The DART committee provides a forum where scientists from industry, government and academia can exchange information and initiate activities to advance science related to DART, and to develop consensus on the appropriate use of experimental data for human health risk assessment.
The goal of this workshop is to convene key stakeholders to discuss both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy. Through the sharing of case examples, followed by longer in-depth discussion within each session, the goal is to begin to address gaps in biology, current tools, and other aspects of pregnancy risk that need to be considered during drug development.
Save the date! HESI DART Committee and European Teratology Society Workshop on Thyroid Hormone Assessment: Implications for Developmental and Reproductive Toxicology
This satellite workshop to the 45th Annual Meeting of the European Teratology Society is addressed to participants working in industries or regulatory bodies who are involved in testing and assessment of the potential developmental toxicity of chemicals.
This workshop will consider new strategies to identify developmental hazards taking into account the current state of science which may include alternative possibilities or improvements to the current Segment 2 design. These considerations could include the use of new technology to overcome some of the limitations in predicting human response with current animal models or completely new radical approach to developmental toxicity hazard identification. These may range from having a critical paradigm to deciding when non-clinical studies are needed to the use of biotechnology and computational models or hazard characterization. Working groups can consider either strategy, or combinations of the two.
The goal of this workshop is to convene key stakeholders to discuss both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy. Through the sharing of case examples, followed by a longer in-depth discussion within each session, the goal is to begin to address gaps in biology, current tools, and other aspects of pregnancy risk that need to be considered during drug development.
The workshop is intended to provide an interdisciplinary forum for industry, academia and regulatory scientists to discuss:
The current state of reproductive immunology
How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
What additional tools/methods are currently being developed that could address gaps
Global regulatory considerations across various immunomodulatory modalities
Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).
Registration: Up-to-date information and registration can be found here. Registration will close on February 5, 2020. Due to the format and structure of this workshop, attendance is restricted to in-person attendees only.
Recent updates to OECD developmental/reproductive toxicology guidelines and other regulatory guidelines and guidance require the measurement of thyroid hormone levels in the blood of mammalian laboratory species during development. Preliminary analyses indicate that there is a wide variability across laboratories in the methods being used to measure thyroid hormones in young rodents, as well as in the success of obtaining reliable data. Even though publicly available regulatory guidelines and guidance address study design, they allow varied approaches to thyroid hormone measurement in rodents, and an optimal study design or logical approach to thyroid hormone testing in young rodents has not yet been established in a regulatory testing context. Validity, accuracy, sensitivity and reproducibility of the assays are issues of concern. It is not clear to what extent variability in the data can be attributed to methodological issues or to innate biological variability.
WORKSHOP AIMS
Present the state-of-the-science on thyroid hormone assessments, specifically as it relates to preclinical methods and data collection, and identify gaps and knowledge as it relates to regulatory DART testing,
Provide clarification and guidance regarding the collection (timing and methods), assessment (standardization and validation), and interpretation of thyroid hormone data (as it relates to adversity) for regulatory toxicology and risk assessment,
Discuss and come to consensus on recommendations on how to improve data interpretation/understanding of thyroid changes and their relationship to adverse outcomes
The Thyroid Axis - Overview of Anatomy, Physiology, Regulation in Mammalian Systems Mary Gilbert, U.S. EPA (Download presentation)
An AOP Network for Thyroid Hormone Disruption and Adverse Outcomes Kevin Crofton, R3Fellows, LLC (Download presentation)
Mild Thyroid Dysfunction During Pregnancy; Consequences for Pregnancy Outcome and Fetal Development Robin Peeters, Erasmus University (Download presentation)
Session 2: Methodologies & Interpretation
Regulatory Requirements for Evaluation of Thyroid Status Sue Marty, Dow (Download presentation)
Pathology Endpoints: Evaluation of Thyrotoxicants in Animal Studies Brent Walling, Charles River (Download presentation)
Overview of In Vitro Assays to Investigate Chemicals for Thyroid-Axis Disrupting Potential Michael Hornung, U.S. EPA (Download presentation)
The goal of this workshop is to convene key stakeholders to discuss both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy. Through the sharing of case examples, followed by a longer in-depth discussion within each session, the goal is to begin to address gaps in biology, current tools, and other aspects of pregnancy risk that need to be considered during drug development.
The workshop is intended to provide an interdisciplinary forum for industry, academia and regulatory scientists to discuss:
The current state of reproductive immunology
How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
What additional tools/methods are currently being developed that could address gaps
Global regulatory considerations across various immunomodulatory modalities
Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).
Registration: Up-to-date information and registration can be found here. Registration will close on February 5, 2020. Due to the format and structure of this workshop, attendance is restricted to in-person attendees only.
Van den Anker JN, McCune S, Annaert P, Baer GR, Mulugeta Y, Abdelrahman R, Wu K, Krudys KM, Fisher J, Slikker W, Chen C, Burckart GJ, Allegaert K
Drug dosing in neonates should be based on integrated knowledge concerning the disease to be treated, the physiological characteristics of the neonate, and the pharmacokinetics (PK) and pharmacodynamics (PD) of a given drug. It is critically important that all sources of information be leveraged to optimize dose selection for neonates. Sources may include data from adult studies, pediatric studies, non-clinical (juvenile) animal models, in vitro studies, and in silico models.
Bueters R, Bael A, Gasthuys E, Chen C, Schreuder MF, Frazier KS
This review provides insight in cross-species developmental differences of absorption, distribution, metabolism, and excretion properties in the kidney, which should be considered in neonate/juvenile study interpretation, hypotheses generation, and experimental design.
Luc M. De Schaepdrijver, Pieter P. J. Annaert and Connie L. Chen
The HESI Developmental and Reproductive Toxicology (DART) Committee launched a multisector collaborative research effort to increase the knowledge base in the nonclinical neonatal space to better inform decisions made in the clinic.
April Neal-Kluever, Jeffrey Fisher, Lawrence Grylack, Satoko Kakiuchi-Kiyota and Wendy Halpern
This review is part of a multisector collaborative research effort coordinated by the HESI Developmental and Reproductive Toxicology (DART) Committee to increase the knowledge base in the nonclinical neonatal space to better inform clinical treatment decisions made for the newborn patient population (De Schaepdrijver et al., 2018).
Anthony R. Scialli, George Daston, Connie Chen, Prägati S. Coder, Susan Y. Euling, Jennifer Foreman, Alan M. Hoberman, Julia Hui, Thomas Knudsen, Susan L. Makris, LaRonda Morford, Aldert H. Piersma, Dinesh Stanislaus, Kary E. Thompson
Summary from the HESI workshop on embryo‐fetal development testing, considers how we might design developmental toxicity testing if we started over with 21st century knowledge and techniques. The paper considers what might make current protocols more predictive for human risk.
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