SOT and the US Food and Drug Administration Center for Food Safety and Applied Nutrition (US FDA CFSAN) cordially invite you to join us for our May 4, 2023 colloquium, “Evolving Science in Developmental Immunology and Immunotoxicity.” There is no charge for this webcast. The SOT FDA Colloquia are an update on toxicological science rather than a public forum for discussion of toxicology regulatory issues. The co-chairs of this session are Leigh Ann Burns Naas, Magnolia Toxicology Consulting LLC, and Patrick Crittenden, US FDA CFSAN.
Overview
Over the past two decades the interest in developmental immunotoxicology (DIT) has grown substantially as a result of the need to more fully understand age-related susceptibility to a variety of potentially toxic compounds. The immature immune system is especially vulnerable to environmental insults, and immunotoxic exposures during critical prenatal and postnatal periods in development may lead to persistent immune dysfunction. Epidemiological evidence suggests that there is an increasing incidence of immune-mediated developmental disorders in children related to exposures to chemical substances in their environment. In recent years, the role of the microbiome in immune system development has also become evident and this extends to the role of the mother in seeding the fetal/infant microbiome both in utero and at birth, which may impact several aspects of development, including immune system maturation. Therefore, alterations in both maternal and fetal environmental exposures mediated by things such as nutrition and chemical exposure have the potential to result in varied risks to the developing immune system that can influence the risk of immune-related disease in children and adults. Understanding how to assess the risk to the developing immune system in animal studies is of high importance. As interest in DIT has grown, our understanding of the mammalian immune system has continued to swell, including a more sophisticated understanding of the developing immune system and the comparative developmental timelines across mammalian species. While the general stages of immune development are quite similar, it clear is that in terms of temporal development, a rat is not a dog is not a monkey is not a human. This makes it paramount to understand these differences when conducting and interpreting nonclinical safety studies. This colloquium will present the state of the science of developmental immunotoxicology and the challenges to supporting hazard identification and risk evaluation.
Schedule (All times US EDT, UTC -4)
9:00 AM‒9:10 AM
Welcome from US FDA/SOT: Dori Germolec, PhD, 2023‒2024 SOT President, NIEHS/NTP, Durham, NC
9:10 AM‒10:00 AM
Introduction of Speakers
“The Evolution of the Discipline of Developmental Immunotoxicology”
Leigh Ann Burns Naas, PhD, DABT, ATS, ERT, Magnolia Toxicology Consulting, LLC, Traverse City, MI
10:00 AM‒10:35 AM
“Comparative Developmental Immunology and Implications for Testing and Data Interpretation”
Hollie Skaggs, PhD, Horizon Therapeutics, Wilmington, DE
10:35 AM‒10:45 AM
Break
10:45 AM‒11:20 AM
“Chat Womb: Maternal-Fetal Communication and Its Role in Fetal Programming”
Kjersti M. Aagaard, MD, PhD, FACOG, Baylor College of Medicine, Houston, TX
11:20 AM‒11:55 AM
“Human Prenatal Hematopoiesis Is Developmentally and Functionally Distinct from Its Postnatal Counterpart: Implications for Developmental Immunotoxicology”
Eliver Ghosn, PhD, Emory University School of Medicine, Atlanta, GA
11:55 AM‒12:20 PM
“Paving the Road toward the Development and Acceptance of Alternative (In Vitro) Methods to Assess Developmental Immunotoxicity”
Fenna Sille, PhD, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD
12:20 PM‒12:55 PM
Roundtable Discussion
Moderator: Patrick Crittenden, US FDA/CFSAN
Panel: All speakers
Recordings of previous colloquia and speaker slides are available on the SOT FDA Colloquium web pages.
This includes the materials for the January 19, 2023, colloquium “Alternative Toxicological Approaches for Process-Formed Constituents in Food.” When process-formed compounds are found unexpectedly in the diet, there can be a need for a rapid risk assessment that would benefit from methods that can be executed faster than traditional in vivo methods. Thus, these compounds represent an interesting test case to leverage new approach methods (NAMs) to help risk assessors and regulators better understand the biological effects of these compounds and prioritize them for additional investigation. This colloquium brought together researchers, risk assessors, and regulators to discuss opportunities to leverage a mixture of traditional testing and NAMs to help solve real-world, complex toxicology problems.
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