April 20, 2021 – April 21, 2021
Virtual meeting, hosted by the HESI DART Committee
The HESI DART Committee 2021 Spring Meeting will take place on April 20-21, 2021 from 9am-1pm EST. The virtual meeting is open to DART Committee participants only.
February 11, 2020
Silver Spring, Maryland, USA
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 ...
May 9, 2019 – May 10, 2019
Washington, District of Columbia, USA
Save the date! HESI DART Committee and European Teratology Society Workshop on Thyroid Hormone Assessment: Implications for Developmental and Reproductive Toxicology
September 4, 2017
Budapest, Hungary
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.
April 19, 2017 – April 20, 2017
Washington, District of Columbia, USA
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 ...
September 2, 2015 – September 3, 2015
Amsterdam, Netherlands
This satellite workshop was held in conjunction with the European Teratology Society Annual Meeting.
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ABOUT THE EVENT
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.
[post_title] => FDA/CDER - HESI Immunomodulators and Pregnancy Risk Assessment Workshop
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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
WORKSHOP AGENDA
Click here to download the workshop agenda.
Session 1: Setting the Stage
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)
Session 3: Global Thyroid Activities
Overview of Ongoing Thyroid Activities in the European Union and United States
Manon Beekhuijzen, Charles River (Download presentation)
HESI DART - ETS Thyroid Hormone Survey - Results & the Path Forward
Pragati Coder, Charles River (Download presentation)
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