Developmental and Reproductive Toxicology (DART) Committee

 

Developmental and Reproductive Toxicology (DART) Committee

Mission Statement

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.

Committee Contacts

HESI Staff

Connie Chen, PhD, MPH
cchen@hesiglobal.org

Shermaine Mitchell-Ryan, PhD
smitchell-ryan@hesiglobal.org

Leadership Team

Susan Makris, MS
US Environmental Protection Agency

Kary Thompson, PhD
Bristol-Myers Squibb

Members and Fact Sheet

Committee SharePoint Log-In

Committee Events

FDA/CDER – HESI Immunomodulators and Pregnancy Risk Assessment Workshop

Silver Spring, MD, 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 is to begin to address gaps in biology, current tools, and other aspects of pregnancy risk that need to be considered during drug development.

Read more

Rethinking Developmental Toxicity Testing: Evolution or Revolution

Washington, DC, 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 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.

Read more

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				FDA CDER Immunomodulators and Pregnancy Workshop
	

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:

  1. The current state of reproductive immunology
  2. How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
  3. What additional tools/methods are currently being developed that could address gaps
  4. 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.

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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

  1. 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,
  2. 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,
  3. Discuss and come to consensus on recommendations on how to improve data interpretation/understanding of thyroid changes and their relationship to adverse outcomes
dreamstime_s_127655942

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) [post_title] => HESI DART Committee Thyroid Hormone Assessment Workshop [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => hesi-dart-committee-thyroid-hormone-assessment-workshop [to_ping] => [pinged] => [post_modified] => 2020-08-28 10:33:11 [post_modified_gmt] => 2020-08-28 15:33:11 [post_content_filtered] => [post_parent] => 0 [guid] => http://hesiglobal.org/?post_type=event&p=20795 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 4892 => 28 => 2017-08-02 14:26:43 [post_date_gmt] => 2017-08-02 19:26:43 [post_content] => [post_title] => Best Practices in Interpreting Developmental Toxicity Data for Classification and Labeling [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => clp-cmr [to_ping] => [pinged] => [post_modified] => 2018-01-12 10:14:28 [post_modified_gmt] => 2018-01-12 15:14:28 [post_content_filtered] => [post_parent] => 0 [guid] => http://hesiglobal.org/?post_type=event&p=4892 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 4241 => 28 => 2016-09-29 12:07:01 [post_date_gmt] => 2016-09-29 17:07:01 [post_content] => [post_title] => Rethinking Developmental Toxicity Testing: Evolution or Revolution [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => rethinkingdevtox [to_ping] => [pinged] => [post_modified] => 2017-05-04 14:50:17 [post_modified_gmt] => 2017-05-04 19:50:17 [post_content_filtered] => [post_parent] => 0 [guid] => http://hesiglobal.org/?post_type=event&p=4241 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) [4] => WP_Post Object ( [ID] => 2065 => 12 => 2016-04-28 09:02:34 [post_date_gmt] => 2016-04-28 14:02:34 [post_content] => [post_title] => Pregnancy and Lactation Labeling Workshop [post_excerpt] => [post_status] => publish [comment_status] => closed [ping_status] => closed [post_password] => [post_name] => pregnancy-and-lactation-labeling-workshop [to_ping] => [pinged] => [post_modified] => 2016-04-28 09:19:40 [post_modified_gmt] => 2016-04-28 14:19:40 [post_content_filtered] => [post_parent] => 0 [guid] => https://ilsi.org/hesi/?post_type=event&p=2065 [menu_order] => 0 [post_type] => event [post_mime_type] => [comment_count] => 0 [filter] => raw ) ) [post_count] => 5 [current_post] => -1 [in_the_loop] => [post] => WP_Post Object ( [ID] => 22078 => 105 => 2020-01-02 13:06:03 [post_date_gmt] => 2020-01-02 18:06:03 [post_content] => FDA CDER Immunomodulators and Pregnancy Workshop

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:

  1. The current state of reproductive immunology
  2. How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
  3. What additional tools/methods are currently being developed that could address gaps
  4. 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.

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Committee Publications

All Publications

Approaches to Dose Finding in Neonates, Illustrating the Variability Between Neonatal Drug Development Programs

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.

Read more

Ontogeny and Cross-Species Comparison of Pathways Involved in Drug Absorption, Distribution, Metabolism, and Excretion in Neonates (Review): Kidney

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.

Read more

Physiology of the Neonatal Gastrointestinal System Relevant to the Disposition of Orally Administered Medications

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).

Read more

Rethinking developmental toxicity testing: Evolution or revolution?

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.

Read more

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