Program
Program Highlights
Education Courses
Separate registration is required for the Education Courses.
Education Course 1
The Principles of Teratology
Organized by the Education Committee
This course will focus on the principles of teratology and their application. Topics addressed will include the timeline of important events in embryo-fetal development across species; direct and indirect causes of developmental toxicity, including those of maternal, fetal, and placental origin; the common pathways and mechanisms by which teratogens may act; how developmental toxicants are typically detected through studies conducted in animals; and how epidemiological studies contribute to the detection of potential teratogens.
Education Course 2
The ABCs of EFDs: Fundamentals of Embryofetal Development Testing
Organized by the Education Committee
This course aims to discuss the principles applied to plan, deliver, and communicate embryofetal testing for pharmaceuticals in clinical development. The why, when, and how to conduct these studies and the rationale for decisions made in study design, conduct, and interpretation will be addressed. This is a course about the concepts that guide the decisions throughout the process. The first session will focus on setting the overall study strategy on which type of study, in which species, and when they should be conducted. The second session will review aspects of study design and the components of a quality study, including maternal-litter exposure and pharmacodynamic considerations. The applications of these principles to modify study designs for the testing of new modalities will be included. Followed by a session on how to manage study conduct when faced with in-life challenges (tolerability, food supplementation, rabbit abortions). Next, a session will cover the data interpretation principles specific to EFDs followed by a session on the communication of study results including when expedited reporting is required and how EFD data informs clinical protocol decisions, informed consent, and product labeling.
Lunch and Learn Mini Course
Genomics and Multi-omic AI Applications for Birth Defect Research
Organized by the Education Committee
This course will focus on AI in genomics and multi-omics. Attendees can expect a practical perspective with a focus on learning how to integrate AI applications into their work. The first half of this mini course will delve into areas including genome-wide interrogations, leveraging relevant databases, and noncoding variation. The second half of the course will focus on multimodal AI systems and AI in multi-omics including such topics as the integration of multiple data types and in situations when data is scarce, genomics and transcriptomics integration, utilizing RNAseq in combination with genomics and transcriptomics, and metagenomics.
Special Lectures
Josef Warkany Lecture
This lecture recognizes Josef Warkany’s contributions to BDRP. Dr. Warkany was the first person to demonstrate that exposure to environmental chemicals is responsible for the production of congenital malformation. His early studies culminated in the formulation of the scientific principles of teratology. This award recognizes a scientist who has significantly contributed to the field throughout their career. Dr. Sonja A. Rasmussen from Johns Hopkins School of Medicine will present the Warkany Lecture on Sunday, June 29, 2025, at 8:00 am.
Antiretroviral Drugs and Use in Pregnancy/Lactation
Robert L. Brent Lecture: Teratogen Update
(Joint with DNTS and OTIS)
This lecture recognizes Robert L. Brent's contributions to the Society for Birth Defects Research and Prevention and particularly for the implementation of the “Teratogen Update.” The purpose of the Robert L. Brent Lecture is to facilitate the discussion of new and old teratogens during the Annual Meeting. Dr. Vani Vannappagari from ViiV Healthcare will present the Brent Lecture on Tuesday, July 1, 2025, at 8:00 am.
F. Clarke Fraser New Investigator Award
Organized by the BDRP Awards Committee
This award honors F. Clarke Fraser, one of the founding members of the Society for Birth Defects Research and Prevention, for his many contributions to the field of developmental toxicology. The award recipient must be an active member of the Society for Birth Defects Research and Prevention with evidence of a successful, independent research career in birth defects research.
James G. Wilson Publication Award
Organized by the BDRP Publications Committee
This award honors James G. Wilson, one of the founding Society members, and is presented in recognition of the best paper accepted or published in the journal Birth Defects Research during the prior year. The dual purpose of the award is to provide recognition to the author(s) of the best paper and to encourage authors trained in various disciplines to submit high-quality papers to Birth Defects Research.
Patricia Rodier Mid-Career Award for Research and Mentoring
Organized by the DNTS and BDRP Awards Committees
This award honors the legacy of Dr. Patricia Rodier, a past President of the Developmental Neurotoxicology Society (DNTS) and a Council member of the Society for Birth Defects Research and Prevention (BDRP). The award is presented in a joint session during the concurrent annual meetings of BDRP and DNTS. The awardee will give a presentation related to his/her research that is intended to serve as a demonstration of independent mid-career research in a field relevant to BDRP and DNTS.
Agnish Fellowship
Organized by the BDRP Education Committee
This award recognizes Narsingh Agnish's contributions to the Society for Birth Defects Research and Prevention, particularly the implementation of the Education Courses. The Narsingh Agnish Fellowship is awarded to a long-standing member of the Society for Birth Defects Research and Prevention late in their career who has made a major contribution to education in the field of teratology or a related discipline.
FETAL SURGERY
Keynote Lecture
Dr. Sarah G. Običan from the University of South Florida will present the Keynote Lecture on Monday, June 30 at 8:00 AM.
BDRP and European Teratology Society Exchange Lecture
The Society for Birth Defects Research and Prevention and the European Society for Birth Defects Research and Prevention Exchange Lecture provides the two societies with a forum to discuss different views on a selected topic.
Symposia
Down Syndrome: Assessing Outcomes across the Lifespan Symposium
(Joint with NBDPN)
Down syndrome was first recognized in 1866, and its cause (an extra copy of chromosome 21) was identified in 1958. However, the study of the co-occurring conditions seen in persons with Down syndrome remains an active area of research, stimulated in part by a new trans-NIH research initiative focusing on health and quality-of-life needs for persons with Down syndrome, called the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project. This session will discuss recent updates in surveillance and research regarding Down syndrome with speakers involved in the INCLUDE project discussing progress in this initiative. Information on conditions for which persons with Down syndrome are at increased risk (i.e., leukemia, autism, and Alzheimer’s disease) and decreased risk (i.e., solid tumors) and what is known about the reasons for these differences in risk will also be discussed. This research provides insights into these conditions in the population of persons with Down syndrome, as well as the general population.
Opportunities and Applications of NAMs for DART Testing from Hazard to Risk Assessment Symposium
This session will delve into the innovative application of New Approach Methodologies (NAMs) in Developmental and Reproductive Toxicology (DART), addressing the growing need for advanced methods to enhance regulatory decision-making and human risk assessment in developmental toxicology. First, the issues, needs, and decision frameworks of regulatory authorities for developmental toxicology will be discussed, highlighting opportunities for NAMs to streamline and improve assessments. Insight will be provided on recent guidance for validation and application, specifically regarding state-of-the-art tests for DART and how to define the applicability domain. One of the crucial issues is how in vitro test results can be translated to human biology to facilitate more informed, relevant assessments, often requiring advanced computational approaches. New developments in PBPK modeling can support the translation of concentrations that trigger responses in in vitro systems to predicted and measured human exposures. Practical examples for in silico models that allow quantitative in vitro-in vivo extrapolation will be presented and discussed, as well as curated high throughput screening data mapped to mechanistic target groupings and developmental toxicity modes of action. This session is designed for researchers, regulators, and industry professionals involved in developmental toxicology and risk assessment. Attendees will gain valuable insights into the latest advancements in NAMs and their practical applications in regulatory contexts, fostering novel approaches to DART testing.
The Ripple Effect: Neonatal Abstinence Syndrome from Birth to Adolescence Symposium
Joint with DNTS
Neonatal abstinence syndrome (NAS) is the diagnosis given to children prenatally exposed to opiates and other drugs of abuse. With the spread of the opioid epidemic over the past 10 years, significant effort has gone into diagnosis, developing adequate treatment plans, and characterizing expected outcomes within the first few years of life. However, relatively little information exists about long-term outcomes. Additionally, relatively little information is available related to the socioeconomic impact on those outcomes. Moreover, most of the NAS literature has been conducted on children prenatally exposed to opiates, while only a small number of studies have evaluated outcomes in children exposed to other drugs of abuse. The goals of this symposium are to provide the audience with information about the effect of prenatal opioid exposure in animals in comparison to what has been observed in humans; to describe the current knowledge on short- and long-term outcomes and the approaches to treatment, and to identify gaps in the understanding of socioeconomic influences on NAS outcomes.
Birth Defects and Reproductive Issues in Post-Dobbs vs. Women's Health Organization Era Symposium
(Joint with DNTS and OTIS)
Organized by the BDRP Public Affairs Committee
The 2022 Supreme Court decision in the Dobbs v. Jackson Women's Health Organization has resulted in laws banning or limiting access to abortion services in many states in the US. The decision has impacted reproductive health care beyond abortion access, affecting both the physical and mental health of women, disproportionately impacting women of color and those in underserved communities, while intruding on clinical decision-making and affecting the doctor-patient relationship. The Society for Birth Defects Research and Prevention published a statement upholding reproductive health rights, access to necessary services, and information to make informed decisions on reproductive health, in conjunction with healthcare professionals. The Public Affairs Committee symposium aims to present the situation related to birth defects and reproductive health in the post-Dobbs era, with presentations focusing on 1) the implications of the ruling on birth defects surveillance methods; 2) obstetric clinical practice of healthcare professionals providing care for birth defects; 3) ethical complexities in conducting teratology research, including risks for research participants and staff, contributing to new challenges to scientific validity and feasibility of birth defects research; and 4) disparities in health service utilization and health policy implementation perspective for reproductive health.
Integrating In Vitro and Computational Approaches to Identify Novel Developmental and Reproductive Toxicants and Enhance Chemical Hazard Assessments Symposium
The field of toxicology is rapidly evolving, with an increasing emphasis on high-throughput systems to acquire chemical hazard data and provide crucial information for regulatory decisions. The need for efficient, accurate, and ethical methods to assess the developmental and reproductive toxicity of chemicals has driven the advancement of innovative in vitro and computational approaches. These methods promise to revolutionize hazard assessments by offering faster and more reliable and more reliable data acquisition compared to traditional animal testing. To fully harness these advancements, it is essential to develop frameworks that seamlessly integrate computational models/AI and in vitro technologies to generate relevant toxicity information. The integration of these outputs with public tools for exposure, biological activity (in vitro and in vivo), and literature databases can assist in prioritizing chemicals for further investigation and estimating potential risks more effectively. In this symposium, presentations will highlight practical applications of these integrated approaches, utilizing computational strategies combined with in vitro and nonmammalian embryo models to identify novel teratogens relevant to human exposure. The symposium will conclude with a final presenter who will provide current examples of how these data are being utilized in the regulatory arena and offer future insights.
Genomic Studies of Birth Defects: Findings from the Centers for Birth Defects Research and Prevention Symposium
Joint with NBDPN
The Centers for Birth Defects Research and Prevention (CBDRP) is a collaborative group of study sites investigating the causes of birth defects and how to prevent them. Ten Centers conducted the National Birth Defects Prevention Study (NBDPS), a population-based case-control study assessing genetic and non-genetic risk factors for birth defects. Pregnancy exposure data collected during a telephone interview and DNA specimens collected from more than 23,000 families have been used in a variety of analyses (e.g., candidate gene, gene-environment interaction, genome-wide association studies [GWAS], and exome sequencing).
This session will highlight results from NBDPS analyses that assessed genetic risk factors for craniosynostosis, heterotaxy, and transverse limb defects using GWAS or exome sequencing. These high throughput analyses provided large amounts of genetic data that are helping to identify novel genes associated with birth defects and can be used in combination with pregnancy exposure data to investigate gene-environment interactions. The intended audience is conference attendees interested in learning more about this rich resource of genetic and environmental data and how they can be used to better understand and prevent birth defects.
Advancements in Assessing the Effects of Environmental Chemicals on Maternal Health and Fetal Development Symposium
Pregnancy represents a period of susceptibility for both the mother and developing fetus. For the fetus, it is well established that aberrations in fetal development, such as fetal growth restriction, or pregnancy complications are important risk factors for adverse health outcomes during later life. Maternal health later in life is also sensitive to complications experienced during pregnancy, including pregnancy-induced hypertension or gestational diabetes. For example, women diagnosed with pregnancy-induced hypertension are at increased risk of cardiovascular disease or stroke later in life. Many factors play a role in fetal development and pregnancy health, including maternal diet, maternal and fetal epigenetics, and the endogenous hormone environment of the mother, placenta, and fetus. In addition, environmental chemical exposures, especially those with endocrine-disrupting properties, have the potential to influence these processes. This symposium presents advancements in the assessment of environmental chemicals and maternal and fetal health. Presentations include 1) the incorporation of 3-D ultrasound measurements of the fetus and assessment of non-persistent chemicals in maternal urine; 2) the influence of chemical mixtures on diverse indicators of maternal and fetal health, including biomarkers of placental development, repeated measures of maternal blood pressure during pregnancy, and non-nutritive suck behaviors in infants; 3) the role of maternal diet on the effect of environmental chemicals on maternal and fetal health outcomes; and 4) the mediating effect of the placental epigenome on the associations of environmental chemical exposures on spontaneous preterm birth and other aspects of fetal development.
Neurobehavioral Testing in Nonrodent Models Used in Safety Assessment Symposium
Joint with DNTS
Validated methods to assess sensory functions, motor activity and learning and memory are required to meet the minimum guideline requirements for (enhanced) pre- and postnatal developmental [(e)PPND] toxicity studies conducted according to the ICH harmonized guidelines on detection of reproductive and developmental toxicity for human pharmaceuticals [ICH S5(R3)] as well as those intended for development pf pediatric pharmaceuticals [ICH S11]. While these studies are predominantly conducted in rodents, neurobehavioral testing is performed, albeit in a limited capacity, in alternate laboratory animal species such as nonhuman primates (NHP), rabbits and mini-pigs. Historically, the NHP was used to support safety assessment of biologic pharmaceuticals such as monoclonal antibodies. In recent years, with the advent of new modalities, and limited availability of NHPs, the use of alternate models such as mini-pigs and rabbits has increased significantly. This session aims to spotlight the different neurobehavioral testing methods available and in use across a broad spectrum of industry and academic experts. The session will conclude with a regulatory perspective on the data generated using these alternate models are reviewed/approached by reviewers/regulators.
Minimizing Use of Nonhuman Primates for Safety Assessment of Risk to Fertility and Pregnancy Symposium
Nonhuman primates (NHP) are an important, but limited resource to support the safety assessment of new pharmaceuticals, in particular monoclonal antibodies. The use of sexually mature NHPs are even more limited but can be used to inform the risk of infertility and adverse pregnancy outcomes. Current examples of how and why NHP have been considered important to inform developmental and reproductive toxicity (DART) risk and examples of alternative approaches, including the weight of evidence (WoE) will be presented and discussed. Specifically, a retrospective WoE analysis compared to pregnant NHP study outcomes for 65 monoclonal antibodies will be presented. A separate survey of marketed products over a 12-year span will be presented to understand how NHPs have been used to assess the risk of infertility and how it was reflected in the label. Regarding future use of NHP in DART, we will also challenge industry and regulators that WoE should be the default scenario to determine if experimental data are needed, considering non-NHP options (including standard species if appropriate) if that will inform the human risk assessment before considering the use of NHPs only if they will address data gaps not available by other means. If NHPs are needed for DART because no other available test system will provide the necessary data (e.g. pharmacological relevance) for the human risk assessment, we will offer some forward-looking considerations and recommendations for improvement. This workshop is an outcome of a HESI DART working group whose members include industry and health authority representatives from the US, Europe, and Japan.
Workshops
Peer Review Lunch Workshop
(Advance Registration Required)
Organized by the BDRP Publications Committee
TBA
Multidisciplinary Research Needs Workshop
Organized by the BDRP Science Committee
The Multidisciplinary Research Needs Workshop provides a forum for informal discussion on current and emerging topics in birth defects research to facilitate collaboration and identify ways that BDRP might contribute to progressing these topics.
Career Development and Career Options in DART
Professional Development Lunch Workshop
(Separate Registration Required)
Organized by the Student Affairs Committee
Attendees of all career stages are encouraged to participate. Separate registration is required to attend this workshop. Trainees may register at no additional charge, and other attendees pay a nominal fee.
Platforms and Posters
Wilson Presentation Graduate Student and Postdoctoral Fellow Finalists Platform SESSION 1
Organized by the BDRP Student Affairs Committee
A special platform session on Sunday, June 29 showcasing trainees, the future of the field.
BDRP Innovator Award FINALISTS' Platform Session 2
Organized by the BDRP Awards Committee
Three finalists selected from the abstract pool will present their research in this special platform session on Sunday, June 29. The BDRP Innovator Award recognizes innovative and translational research at the intersection of at least two of the following areas: basic science, new technologies, clinical research, policy, and outreach.
PLATFORM SESSION 3
This platform session will feature short presentations of attendees' current research and will provide an opportunity for live Q&A.
POSTER SESSIONS
Attendees present their abstracts during the poster sessions of the meeting. The poster sessions provide a relaxed atmosphere to interact with trainees and established scientists while viewing the latest birth defects research, and enjoying light refreshments. Poster Session 1, a joint event with DNTS and OTIS, will be held on Sunday, June 29 from 6:00 pm until 7:30 pm. Poster Session 2, a joint event with NBDPN, will be held on Monday, June 30, from 5:30 pm until 7:00 pm.
Special Events
Warkany Tea
This event honors Josef Warkany, one of the founders of the Society for Birth Defects Research and Prevention and one of the first researchers to show that factors in the environment could cause birth defects. Dr. Warkany helped to develop guidelines for the field of teratology, the study of birth defects. The Warkany Tea provides and place and time for Annual Meeting attendees to network and discuss their research, the foundation of the Society. The Warkany Tea will take place on Wednesday, July 2.
Student Career Event
The Student and Postdoctoral Fellows Career Event is a great networking opportunity that will take place on the evening of Sunday, June 29. As you prepare for the next phase in your professional career, we offer you this opportunity to meet your fellow trainees and to interact with scientists from academia, government, and industry while enjoying drinks and dessert.
Social Event & Awards Presentations
Join us for an evening of celebration and recognition as we honor the 2025 Annual Meeting Awardees. This special event includes dinner and an opportunity to enjoy the exchange of scientific ideas with both new and old friendships formed at the Annual Meeting. Your presence will make this event truly special. Your ticket to the Social Event is included in your meeting registration (nontransferable). Please purchase tickets for any guests you wish to bring no later than Sunday, June 29. Tickets are not required for children 12 and under.