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Publications

Utility of Animal Cell-Based Microphysiological Systems to Support Human Drug Development

Devine, P. J., Ekert, J., Kopec, A. K., Stresser, D. M., Ramsden, D., Szilagyi, J., Hewitt, P., Hardwick, R. N., Laing, S., Van Vleet, T. R., Moalli, M., & Bajaj, P. (2025). Pharmaceutical industry perspective on the utility of animal cell-based microphysiological systems to support human drug development. ALTEX, 10.14573/altex.2407122.

Utility of Animal Cell-Based Microphysiological Systems to Support Human Drug Development

Jul 25, 2025

Exploring the synergy of CRISPR and microphysiological systems

Celauro, E., Saleh, A. F., Mahalingaiah, P. K., Mohamet, L., David, R., & Nitsch, R. (2025). Exploring the synergy of CRISPR and microphysiological systems. ALTEX - Alternatives to Animal Experimentation. https://doi.org/10.14573/altex.2403251

Exploring the synergy of CRISPR and microphysiological systems

May 9, 2025

Gene Editing

Celauro, E., Saleh, A. F., Mahalingaiah, P. K., Mohamet, L., David, R., & Nitsch, R. (2025). Exploring the synergy of CRISPR and microphysiological systems. ALTEX – Alternatives to Animal Experimentation

Gene Editing

May 9, 2025

2023 IQ MPS | FDA Workshop - Roles of Animal-cell Based MPS in Drug Discovery and Development and 3Rs Applications of MPS

Devine, P. J., Guha, M., Ekert, J. E., Kopec, A. K., Gosset, J. R., Freag, M. S., Wagoner, M. P., Hewitt, P., Harris, K., Lemmens, M., Sadrieh, N., et al. (2025). Considerations from the pharmaceutical industry (IQ MPS Affiliate) workshop on animal microphysiological systems and 3Rs in drug development. ALTEX – Alternatives to Animal Experimentation

2023 IQ MPS | FDA Workshop - Roles of Animal-cell Based MPS in Drug Discovery and Development and 3Rs Applications of MPS

Apr 11, 2025

Cell Therapies

Candarlioglu, P. L., Delsing, L., Gauthier, L., Lewis, L., Papadopoulos, G., Freag, M., Chan, T. S., Homan, K. A., Fellows, M. D., Pointon, A. (2024) Application of Microphysiological Systems for Nonclinical Evaluation of Cell Therapies. ALTEX Alternatives to animal experimentation

Cell Therapies

Jul 16, 2024

Landscape Survey

Baker, T. K., Van Vleet, T. R., Mahalingaiah, P. K., Grandhi, T. S. P., Evers, R., Ekert, J., Gosset, J. R., Chacko, S. A., & Kopec, A. K. (2024). The Current Status and Use of Microphysiological Systems by the Pharmaceutical Industry: The International Consortium for Innovation and Quality Microphysiological Systems Affiliate Survey and Commentary. Drug metabolism and disposition: the biological fate of chemicals, 52(3), 198–209.


Landscape Survey

Feb 14, 2024

In Vitro Models for Reducing or Replacing Animal Models

Stresser, D. M., Kopec, A. K., Hewitt, P., Hardwick, R. N., Van Vleet, T. R., Mahalingaiah, P. K. S., ... & Homan, K. A. (2023). Towards in vitro models for reducing or replacing the use of animals in drug testing. Nature Biomedical Engineering, 1-6.   

In Vitro Models for Reducing or Replacing Animal Models

Dec 27, 2023

2021 IQ MPS | FDA Workshop - Standardization of Complex In Vitro Models in Drug Development

Tomlinson, L., Ramsden, D., Leite, S. B., Beken, S., Bonzo, J. A., Brown, P., ... & Hardwick, R. N. (2023). Considerations from an international regulatory and pharmaceutical industry (IQ MPS Affiliate) workshop on the standardization of complex in vitro models in drug development. Advanced Biology, 2300131.

2021 IQ MPS | FDA Workshop - Standardization of Complex In Vitro Models in Drug Development

Oct 9, 2023

Disease Models

Irrechukwu, O., Yeager, R., David, R. ., Ekert, J., Saravanakumar, A. and Choi, C. K. (2023) Applications of microphysiological systems to disease models in the biopharmaceutical industry: Opportunities and challenges. ALTEX - Alternatives to animal experimentation..

Disease Models

Jul 20, 2023

Immune System

Wang, X., Kopec, A., Collinge, M., David, R., Grant, C., Hardwick, R., Navratil, A., Patel, N., Rowan, W. and Marshall, N. (2022) Application of Immunocompetent Microphysiological Systems in Drug Development: Current Perspective and Recommendations. ALTEX - Alternatives to animal experimentation.

Immune System

Mar 29, 2023

Oligonucleotides

Ramsden, D., Belair, D. G., Agarwal, S., Andersson, P., Humphreys, S., Dalmas, D. A., ... & Cichocki, J. A. (2022) Leveraging microphysiological systems to address challenges encountered during development of oligonucleotide therapeutics. ALTEX-Alternatives to animal experimentation.

Oligonucleotides

Apr 11, 2022

2020 IQ MPS | FDA Workshop - Perspectives on the evaluation and adoption of complex in vitro models in drug development

Baran, S. W., Brown, P. C., Baudy, A. R., Fitzpatrick, S. C., Frantz, C., Fullerton, A., … Ekert, J. E. (2022). Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate). ALTEX - Alternatives to Animal Experimentation, 39(2), 297–314

2020 IQ MPS | FDA Workshop - Perspectives on the evaluation and adoption of complex in vitro models in drug development

Apr 11, 2022

Cardiovascular

Pointon, A., Maher, J., Davis, M., Baker, T. K., Cichocki, J., Ramsden, D., ... & Gintant, G. A. (2021). Cardiovascular Microphysiological Systems (CVMPS) for Safety Studies-A Pharma Perspective. Lab on a Chip.

Cardiovascular

Jan 15, 2021

Gastrointestinal

Peters, M., Choy, A., Pin, C., Leishman, D., Moisan. A., Ewart, L., Guzzie-Peck, P., Sura, R., Keller, D., Scott, C., Kolaja, L. (2019) Developing in vitro Assays to Transform Gastrointestinal Safety Assessment: Potential for Microphysiological Systems. Lab on Chip.

Gastrointestinal

Feb 21, 2020

MPS Organotypic Manuscript 1.0 Introduction

Fabre, K., Berridge, B., Proctor, W., Ralston, S., Will, Y., Baran, SW., Yoder, G., Van Vleet, T. (2019) An Introduction to the Characterization and Use of Microphysiological Systems (MPS) in Pharmaceutical Safety and ADME Applications. Lab on a Chip.

MPS Organotypic Manuscript 1.0 Introduction

Feb 10, 2020

Biologics

Peterson, N., Mahalingaiah, P. K., Fullerton, A., Di Piazza, M. (2019) Application of 3D Cultures and Microphysiological Systems in Biopharmaceutical Research and Development. Lab on a Chip.

Biologics

Jan 22, 2020

Kidney

Philips, J.A., Grandhi, T.S.P., Davis, M., Gautier, J.C., Hariparsad, N., Keller, D., Sura, R., Van Vleet, T. (2019) A Pharmaceutical Industry Perspective on Microphysiological Kidney Systems for Evaluation of New Therapies. Lab on a Chip.

Kidney

Jan 22, 2020

ADME

Fowler, S., Chen, W.L.K., Duigan, D., Gupta, A., Hariparsad, N., Kenny, J., Lai, G., Liras, J., Phillips, J., Gan, J. (2019) Microphysiological Systems for ADME-Related Applications: Current Status and Recommendations for System Development and Characterisation. Lab on Chip.

ADME

Jan 6, 2020

Liver

Baudy, A.R., Otieno, M.A., Hewitt, P., Gan, J., Roth, A., Keller, D., Sura, R., Van Vleet, T.R., Proctor, W.R., (2019) Liver Microphysiological Systems Development Guidelines for Safety Risk Assessment in the Pharmaceutical Industry. Lab on a Chip.

Liver

Nov 20, 2019

Skin

Hardwick, R.N., Betts, C.J., Whritenour, J., Sura, R., Thamsen, M., Kaufman E., Fabre K., (2019) Drug-Induced Skin Toxicity: Gaps in Preclinical Testing Cascade as Opportunities for Complex In Vitro Models and Assay. Lab on a Chip.

Skin

Oct 10, 2019

Lung

Ainslie, G. R., Davis, M., Ewart, L., Lieberman, L. A., Rowlands, D. J., Thorley, A. J., Yoder, G., Ryan, A. M. (2019). Microphysiological lung models to evaluate the safety of new pharmaceutical modalities: a biopharmaceutical perspective. Lab on a Chip.

Lung

Aug 30, 2019

Navigating Tissue Chips from Development to Dissemination

Ewart, L., Fabre, K., Chakilam, A., Dragan, Y., Duignan, D. B., Eswaraka, J., Gan, J., Guzzie-Peck, P., Otieno, M., Jeong, C. G., Keller, D. A., de Morais, S. M., Phillips, J. A., Proctor, W., Sura, R., Van Vleet, T., Watson, D., Will, Y., Tagle, D., & Berridge, B. (2017). Navigating tissue chips from development to dissemination: A pharmaceutical industry perspective. Experimental biology and medicine (Maywood, N.J.), 242(16), 1579–1585.

Navigating Tissue Chips from Development to Dissemination

Jun 16, 2017

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