This satellite workshop was held in conjunction with the European Teratology Society Annual Meeting.
Pregnancy and Lactation Labeling Workshop
September 2, 2015 – September 3, 2015
Amsterdam, Netherlands
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
September 2, 2015 – September 3, 2015
Amsterdam, Netherlands
This satellite workshop was held in conjunction with the European Teratology Society Annual Meeting.
May 20, 2015 – May 21, 2015
Arlington, Virginia, USA
The recently finalized Pregnancy Labeling and Lactation Labeling Rule changes the organization of the current Pregnancy and Nursing Mothers section of the US package insert of prescription drugs. In response to these changes in prescription drug labeling, the HESI Developmental and Reproductive Toxicology (DART) Committee ...
April 20, 2015 – April 21, 2015
Arlington, Virginia, USA
Developing and using specific imaging technologies (e.g., micro-CT, MRI) allows for alternative methods for evaluating structural birth defects in animal models.
May 17, 2011 – May 18, 2011
Washington, DC, USA
This workshop was sponsored by the HESI Developmental and Reproductive Toxicology Technical Committee (DART).
May 5, 2010 – May 6, 2010
Washington, DC, USA
This workshop was sponsored by the HESI Developmental and Reproductive Toxicology Technical Committee.
April 29, 2010 – April 30, 2010
Washington, DC, USA
The purpose of this Developmental and Reproductive Toxicology (DART) Technical Committee workshop was to provide a comprehensive and critical evaluation of developmental toxicity testing in the face of technological advances and improved mechanistic information.
Reproductive Toxicology, 2014
A β-actin-luc transgenic mouse model was used to evaluate whether embryo-fetal exposure could occur after intravaginal administration of a compound.
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2007
While an evaluation of the estrous cycle in laboratory rodents can be a useful measure of the integrity of the hypothalamic-pituitary-ovarian reproductive axis, it can also serve as a way of insuring that animals exhibiting abnormal cycling patterns are disincluded from a study prior to exposure to a test compound.
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2013
This study was conducted as part of an ILSI-HESI International Life Sciences Institute-Health & Environmental Sciences Institute consortium effort to assess the utility of circulating Inhibin B as an early biomarker of Sertoli cell-specific testicular toxicity in rats.
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2013
This study was conducted as part of an ILSI-HESI consortium effort to assess the utility of circulating inhibin B as an early biomarker of testicular toxicity in rats.
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2013
In a repeat oral dose toxicity study, all of 16 male rats given 100 mg/kg/day GSK1322888 sustained testicular injury after 4 weeks of treatment; the findings were not reversible after 12 weeks off-dose.
Birth Defects Research Part B: Developmental and Reproductive Toxicology, 2013
Serum Inhibin B was measured in two studies of known testis-toxic drug candidates.
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-3859
740 15th Street NW, Suite 600
Washington, DC 20005
Sign up for our monthly e-newsletter.