Teratology Society
Members' Section
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Posted 05-Feb-2002
President's Message 2002 will be a busy year for the Teratology Society. Many important activities that have been undertaken recently are reaching culmination, and several exciting new initiatives are being pursued. Phil Mirkes has been selected as the next Editor of Teratology. Phil's selection followed an exhaustive evaluation of 7 strong candidates by an Editor Selection Committee chaired by Rich Miller. The Committee interviewed the candidates, reviewed their qualifications and vision for our journal, and, after difficult deliberation, recommended three outstanding individuals to Council. Council’s choice was also difficult, but we are confident that Phil Mirkes will be a terrific Editor-in-Chief when he takes over from Lew Holmes in January 2003. At about the same time, our journal will undergo another transition — to a new three-part journal, Birth Defects Research. Teratology will become Part A: Clinical and Molecular Teratology. Each of the two other parts will have its own editor, and we are striking new Search Committees to help select the first Editors of Birth Defects Research, Part B: Developmental and Reproductive Toxicology and Birth Defects Research, Part C: Reviews in Embryology. More information about these editorship searches will be announced shortly, along with a call for nominations. The names chosen for the three parts of Birth Defects Research are those preferred by most people in a recent membership poll. The aims and scope of each of the parts are posted on our website at http://teratology.org/members/jmissions.pdf. We are currently completing negotiations with Wiley-Liss for the relaunch of our journal, and another Issues Forum will be held to discuss our progress at the Annual Meeting. The 42nd Annual Meeting will be held in Scottsdale, Arizona, on June 22-27, 2002. The meeting will feature an outstanding set of education sessions, several excellent symposia, and the best of your contributed papers and posters. For more information about the meeting, see the article in this Newsletter or check out the program at http://teratology.org/meetings/ts2002.htm. The Society is holding its second Strategic Planning Session in Nashville, Tennessee, on March 14-15, 2002. The time and place were chosen to minimize travel costs, as many of the participants will be attending the Society of Toxicology Meeting in Nashville following the session. Although only a small number of people will be able to attend the session, we are working hard to assure that the group is representative of our diverse membership. In addition, we want to bring all of our members’ ideas, concerns and aspirations for the Teratology Society to the session. Please take a minute to complete the survey at http://teratology.org/members/survey3.htm if you have not already done so. Your Council and Public Affairs Committee are working on a number of public policy issues that concern us as teratologists. The Committee drafted and Council approved a letter that has been sent to US Department of Health and Human Services Secretary Thompson regarding labeling of drugs for use in pregnancy. We are providing comments to the FDA on their Draft Guidance for Reviewers on the Integration of Study Results To Assess Concerns About Human Reproductive and Developmental Toxicities (see article in this Newsletter). We are also working with the FDA and CDC to improve post-marketing surveillance of drugs for developmental toxicity. Our website has become a principal means of communication within the Society, and Robert Felix and his Website Committee are working to make the site more informative and easy to use. Please contact Robert or me if you have ideas for the website. In fact, I would be anxious to hear your ideas about how we can improve any aspect of the Society — the website, our journal, the meeting, our educational activities, our involvement in public affairs, or something we should be doing but aren't. The easiest way to reach me is by e-mail at frid@interchange.ubc.ca. 2002 will be a busy year for the Teratology Society, and we intend to take full advantage of the scientific and professional opportunities that lie before us. Jan
Friedman, M.D., Ph.D.
Submitted by William Slikker, Jr., Ph.D. Come to Scottsdale and be an active participant in the largest gathering of Teratologists in 2002. Hear the latest research in either platform or poster formats. Enjoy the presentations of your peers in eight different symposia. Listen to the views of well-postioned colleagues: Bernard Schwetz, Acting Principal Deputy Commissioner, FDA and Jose Cordero, Director National Center on Birth Defects and Developmental Disabilities, CDC. Sign up for a one-day and/or mini-educational course. Judge for yourself the outcome of the "Great Debate: Is there an all or none phenomenon in Teratology?" Take note of the significant scientific contributions of the Warkany and Wilson Publication award winners. All these opportunities and more await you at the Annual Teratology Meeting in Scottsdale, AZ, June 22-27, 2002 (see the preliminary program at our web site: www.Teratology.org). The members of the Program Committee: Judy Buelke-Sam, Mildred Christian, Michael Cunningham, Donna Farmer, Deb Hansen, Tony Machado, Rich Miller, Phil Mirkes, Shelly Tyl and Patrick Wier, have made all this possible. Please join me in thanking them. I also thank the membership at large for their contributions to the Program content. Before last year’s Annual Meeting, we asked for symposium proposals and the Program Committee was blessed with many fine ideas, suggestions and requests. Input was not only received from our own membership but also from that of our sister Societies. The working relationships with ETS, MTA, MARTA, NBTS, OTIS, etc. are vital to us and we will continue to foster our fruitful collaborations. In order to provide more time to interact with our colleagues in an informal setting, we have reintroduced the continental breakfast on Monday through Thursday mornings. I hope you will enjoy the convenience of coffee and assorted pastries before our morning sessions, and use this time to get acquainted with new and current members of all the Societies. So come to Scottsdale and immerse yourself in the blue water of the pools, the green of the golf course, the beauty of the Fairmont Scottsdale Princess Resort, the cutting-edge science and the warmth of renewed friendships in the Arizona sun. See
you in Scottsdale
Submitted by William Slikker, Jr., Ph.D., Donna Farmer, Ph.D., and Deborah Hansen, Ph.D. Knowledge is a wonderful thing and you can have an opportunity to learn plenty by attending two education course offerings at this year's Annual Teratology Meeting. Both the traditional one-day course and the new mini-course have an excellent set of instructors and a detailed syllabus. The Education Committee, chaired by Donna Farmer, has selected the timely topic of Mechanisms, Biomarkers, Data Interpretation: An Integrative Risk Assessment using Developmental Neurotoxicity as a Model, for this year's course. The eight course instructors will review current risk assessment and integrated risk assessment approaches, using developmental neurotoxicity to provide a framework for application of these concepts. These topics were chosen in response to numerous Teratology Society member requests for courses in these areas. The course begins on Saturday afternoon, June 22, with an overview of risk assessment. In health, safety and environmental policy issues, the tools of risk assessment provide the essential foundation for risk analysis. Steps currently used in conducting health risk assessments will be discussed, as well as steps being considered to improve this process. Such steps include incorporation of biological information and mechanistic events at multiple levels to provide a more comprehensive evaluation of potential risk. Thus, several presentations will follow on the development of the nervous system, molecular and functional aspects of nervous system development and developmental neurotoxicity, to set the stage for consideration of this information in a risk assessment paradigm. These will begin with an overview of the pre- and postnatal development and function of the nervous system. The last two presentations on Saturday will address current and future methods/approaches available for evaluating abnormal development of the nervous system from subcellular to the organism. First a discussion of molecular markers of nervous system development followed by structural and functional outcomes already recognized to result from teratogens and how these effects are related to time of exposure and time of testing. The presentations on Sunday morning, June 23, will focus on developmental neurotoxicity testing, results and data interpretation. The potential neurotoxicity, including developmental neurotoxicity, of exogenous substances is currently evaluated in a variety of ways including new studies mandated by regulatory agencies. The first presentation will focus on the practical and logistical considerations of conducting developmental neurotoxicity studies, the data interpretation and challenges. The results of studies examining effects of the pesticide, chlorpyrifos, on developmental processes of the nervous system at multiple levels will be described next. The final presentation will pull together concepts introduced in previous talks as they pertain to the use/application of Biologically-Based Dose-Response Models in an integrated risk assessment framework for developmental toxicants. The course will wrap up with a panel discussion on status and issues in identifying and understanding mechanisms of developmental neurotoxicants, and evaluating risk. For the first time, the Teratology Society will include a mini-course as a part of our Annual Meeting. The purpose of the mini-course, organized by Deborah Hansen, is to cover a topic in more detail than is possible during a platform presentation and to get practical insights from experts in the area. The first mini-course will be held on Tuesday morning, June 25, before other programming and cover issues of Experimental Design and Biostatistics. Dr. Robert Holson will present basic statistical analysis for prenatal reproductive and developmental toxicity studies - such as appropriate tests for various endpoints, situations with unequal N's, and whole litter versus using representative fetuses from a litter. Dr. Paul Foster will compare and contrast prenatal versus post natal evaluations (especially with regard to number of animals evaluated) with an emphasis on what we’ve learned from looking at endocrine active chemicals that might influence study design. This may include issues of culling, the value of sexually dimorphic indicators of maturity as well as issues concerning microarray analysis of fetal tissues. So sign up today (the registration form can be found at http://teratology.org/meetings/2002registration.pdf) and take advantage of both of these educational course offerings.
Submitted by Martha Werler, Sc.D. We are soliciting nominations for this honorable award. Eligible candidates should: 1) be active in the Teratology Society, 2) have a successful independent research career, and 3) be within~ten years of having received their doctoral degree. Please consider eligible colleagues, past students, or anyone who you think may deserve this honor. Contact Martha Werler (mwerler@slone.bu.edu) by February 25, with nominations or questions.
Submitted by Janet Uriu-Adams, Ph.D. The annual Teratology Society meeting is an excellent opportunity for graduate students and postdoctoral fellows to present their work and interact with interested scientists. Continuing student participation and contribution are absolute keys to the future of the society. There are numerous opportunities for student awards (see the Teratology Society website for more details). The James C. Bradford Memorial Award will be given to a student for best paper in the poster competition. The Wilson Presentation Award will be given to two students (predoctoral/postdoctoral) for best paper in the platform competition. Abstracts and optional but highly recommended supporting materials received by the abstract deadline (February 7, 2002) will be reviewed by the Student Affairs Committee and a maximum of eight finalists will present their research at a special student plenary session on Monday, June 24 (10 a.m. to 12 p.m.). There will be no concurrent sessions so as to give the students maximum visibility and recognition of their achievements. Judging will be by the Student Affairs Committee based on the following criteria:
A limited number of Young Investigator Travel Awards are also available to eligible graduate students and postdoctoral fellows to help defray a portion of the cost of attending the meeting. Award recipients must agree to provide audiovisual assistance during platform presentations at the annual meeting. The Marie W. Taubeneck Memorial Award recognizes a graduate student or postdoctoral fellow for scholarship in teratology and service to the Society. Students will receive a ballot with the candidate’s names prior to the meeting and will vote for the candidate of their choice at the meeting. The final decision will be made by the Student Affairs Committee. All student awards will be announced at the James G. Wilson and F. Clarke Fraser Awards Luncheon on Thursday, June 27 (11:45-1:00 p.m.). We hope you will join us in recognizing the student's achievements. Several student events are being planned for this year's meeting. Following the March of Dimes Symposium (organized by Patrick Wier and Karen Augustine), there will be a special session to provide students the opportunity to meet with the MOD Symposium speakers (Sunday, June 23; 5:00-6:00 p.m.). Donald Mattison will be the moderator for the session. On Monday evening (June 24; 7:30-10:30 p.m.), MARTA and MTA will host a dinner and interview skills workshop for all graduate students and postdoctoral fellows (see announcement below). This will be a fun opportunity to meet your fellow students, and to interact with scientists representing all facets of the Society. In addition, Michael O’Hara will be organizing a special student outing. Potential activities include horseback riding or mountain biking (details will be forthcoming). Students who are interested in finding out more can contact Michael at mfo001@jefferson.edu. The 2002 Student Affairs Committee members are: Jan Uriu-Adams (chair), Jack Bishop, Bruce Buehler, Michael O'Hara (student member), and Bill Slikker (Council liaison). MARTA/MTA Student Career Event: Attention ALL Pre and Postdoctoral Students! On Monday, June 24, from 7:30 — 10:30 PM the Middle Atlantic Reproduction and Teratology Association (MARTA) and Midwest Teratology Association (MTA) will host a Student Career Event for all students attending the joint annual meetings of the Teratology Society, Neurobehavioral Teratology Society (NBTS) and the Organization of Teratology Information Services (OTIS). You will be treated to plenty of food and drink while being offered information on interviewing do's and don'ts in preparation for that next phase in your professional career. In addition to the brief interviewing skills component of the evening, you will have plenty of opportunity for one-on-one interactions with scientists representing Academia, Industry, Contract Organizations, Consultants, and the Government who have agreed to make themselves available. You will be invited to discuss these various career paths, your future, and to make some valuable contacts all while being treated to dinner. This event has been overwhelmingly well received by students in past years and we hope to see you there. The organizing committee for this event (Theresa Fico, Utpal Gupta, Mary Giknis, Sandra Wood, Ben Fisher, Steve Harris, Jeff Pitt, and Gary Chmielewski), would like to acknowledge the generous financial support received from Pfizer, Aventis, Pharmacia, and Covance making this event possible.
Nominations and Elections Committee
In December 2001, the Nominations and Elections Committee reviewed the nominees for the positions of Vice President-Elect and Councilor. The Ballot and Candidate summaries containing information regarding each individual’s qualifications will be mailed to you in March. The following members are the candidates for the positions: Vice President-Elect:
Councilor:
The Committee members would like to thank each candidate for accepting the challenge to run for office and for their willingness to contribute to the future of the Society. Current Teratology Society members can expect to receive the printed ballot including candidates' statements in March with a June deadline for returning your votes. Remember that petitions for additional nominations, signed by at least 5% of members, can be accepted through April 22, 2002. I would also like to thank each Committee member for volunteering to work on this Committee and for their contribution to making this a successful election. Kok-Wah
Hew Membership Committee
The Membership committee has approved 11 Regular members, 1 Associate Member, and 4 Student members since May 1, 2001; for a total of 16 new members. We are currently seeking volunteers to attend the Teratology booth at the Society of Toxicology annual meeting in Nashville this year. This would involve attending the booth to provide interested individuals with information about the Teratology Society for 2 hours per shift. Ideally, there will be two people at the booth per shift. The booth will be open on Monday, March 18 from 9:30 AM to 5:00 PM, and on Tuesday and Wednesday, March 19 and 20 from 8:00AM to 5:00 PM. If you are interested and willing to do this, please contact Jeff Peters at mailto:%20jmp21@psu.edu, and let him know the time slots you would be available. Please stop by the Teratology booth at the March SOT meeting if you know of anyone who would be interested in joining the Society, or just to say hi. Public Affairs Committee
Pregnancy Label Revision Following the symposium presented at the Montreal meeting in June, the Public Affairs Committee developed a letter to the Secretary of Health and Human Services regarding the FDA's progress on the pregnancy label revision. This letter has been approved by Council and has been sent on behalf of the Society. The text of this letter is printed below. Members of the Society as individuals may wish to communicate to their legislators on this important issue as well. Tommy
G. Thompson Dear Secretary Thompson: The Teratology Society, a multidisciplinary scientific society founded in 1960, is dedicated to understanding the causes and biological processes leading to birth defects and their prevention. Among its many activities, the Teratology Society addresses public health issues regarding the causes and prevention of birth defects. We are writing to call your attention to an important issue that we believe deserves to be given a high priority for action. Numerous studies in the United States have shown that medications are frequently prescribed to pregnant women. As a result, each year hundreds of thousands of pregnant women and their health care providers seek information regarding the potential risks of these medications to the developing embryo or fetus. The most easily accessible and most commonly used source of this information is the pregnancy portion of the FDA-approved product label. Although other resources are available, the pregnancy section of the product label is perceived by pregnant women and clinicians as being authoritative. However, we believe that the ABCDX system that the FDA currently uses to label drugs with respect to pregnancy safety is confusing, incomplete and, in some cases, inaccurate. This can lead to misperceptions of risk and mismanagement of pregnancies. In response to these concerns, the FDA Pregnancy Labeling Task Force has invested a considerable amount of effort in exploring alternatives to the current system over the last several years. Despite the formidable challenges involved in revising such a complex and far-reaching set of rules, we believe that the Task Force has made substantial progress in developing an acceptable plan. We applaud this work; however, we are frustrated that the progress toward implementation of these revisions seems to have come to a halt. We view revision of the FDA use-in-pregnancy labels to be a matter of urgency because it impacts the health and well-being of numerous pregnant women and their children. We urge you to move forward in the regulatory process for this important initiative as soon as possible. As members of the Teratology Society, we would be pleased to assist in any way possible. Draft Guidance on Preclinical Testing of Drugs for Reproductive Toxicity In response to the call for public comment on the Draft Guidance document ("the wedge") posted by the FDA on November 16, 2001, the Public Affairs Committee has developed a response letter. Following approval by Council, this letter will be submitted as the official position statement of the Teratology Society. For Society members who have not read the document or who wish to independently submit comments to the FDA, the draft guidance is located at http://www.fda.gov/cder/guidance/4625dft.pdf. | ||||||||||||