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Annual Meeting 2016

CME Program

This event is approved for up to 25.25 credits by the Office for Continuing Professional Development. The Office for CPD, Faculty of Medicine, McGill University is fully accredited by the Committee on Accreditation of Canadian Medical Education (CACME).

This event is an Accredited Group Learning Activity as defined by the Maintenance of Certification program of the Royal College of Physicians and Surgeons of Canada.

Through an agreement between the Royal College of Physicians and Surgeons of Canada and the American Medical Association, physicians may convert Royal College MOC credits to AMA PRA Category 1 Credits™. Information on the process to convert Royal College MOC credit to AMA credit can be found at www.ama-assn.org/go/internationalcme.

Each physician should claim only credit commensurate with the extent of their participation in the activity.

If you wish to participate in the CME Program you must Register for the Teratology Society Annual Meeting and inform the headquarters office of your participation. All participants are required to provide their full name, license number, and their complete contact information. Click here to access online CME Info Form. CME Program participants will also be required to sign in on the daily sign-in sheets and designate the credit type and credit quantity. Failure to do this will make the participant ineligible to receive CME credits.

Daily Breakdown of CME Credits
The following is the daily breakdown of credits available. Each attendee is responsible for claiming credit commensurate with the extent of their participation in the scientific activities.

Saturday, June 25: 4.5 credits
Sunday, June 26: 2 credits
Monday, June 27: 7.25 credits
Tuesday, June 28: 7.5 credits
Wednesday, June 29: 4 credits

2016 Teratology Society CME Program
Grand Hyatt San Antonio, San Antonio, Texas

Saturday, June 25, 2016

   

8:45 AM–12:00 Noon

Education Course Session 1 – Texas Ballroom D

 

(Separate Registration Required)

 

Embryology in Modern Times

   
8:45 AM–9:30 AM Embryology in Modern Times: Periconceptual Period
  Gary C. Schoenwolf, University of Utah
  Learning Objective: Attendees will have a better understanding about the major events of the periconceptional period that may go awry and jeopardize pregnancy and compromise the in utero and postnatal health of the child.
   
9:30 AM–10:30 AM Break
   
10:30 AM–11:15 AM The Fetal Period: Functional Consequences
  Charles V. Vorhees, Cincinnati Children's Hospital Medical Center
 

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.

   
11:15 AM–12:00 Noon Embryology and Physiology of the Perinatal Period
  Sarah G. Obican, University of South Florida
 

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.

   

1:35 PM–4:50 PM

Education Course Session 2 – Texas Ballroom D

 

(Separate Registration Required)

  Development and Teratology of the Heart
   
1:35 PM–2:20 PM Cardiac Development: A Delicate Interplay of Form and Function
  H. Scott Baldwin, Vanderbilt Children's Hospital
  Learning Objectives: Attendees will understand the basic milestones of early cardiac development with a particular emphasis on the discrete and unique cell populations that contribute to cardiac development. In addition to early morphogenetic events that might be subject to teratogen exposure, the attendee will also appreciate importance of latter remodeling events in late gestational and early perinatal development that are critical to normal cardiac function and thus be able to identify specific process vulnerable to environmental perturbation.
   
2:20 PM–3:05 PM Abnormal Heart Development
  Mary R. Hutson, Duke University School of Medicine
 

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.

   
3:05 PM–4:05 PM Break
   
4:05 PM–4:50 PM Clinical Management of Congenital Heart Defects
  George A. Porter, MD, University of Rochester
 

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.

   

 

Sunday, June 26, 2016

   

8:15 AM–9:00 AM

Josef Warkany Lecture – Texas Ballroom D

 

Framing Our Birth Defects Questions with Systems Biology: Leaning from Our Mentors

 

Lecturer: Elaine M. Faustman, University of Washington

 

Learning Objectives: Attendees will have a better understanding the critical role of systems based scientific approaches for identifying causes of Birth Defects. The will be able to characterize the importance of linking genetic and environmental information for informing mechanisms of teratogenesis. They will be able to discuss the importance of mentorship for professional development in multi-disciplinary fields such as Birth Defects.

   
2:35 PM–3:55 PM

Pregnancy Registry Updates Symposium – Texas Ballroom E

   
2:35 PM–2:55 PM Gestational Age at Enrollment
  Sonia Hernandez-Diaz, Harvard School of Public Health
 

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.

   
2:55 PM–3:15 PM         Prevalence Reference Rates for Pregnancy Registries and for Labeling
  Leyla Sahin, US Food and Drug Administration
 

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.

   
3:15 PM–3:35 PM         Modern Methods of Pregnancy Registry Recruitment: Successes and Challenges
  Jennifer Zellner, University of California, San Diego
 

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.

   
3:35 PM–3:55 PM Minor Anomalies: An Unreliable Outcome for Pregnancy Registries
  Lewis B. Holmes, MassGeneral Hospital For Children
 

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.

 

Monday, June 27, 2016

   
8:00 AM–9:00 AM Keynote Speaker – Texas Ballroom D
  Translating Rapid Whole Genome Sequences into Precision Medicine for Babies in Intensive Care Nurseries
  Speaker: Stephen F. Kingsmore, Rady Pediatric Genomics and Systems Medicine Institute
  Learning Objectives: Attendees will learn about the organization of regional NICUs and PICUs, common presentations of genetic diseases in newborns, the state-of-the-art in methods for rapid diagnosis of genetic diseases by whole genome sequencing , and ongoing studies of clinical utility and cost-effectiveness of genomic sequencing in newborns.
   
9:05 AM–12:00 Noon Wiley-Blackwell Symposium – Texas Ballroom D
  Neurodevelopmental Deficits from Fetal Exposure to Methamphetamine, Cocaine and Alcohol: Emerging Mechanisms and Human Consequences
   
9:05 AM–9:45 AM Oxidative Stress Mechanisms of Neurodevelopmental Deficits Initiated by Methamphetamine and Ethanol
  Peter G. Wells, University of Toronto
 

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.

   
9:45 AM–10:25 AM Effects of Methamphetamine on Brain and Behavioral Development
  Charles V. Vorhees, Cincinnati Children's Hospital Medical Center
 

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.

   
10:25 AM–10:40 AM Break
   
10:40 AM–11:20 AM Dopaminergic Mechanisms of Cocaine-Initiated Neurodevelopmental Deficits
  Gregg D. Stanwood, Florida State University
 

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.

   
11:20 AM–12:00 Noon Human Neurodevelopmental, Behavioral, and Growth Consequences of Exposure to Prenatal Methamphetamine and Alcohol
  Lynne M. Smith, Harbor-UCLA Medical Center
 

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.

   
   
1:30 PM–5:30 PM March of Dimes Symposium – Texas Ballroom D
  New Approaches to the Treatment of Birth Defects
   
1:30 PM–2:15 PM Tuberous Sclerosis Complex: From Bedside to Bench and Back Again
  Hope Northrup, University of Texas Medical School at Houston
 

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.

   
2:15 PM–3:00 PM Treatment of Lysosomal Storage Diseases: Lessons for Other Genetic Disorders
  Lorne Clarke, University of British Columbia, Vancouver
 

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.

   
3:00 PM–3:15 PM Break
   
3:15 PM–4:00 PM Bone Marrow Transplantation and Umbilical Cord Blood Transplantation for Inborn Errors of Metabolism
  Vinod K. Prasad, Duke University
 

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.

   
4:00 PM–4:45 PM In Utero Treatment of Meningomyelocele: Open and Minimally Invasive Fetal Surgery
  Michael A. Belfort, Baylor College of Medicine, Houston
  Learning Objectives: Attendees will be able to explain the anatomy and embryology of neural tube defects; discuss open fetal surgery for neural tube defects and the risks and benefits vs. postnatal repair; and discuss fetoscopic neural tube repair.
   
4:45 PM–5:30 PM

In Utero Treatment of Cardiac Malformations

  Wayne Tworetzky, Boston Children's Hospital
  Learning Objectives: Attendees will have a better understanding of the advances in prenatal diagnosis and ultrasound-guided surgical and catheterization techniques.
   
1:35 PM–4:50 PM Integrative In Vitro Models for Neurovascular Development Function Symposium – Texas Ballroom F
   
1:35 PM–2:20 PM Assembly of Stem Cell-Derived Human Tissues for Screening Applications
  William Murphy, University of Wisconsin
  Learning Objectives: Attendees will learn how reprogrammed human cells are being used to generate human tissues in a dish (outside the body); how human tissues in a dish can be self-assembled for use in high throughput screening applications; and how microscale human tissues can be used to generate new insights about chemical compounds, including drug efficacy, toxicity, and mechanism of action.
   
2:20 PM–3:05 PM Blood-Brain-Barrier Development and Function
  Sherry Ferguson, National Center for Toxicological Research, US FDA
  Learning Objectives: The attendee with have a better understanding of the basic functions and composition of the adult blood-brain-barrier, the temporal progression of the major stages of blood-brain-barrier development in human and laboratory animals, and the potential subsequent implications of poor blood-brain-barrier development or increased blood-brain-barrier permeability.
   
3:05 PM–3:20 PM Break
   
3:20 PM–4:05 PM High-Throughput Screening of Zebrafish to Identify Modifiers of Nervous System Development and Function
  Randall T. Peterson, Harvard Medical School
  Learning Objectives: The attendee will have a better understanding of how high-throughput assays using zebrafish embryos can be used to identify the therapeutic, teratogenic, and toxic effects of small molecules.
   
4:05 PM–4:50 PM Human Neurovascular Unit On-A-Chip: Microscale Systems for Tissue-Level Response
  John Wikswo, Vanderbilt University
  Learning Objectives: Attendees will have gained an appreciation for 1) the role of scaling laws in the design of organs-on-chips and the constraints this places on fluid volumes and device properties; 2) the need for miniature pumps and valves to control organs-on-chips and their interconnection; 3) how analytical chemistry applied to the organ-on-chip exometabolome can provide information nondestructively about the response of the tissue to drugs and toxins; 4) what can be learned about the blood-brain barrier and cortical neurons from a human neurovascular unit; 5) some of the challenges in creating and interpreting an in vitro model of the developing brain.
 

Tuesday, June 28, 2016

 

 

7:00 AM–8:30 AM

Sunrise Mini Course – Texas Ballroom D

 

(Separate Registration Required)

  “Big Data”
   
7:00 AM–7:45 AM Diagnosis and Management of Big Data: Practical Considerations for Prospective Biomedical Studies
  Jeanne Holden-Wiltse, University of Rochester School of Medicine and Dentistry
  Learning Objectives: The attendee will have better understanding of the challenges with biomedical big data management, and how to better compile, record, and utilize the data.
   
7:45 AM–8:30 AM Spatial Epidemiology Approaches in Birth Defects Research
  Rebecca C. Fry, UNC Gillings School of Global Public Health
  Learning Objectives: At the end of this presentation, audience members will be able to: 1) Understand the concept of environmental data geocoding; 2) Understand ecologic study design to assess environment-birth defect association; 3) Name chemicals for which convincing evidence of environmental-birth defects association exist; 3) Understand why toxic metals are dangerous for the developing fetus; and 4) Describe results from recent studies investigating the influence of toxic metals on birth defects as well as the implication of such results.
   

8:30 AM–9:00 AM

Robert L. Brent Lecture-Teratogen Update – Texas Ballroom D

 

Preventing the Preventable: Where Do We Stand on Fetal Alcohol Spectrum Disorders in 2016?

  Speaker: Christina D. Chambers, University of California San Diego
 

Learning Objective: Attendees will be understand the current burden of fetal alcohol spectrum disorders, the trends in maternal exposure in the US and the most current approaches to reversing these trends and reducing the burden of these conditions.

   
9:05 AM–12:00 Noon Public Affairs Symposium – Texas Ballroom D
  Depression and Its Treatment in Pregnancy
   
9:05 AM–9:45 AM Depression Treatment in Pregnancy: Are We Asking the Right Questions?
  Katherine L. Wisner, Northwestern University
  Learning Objectives: The attendee will be able to describe the impact of pregnancy on the natural history of major depression, discuss the heterogeneity of clinical presentations and differentiate unipolar from bipolar depression, and review treatments for depression during pregnancy and breastfeeding.
   
9:45 AM–10:25 AM What Can Prenatal Exposure to SSRI Antidepressants Teach Us About Child Development?
  Timothy Oberlander, University of British Columbia
 

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.

   
10:25 AM–10:40 AM Break
   
10:40 AM–11:20 AM The Safety of Tricyclic Antidepressants and Mood Stabilizers in Pregnancy: What Should We Use for the Treatment of Bipolar Disorders?
  Asher Ornoy, Hebrew University Hadassah Medical School
  Learning Objectives: The attendee will have a better understanding of non-SSRI anti-depressants. They will be able to describe the teratogenic effects of lithium, carbamazepine, oxcarbazepine and valproic acid on the developing embryo and fetus, and discuss the effects of tricyclic antidepressants on the embryo and fetus. The presentation will also raise the issue of whether these teratogenic drugs should be avoided during pregnancy.
   
11:20 AM–12:00 Noon New Insights into How SSRIs Shape the Developing Brain: From Mice to Public Health Implications
  Jay Gingrich, Columbia University, Sackler Institute of Developmental Psychobiology
  Learning Objectives: Attendees will understand the effects of SSRI exposure on brain development; have new knowledge about how timing and dosage can affect outcomes; and appreciate how the serotonergic system changes during development.
   
9:30 AM–12:15 PM Every Assay Needs an Anchor: The Search for Reference Developmental Toxicants Workshop – Texas Ballroom E
   
9:30 AM–10:00 AM

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.

   
10:00 AM–10:30 AM

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.

   
10:30 AM–10:45 AM

Break

   
10:45 AM–11:15 AM

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.

   
11:15 AM–11:45 AM

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.

   
11:45 AM–12:15 PM

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.

   
1:30 PM–3:10 PM

The Increasing Prevalence of Gastroschisis Symposium – Texas Ballroom E

   
1:30 PM–1:50 PM

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.

   
1:50 PM–2:10 PM

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.

   
2:10 PM–2:30 PM

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.

   
2:30 PM–2:50 PM

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.

   
2:50 PM–3:10 PM

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.

   
1:40 PM–5:05 PM

Advances in Placental Research Symposium – Texas Ballroom D

   
1:40 PM–2:10 PM

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.

   
2:10 PM–2:50 PM

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.

   
2:50 PM–3:30 PM

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.

   
3:30 PM–3:45 PM

Break

   
3:45 PM–4:25 PM

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.

   
4:25 PM–5:05 PM Placenta-Specific microRNAs and Pregnancy Health
Yoel Sadovsky, Magee Womens Research Institute, University of Pittsburgh
Learning Objectives: The attendee will be able to recognize the role of placental trophoblasts in supporting fetal health; assess novel functions of microRNAs within the human placenta; and define the current understanding of maternal-fetal microRNA communication across the placental interface.
   

Wednesday, June 29, 2016

   
8:00 AM–8:30 AM Narsingh Agnish Fellow Lecture – Texas Ballroom D
  Educational Convergence of Sciences: Basic-Clinical-Discovery-Regulatory
 

Speaker: Richard K. Miller, University of Rochester Medical Center
Learning Objectives: To review and demonstrate how the diverse discipline of teratology can be directed to educating practicing clinicians in family medicine, midwifery, obstetrics/gynecology and pediatrics. Define the critical elements in the application of teratology principles for research, pharmaceutical/chemical development, regulation, risk management and counseling as developed by the Teratology Society Education Course over 30 years. Identify the essential elements in the teratology training of the next generation of medical students, graduate students, residents and fellows.

 

 

11:25 AM–12:25 PM

Strategies for Postapproval Assessment Workshop – Texas Ballroom D

   
11:25 AM-11:45 AM

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.

   
11:45 AM-12:05 PM

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.

   
12:05 PM-12:25 PM

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.

 

 

1:35 PM–4:30 PM

Assessing the Developmental Toxicity of Nanomaterials Symposium – Texas Ballroom D

   
1:35 PM–2:15 PM

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.

   
2:15 PM–2:55 PM

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.

   
2:55 PM–3:10 PM

Break

   
3:10 PM–3:50 PM

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.

   
3:50 PM–4:30 PM Overview of Nanomaterial Regulation: Data Gaps and Research Needs for Risk Assessment
Maureen Gwinn, Office of Research and Development, US EPA
Learning Objectives: Attendees will learn about the potential issues and limitations of current toxicity testing strategies for gaining a better understanding of nanomaterials, with a focus on developmental toxicity testing.
 

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