This is an internal DART Committee Meeting
DART 2022 Annual Spring Meeting
May 4, 2022 – May 5, 2022
DART, Virtual
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.
Award: For 2024, two selected candidates will each receive 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). The award must be used within 12 months of receipt. A required “Proof of attendance” is to be submitted no later than 30 days after the sponsored event.
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.
NEW Submission Deadline: 1 July, 2024
Application Form: Download here
Congratulations to the 2023 Developmental and Reproductive Toxicology (DART) Committee Professional Development Award recipients!
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.
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.
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.
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.
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.
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.
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.
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.
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.
This project aims to define which preweaning developmental landmarks (PDLs) have value, interpretation, and benchmark responses through both a survey and data collection.
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.
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.
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.
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.
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.
National Institute of Environmental Health Sciences / National Toxicology Program
Pfizer
May 4, 2022 – May 5, 2022
DART, Virtual
This is an internal DART Committee Meeting
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 ...
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2010
There continue to be many efforts around the world to develop assays that are shorter than the traditional embryofetal developmental toxicity assay, or use fewer or no mammals, or use less compound, or have all three attributes.
1999
This workshop report was published by HESI, Washington, DC.
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2013
A cross-laboratory analytic evaluation of a commercially available human inhibin B ELISA for measuring inhibin B in rat serum and plasma has been undertaken.
Pharmaceutics, 2020
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 ...
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2007
This review provides a summary of the normal biology, development, and morphology of the breast in nonhuman primates (macaques), and of the major published work addressing hormonally-induced changes in the breast of these animals.
Reproductive Toxicology, 2015
Risk assessment for indirect exposure to small molecule pharmaceuticals in semen to the conceptus has traditionally been handled by calculations based on assumptions that any embryo-fetal exposure would be secondary to maternal absorption and redistribution.
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