Trust Your Gut: Establishing Confidence in Gastrointestinal Models

An Overview of the State of the Science and Contexts of Use
Webinar Series & Workshop

Translucent human torso with digestive tract highlighted

Webinar Series:

  • Webinar 1 – Absorption and Pharmacokinetics: Monday, September 18, 9:00-10:00 a.m. EDT
  • Webinar 2 – Microbiome Effects on Toxicity: Wednesday, September 20, 9:00-10:00 a.m. EDT
  • Webinar 3 – Evaluating Potential Allergenicity: Friday, October 6, 9:00-10:00 a.m. EDT

Register to attend Webinar 3 on October 6
You need only register once to attend all three webinars.

View agenda for all webinars (updated September 13)

Workshop: October 11-12, 9:00 a.m.-12:00 noon EDT both days
Porter Neuroscience Research Center, National Institutes of Health, Bethesda, MD

Register to attend the workshop in person

Register to view the workshop webinar

View workshop agenda (updated September 18)

One of the most common chemical exposure routes is via the gastrointestinal tract (GIT). Orally administered substances are first metabolized by the GIT, and both parent substance and any formed metabolites have the potential to be absorbed through the GIT. During these processes, either or both may damage the GIT. Since toxicity in the GIT can result in systemic toxicity, screening of potential toxicants could provide an efficient way to identify potential systemic toxicants. Even in the absence of toxicity, understanding GIT absorption provides insight into systemic exposure levels that inform the potential for toxicity in other target organs.

While in vivo rodent studies have historically been used for understanding GIT absorption and toxicity, animal models have well-documented anatomical, physiological, and biochemical differences from humans. Mammalian cell culture methods of varying complexity can be used in a variety of applications including rapid response, metabolism/metabolite secretion, and microbiome studies, and generating data for pharmacokinetic modeling. Accordingly, NICEATM, NIEHS, FDA, EPA, CPSC, DoD, the Johns Hopkins Center for Alternatives to Animal Testing, and Unilever are organizing this workshop on the state of the science for using NAMs to predict GIT absorption and toxicity. Interested persons may attend the workshop in person at the National Institutes of Health in Bethesda, MD or view the workshop presentations via webcast.

A series of three preliminary webinars will introduce the three principal topics of the workshop:

  1. De-risking systemic toxicity, understanding absorption/pharmacokinetics;
  2. Gastrointestinal toxicity; and
  3. Evaluating potential allergenicity.

These preliminary webinars will help lay the foundation for the subsequent in-person workshop (with virtual component) where speakers from academia, industry, and regulatory bodies will dig deeper into exploring the state of the science for absorption and metabolism models, integrating the microbiome, and GIT toxicity models.