web-based
membership survey, 24 Society members participated
in the two-and-a-half day planning session, led by a
team of professional facilitators. This session was
designed to build on the work accomplished through
previous Strategic Planning Sessions and was focused
on 3 areas: 1) scientific excellence and leadership, 2)
membership recruitment and retention, and 3) outreach
and partnerships. The 2007 workshop looked at
Society strengths as the base for change and
generated a great deal of excitement about
opportunities for the Society to explore in moving
forward during the next five years. During the session,
specific themes for strategic emphasis were identified
by the participants. These include: improved visibility
of the Society, communication, a shared scientific
identity, the design of the annual meeting, and
membership. Core working groups focused on each of
these themes were established, and will carry on this
work in collaboration with Council and the Society
membership to further delineate the activities
necessary to achieve the identified goals, and the
action steps required for implementation. A detailed
presentation of the planning session and the initial
outputs from the work groups will be made at the
Issues Forum at the annual meeting in Pittsburgh, on
Tuesday, June 26, beginning at 5:00 PM. Members are
urged to attend to learn more about this exciting event
and to find out how they can be involved in the process
of shaping the future of the Society.

Survey Says...

Deborah Hansen

A twenty-four question survey was distributed to
members of the Teratology Society about a month
before the Strategic Planning Meeting. The survey was
designed by the facilitators for the meeting. Its purpose
was to take the pulse of the membership in 3 areas: the
strategic focus of the Society, how the Society
operated, and their point of view of the Society. While
only 17% of members responded to at least some of
the questions, the total number of responses was 116,
which is a reasonable rate for this type of survey.

A large majority of respondents agreed that the
Society’s mission is relevant for the next five to ten
years. However, a large proportion was not sure that
they clearly understood the Society’s strategic goals,
and only about half thought that we were choosing the
right area on which to focus. The strategic focus areas
for the Society were identified as scientific excellence
and leadership, recruitment and retention of members,
communication (both internal and external) and
outreach. These were also the main focus areas
identified by Council and the other participants in the
Strategic Planning Meeting.

It was also clear from the survey that we need to do a
better job of communication regarding our Committees.
About half of the respondents didn’t understand the
purpose and objective of some of our Committees, and
a large proportion weren’t sure if there was overlap
between Committees.

The results of the survey were discussed at the
Strategic Planning Meeting and will be used in helping
us to identify our goals and action items.

Public Affairs Committee Update

Janine Polifka

The Public Affairs Committee is pleased to announce
that a Community Outreach Event on Fetal Alcohol
Syndrome/Fetal Alcohol Effects is planned at the
University of Pittsburgh prior to the Society’s annual
meeting. Jointly organized by Megan Adamson, Tina
Chambers and Janine Polifka, it built upon a planned
joint OTIS/NBTS/TS symposium on FASD. Local
collaboration with Dr. Elizabeth Gettig who is the
Director of the Genetic Counseling Program at the
University of Pittsburgh helped to locate a venue at the
University of Pittsburgh and to recruit genetic
counseling students for the course. Dr. Sylbia Kunst, a
principal at the Pioneer Education Center in Pittsburgh,
was contacted to help recruit special education
teachers and other education professionals to attend
the workshop. Since the workshop falls into a week of
professional development, Dr. Kunst plans to extend a
district wide invitation that will also include social
workers, school nurses, and building administrators.

The program will begin with a continental breakfast for
participants followed by opening remarks presented by
Dr. Sylbia Kunst. Dr. Nancy Day will present an
overview of FASD which will include the causes and
characteristics of FASD, the diagnostic criteria for
FASD and how to obtain services for children and
adults with FASD. Kathleen Mitchell will then discuss
the lifelong effects of FASD on individuals and families.
Elizabeth Parra Dang will then discuss educational
curricula and media materials that are available from
the CDC. And last, but not least, Drs. Kathy Sulik and
Marianne Meeker will discuss “Better Safe than Sorry:
Preventing a tragedy”. The workshop will conclude
with lunch and an opportunity for participants to
network.

The FAS/FAE workshop will be held on Tuesday, June
26, 2007 between 7:30 AM-Noon in Parran Hall at the
University of Pittsburgh. Registration for the workshop
is free. Anyone who is interested in attending the
course should contact Janine Polifka at
polifka@u.washington.edu.

Member News

Drugs During Pregnancy & Lactation, 2nd
Edition. Written by world renowned experts Christof
Schaefer, Paul Peters and Teratology Society Past
President Richard K. Miller, it provides conclusive
information on the prevention of birth defects through
the safe use of drugs before pregnancy, as well as
during pregnancy and lactation. The latest edition is
the resource for any practicing OB/GYN, family
physician, midwife, or pharmacist who prescribes
medicinal products to or evaluates environmental or
occupational exposures in women who are or may
become pregnant. Receive a 20% discount when you
ORDER NOW at http://books.elsevier.com using
offer code 89022 at checkout.

From the President's Desk

Elaine Faustman

It has been an exciting year, and this annual
meeting will be special for me as your President. I
invite you to enjoy and learn as we come together
in Pittsburgh. I do want to call your attention to
several items as we move towards our meeting
time.

Dr. Ann Streissguth is the 2007 Warkany Lecturer

I am pleased to announce that Dr. Ann Streissguth
is our 2007 Warkany Lecturer. The title of her talk
will be “Fetal Alcohol Spectrum Disorders from
Teratology to Public Health” and will reflect her
longstanding, highly productive research career
and personal commitment to public health. Dr.
Streissguth is a Professor emeritus at the
University of Washington in the Department of
Psychiatry and Behavioral Sciences. Her MS
training was in child development from the
University of California Berkeley and her doctoral
degree is in Clinical Psychology from the
University of Washington.

Dr. Streissguth and her research and clinical
colleagues have been actively involved in
research on the prevention of FAS and FAE since
1974. She is the recipient of numerous awards
including a NIH Merit Award, the International
Jellinek Memorial Award for Advancement in the
Field of Alcohol Studies, the Silver Key award
from the National Council on Alcoholism and Drug
Dependence and was a recipient of New York
State’s “Women of the Century” Awards (to name
just a few). When I had the pleasure to contact
Ann and tell her that she had been nominated as
the Warkany Lecturer, she immediately described
some of her new research on brain imaging. She
also, in the same breath, mentioned that one of
the FAS kids from the first years of her longitudinal
study had just re-contacted her and was asking for
advice. This need to “be there for her kids” and to
continue to “be there for her kids” is a wonderful
reflection of personal commitment to help these
affected children and their families. This blend of
highly relevant and significant scientific research
along side with a public health commitment to
prevention and intervention is why she was
chosen as this year’s Warkany Lecturer. She
recounted to me her visits with Dr. Joe Warkany
when he would spend his summers in Seattle.

I invite you to celebrate her career and hear about
her new research on Monday, June 25 at 8:15 AM
at the Teratology Society meeting. To learn more
about Ann’s research and see interviews with her,
we encourage you to visit her website at
http://depts.washington.edu/fadu/Ann.Streissguth.bio.html.

2007 Warkany Lecturer:
Dr. Ann Streissguth

“Mentor Core” for Teratology

Elaine Faustman

Those of you who are fans of NPR “Story Core”
interviews with family members and friends will enjoy a
new feature at our 2007 annual meeting. We welcome
you to interview your mentor and/or distinguished
colleagues at the annual meeting. We will be compiling
a series of video clips to document the roles that our
long-standing Teratology members have played in the
history and future of our Society.

If you would like to do one of these interviews, there will
be a sign-up sheet to schedule “booth” time to run a 5–
7 minute interview. We will provide some example
questions that you may want to use to focus these
interviews. Groups are welcome as well as one-on-one
interviews. Please join us in this new activity to
celebrate our members! We will be trying this on a trial
basis and will be interested in hearing your feedback as
we work on this project over the next few years.

Dr. Narsingh Agnish at the 2006 Annual Meeting.

Updates on US Pediatric Legislation

Melissa Tassinari

This is a busy time in the U.S. Congress. Two key
pieces of legislation concerning the conduct of pediatric
clinical trials are up for re-authorization; the Best
Pharmaceuticals for Children’s Act (BPCA) and the
Pediatric Research Equity Act (PREA). The combined
effect of these laws has resulted in over 800 studies,
more than 47,000 patients studied and more than 129
new labels with information to treat children1. Right
now, the Senate has passed its version of the reauthorization
and the House has taken up the Bills for
debate. The 2 laws provide a ‘stick’ and a ‘carrot’ for
the pharmaceutical industry. The ‘stick’ is PREA which
mandates a study in pediatric populations for the
approved adult indications for that medicine. BPCA is
the ‘carrot’ which allows for an added 6 months patent
extension in return for work done under a plan issued
by the FDA called a Written Request. While both laws
are expected to be reauthorized, and must be by
October 1, 2007, the challenge is in the proposed
modifications to the current laws. In particular, the
length of the exclusivity award, and the means to
determine how that exclusivity is awarded is under
intense debate. Recent publications have indicated
that any reduction of the incentives for conducting
pediatric studies would likely result in a decline in the
number of studies and areas of pediatric disease that
are studied.2,3 The cost, complexity and time that these
pediatric program take has risen significantly over the
10 years that these laws have be in force.4 If some of
the new provisions are enacted, the FDA will be
expected to change the way it handles the many
pediatric programs that it oversees in ways that are, in
some respects, redundant to the functioning process
already in place. These laws are important and have
worked well, let’s hope that they are renewed without
language that reduces their effectiveness in delivering
much needed information to the health care providers
and parents of the children who need it.

1. US FDA: www.fda.gov/cder/pediatric (May 2007)
2. Li, JS et al.: JAMA. 2007;297:480-488
3. Schachter,AS and Ramoni MF:
www.nature.com/reviews/drugdisc (June 2007)
4. Tufts CSDD Impact Report vol. 9, no. 2,
March/April 2007

Latest News on the National Children’s Study

Carole Kimmel

Many of you are probably aware that full funding for the
NCS was part of the fiscal year 2007 budget continuing
resolution passed by Congress. However, a
Congressional request for NCS funding is required
each year. Efforts are currently underway in Congress
to add $14 billion to the FY 2008 Labor-HHS-Education
budget that would fund vital health and education
programs, including the National Children’s Study. The
2008 funding need for the NCS is $111 million.

BACKGROUND. The National Children's Study (NCS)
is a large longitudinal study designed to examine the
effects of environmental influences on the health and
development of more than 100,000 U.S. children from
before birth to age 21. The goal of the Study is to
improve the health and well-being of America’s
children. The NCS is designed to examine many
aspects of children's lives, from family genetics; to the
constructed world of neighborhoods and schools; to
chemical exposures linked to the atmosphere, food or
water supplies; to the social and behavioral
environment in which children grow and develop. The
ability to examine multiple exposures and link them in
cause-effect relationships with multiple outcomes is the
defining characteristic of the National Children's Study,
and the focus of the Study Plan. Children's health
outcomes to be examined and improved through the
use of data generated by the Study include pregnancy
outcomes, growth, obesity, diabetes, neurobehavioral
and cognitive development, asthma, injury, and
reproductive development and function. The repository
of biological and environmental samples to be collected
in the Study will provide material for additional
questions to be addressed for decades to come. A
significant amount of effort and resources have gone
into laying the groundwork for the Study over the past 7
years. This major interagency collaboration (NICHD,
NIEHS, CDC, EPA) has included over 2500 scientists
and community members from academia, industry,
professional organizations, and advocacy and public
interest groups. Much more information about planning
for the Study can be found on the NCS website
(www.nationalchildrensstudy.gov ).

In 2005, the initial seven Centers, or Vanguard Centers,
and the Coordinating Center for the NCS were funded.
The Vanguard Centers have been assisting in refining
the protocol and will be conducting pilot testing of the
protocol in advance of the full Study. The Coordinating
Center is the central processing group that will provide
scientific, technical, and logistical support to all Study
Centers and is responsible for information
management, statistical sampling, data collection and
analysis, and quality control. A repository as well as
analytical laboratories are currently being planned.

CURRENT EFFORTS. The Research Plan, which will
be reviewed by the National Academy of Sciences, is
being completed and there will be an opportunity for
public comment. The Research Plan will describe the
general plan for the Study, the hypotheses and the
exposure and outcome measures to be included. A
more detailed protocol and operations manual are also
under development.

With the 2007 funding, an RFP was released in early
March to fund approximately 15-20 new Centers to
cover up to 30 sites for the Study. These Centers will
be selected and funded by the end of FY 2007. It is
expected that an additional wave of Centers will be
funded in subsequent years to complete the total of
approximately 40 Centers and 105 sites for the Study.

rev. 19-June-2007