Separate registration is required for the Education Course and the Sunrise Mini Course, so please register early!

• Education Course
  • Session 1
    Embryology in Modern Times
    This course will cover embryology and modern advances that help us better understand the various stages of development from periconception through the perinatal period. These methods may include new imaging techniques, molecular analyses, genetic methods (e.g., epigenetics), etc.
  • Session 2
    Development and Teratology of the Heart
    The cardiovascular system is the first system to form and function in an embryo. In this session, the expert speakers will provide you with an understanding of normal embryonic and fetal heart development, and what can go wrong during critical periods of cardiac development that may result in a baby born with a congenital heart defect, the most common type of birth defects. The session will also update the participants’ knowledge on the teratogenic exposures that are currently known to adversely affect cardiac development, and finally emphasize on the clinical management of babies with heart defects.
• Sunrise Mini Course
  “Big Data”
  Sign up to attend the Sunrise Mini Course to learn how large datasets are currently being collected, stored, and analyzed to further our understanding of the origins of birth defects. Jeanne Holden-Wiltse, University of Rochester School of Medicine and Dentistry, will present management strategies for large datasets collected from prospective studies, giving attendees a clear understanding of the challenges with biomedical big data management, and how to better compile, record, and utilize the data. Subsequently Rebecca C. Fry, UNC Gillings School of Global Public Health, will describe spatial approaches in data analysis to elucidate environmental factors associated with birth defects. After her presentation, attendees will understand how environmental data geocoding can be used to assess environment-birth defect associations.

Keynote Speaker
Our keynote speaker is Stephen F. Kingsmore, MD, DSc, President and CEO of the Rady Pediatric Genomics and Systems Medicine Institute at Rady Children’s Hospital in San Diego, California. Among his pioneering achievements, Dr. Kingsmore developed the 50 hour genome, a process by which doctors are able to decode and interpret a newborn baby’s genome in just two days. The genetic test, named one of the top 10 medical breakthroughs of 2012 by Time Magazine, rapidly screens the DNA of babies for about 4,500 diseases known to be linked to single-gene mutations. The title of Dr. Kingsmore’s presentation is “Translating Rapid Whole Genome Sequences into Precision Medicine for Babies in Intensive Care Nurseries”, where he will update on advances in whole genome sequencing that have cut the time for testing to only 26 hours. Make plans to attend Dr. Kingsmore’s lecture on Monday, June 27 at 8:00 am.

Josef Warkany Lecture
This award honors Josef Warkany, one of the founding members of the Society for Birth Defects Research and Prevention and recognizes a scientist who has significantly contributed to the field of teratology during his/her career.

The F. Clarke Fraser Award
This award honors F. Clarke Fraser, one of the founding members of the Society for Birth Defects Research and Prevention, for his many contributions to the field of developmental toxicology. The recipient will give a presentation related to his/her research. It is intended that the presentation will serve as a demonstration to pre- and postdoctoral students of the development of an independent career in birth defects research.

James G. Wilson Publication Award
This annual award is presented in recognition of the best paper published in the journal Birth Defects Research and honors a founding member of the Society for Birth Defects Research and Prevention.

Patricia Rodier Mid-Career Award for Research and Mentoring
This award honors the legacy of Dr. Patricia Rodier, a past President of the Developmental Neurotoxicology Society and a Council member of the Society for Birth Defects Research and Prevention. The award is presented during the annual joint meeting of the Developmental Neurotoxicology Society and Society for Birth Defects Research and Prevention. The awardee will give a presentation related to his/her research at a jointly-sponsored session at the annual meetings. It is intended that the presentation will serve as a demonstration of independent mid-career research in neurobehavioral teratology, birth defects, or other related fields.

Robert L. Brent Lecture—Teratogen Update
This lecture recognizes Robert L. Brent’s contributions to the Society for Birth Defects Research and Prevention and particularly to the implementation of the “Teratogen Update.” The purpose of the Robert L. Brent Lecture is to facilitate discussion of current hot topics in teratogen research during the Annual Meeting. The 2016 Robert L. Brent Lecture will be presented on Tuesday, June 28 at 8:30 am by Christina D. Chambers, University of California, San Diego.

Narsingh Agnish Fellow Lecture
This Fellowship was established to recognize Dr. Narsingh Agnish's contributions to the Society for Birth Defects Research and Prevention, and particularly to the implementation of the Education Course. The fellowship is awarded to a long-standing member of the Society for Birth Defects Research and Prevention who has made a major contribution to education in the field of teratology or a related discipline. The 2016 Narsingh Agnish Fellow Lecture will be presented by Richard K. Miller, University of Rochester Medical Center on Wednesday, June 29 at 8:00 am.

Society for Birth Defects Research and Prevention and European Society for Birth Defects Research and Prevention Exchange Lecture
GMOs and Glyphosphate
The US and Europe have divergent regulatory approaches regarding genetically modified organisms (GMOs) in agriculture and the food supply. There is a broad scientific consensus that foods derived from GM crops do not pose an increased risk compared to non-GM foods. Yet, there is also a continuing history of passionate consumer advocacy and scientific discourse on hazards and potential risks associated with GM crops and the increased use of herbicides on these crops. One such herbicide, glyphosate, has been implicated as a developmental and reproductive toxicant in some published studies but not in regulatory reviews. The exchange lecture speakers will explore the truths and myths surrounding GM crops, glyphosate exposures, and potential hazards to human reproductive health, within the US and European regulatory context.

ILSI HESI Symposium
Ontogeny of the FcRn in Gestation across Species: Implications for Monoclonal Antibody Developmental Toxicity Testing and Human Risk Assessment
With the increasing development and use of Fc-containing biopharmaceuticals, primarily immunoglobulins (IgGs), there is a need to better understand the potential placental transfer of these molecules for assessing embryonic and fetal exposure risk. Available data indicate the primary mechanism for placental transfer of Fc-containing molecules across mammalian species is via neonatal Fc-receptor (FcRn) mediated placenta/yolk sac transcytosis. Although exposure to the embryo during the period of major organogenesis is considered to be markedly lower than during late stage fetal development, placental transfer data are quite sparse across all species, particularly during the embryonic period. This symposium will present an overview of the current state of science on FcRn-mediated placental transfer, results of recent research to determine the ontogeny of FcRn in placenta/yolk sac throughout gestation across several animal species including humans, and discuss the implications of the findings for human risk assessment.

The State of the Art of Testing Drugs: Present and Future Symposium
Data from mammalian models, principally the rat, rabbit, and non-human primate have been the standard for regulatory assessments of drugs and industrial chemicals for several decades. The use of mammalian models will remain the standard for hazard assessment in the near future, at least until the artificial embryo becomes a complete model sometime in the next few decades. With the introduction of the harmonized guideline for testing medicinal products in 1994, and more recently with the inception of nonclinical pediatric testing guidelines, the lessons learned are being evaluated to potentially modernize the approach to reproductive testing and to harmonize testing strategies for nonclinical pediatric drug development. The possible changes to the existing ICH S5 guidance and the “buzz” of the S11 guidance are based on the introduction of new classes and more targeted uses of drugs, along with recent experience with high throughput screening for chemicals, and the use of in vitro, ex vivo, alternative mammalian animal models and nonmammalian models for hazard assessment. Target biology also plays an important role in identifying potential risks of the developing offspring to reproductive toxicants, lending to customization of the developmental and reproductive toxicity testing strategy. In some cases, understanding of the target’s role in embryo-fetal development, information from knockout models and knowledge of compounds in the same class may mitigate the need for in vivo DART studies, using a weight of evidence approach. Combined with the pressure to reduce animal usage and the fact that the required reproductive, developmental, and juvenile toxicity tests are being conducted later in the drug development process, it is imperative that we understand the short-term and long-term implications of the proposed changes to our current regulatory testing. This symposium will focus on the current state of the art of regulatory testing, including introduction of alternative mammalian animal models and non-mammalian models, possible changes to the current ICH S5 guideline, summarize the current state of the proposed harmonized S11 pediatric guidance and provide information on the practical application of these new testing paradigms to continue meet our needs for drug development.

Pregnancy Registry Updates Symposium (Joint with OTIS)
The session will include 4 invited speakers and 5 abstract presentations to address current topics and updates for pregnancy registries. The updates will address the issues of enrollment timing, comparison prevalence rates, recruitment strategies, inclusion of minor malformations, comparison group issues, and database vs. registry studies.

Wiley-Blackwell Symposium (Joint with DNTS)
Neurodevelopmental Deficits from Fetal Exposure to Methamphetamine, Cocaine, and Alcohol: Emerging Mechanisms and Human Consequences
In utero fetal exposure to alcohol (ethanol), methamphetamine and cocaine is associated in animals and humans with postnatal neurodevelopmental deficits. The morbidity and sociological and financial costs of such exposures in humans are substantial, with increasing awareness and growing concern among clinicians and the general public. This symposium will present emerging data from animal models revealing mechanisms that contribute to these neurodevelopmental deficits and determine individual risk, complemented by recent results from human studies revealing the human consequences and potential underlying mechanisms. Insights from the animal models may facilitate the development of diagnostic biomarkers for high-risk individuals, and novel strategies for therapeutic mitigation. The first speaker will discuss the involvement of reactive oxygen species and DNA oxidation as one contributing mechanism in neurodevelopmental deficits initiated by in utero fetal exposure to methamphetamine and ethanol. The second speaker will discuss receptor-mediated mechanisms involved in methamphetamine-initiated neurodevelopmental deficits, and the third speaker will focus upon dopaminergic mechanisms of cocaine-initiated neurodevelopmental deficits. The final speaker will present recent results from human studies characterizing the human postnatal neurodevelopmental consequences of fetal exposure to methamphetamine and alcohol.

March of Dimes Symposium
New Approaches to the Treatment of Birth Defects
Prevention of birth defects has always been a major goal of teratology research, but most birth defects have genetic or complex causes that make prevention difficult or impossible. In the past, birth defects and genetic diseases were often considered to be untreatable, and progress in developing effective therapeutic interventions was slow because of the rarity and heterogeneity of most kinds of birth defects and because of our poor understanding of their underlying pathogenesis. Over the past several years, as our understanding of pathogenesis has begun to improve, there has been substantial progress in the treatment of birth defects. This symposium will review several examples in which understanding the molecular mechanisms underlying birth defects or genetic diseases has led to the development of novel surgical or medical therapies that substantially improve the lives of affected patients.

Integrative In Vitro Models for Neurovascular Development Function Symposium (Joint with DNTS)
Recent advances using human stem cells and zebrafish embryogenesis that can be ushered through differentiation and developmental maturation offer an unprecedented opportunity to develop predictive systems for toxicological assessment. The use of human cells is an advantage because there is no need to extrapolate across species, but even so, there may be the requirement that different cell types interact in a three-dimensional (3-D) relationship in order to provide prediction of the intact human. In the developing brain, multiple cell types including endothelial cells, pericytes, astrocytes, oligodendrocytes, microglia and neurons/neuroblasts interact with one another through a shared microenvironment. The 3-D spatial configuration can reflect normal biological functioning in a predictive manner upon drug/chemical exposure. The use of positive and negative test agents allow confirmation of the reproducibility of these in vitro test systems in different laboratory settings.

Public Affairs Symposium (Joint with DNTS and OTIS)
Depression and Its Treatment in Pregnancy
The prevalence rates of depression during pregnancy have been estimated as 7.4%, 12.8% and 12.0%, for the first, second and third trimesters, respectively. The prevalence of depressive episodes in the first postpartum year is even greater than during pregnancy. Due to increasing use of antidepressants, the frequency of antidepressant use during pregnancy has increased from 2.5% in 1998 to over 8% in 2006 in the United States, as reported by the National Birth Defects Prevention Study. The most frequently prescribed antidepressants are selective serotonin reuptake inhibitors (SSRIs), which were first introduced for clinical use in the 1980s. They have better tolerability and safety compared with other antidepressants like tricyclic antidepressants (TCA). Antidepressants exert their effects by enhancing and prolonging serotonergic neurotransmission due to an increase in synaptic dopamine concentrations. SSRIs and TCA are generally considered to be safe in pregnancy. Mood stabilizing drugs like lithium, carbamazepine, valproic acid and lamotrigine are also often used for the treatment of bipolar disorder. Some of them have significant teratogenic potential, and many may affect the neonate and/or have long term neurodevelopmental effects. When evaluating the risk/benefit ratio of SSRIs or other antidepressant treatment in pregnancy, the risks associated with treatment discontinuation should also be considered. Abrupt discontinuation of psychotropic drugs in pregnancy may be associated with physical and psychological adverse effects including a high frequency of relapse. Depression is associated with an increased risk for preterm delivery, and the risk of preterm delivery increases with increasing severity of depression. Maternal depression may also have adverse effects on the developing infant and child. Thus, a discussion of the possible effects of depression/bipolar disorder and its treatment in pregnancy is an issue with major importance in teratology and neurodevelopment of the prenatally-exposed offspring.  

Increasing Prevalence of Gastroschisis Symposium
Gastroschisis is a serious birth defect in which the intestines protrude through an opening in the abdominal wall.  Gastroschisis is important because

• It requires urgent surgery at the time of birth;
• It disproportionately affects infants of young mothers;
• It may be associated with complications, such as difficulties in eating, digestion, and growth; and
• The prevalence continues to increase.

Reports from the United States and many other countries conducting birth defects surveillance have shown ongoing increases in gastroschisis since the 1980s.   A better understanding of the causes of gastroschisis and of prevention measures is urgently needed.  This symposium will

• Review surveillance findings;
• Describe what is known about cellular and molecular mechanisms involved in the embryology of gastroschisis;
• Characterize studies of potential genetic and non-genetic risk factors for gastroschisis;
• Explore common exposures in populations at greatest risk for gastroschisis; and
• Discuss newer evidence regarding infection as a risk factor. 

Advances in Placental Research Symposium
This appears to be the year for the study of the Human Placenta at NIH. However, many novel and sophisticated investigations have been undertaken in the past few years, which are clarifying our understanding of fetal and childhood health and disease. This symposium assembles leading experts in the field to address many areas of research concentration with the emphasis on improving pregnancy outcomes and postnatal development. For example, did you know that human placental RNA and microRNA appear to be stable for RNA sequencing even if saved for 3 hours or more hours after delivery. Do you know why? The ability to study genomics, epigenetics, imaging in the human placenta are just exploding with interest. Integration of environmental exposures with assessment of genomic methylation, oxidative stress and vascular pathology are providing guidance for Utrasound, Magnetic Resonance Imaging and Elastography. Functional in utero assessments of the human placenta are at the horizon now.

Assessing the Developmental Toxicity of Nanomaterials Symposium
The expanding global synthesis, manufacture, and application of nanomaterials is resulting in both inadvertent and deliberate exposures to pregnant women and their fetuses, e.g., through the environment and in pharmaceuticals. The consequences of such exposures are not fully understood. Research in this area is challenging, but progress has been made in characterizing developmental hazards of nanomaterials. This session will include an overview of nanomaterial characteristics, potential exposures, and research challenges. Presentations will summarize research that demonstrated developmental effects of nanomaterial exposures in laboratory animal models. Additionally, the current status of nanomaterial regulation and research planning will be discussed. This symposium will be of interest to researchers and risk assessors in both environmental and pharmaceutical health sciences. It will illustrate the relative paucity of information on a class of substances with high exposure potential and generate a platform for a conversation on future research in the field of developmental nanotoxicity.

Student and Postdoctoral Fellow Lunch Workshop
Student-Postdoctoral Professional Development Workshop is a brown-bag luncheon where trainees hear from early and established researchers in industry, government and academe about issues critical to their careers. Short presentations are followed by an informal Q&A.

• Publishing in the Sciences. This talk will offer tips on how to prepare manuscripts for top journals in birth defects research from the editor of BDR-A.
  
• The Most Common Mistakes in Statistical Analysis: How to Recognize and Avoid Them. The typical graduate student gets a single course in data analysis, but minimal training on the types of analyses needed for many developmental biology and teratology studies. This presentation will provide background on how to design studies and data analyses with strong validity.
  
• Finding Your Place in a Transdisciplinary World. The Society for Birth Defects Research and Prevention was one of the earliest pioneers in understanding the power of working across disciplines on an important problem in biomedical science. This presentation will provide an overview on the importance of team-building and career transitions.
  
• Growing Pains: Moving from Mentee to an Independent Career. No matter what your career path, you need to establish your own record of accomplishments distinct from those of your research and career mentors. This presentation will focus on how to navigate this important early career transition.

Every Assay Needs An Anchor: The Search for Reference Developmental Toxicants Workshop
The large number of untested chemicals in the environment that could be contributing to the incidence of teratology and developmental neurotoxicity, coupled with the rapid advancement of technologies that allow mechanistic querying, are driving the development of novel in vitro systems for screening, hazard assessment, and understanding of developmental toxicity. Novel and existing systems require validation against well curated sets of reference chemicals to achieve scientific and regulatory acceptance and application. These reference chemicals must be based on high quality data, and consider critical factors such as exposure, pharmacokinetics, and windows of susceptibility among others. In turn, reference chemicals with well understood developmental toxicity mechanisms and potencies allow for the characterization and expansion of new systems, such as small model organisms and computational tools. This session will present a number of ongoing research projects in academia, industry, and government to develop and test reference chemicals for developmental-, reproductive-, and developmental neuro- toxicity. The endocrine disruptor screening program (EDSP) has a number of examples where high-quality reference chemical lists are currently being curated and used to validate novel methods (e.g. ToxCast) to screen for developmental toxicants. The National Toxicology Program is spearheading an effort to compile and test an expert-driven list of reference developmental toxicants with a wide range of potencies and effects. We anticipate that this topic will be of high scientific interest for Society for Birth Defects Research and Prevention members, as well as NBTS, and the presentations and ensuing discussions may help guide the fields of test development, interpretation, and validation.

Strategies for Postapproval Assessment Workshop
Medication use in pregnancy is common, yet the fetal safety of many of the most frequently used medications is unknown. In light of recent changes to the pregnancy and lactation labeling of medications, this session will provide an overview of strategies for post-approval assessment of medication safety in pregnancy. Proposed talks will cover: 1) considerations when designing a data collection approach to maximize success in collection of exposures and outcomes,
2) an FDA perspective on how reviewers assess risk for approving the labeling, and spotlights on two specific data sources:
3) the Birth Defects Study to Evaluate Pregnancy exposures (BD-STEPS), which is the next endeavor for the Centers for Birth Defects Research and Prevention, building upon the foundation of the National Birth Defects Prevention Study, and
4) the United States Medicaid Analytic Extract (MAX) data, which is being used to document the prevalence of selected medication use among pregnant women and explore associations with adverse pregnancy outcomes. The last two talks will include strengths and limitations of the case-control study design and administrative database approaches, tying back to the first presentation on data collection strategies.

Science and Public Policy Workshop
How it Affects You and How You Can Shape It
In the 21^st Century, public policy has a huge impact on the way that science is done. Decisions about funding and a host of regulatory issues involving animals, fetal tissue, grant applications, reporting, and publications affect the daily activities of working scientists. What can working scientists do to ensure that research progress is not harmed? The Society for Birth Defects Research and Prevention is a member organization of the Federation of American Societies for Experimental Biology (FASEB), the nation’s largest coalition of biomedical researchers, representing 27 scientific societies and over 120,000 researchers from around the world. FASEB is recognized as the policy voice of biological and biomedical researchers. This session will introduce Society for Birth Defects Research and Prevention members and other meeting attendees to the work FASEB does in the science policy arena as well as the breadth of resources FASEB is able to provide to Society for Birth Defects Research and Prevention members, including fact sheets, articles and reports.

Special Report

Exploring the Link between Zika Virus and Microcephaly
As a potential association between the Zika virus contracted during pregnancy and microcephaly in the infant is investigated in Brazil, the latest research surrounding the outbreak will be discussed on June 29 in a Special Report session. Hear directly from researchers working on the front lines of this health crisis. "While the association of Zika virus infection and microcephaly is still under investigation, there's no denying the fact that there has been a dramatic increase in the number of microcephaly cases reported in Brazil," said Tacey E.K. White, PhD, Society for Birth Defects Research and Prevention President. "In keeping with our mission of providing cutting-edge research and authoritative information related to birth defects and developmentally-mediated disorders, it's crucial that our Society's top minds come together in order to get closer to providing some answers to this outbreak."

Exhibits
The Society for Birth Defects Research and Prevention is pleased to offer a venue for companies who are active in the field of teratology to meet with the Annual Meeting attendees. Exhibitors will be on hand to discuss how their products and services can help you achieve your research and professional goals. Plan to visit the exhibitors and learn more about their products and services during the Welcome Reception and both poster sessions.

Welcome Reception
Don’t miss the first networking opportunity of the meeting. This is an excellent time establish collaborative opportunities, interact with Exhibitors, and to catch up with old friends and make new ones.

Student and Postdoctoral Fellow Research Showcase
The Student and Postdoctoral Fellow Research Showcase is new and exciting opportunity for students and postdoctoral fellows to showcase their research. The showcase will take place during the Welcome Reception on Sunday, June 26, 2016 from 6:00 pm–7:30 pm and is open to all students and postdoctoral fellows assigned to a Poster or Platform Session.

Spouse/Guest Meet-and-Greet
The Spouse/Guest Meet-and-Greet event is a great opportunity to meet fellow travelers, touch base with past friends, and coordinate your plans for exploring everything that San Antonio has to offer. Please join us at 10:00 am on Sunday, June 26 in the Republic A room at the Grand Hyatt San Antonio. The event will provide an opportunity for you to ask city experts suggestions for must-see attractions in San Antonio or have them answer any questions you may have about the city and its history. This event is free and open to guests of all registered attendees of the Society for Birth Defects Research and Prevention, DNTS and OTIS meetings.

TS/OTIS/DNTS Joint Poster Session 1 and Poster Session 2
Attendees present abstracts during the poster sessions of the meeting. The poster sessions provide a relaxed atmosphere to interact with both trainees and established scientists while viewing the latest birth defects research.

Society for Birth Defects Research and Prevention 35th Annual Volleyball Game
Whether you want to join the game or cheer on your colleagues, don’t miss this lively event! For the past 34 years the attendees of the Society for Birth Defects Research and Prevention meeting have gathered on a local volleyball court and enjoyed a friendly, albeit competitive, game of volleyball. This year’s event will be held at the Factory of Champions. Those who want to participate should meet in the hotel lobby at 6:00 AM on Wednesday, June 29 to catch a cab to the court.

Annual Banquet
Once the scientific sessions have ended, it is time to honor recipients of awards conferred during the meeting, celebrate the exchange of scientific ideas, and enjoy both new and old friendships formed at the Annual Meeting. The evening concludes as the Society’s President passes on the gavel to new leadership and everyone dances the night away. 

Each Society for Birth Defects Research and Prevention attendee receives a ticket to the banquet with their meeting registration. The tickets are nontransferable. Additional tickets can be purchased at the registration desk for guests. Badges and banquet tickets are required to attend the banquet.