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.

HESI DART Professional Development Awardees

Congratulations to the 2023 Developmental and Reproductive Toxicology (DART) Committee Professional Development Award recipients! Each recipient received a $2000.00 USD award to support attendance at relevant scientific conferences, workshops, training courses, or another related opportunity that contributes to professional development.

Mackenzie Connell, PhD Student
University of Florida, Florida, USA
Public and Environmental Health
Area of focus: Environmental stressors that affect organisms during critical reproductive windows

Bio: Mackenzie first joined the Warrior Aquatic, Translational, and Environmental Research (WATER) lab in 2017 while pursuing her B.S. in public health with a focus in life and pre-health sciences. She then went on to earn a Master of Public Health Degree from Wayne State University with a concentration in urban public health practice in Detroit, MI where reproductive health and birth outcomes are a major public health concern. Mackenzie has had the opportunity to learn about environmental health and contribute to epidemiological and toxicological research in her time with the WATER Lab, Michigan Antibiotic Resistance Reduction Coalition, and Henry Ford Health System. Combining her background and education in Public Health Analytics, Mackenzie plans to build on these foundational skills as she works toward her PhD in Public and Environmental Health at the University of Florida. Mackenzie has a passion for maternal and reproductive health and will continue to investigate the environmental stressors that affect organisms during critical reproductive windows.

Madeline Vera-Colón, PhD Candidate
UC Irvine, California, USA
Environmental Health Sciences
Area of focus: The effect of environmental toxins on osteogenic differentiation

Bio: Madeline Vera-Colón is a first-year PhD student in the Environmental Health Sciences program at UC Irvine. She works within the laboratory of Dr. Nicole Sparks, who is a new Assistant Professor studying how prenatal toxicant exposure may impact bone development. Madeline’s dissertation project encompasses the fields of developmental, molecular, and environmental toxicology. Madeline is a first generation Mexican American and college graduate in her family. She is passionate about promoting STEM careers to historically excluded groups. She is involved in many committees that share these same values. Madeline hopes to one day provide mentorship to the next generation of scientists and help promote diversity in her future career.

Working Groups

  • Anogenital Distance and Nipple Retention

    To promote harmonization of anogenital distance (AGD) and nipple/areola retention measurement in male rats, this project aims to publish a review of existing methods and recommend best practices and considerations for these two methods.

  • Thyroid Hormone Assessments

    In collaboration with the European Teratology Society, the joint working group has collected historical data on thyroid hormone measurement in rodent studies to determine best practices for these measurements.

  • Pubertal Assessment

    The goal of this working group is to determine the degree of reliability and human relevance of in vitro rodent markers/assays for puberty timing endpoints by critically evaluating the epidemiological and toxicological literature on both normal development and altered development after exposures. A series of review articles are underway and anticipated to be completed in 2022.

  • Juvenile Clinical Pathology Endpoints

    Clinical pathology data from control animals in previously conducted juvenile animal toxicity studies has been gathered. Data analysis is underway, and a manuscript that could be used as a reference across the industry is in development.

  • Preclinical Considerations for Pregnant and Lactating Women in Clinical Trials

    A points-to-consider manuscript is in development, outlining initial approaches to inclusion, the role of nonclinical data, and common practices during global drug development plans.

  • DARTable Genome

    This working group aims to enable better predictive toxicology for DART effects by sharing relevant knowledge of chemical-protein target interactions, pharmacokinetics, and major developmental toxicity study outcomes. To this end, the team has initiated two case studies on the well characterized teratogens, Retinoic Acid and Thalidomide.

  • microCT

    This group strives to provide additional information and confidence that fetal skeletal examination using microCT is acceptable for regulatory use in nonclinical fetal evaluation studies. The study design and participants in a multi-site in vivo study comparing microCT and alizarin red staining is being finalized. Experimental work is anticipated to begin in 2022.

  • Immunomodulators and Pregnancy Risk

    This working group, in collaboration with the HESI Immuno-Safety Technical Committee (ITC), convened key stakeholders to discuss both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy. This group will sunset after the workshop publication is completed.

  • Preweaning Developmental Endpoints

    This project aims to define which preweaning developmental landmarks (PDLs) have value, interpretation, and benchmark responses through both a survey and data collection.

  • QSAR Model of Rodent Placental Transfer

    This working group will collect data on a diverse set of compounds to increase the predictive power of a QSAR model for the prediction of placental transfer in rats; outputs from this model can be used as a tool to enhance the exposure based predictions of in vitro assays.

  • Adverse DART Effects Training Course

    This working group is organizing a series of webinar modules to train federal and international regulators, clinicians, academic investigators, contract research organization scientists, and private sector scientists on the best practices and principles of interpreting DART data in the context of regulatory frameworks and processes.

  • Dysotcia

    The goal of the project is to survey labs using HanWister and Sprague Dawley rats in DART studies to understand if reproductive performance in the strain is waning/evolving. Team will publish findings on this analysis.

  • DART NAMs/Alternatives

    This scoping group aims to create a new approach methodologies (NAMs) toolbox that will provide for and clarify the context of use for alternative assays that will comply with various regulatory guidelines so that they can ultimately validate for us as a NAM.

  • DART Trainee Program

    This new initiative aims to leverage the HESI DART Committee’s membership and technical work to facilitate career development (with a focus on training and networking) of the next generation of developmental toxicologists. The program(s) will be advertised outside of the traditional and well-established networks to expand our reach to individuals who belong to historically under-represented groups, thereby broadening the pool of trainees.

HESI Staff

Leadership Team

  • Vicki Sutherland, PhD

    National Institute of Environmental Health Sciences / National Toxicology Program

  • Kary Thompson, PhD

    Janssen Pharmaceuticals

Committee Events

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HESI DART Workshop: Strategies for Oligonucleotides

October 17, 2023 – October 18, 2023

Hybrid, HESI Offices, Washington DC

This workshop will consider application of DART principles to fit attributes of ASOs, siRNAs and other oligonucleotide therapeutics and highlight gaps and challenges associated with determining the most appropriate strategies to account for potential risk to a varied patient population and spectrum of disease conditions.

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EUROTOX 2023

September 10, 2023 – September 13, 2023

Ljubljana, Slovenia

57th Congress of the European Societies of Toxicology.

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Society for Birth Defects Research and Prevention 2023 Annual Meeting

June 25, 2023 – June 28, 2023

Charleston, South Carolina

HESI DART science advisor Dr. Steven van Cruchten (Antwerp University) is a featured speaker in the “Applications of New Approach Methods in Developmental and Reproductive Toxicology Symposium” scheduled for 28 June 2023. His talk “How to Gain Confidence for Using NAMs in the Regulatory Arena of DART Testing” will ...

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DART 2023 Spring Business Meeting

May 11, 2023

Washington, DC, USA

The HESI Developmental and Reproductive Toxicology Technical Committee will be hosting it's annual spring business meeting in Washington DC at the HESI Offices. Those who cannot attend in person are welcome to join online. This is an internal committee meeting.

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Committee Publications

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The benefits, limitations and opportunities of preclinical models for neonatal drug development

Disease Models & Mechanisms, 2022

Sarah Campion, Amy Inselman, Belinda Hayes, Costanza Casiraghi, ...

Increased research to improve preclinical models to inform the development of therapeutics for neonatal diseases is an area of great need. This article reviews five common neonatal diseases – bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, perinatal hypoxic–ischemic ...

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Ontogeny of Hepatic Transporters and Drug-Metabolizing Enzymes in Humans and in Nonclinical Species

Pharmacological Reviews, 2021

van Groen BD, Nicolaï J, Kuik AC, Van Cruchten S, van Peer E, ...

The liver represents a major eliminating and detoxifying organ, determining exposure to endogenous compounds, drugs, and other xenobiotics. Drug transporters (DTs) and drug-metabolizing enzymes (DMEs) are key determinants of disposition, efficacy, and toxicity of drugs. Changes in their mRNA and protein expression levels ...

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

Pharmaceutics, 2020

Van den Anker JN, McCune S, Annaert P, Baer GR, Mulugeta Y, ...
  • HESI - Health and Environmental Sciences Institute

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 ...

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

Drug Metabolism and Disposition, 2020

Bueters R, Bael A, Gasthuys E, Chen C, Schreuder MF, Frazier KS
  • HESI - Health and Environmental Sciences Institute

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.

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

Drug Metabolism and Disposition, 2019

Neal-Kluever A, Fisher J, Grylack L, Kakiuchi-Kiyota S, ...

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 ...

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