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3. Trust Your Gut : Establishing Confidence in Gastrointestinal Models - An Overview of the State of the Science and Contexts of Use

Author

Debad, Susan, Allen, David, Bandele, Omari, Bishop, Colin, Blaylock, Michaela, Brown, Paul, Bunger, Maureen K., Co, Julia Y., Crosby, Lynn, Daniel, Amber B., Ferguson, Steve S., Ford, Kevin, da Costa, Goncalo Gamboa, Gilchrist, Kristin H., Grogg, Matthew W., Gwinn, Maureen, Hartung, Thomas, Hogan, Simon P., Jeong, Ye Eun, Kass, George E. N., Kenyon, Elaina, Kleinstreuer, Nicole C., Kujala, Ville, Lundquist, Patrik, Matheson, Joanna, McCullough, Shaun D., Melton-Celsa, Angela, Musser, Steven, Oh, Ilung, Oyetade, Oluwakemi B., Patil, Sarita U., Petersen, Elijah J., Sadrieh, Nakissa, Sayes, Christie M., Scruggs, Benjamin S., Tan, Yu-Mei, Thelin, Bill, Nelson, M. Tyler, Tarazona, Jose, V, Wambaugh, John F., Yang, Jun-Young, Yu, Changwoo, Fitzpatrick, Suzanne, Debad, Susan, Allen, David, Bandele, Omari, Bishop, Colin, Blaylock, Michaela, Brown, Paul, Bunger, Maureen K., Co, Julia Y., Crosby, Lynn, Daniel, Amber B., Ferguson, Steve S., Ford, Kevin, da Costa, Goncalo Gamboa, Gilchrist, Kristin H., Grogg, Matthew W., Gwinn, Maureen, Hartung, Thomas, Hogan, Simon P., Jeong, Ye Eun, Kass, George E. N., Kenyon, Elaina, Kleinstreuer, Nicole C., Kujala, Ville, Lundquist, Patrik, Matheson, Joanna, McCullough, Shaun D., Melton-Celsa, Angela, Musser, Steven, Oh, Ilung, Oyetade, Oluwakemi B., Patil, Sarita U., Petersen, Elijah J., Sadrieh, Nakissa, Sayes, Christie M., Scruggs, Benjamin S., Tan, Yu-Mei, Thelin, Bill, Nelson, M. Tyler, Tarazona, Jose, V, Wambaugh, John F., Yang, Jun-Young, Yu, Changwoo, and Fitzpatrick, Suzanne

Abstract

The webinar series and workshop titled "Trust Your Gut: Establishing Confidence in Gastrointestinal Models - An Overview of the State of the Science and Contexts of Use" was co-organized by NICEATM, NIEHS, FDA, EPA, CPSC, DoD, and the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) and hosted at the National Institutes of Health in Bethesda, MD, USA on October 11-12, 2023. New approach methods (NAMs) for assessing issues of gastrointestinal tract (GIT)related toxicity offer promise in addressing some of the limitations associated with animal-based assessments. GIT NAMs vary in complexity, from two-dimensional monolayer cell line-based systems to sophisticated 3-dimensional organoid systems derived from human primary cells. Despite advances in GIT NAMs, challenges remain in fully replicating the complex interactions and processes occurring within the human GIT. Presentations and discussions addressed regulatory needs, challenges, and innovations in incorporating NAMs into risk assessment frameworks; explored the state of the science in using NAMs for evaluating systemic toxicity, understanding absorption and pharmacokinetics, evaluating GIT toxicity, and assessing potential allergenicity; and discussed strengths, limitations, and data gaps of GIT NAMs as well as steps needed to establish confidence in these models for use in the regulatory setting.

Published
2024
Full Text
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4. Trust your gut: Establishing confidence in gastrointestinal models - An overview of the state of the science and contexts of use.

Author

Debad S, Allen D, Bandele O, Bishop C, Blaylock M, Brown P, Bunger MK, Co JY, Crosby L, Daniel AB, Ferguson SS, Ford K, Gamboa da Costa G, Gilchrist KH, Grogg MW, Gwinn M, Hartung T, Hogan SP, Jeong YE, Kass GE, Kenyon E, Kleinstreuer NC, Kujala V, Lundquist P, Matheson J, McCullough SD, Melton-Celsa A, Musser S, Oh I, Oyetade OB, Patil SU, Petersen EJ, Sadrieh N, Sayes CM, Scruggs BS, Tan YM, Thelin B, Nelson MT, Tarazona JV, Wambaugh JF, Yang JY, Yu C, and Fitzpatrick S

Subjects
Humans, Animals, Models, Biological, Risk Assessment methods, Toxicity Tests methods, Gastrointestinal Tract, Animal Testing Alternatives methods
Abstract

The webinar series and workshop titled “Trust Your Gut: Establishing Confidence in Gastrointestinal Models – An Overview of the State of the Science and Contexts of Use” was co-organized by NICEATM, NIEHS, FDA, EPA, CPSC, DoD, and the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) and hosted at the National Institutes of Health in Bethesda, MD, USA on October 11-12, 2023. New approach methods (NAMs) for assessing issues of gastrointestinal tract (GIT)- related toxicity offer promise in addressing some of the limitations associated with animal-based assessments. GIT NAMs vary in complexity, from two-dimensional monolayer cell line-based systems to sophisticated 3-dimensional organoid systems derived from human primary cells. Despite advances in GIT NAMs, challenges remain in fully replicating the complex interactions and pro­cesses occurring within the human GIT. Presentations and discussions addressed regulatory needs, challenges, and innovations in incorporating NAMs into risk assessment frameworks; explored the state of the science in using NAMs for evaluating systemic toxicity, understanding absorption and pharmacokinetics, evaluating GIT toxicity, and assessing potential allergenicity; and discussed strengths, limitations, and data gaps of GIT NAMs as well as steps needed to establish confidence in these models for use in the regulatory setting.

Published
2024
Full Text
View/download PDF

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