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.

Congratulations to the 2024 Developmental and Reproductive Toxicology (DART) Committee Professional Development Award recipients!

Award: For 2024, two selected candidates each 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 (e.g., laboratory visit for specialized training or another venture).

Qualifications and Requirements: Eligible candidates must be currently enrolled in a graduate program (MS or PhD candidates) and involved in research related to developmental or reproductive toxicology, pathology, or a related field (e.g. cell biology, biochemistry) OR hold a current postdoc position/appointment (no longer than 5yrs) related to these research areas.

2024 Awardees

Elena Kozlova, PhD Candidate
University of California, Riverside, USA
Dissertation research: Impact of early-life exposure to polybrominated diphenyl ethers (PBDEs) on social brain development.

Bio: Elena Kozlova is a Neuroscience PhD Candidate at the University of California, Riverside, in the laboratory of Dr. Margarita Curras-Collazo, which focuses on neurotoxicology. Her dissertation research examines how early-life exposure to polybrominated diphenyl ethers (PBDEs) affects social brain development utilizing behavioral, molecular, and chemogenomic techniques. Specifically, Elena investigates how PBDEs impact thyroid hormone and the ‘social’ neuropeptide oxytocin and explores potential interventions through maternal thyroid and probiotic supplementation. She is passionate about advancing diversity in STEM through undergraduate training and community outreach initiatives.

Parisa Varshoaz, PhD Candidate
Laurentian University, Ontario, Canada
Dissertation research: Investigating the role and regulation of retinoic acid (RA) signaling during cranial development.

Bio: Parisa Varshoaz is a PhD candidate in the Biomolecular Sciences program conducting research under the supervision of Dr. Alexander Moise at Laurentian University and in the Medical Sciences Division of Northern Ontario School of Medicine University. Her work focuses on investigating the role and regulation of retinoic acid (RA) signaling during cranial development. Specifically, she studies how mutations affecting RA levels contribute to the pathogenesis of craniosynostosis, a group of congenital disorders characterized by premature fusion of cranial sutures. Additionally, Parisa explores the self-regulatory mechanisms that modulate RA signaling, particularly in response to feedback regulation and Yes-associated protein (YAP) signaling.

2023 Award Winners

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

  • Alternatives to Sexually Mature Non-Human Primates (NHPs) for DART Safety Assessments

    Acknowledging the limited supply of NHPs, this group aims to develop a White Paper assessing the current use of sexually mature NHPs for all aspects of developmental & reproductive toxicology (DART; risk of adverse pregnancy outcomes & infertility) including potential alternative approaches; To ensure the continuity of effective testing strategies that aid in the prediction of DART related adverse events:

    • Encourage the conservation and restricted use of this model for the most appropriate applications
    • Highlight use of alternative approaches with the potential to produce the same, if not superior results

    Leadership: Christopher Bowman (Pfizer)
    HESI Staff: Shermaine Mitchell-Ryan

  • Anogenital Distance and Nipple Retention

    The aim of this work group is to promote harmonization of AGD and nipple/areola retention measurement in male rats. This group is finalizing their paper which includes a review of existing methods and recommend best practices and considerations for these two methods.

    Leadership: Alan Hoberman (Charles River Laboratories), Louise Youngs (Syngenta)
    HESI staff: Connie Chen

  • DARTable Genome

    The aim of this project is to advance predictive toxicology for DART effects by integrating and sharing critical insights into chemical-protein target interactions, pharmacokinetics, and key developmental toxicity study outcomes. While challenges with publicly accessible data—such as limited availability and variability in TK parameters—were identified, the team recognized the importance of presenting the model’s potential contributions to the field. The manuscript will focus on the conceptual framework of the model, highlighting its promise while addressing challenges related to data consistency and assay reliability in the discussion section. To illustrate the model’s utility, the team initiated a case study on the well-characterized teratogen, Retinoic Acid

    Leadership: Richard Currie (Syngenta), Allen Kaczor (Merck & Co)
    HESI staff: Shermaine Mitchell-Ryan

  • DART Strategies for Oligonucleotides

    Oligonucleotides (ON) represent a novel pharmacotherapeutic drug class. ON have both small molecule and biotherapeutic attributes and there are no class-specific ICH or FDA guidance documents to provide a clear blueprint for nonclinical safety testing, including for DART. Currently, these compounds are regulated as small molecules, but certain compound characteristics aligning to that of biologics raises the need to evaluate if a traditional small molecule DART assessment is appropriate. The committee organized a workshop, held on October 17-18, 2023, that considered applications 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.

    Leadership: Bethany Hannas (Eli Lilly & Co.), Michael Templin (Charles River Laboratories)
    HESI staff: Connie Chen

  • DART NAMs/Alternatives

    This work group aims to create a new approach methodology (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 validated for use as a NAM. Three publications – one focused on hypothesis-generation, one focused on the use of NAMs in pharmaceuticals, and one focused on the use of NAMs in chemicals – will be submitted to the Special Issue of Reproductive Toxicology. A second phase of work is focusing on convening a workshop in Spring 2025 to map out concrete path forward for increase regulatory acceptance.

    Leadership: Allen Kaczor (Merck & Co.), Steven van Cruchten (U Antwerp)
    HESI Staff: Connie Chen

  • 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.

  • Dystocia

    This work group aims to understand common practices in identifying and reporting dystocia through a qualitative survey that addresses key aspects of dystocia and standard protocols for identification and reporting. The information gathered will inform a best practices manuscript that will benefit the wider scientific community.

    Leadership: Pragati Coder (Charles River Laboratories), Rashin Gaffhari (Corteva AgriSciences)
    HESI Staff: Shermaine Mitchell-Ryan

  • Extended One-Generation Reproductive Toxicity Studies: A Retrospective analysis

    The Working Group recently published a review paper titled “Review of dose setting for the extended one-generation reproductive toxicity studies (OECD TG 443): Considerations on ECHA’s dose level selection recommendations.” This paper reflects the collaborative efforts of the group to address challenges arising from the rapidly evolving regulatory landscape. The manuscript provides a detailed rationale highlighting the misalignment of new dose selection recommendations with health authorities’ commitment to conducting rigorous, high-quality studies while minimizing unnecessary animal use. It also emphasizes the ethical and animal welfare concerns associated with excessively high dosing, advocating for a balanced approach that upholds both scientific integrity and ethical standards.

    Building on this effort, the team will join the Weight of Evidence (WOE) Multigen Waiver Scoping Team to perform a comprehensive review of multigeneration reproductive toxicology studies.

    Leadership: Jason Manton (Toxiqua)
    HESI staff: Shermaine Mitchell-Ryan

  • Germline Transmission/New Modalities

    At the Fall 2024 Business meeting, the committee approved the launch of a new working group that will focus on best practices for cell and gene therapies discussions and risk assessment for DART and germline transmission. One of the key outputs will be a workshop in Spring 2026.

    Leadership: Caren Villano (Boehringer Ingelheim), Katie Turner (JnJ)
    HESI staff: Connie Chen

  • 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.

    Leadership: Lindsay Tomlinson (Pfizer), Nicola Powles-Glover (RSA) Stephanie Powlin (Takeda)
    HESI staff: Connie Chen

  • microCT

    This work group aims to provide additional information and confidence that fetal skeletal examination using micro-CT is acceptable for regulatory use in nonclinical fetal evaluation studies. The study design and participants in a multi-site in vivo study comparison microCT and alizarin red staining in both rats and rabbits. Experimental work is underway, and final results are expected in 2025.

    Leadership: Dan Minck (US FDA/CDER), Kim Brannen (Merck & Co.), Mary Ellen McNerney (US FDA/CDER)
    HESI staff: Connie Chen

  • Preclinical Considerations for Pregnant and Lactating Women in Clinical Trials

    This work group is finalizing a points to consider manuscript outlining initial approaches to inclusion, the role of nonclinical data, and common practices during global drug development plans.

    Leadership: Dinesh Stanislaus (GSK)

    HESI staff: Connie Chen

  • 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.

    This group is temporarily on hold while additional data is being generated.

  • Pubertal Assessment

    This work group aims to identify reliable in vivo rodent markers and in vitro assays that are predictive of agents (chemical or pharmaceutical) that affect human puberty timing (and by puberty timing we are including initiation, progression, and completion). A review article is currently underway and anticipated to be completed in 2025.

    Leadership: Natasha Catlin (Pfizer)
    HESI staff: Shermaine Mitchell-Ryan

  • Thyroid Hormone Assessments

    In collaboration with the European Teratology Society, the joint workgroup has collected historical data on thyroid hormone measurement in rodent studies to determine best practices for these measurements. The workshop proceedings will be submitted for publication by the close of the year. Next steps for a new round of data collection and database development are under discussion.

    Leadership: Pragati Coder (Charles River Laboratories), Susan Makris (US EPA, retired)
    HESI staff: Connie Chen

  • Past Working Groups

    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.

    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.

HESI Staff

Leadership Team

  • Christopher Bowman, PhD

    Pfizer

  • Steven van Cruchten, PhD

    University of Antwerp

Committee Events

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HESI DART Committee Fall Business Meeting

October 22, 2024 – October 23, 2024

Virtual, HESI DART Committee

The HESI Developmental and Reproductive Toxicology (DART) Committee will hold their Fall meeting virtually over two half-days. During the meeting, the committee will hear updates on its various working groups and consider the adoption of new ones.

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52nd Annual European Teratology Society Meeting

September 15, 2024 – September 18, 2024

Bologna, Italy

Members from the HESI Developmental and Reproductive Toxicology (DART) Committee Alternatives to the Use of Non-Human Primates for DART Studies Working Group will participate in the “DART strategies for New Therapeutic Modalities” symposium to share insights and updates from these impactful DART initiatives. This ...

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EUROTOX 2024

September 8, 2024 – September 11, 2024

Copenhagen, Denmark

Members of the HESI DART, eSTAR and GTTC Committees will be in attendance at EUROTOX 2024 taking place September 8-11 in Copenhagen.

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Committee Publications

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HESI workshop summary: Interpretation of developmental and reproductive toxicity endpoints and the impact on data interpretation of adverse events

Birth Defects Research, 2024

Green et al.

Output from the HESI DART workshop entitled, “Interpretation of Developmental and Reproductive Toxicology in Regulatory Contexts and Frameworks” has been published. The purpose of the workshop was to capture key consensus approaches used to assess DART risks associated with chemical and pharmaceutical product exposure ...

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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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