Report of the Assay Guidance Workshop on 3-Dimensional Tissue Models for Antiviral Drug Development

Robert Jordan; Stephanie L Ford-Scheimer; Rodolfo M Alarcon; Anthony Atala; Jeffrey T Borenstein; Kyle R Brimacombe; Sara Cherry; Hans Clevers; Mindy I Davis; Simon G P Funnell; Lee Gehrke; Linda G Griffith; Abigail C Grossman; Thomas Hartung; Donald E Ingber; Nicole C Kleinstreuer; Calvin J Kuo; Emily M Lee; Christine L Mummery; Thames E Pickett; Sasirekha Ramani; Edwin A Rosado-Olivieri; Evi B Struble; Zhengpeng Wan; Mark S Williams; Matthew D Hall; Marc Ferrer; Sarine Markossian

doi:10.1093/infdis/jiad334

Report of the Assay Guidance Workshop on 3-Dimensional Tissue Models for Antiviral Drug Development

J Infect Dis. 2023 Oct 3;228(Suppl 5):S337-S354. doi: 10.1093/infdis/jiad334.

Authors

Robert Jordan¹, Stephanie L Ford-Scheimer², Rodolfo M Alarcon³, Anthony Atala⁴, Jeffrey T Borenstein⁵, Kyle R Brimacombe², Sara Cherry⁶, Hans Clevers⁷, Mindy I Davis³, Simon G P Funnell^{8

9}, Lee Gehrke^{10

11}, Linda G Griffith^{12

13}, Abigail C Grossman², Thomas Hartung^{14

15}, Donald E Ingber^{11

16

17

18}, Nicole C Kleinstreuer¹⁹, Calvin J Kuo²⁰, Emily M Lee², Christine L Mummery²¹, Thames E Pickett³, Sasirekha Ramani²², Edwin A Rosado-Olivieri²³, Evi B Struble²⁴, Zhengpeng Wan¹², Mark S Williams³, Matthew D Hall², Marc Ferrer², Sarine Markossian²

Affiliations

¹ Bill and Melinda Gates Foundation, Seattle, Washington, USA.
² National Center for Advancing Translational Sciences, National Institutes of Health, Rockville, Maryland, USA.
³ National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
⁴ Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
⁵ Draper Laboratory, Cambridge, Massachusetts, USA.
⁶ Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁷ Hubrecht Institute, Utrecht, The Netherlands.
⁸ UK Health Security Agency, Salisbury, United Kingdom.
⁹ Quadram Institute Bioscience, Norwich, United Kingdom.
¹⁰ Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
¹¹ Harvard Medical School, Boston, Massachusetts, USA.
¹² Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
¹³ Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
¹⁴ Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
¹⁵ Department of Molecular Microbiology and Immunology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA.
¹⁶ Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, Massachusetts, USA.
¹⁷ Harvard School of Engineering and Applied Sciences, Cambridge, Massachusetts, USA.
¹⁸ Boston Children's Hospital, Boston, Massachusetts, USA.
¹⁹ National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle, North Carolina, USA.
²⁰ Department of Medicine, Division of Hematology, Stanford University School of Medicine, Stanford, California, USA.
²¹ Leiden University Medical Center, Leiden, The Netherlands.
²² Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
²³ RumiViro, RUMI Scientific, Inc, New York, New York, USA.
²⁴ US Food and Drug Administration, Silver Spring, Maryland, USA.

Abstract

The National Center for Advancing Translational Sciences (NCATS) Assay Guidance Manual (AGM) Workshop on 3D Tissue Models for Antiviral Drug Development, held virtually on 7-8 June 2022, provided comprehensive coverage of critical concepts intended to help scientists establish robust, reproducible, and scalable 3D tissue models to study viruses with pandemic potential. This workshop was organized by NCATS, the National Institute of Allergy and Infectious Diseases, and the Bill and Melinda Gates Foundation. During the workshop, scientific experts from academia, industry, and government provided an overview of 3D tissue models' utility and limitations, use of existing 3D tissue models for antiviral drug development, practical advice, best practices, and case studies about the application of available 3D tissue models to infectious disease modeling. This report includes a summary of each workshop session as well as a discussion of perspectives and challenges related to the use of 3D tissues in antiviral drug discovery.

Keywords: 3D tissue models; SARS-CoV-2; antiviral drug discovery; body-on-a-chip; human pluripotent stem cells (hPSCs); induced pluripotent stem cells (iPSCs); microphysiological systems (MPS); organ-on-a-chip; organoid; tissue-derived stem cells.

Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.

Publication types

Research Support, N.I.H., Intramural

MeSH terms

Antiviral Agents* / pharmacology
Antiviral Agents* / therapeutic use
Biological Assay
Drug Discovery*

Substances

Antiviral Agents