STUDENT & POSTDOC CORNER

    Developing the Next Generation of Teratologists

    Cast your vote for the 2016 Marie W. Taubeneck Award

    Training Materials

    FileDate
    SLC Use of Animal Models of Disease for Toxicity Prediction Webinar Series

    The Scientific Liaison Coalition (SLC) has developed a Use of Animal Models of Disease for Toxicity Prediction Webinar Series. This series provides pharmaceutical industry and regulatory perspectives on this topic. Registration is required to participate in live webinars. Recordings will be posted when available.

    1. The Use of Animal Models of Disease in Safety Assessments

    LINK TO RECORDING

    Presented by: Diann L. Blanset, PhD, DABT, Boehringer Ingelheim: Preclinical safety studies for proposed pharmaceutical products are usually conducted in healthy animals. The appropriate species for these studies are selected based on the relative pharmacological activity/potency and metabolite profiles between the proposed species and humans. The studies are then designed to mimic the clinical dosing regimen with respect to the route of administration, duration of treatment, and dosing interval. As these studies are conducted in healthy animals, they generally mimic the characteristics of the clinical population for first in human (FIH) Phase I trials in normal subjects (healthy volunteers). However, they do not mimic the characteristics of subjects in later clinical trials or in FIH Phase I trials conducted in subjects with disease. This deviation from the principle of mimicking the clinical conditions of use can be very important in certain disease indications where the disease condition can dramatically affect the safety of the pharmaceutical. The aim of this webinar is to review the use of animal models of disease in the evaluation of exaggerated pharmacology and toxicity to improve the relevance and extrapolation of the assessments to the intended disease population. The basic principles of the use of animal models of disease will be reviewed as well as the advantages and disadvantages of these models. In addition, specific examples of the use of these models in safety assessments will be presented.

    2. Regulatory Perspective on the Use of Animal Models of Disease in Drug Development

    LINK TO RECORDING

    Presented by: Sruthi King, PhD, Pharmacology/Toxicology Team Leader in the Division of Clinical Review in the Office of Generic Drugs within the Center for Drug Evaluation and Research at the US Food and Drug Administration (CDER/FDA). Prior to her current role, Dr. King was a primary nonclinical reviewer for seven years in the Division of Gastroenterology and Inborn Errors Products in the Office of New Drugs within CDER/FDA. She has spoken on the topic of using animal models for nonclinical safety assessment and their utility in supporting rare disease drug development, most recently at the 2015 Annual Meeting of the American College of Toxicology. Dr. King also has co-authored a chapter on this topic in second edition of Pediatric Drug Development: Concepts and Applications. The objective of this presentation is to highlight current regulatory practices within CDER/FDA with case studies in which animal models of disease were used in nonclinical safety studies. At this time, the FDA recommends the use of animal models of disease be used in “proof of concept” studies, unless the sponsor provides acceptable justification that the animal model is the most relevant species for pharmacology and toxicology testing. However, the use of animal models, particularly for rare disease drugs, is increasing and regulators are tasked with determining whether the data generated in these models are adequate to support drug development and approval of safe and effective therapies, with limited clinical trial data. In general, nonclinical studies to support clinical trial initiation and ongoing development of small molecules and biologics are guided by ICH M3 and ICH S6; however, review divisions may apply regulatory flexibility. 

    3. Animal Models of Human Disease for Nonclinical Safety—Why, What and When…

    Tuesday, June 21, 11:00 AM–12:30 PM ET

    Online Registration>>

    Presented by Sherry J. Morgan, DVM, PhD, ACVP, ABT, ABVT joined Abbott/AbbVie, Inc. in 1990. She currently serves a dual role as a pathologist and a Director of Scientific Projects, providing toxicology and pathology guidance for Discovery and Development projects. Dr. Morgan also provides interpretative nonclinical risk assessment summaries of numerous potential in-licensing compounds, helping to guide the selection process of novel compounds. She is board certified by the American College of Veterinary Pathologists, the American Board of Veterinary Toxicologists, and the American Board of Toxicology. Her publication list includes approximately 30 journal articles, 20 book chapters, and 30 abstracts/posters. Topics on the use of animal models span therapeutic indications including oncology, joint diseases, neurodegeneration, cardiovascular disease, and endocrine and metabolic diseases. She also has contributed to the validation of non-invasive imaging technologies using traditional pathology endpoints. In this presentation, the rationale for the use of animal models of disease will be discussed as it pertains to different adverse drug reactions for which there is relatively low predictability with conventional animal models. Some of the possible reasons for lack of concordance between different organ systems will be covered as well. The presentation will conclude with general recommendations when considering using an animal model of animal disease as well as some examples of studies involving animal models of disease.

     

    This webinar series is open to members of the Teratology Society through our membership in the SLC.

     

     

    2016-06-09 14:21:25
    Medication Prescribing for Pregnant and Childbearing-aged Women Webinar - Recording Available

    Webinar: AAP Medication Prescribing for Pregnant Women

    Recording available - see links below.

    On January 26, 2016, in collaboration with the Centers for Disease Control and Prevention (CDC) National Center on Birth Defects and Developmental Disabilities, the American Academy of Pediatrics Program to Enhance the Health and Development of Infants and Children (PEHDIC) offered a free webinar with the aim of educating health care providers about medication safety during pregnancy and resources to help counsel women on treatment decisions before and during pregnancy.

    The webinar, led by Christina Chambers, PhD, epidemiologist, UC San Diego professor and Teratology Society past-president, as well as Cheryl Broussard, PhD, Health Scientist at the CDC’s Birth Defects Branch, provides an overview of what is known about medication safety during pregnancy, relevant clinical considerations for prescribers and pharmacists and resources to help counsel women regarding treatment decisions before and during pregnancy.

    Taking some medications early in pregnancy—often before women know they are pregnant—can increase the risk for some birth defects and other poor pregnancy outcomes. “While pregnant women should not stop or start taking any type of medicine without first talking with a health care provider, the information available to health care providers to guide and support the decision making process is limited,” explained Chambers. “We hope to provide some insight and resources to make that process easier for them.”

    A recording of this webinar as well as the presentation slides and question and answer summary are available as follows:

    Webinar Recording – Click here

    Webinar Presentation Slides – Click here

    Webinar Question & Answer Summary – Click here

     

     

     

    2016-03-04 14:06:50
    Webinar: Neurodevelopmental & Psychosocial Issues in Children with Congenital Heart Defects, Nov. 12

    Webinar: Neurodevelopmental and Psychosocial Issues in Children with Congenital Heart Defects: Expected Not Accepted

    Thursday, November 12 at 3 pm ET

    Hosted by American Academy of Pediatrics (AAP) in collaboration with the National Center on Birth Defects and Developmental Disabilities (CDC)

    Children with Congenital Heart Defects (CHDs) are living longer, have increased risk of neurodevelopmental and psychosocial issues, and are more likely to receive special education services. Early deficit identification through screening can help children achieve optimal outcomes. Faculty will summarize current evidence related to children with CHDs and developmental issues, review guidelines for periodic screening and evaluation, and present strategies to enhance outcomes. There is no charge to attend; however prior registration is required.

     

    2015-11-07 08:24:48
    CDC’s Public Health Grand Rounds: “Public Health Strategies to Prevent Preterm Birth," Nov. 16

    CDC’s Public Health Grand Rounds: “Public Health Strategies to Prevent Preterm Birth”

    LIVE WEBCAST Monday, November 16th from 10:00 am ET to 11:00 am ET

    Presentations:

    Wanda Barfield, MD, MPH
    Director, Division of Reproductive Health
    National Center for Chronic Disease Prevention and Health Promotion, CDC
    "Preterm Birth in the United States: Where We Stand" 

    Arthur James, MD
    Associate Clinical Professor, Department of Obstetrics and Gynecology
    Ohio State University Wexner Medical Center
    "Tackling the U.S. Black and White Racial Disparity in Infant Mortality"

    Zsakeba Henderson, MD
    Medical Officer, Division of Reproductive Health
    National Center for Chronic Disease Prevention and Health Promotion, CDC
    "Preventing Preterm Birth One State at a Time: Perinatal Quality Improvement Collaboratives"

    Jennifer L. Howse, PhD 
    President
    March of Dimes Foundation
    "The 2030 Goal: Public-Private Partnerships to Prevent Preterm Birth"

    For individuals who are unable to view the session during the scheduled time, the archived presentation will be posted 48 hours after the live webcast. 

    Description:

    During the final months of pregnancy, a growing baby goes through important stages of development. The earlier a baby is born, the higher the risk of death or serious disability. Preterm birth, the birth of an infant before 37 weeks of pregnancy, is the most common underlying cause of infant death, contributing to two-thirds of all infant deaths in the United States. Infants born before 32 weeks gestation bear the biggest burden – representing more than 50 percent of infant deaths. Premature births also pose a long-lasting financial burden on the individual, their families and society. In 2005, the Institute of Medicine reported that each year the cost associated with premature birth in the United States was over $26 billion.

    Since 1990, the nation's overall infant mortality rate has declined nearly 35 percent and the rate of preterm births decreased to 11.3 percent in 2013. However, these national declines have not erased racial disparities within the US. Preterm-related causes of death are more than three times higher for black infants than for white infants. Disparities are also seen for Native American infants.

    Preterm birth is complex and remains a challenge because its causes are numerous, and poorly understood. Modern technology and stronger public health strategies have made a significant impact in reducing preterm births and infant mortality. However, we still have a lot to learn about the causes of premature birth in order to prevent it and protect the youngest members of our society, especially among racial and ethnic minorities.

    This session of Grand Rounds discusses how concerted efforts to improve surveillance data, better medical care and prevention, and stronger public health partnerships, can accelerate progress in reducing preterm births and improving neonatal outcomes.

     

     

    2015-11-07 08:23:37
    SLC Webinar: Industry Perspective on Biomarkers - Recording Available

    A recording is now available of the Scientific Liaison Coalition (SLC) Industry Perspective on Biomarkers Webinar that aired live on October 28, 2015.  

    This webinar features Eugene E. Marcantonio, MD, PhD, Associate Vice President, Translational Pharmacology at Merck Research Laboratories (MRL) and provides an overview of how biomarkers are used in clinical trials in the pharmaceutical industry. Most of the discussion focuses on fit for purpose biomarkers that have been developed in order to make critical decisions in early drug development. Dr. Marcantonio joined MRL in 2007 and has been involved in the early clinical development of a number of compounds in multiple disease areas and now is the lead for Infectious Diseases and Vaccines as well as for Immunology. 

    The recording of this webinar is posted on BDR Connection in the Educational Webinars File file, which houses several recordings of past webinars, including previous SLC Biomarker webinars.

    The mission of the SLC is “improving the ability of societies to partner with other domestic and international organizations that have objectives consistent with the goal of increasing the impact of the science of toxicology to improve public health” by

    • Strengthening partnerships among scientific- and health-based organizations to increase awareness of the impact of toxicology and related subjects on human health; and
    • Functioning as a means to enhance cooperation among societies as equals with the goal of accomplishing tasks benefitting human health and disease prevention through joint and several shared activities.

    The Teratology Society is a member of the SLC which affords Teratology Society members access to live and recorded SLC webinars.

     

     

     

    2016-02-05 07:17:49
    Webinar: Applications of iPS-Cell Derived Tissues in Safety Assessment - Recording Available

    A recording is available of the webinar entitled "Applications of iPS-Cell Derived Tissues in Safety Assessment" featuring Dr. Kyle Kolaja, Vice President, Business Development, Cellular Dynamics International.

    This webinar aired live on September 17, 2015, hosted by the American College of Toxicology in collaboration with the Teratology Society, British Toxicology Society, SOT Stem Cells Specialty Section, and Society of Toxicologic Pathology.

    Abstract: The ability to make pluripotent stem cells from adult somatic cells has revolutionized cell biology, especially as access to differentiated tissues from induced pluripotent stem cells has improved. Differentiated cells from induced pluripotent cell are more similar to intact tissue than cell lines or primary culture and rodents thus have begun to change the standard models to more human in vitro based models. In this talk, numerous examples where stem cell derived tissues have replaced, refined, and/or reduced the reliance on animal models in drug screening, toxicology, and product safety are highlighted.

    Click HERE to view the recorded webinar.

    A PDF of the slide deck is also available below.

    Webinar materials are property of the speaker and the American College of Toxicology and are intended for use by the host society and cohost societies' members for educational purposes only. Any distribution or copy of the materials is prohibited. By downloading from the link provided you agree to the terms expressed above. 

     

    2016-02-05 07:23:58
    Fundamentals of Ethics in Research - Recording

    This presentation, "Fundamentals of Ethics in Research," by Bernard Robaire, PhD, McGill University, was given and recorded with permission on Saturday, June 27, 2015, as part of the Education Course at the Teratology Society's 55th Annual Meeting in Montreal, Quebec.

    https://aim-hq.webex.com/aim-hq/ldr.php?RCID=85f9da28b73d1ab06827190a55ffe784

     

    2016-03-08 08:54:25
    Global Regulatory Guidelines & Risk Assessment for Occupational and Environmental Hazards- Recording

    This presentation, "Global Regulatory Guidelines and Risk Assessment for Occupational and Environmental Hazards," by Elaine Z. Francis, Sandcastle Toxicology, and Alan M. Hoberman, Charles River, was given and recorded with permission on June 27, 2015 as part of the Education Course at the Teratology Society's 55th Annual Meeting in Montreal, Quebec.

    https://aim-hq.webex.com/aim-hq/ldr.php?RCID=b9eedc6c856a061b98ce3bd23656a45e

     

    2016-03-08 08:55:41
    SLC Webinar: Regulatory Perspective on Biomarker Presentation - Recording Available

    A recording of the Scientific Liaison Coalition (SLC) webinar, Biomarker Utility and Acceptance in Drug Development and Clinical Trials: An FDA Regulatory Perspective, is now available. This is the first of three SLC webinars discussing issues related to the types of biomarkers, their use, and some of the challenges that lie ahead.

    Presenters:

    Shashi Amur, PhD, Scientific Lead of the Biomarker Qualification Program in the Office of Translational Sciences, Center for Drug and Evaluation Research (CDER), US Food and Drug Administration ( FDA), and

    Christopher L. Leptak, MD, PhD, Biomarker and Companion Diagnostics Lead for the Office of New Drugs within CDER/FDA and Co-Director of the Biomarker Qualification Program

    The objectives of this webinar are to: (1) define the different types of biomarkers and how they may be used in drug development programs, (2) describe the different pathways that can lead to regulatory acceptance, (3) provide examples of biomarkers accepted into drug development through IND/NDA/BLA submissions, (4) offer specifics about the qualification program pathway including the history that includes qualification of nonclinical safety biomarkers, (5) update of the qualification status, (6) share some best practices to consider when developing a biomarker for regulatory use, and (7) provide information regarding opportunities for engagement with the FDA if you are considering developing a biomarker for regulatory use. 

    Dr. Amur's current research interests include biomarkers in Autoimmune Diseases and in Alzheimer’s disease, drug-induced liver toxicity, pharmacogenomics, and HLA-associated adverse events. She is Past Chair of the Pharmacogenomics Focus Group, American Association of Pharmaceutical Scientists.

    The focus of Dr. Leptak's work is on biomarker development and diagnostic device utility in clinical trials and drug development, both for drug-specific programs as well as qualification. He is charged with identifying policy, process, and regulatory science needs within the codevelopment space and is involved in multiple inter-office and inter-center working groups to address those needs.

    Click HERE to view recorded webinar.

     

    The Teratology Society is a member of the SLC whose mission is “improving the ability of societies to partner with other domestic and international organizations that have objectives consistent with the goal of increasing the impact of the science of toxicology to improve public health” by:

    • Strengthening partnerships among scientific- and health-based organizations to increase awareness of the impact of toxicology and related subjects on human health; and
    • Functioning as a means to enhance cooperation among societies as equals with the goal of accomplishing tasks benefitting human health and disease prevention through joint and several shared activities.
    2016-02-25 13:33:17
    Tips from the Top: Getting Published in High-Impact Journals

    This file contains two Powerpoint presentations entitled "Tips from the Top: Getting Published in High-Impact Journals" by George P. Daston, Birth Defects Research Part B Editor and Michel Vekemans, Birth Defects Research Part A Editor, presented as part of the Student-Postdoctoral Lunch Workshop at the Teratology Society's 54th Annual Meeting in Bellevue, Washington, June 29, 2014.

    2015-08-10 12:28:41
    Tips from the Top: Getting Published in High-Impact Journals

    This file contains two Powerpoint presentations entitled "Tips from the Top: Getting Published in High-Impact Journals" by George P. Daston, Birth Defects Research Part B Editor and Michel Vekemans, Birth Defects Research Part A Editor, presented as part of the Student-Postdoctoral Lunch Workshop at the Teratology Society's 54th Annual Meeting in Bellevue, Washington, June 29, 2014.

    2015-08-10 12:28:41
    Fetal Alcohol Syndrome Webinar Featuring Dr. Kenneth Lyons Jones - Recording Available

    Fetal Alcohol Syndrome Webinar

    This file contains a recording of the live webinar that took place June 17, 2015 at 11:00 am EDT.

    Presented by Dr. Kenneth Lyons Jones, MD, Chief of the Division of Dysmorphology/Teratology at the Department of Pediatrics at the University of California, San Diego, this webinar provides a retrospective look at 40 years of the Fetal Alcohol Syndrome. The presentation is broken into three parts: recognition of the disorder; reaction to that recognition; and finally, where we are today.  

    This webinar is hosted by the Teratology Society with the support of OTIS MotherToBaby and is moderated by Christina Chambers, PhD, MPH, Professor, University of California, San Diego. 

    Recording Link: https://aim-hq.webex.com/aim-hq/lsr.php?RCID=b1041f5191014eaa9bf7a19984247d0d

    (Teratology Society members who wish to share this recording with non-members (e.g., students) may copy the Recording Link, access to which does not require a password.)

    About the Presenter:

    Dr. Kenneth Lyons Jones is the Chief of the Division of Dysmorphology/Teratology at the Department of Pediatrics at the University of California, San Diego and Medical Director of MotherToBaby California. In these activities he has been involved in research, teaching, clinical work and University and public service. His research has focused on the clinical delineation of birth defects, mechanisms of normal and abnormal morphogenesis and the recognition of new human teratogens. Dr. Jones has authored over 400 publications in scientific journals as well as several books, and is the author of Smith’s Recognizable Patterns of Human Malformation which is now in its 7th edition. He was one of two doctors at the University of Washington who first identified Fetal Alcohol Syndrome (FAS) in the United States in 1973.  Over the past 40 years he has continued to make significant contributions to our understanding of the prenatal effects of alcohol, most recently as the head of the Dysmorphology Core of the large NIAAA consortium studying this disorder. Dr. Jones is a Past President of the Teratology Society, Organization of Teratology Information Specialists (OTIS), and Western Society for Pediatric Research. He is a member of the Association of American Physicians.

     

     

    2016-02-05 07:24:40
    Webcast: Metabolics as a Tool for Characterizing the Exposome, May 28-29, 2015

    Metabolomics as a Tool for Characterizing the Exposome, May 28-29, 2015

    National Academy of Sciences Building
    Lecture Room
    2101 Constitution Avenue, NW
    Washington, DC

    REGISTER NOW!

    This workshop is organized by the National Research Council. It is free of charge and will be webcast.  

    Metabolomics—the study of the chemical fingerprints that cellular processes leave behind—is emerging as an important way to characterize exposure. Join the committee on Emerging Science for Environmental Health Decisions and researchers, professionals, and policy experts for a workshop that will explore this new approach to advancing understanding of environmental impacts on human health. Presentations and panel discussions will focus on:

    • The potential for using metabolomics to characterize exposure;
    • Technical issues associated with metabolomics, such as data collection and making data useable with databases;
    • The policy implications of a more thorough understanding of background exposure.

    Download a preliminary agenda

     

    2015-08-20 07:19:20
    Computation Toxicology: A Useful Tool for Hazard Identification and Risk Assessment?

    Computational Toxicology: A Useful Tool for Hazard Identification and Risk Assessment?

    This webinar hosted by the American College of Toxicology aired live on May 20, 2015 at 11:00 AM ET

    In Collaboration with the Teratology Society, British Toxicology Society, SOT Biological Modeling Specialty Section, and Society of Toxicologic Pathology

    Speaker: Dr. Russell Naven, Senior Principal Scientist, Pfizer

    A recording of this webinar is available to Teratology Society members here:

    https://aim-hq.webex.com/aim-hq/lsr.php?RCID=a7b06b3bd20d4c11836af9a697d4f1cb 

     

    2015-08-20 07:18:48
    SLC Webinar - Gatekeeper and Watchman: The Microbiome Enters the Picture -- Recording Available

    On Tuesday, April 28, 2015, the Scientific Liaison Coalition (SLC), of which the Teratology Society is a member, hosted a live webinar, “Gatekeeper and Watchman: The Microbiome Enters the Picture" presented by Ellen Silbergeld, PhD. Teratology Society President Mary Alice Smith served as the moderator for this webinar.  A recording of this webinar is now available.

    Description:  The microbiome, defined most inclusively as a biologically and spatially defined microbial community along with its ecological support system, is newly recognized as an important factor in human development and health status over the lifetime and transgenerationally. For toxicology and epidemiology, we need to reconsider our current modes of thinking about how humans encounter the external environment and to expand our current models for understanding associations between external exposures and health status. Site-specific microbiomes occupy the front line of exposure at portals of entry prior to absorption by inhalation, ingestion or dermal contact. In this “gatekeeper” role, the microbiome within its metagenome (the combined genetic resources of the microbial community) is involved in metabolism of metals and complex chemicals. In addition, in its “watchman” role, the microbiome participates in the overall response of the human organism by signal transduction across the portal of entry to target organs and systems. Exposure-induced changes in the microbiome will affect these signals as well as the internalized exposure transferred across physiological barriers into the host organism.

    Since the human microbiome contains ~100 times as many as the human host, it must be considered in the design and interpretation of epidemiology and toxicology studies. Implications for research will be discussed, with examples.

    Presented by: Ellen Silbergeld, PhD, Professor, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. Her research and professional activities bridge science and policy, with a focus on the incorporation of mechanistic toxicology into environmental and occupational health policy. Dr. Silbergeld also directs a Fogarty Training Program in NonCommunicable Diseases, which is collaboration between Hopkins and the School of Public Health of Mongolia. 

    The Scientific Liaison Coalition includes the American Association for Cancer Research (AACR), American Academy of Clinical Toxicology (AACT), American College of Medical Toxicology (ACMT), American College of Toxicology (ACT), The Endocrine Society (ENDO), Environmental Mutagenesis and Genomics Society (EMGS), International Society for the Study of Xenobiotics (ISSX), Safety Pharmacology Society (SPS), Society for Risk Analysis (SRA), Society of Environmental Toxicology and Chemistry (SETAC), Society of Toxicologic Pathology (STP), Society of Toxicology (SOT), and Teratology Society (Teratology). For additional information about the SLC, please contact Marcia Lawson and visit the SLC website.

     

    2016-02-25 13:34:41
    Oxidative Stress in Abnormal Embryonic and Fetal Brain Development

    This presentation was given June 28, 2014, during the Education Program at the Teratology Society's 54th Annual Meeting in Bellevue, WA.


    Title: Oxidative Stress in Abnormal Embryonic and Fetal Brain Development

    by

    Peter G. Wells, PharmD

    Professor, Faculty of Pharmacy

    University of Toronto

    To view the presentation, click HERE.  

    Please note that it may take a minute or two for the presentation to load.

    2015-08-20 07:19:48
    Of Embryos and Tumors: The Relevance of Teratology

    This presentation was the Narsingh Agnish Fellow Lecture given June 28, 2014, at the Teratology Society's 54th Annual Meeting held in Bellevue, Washington. 

    Title: Of Embryos and Tumors: The Relevance of Teratology

    by Teratology Society Past President

    John M. DeSesso, PhD

    Principal Scientist and Office Director

    Center for Toxicology and Mechanistic Biology

    Exponent

    To view the recording, click HERE

    Please note that it may take a minute or two for the presentation to load.

    2015-08-20 07:20:11
    Teratology Primer, Second Edition

    Teratology Primer is available to all interested individuals.  Your feedback is encouraged.

    2014-10-10 07:20:28


    Copyright © 2016 The Teratology Society. All Rights Reserved
    All material, files, logos and trademarks within this site are copyright their respective organizations.
    Terms of Service - Privacy Policy - Contact