Learning Objectives: Attendees will have a better understanding of fetal brain development, which in rodents, extends into the neonatal period.
They will also have a better understanding of anatomical, neurotransmitter, and receptor ontogeny during the neonatal period and the functional consequences of disruptions to these systems as seen postnatally in abnormal behavior.

Learning Objectives: Attendees will be able to describe the physiologic changes at the end of gestation, the physiologic changes peri-delivery, discuss early postnatal development in the nursery, NICU, and beyond.

Learning Objective: Attendees will gain a basic understanding of heart development and be able to identify important genetic and environmental determinants underlying congenital heart defects.

Learning Objectives: Attendees will have a better understanding of how patients manifest various congenital heart defects and the general goals and modes of therapy for these patients.

Learning Objectives: Attendees will be able to describe how enrollment at different weeks of gestation between cases (using anticonvulsant medications) and controls might affect the rate of detection of malformations.

Learning Objectives: Attendees will be able to describe the process used to arrive at a 1.5% major malformation baseline rate compared to a 3% baseline rate.

Learning Objectives: Attendees will be able to list at least one advantage and one disadvantage for recruiting women to pregnancy registries and other studies through social media.

Learning Objectives: Attendees will be able to define and illustrate minor anomalies and normal variations; present the results of studies of the reproducibility of the findings by two examiners of the same infant; and provide a critique of the limitations of including minor anomalies as an outcome in the assessment of newborn infants exposed to a potential teratogen.

Learning Objectives: Attendees will understand how methamphetamine and ethanol enhance the formation of reactive oxygen species (ROS) in the embryo and fetal brain; how ROS can oxidatively damage cellular macromolecules, and particularly DNA, leading to abnormal development; the protective role of DNA repair; and, how the balance among ROS formation and detoxification, and repair of cellular macromolecules within the embryo and fetus can determine individual risk.

Learning Objectives: Attendees will learn the consequences of developmental methamphetamine (MA) exposure in rats on brain development, learning, and memory. Data showing how MA affects the HPA axis, neurotransmitters, and responses to pharmacological probes of neurotransmitter function will be presented. MA has been hypothesized to induce reactive oxygen species (ROS). Results of an experiment testing this using antioxidant treatment will be shown. Effects on dopamine D1 receptors will be presented. Conclusions will focus on the role of dopamine and D1 receptors in mediating the neurocognitive effects of MA exposure.

Learning Objectives: Attendees will gain a critical appreciation for diverse roles of neuromodulators and neurotransmitters in determining the effects of psychostimulants on brain development. Particular attention will be paid to how developing brain dopamine systems are permanently altered in response to gestational cocaine exposure. Genetic and epigenetic mechanisms of maladaptation and transmission will be discussed.

Learning Objectives: Attendees will be able to identify environmental factors that influence the pharmacologic effects of prenatal methamphetamine exposure; describe the known effects of prenatal methamphetamine on somatic growth; and describe the known effects of prenatal methamphetamine on childhood neurodevelopment and behavior.

Learning Objectives: Attendees will be able to describe clinical findings of TSC in three different organ systems; name the two genes currently known to cause TSC, describe the function in the cell of the protein products of the TSC genes, and list three FDA-approved indications for mTOR inhibitors in TSC patients.

Learning Objectives: Attendees will gain insights into 1) the importance of understanding disease pathogenesis in the development of effective therapies for genetic disorders 2) consideration of multiple and adjunctive therapies for single gene disorders. 3) the importance of longitudinal disease registries as a means to delineate disease natural history, plan clinical trials and capture therapeutic impact.

Learning Objectives: Attendees will understand the basic concepts and scientific basis for the use of hematopoietic stem cell transplantation (HSCT) which includes bone marrow and umbilical cord blood transplantation. They will be able to review the impact of HSCT in the survival and neurological outcomes in patients with inherited metabolic diseases (IMD). They will understand the selection of IMD patients for HSCT.

In Utero Treatment of Cardiac Malformations

Learning Objectives: The attendee will have a better understanding of the developmental effects of in utero SSRI antidepressant exposure in childhood. They will be able to consider whether early behaviors in children with utero SSRI antidepressant exposure represent developmental pathways for anxiety. They will be able to discuss why behavior in some but not all children with prenatal antidepressant exposure might be at risk.

An Expert-Driven Approach to Identifying Reference Developmental Toxicants
Elizabeth A. Maull, National Toxicology Program, NIEHS
Learning Objectives: The attendee will have a better understanding of the ongoing efforts at the National Toxicology Program to create a list of reference developmental toxicants that attempt to cover the spectrum of mechanisms and effects. There will also be a discussion of the challenges around extracting and curating high quality developmental toxicity data from the literature.

Testing in Alternative Assays with a Range of Reference Developmental Toxicants
Nicole Churchill Kleinstreuer, National Institute of Environmental Health Sciences, NTP, NICEATM
Learning Objectives: The attendee will have a better understanding of how certain alternative assays are selected for evaluation at the NTP, and what their preliminary performance is against reference developmental toxicants. Insight will be provided into where in vitro and small model organism testing platforms may be useful and applicable for teratology and developmental toxicology.

Break

A Performance-Based Approach to Validation of Computational Tools for Developmental and Reproductive Toxicity
Patience Browne, US Environmental Protection Agency
Learning Objectives: Attendees will have a better understanding of  the successful validation of a computational model for estrogenic activity based on in vitro HTS data and how it is being used as a replacement for lower throughput in vitro and in vivo test methods. Additional topics will be the importance of reverse toxicokinetic approaches for in vitro to in vivo extrapolation, and ongoing work in the area of (anti)androgenicity.

A High-Throughput Screening Assay to Detect Thyroperoxidase Inhibitors and Discover Structural Alerts
Steven O. Simmons, National Center for Computational Toxicology, US EPA
Learning Objectives: Attendees will have a better understanding of the thyroperoxidase inhibition assay to screen environmental chemicals for thyroid disrupting activity, and the connection to adverse neurodevelopmental outcomes. Scientists will learn about how thyroid hormone (TH) synthesis and signaling modulate critical neurodevelopmental and other biological processes during embryonic growth and development, and the process of scaling a functional assay to screen for thyroid disruption.

High-Content Screening of Developmental Neurotoxicity in Zebrafish Embryos
David C. Volz, University of California, Riverside
Learning Objectives: Attendees will have a better understanding of the development and optimization of a high content screening system using zebrafish to look for compounds that cause developmental neurotoxicity. Attendees will learn about the utility of zebrafish as a small model organism screening tool for environmental chemicals that may be developmental neurotoxicants.

Increasing Prevalence of Gastroschisis Worldwide
Kathryn E. Arnold, Centers for Disease Control and Prevention
Learning Objectives: Attendees will have an understanding of gastroschisis surveillance, will be able to characterize persons at risk for gastroschisis and will be able to describe trends in gastroschisis prevalence.

Embryology of Gastroschisis
Thomas W. Sadler, Consultant
Learning Objectives: Attendees will learn the embryology of gut and ventral body wall development as it relates to the origin of gastroschisis. Attendees will understand the difference between gastroschisis and omphalocele. Attendees will learn the precise stages of embryonic development when gastroschisis is induced. Attendees will gain knowledge about the cellular and molecular mechanisms that cause gastroschisis. Attendees will gain an understanding about how to prevent gastroschisis.

Genetic and Nongenetic Risk Factors for Gastroschisis
Sonja Rasmussen, Centers for Disease Control and Prevention
Learning Objective: Attendees will be able to describe the genetic and nongenetic risk factors for gastroschisis, including the data that support these as risk factors, and to discuss how these risk factors could play a role in the increasing prevalence of the condition.

The Potential Role of Common Exposures in Young Women for Gastroschisis: Sexual Activity, Contraception, Medications, and Drugs
Christina D. Chambers, University of California, San Diego
Learning Objectives: Attendees will be able to describe at least three common exposures in young women that have consistently been related to higher risk of gastroschisis. Attendees will understand how these potential causal factors might be more important in very young women who are at highest risk of gastroschisis.

Investigating the Association between Gastroschisis and Biomarkers of Chlamydia Infection and Inflammation
Marcia Lynn Feldkamp, University of Utah
Learning Objectives: Attendees will be able to describe the pathophysiologic impact of a chlamydia infection Attendees will be able to understand the challenges of investigating chlamydia infection as a risk factor Attendees will gain a better understanding of the association between a recent chlamydia infection and gastroschisis.

Predicting Fetal and Newborn Health: The Role of the Placenta and Its Imaging
Richard K. Miller, University of Rochester Medical Center
Learning Objectives: Attendees will have a better understanding of the integration of imaging, functional assessments in utero and the vascular responses, transport activities and pathology in the human placenta.

In Utero Imaging of the Human Placenta: Approaches for Diagnosis of Fetal Health
Alfred Z. Abuhamad, Eastern Virginia School of Medicine
Learning Objectives: Attendees will gain a better understanding of placental structure and function by ultrasound.

Human Placental Pathology—Diagnosis in the 21st Century: New Approaches and Techniques
Carolyn Margaret Salafia, Placenta Analytics, Inc.
Learning Objectives: The attendee will understand how and to what limits measures of the delivered placenta point to stressors or modifiers of placental growth as early as the first trimester. The attendee will understand the limits of automated or human-assisted computer analysis for placental histopathology, and future potential applications.

Break

Unexpected Beginnings: Role of Pregnancy and Parturition in Establishing Our Microbiome 
Kjersti M. Aagaard, Baylor College of Medicine, Houston
Learning Objectives: The attendee will be able to define multi’omics research, provide a basis for its application in teratology, and gain an understanding as to how placental ‘omics research may be applied to teratology research.

BD-STEPS: The Next Generation of Birth Defects Research
Cheryl S. Broussard, Centers for Disease Control and Prevention
Learning Objectives: Attendees will become familiar with the characteristics of a new US case-control study, the Birth Defects Study to Evaluate Pregnancy exposures (BD-STEPS), which builds upon the foundation of the National Birth Defects Prevention Study. They will be able to recognize strengths and limitations of the case-control study design for birth defects research.

What Is US Food and Drug Administration Looking for to Assess and Label Risk?
Lockwood Taylor, US Food and Drug Administration
Learning Objectives: Attendees will be able to review strengths and limitations of post-marketing evidence commonly used to assess risk of drug-related adverse pregnancy/birth outcomes. They will gain a better understanding of the challenges of interpreting post-marketing evidence for inclusion in labeling and be able to discuss aspects of post-marketing evidence that provide meaningful information to include in labeling.

New Approaches to the Design and Analysis of Studies Evaluating Drug Safety during Pregnancy
Krista Huybrechts, Harvard Medical School
Learning Objectives: Attendees will become familiar with the characteristics, strengths, and weaknesses of large administrative databases, in particular the Medicaid Analytic eXtract, as a data source for perinatal epidemiologic research. They will better understand the implications of using this type of data for optimal study design, conduct, and analysis. They will become acquainted with the opportunities offered by the use of these large databases as well as the type of sensitivity analyses that can be conducted to address some of the weaknesses.

An Overview of Developmental Toxicity Testing for Nanomaterials
Karin Hougaard, National Research Center for the Working Environment
Learning Objectives: Attendees will: 1) be able to define nanomaterials and the difference between ambient and engineered nanosized particles; 2) have an overview of the outcomes of developmental toxicity studies so far and the gaps to be filled; and 3) have understanding of the several mechanistic pathways that may lead to developmental toxicity of nanomaterials as well as the challenges in construction of robust testing strategies.

Inhaled Cadmium Oxide Nanoparticles during Pregnancy Alters Fetal Development and Neonatal Growth in a Mouse Model
Jason L. Blum, New York University School of Medicine
Learning Objectives: Attendees will be able to: 1) understand that exposure to cadmium oxide nanoparticles through inhalation results in translocation of cadmium throughout the body; 2) identify potential mechanisms by which these particles adversely affect both dam and offspring during pregnancy; 3) result in changes to growth of offspring postnatally; 4) describe the potential for exposure during pregnancy to result in changes associated with developmental origins of health and disease; and, 5) understand that toxicant delivery to the neonate via lactation, as occurs with cadmium, is an important exposure route not generally considered when developing occupational safety standards.

Break

Maternal Gestational Nanomaterial Exposures: Uterine and Fetal Microvascular Consequences
Timothy R. Nurkiewicz, West Virginia University School of Medicine
Learning Objectives: Attendees will be able to: 1) understand the critical concepts of pulmonary engineered nanomaterial (ENM) exposure; 2) identify the maternal uterine microvascular mechanisms of dysfunction that follow ENM exposure; 3) identify the fetal ramifications of maternal ENM exposure during gestation; and 4) describe the potential influence of these fetal exposures on adult disease.