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Sharon Barr, Executive Vice-President, BioPharmaceuticals R&D, AstraZeneca

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Topic 15 reading: Organ-on-Chip

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How can the biopharmaceutical industry overcome regulatory, technical, and ethical challenges to integrate MPS into drug development processes more efficiently and effectively

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Regulatory Acceptance of MPS

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1. Promote Standardization and Collaboration: Engage with regulatory bodies to establish standardized protocols for MPS, encouraging consistency and reliability in results. This initiative should aim to reduce variability and enhance reproducibility across different platforms and studies, ensuring that MPS are viewed as reliable tools in regulatory decision-making processes (Tomlinson et al., 2023).

2. Increase Transparency and Open Data Sharing: Encourage the creation of open-access databases for MPS data, which can be used by researchers and regulators to validate and understand the capabilities and limitations of these systems comprehensively (Ewart et al., 2017).

3. Establish Public-Private Partnerships: Develop partnerships between academic institutions, industry, and regulatory bodies. These collaborations are vital for advancing the integration of MPS in drug development and regulatory practices by pooling resources, knowledge, and technologies (Livingston et al., 2016).

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MPS as Predictive Models for Drug Efficacy and Safety:

MPS are shown to replicate human physiological responses more accurately than traditional cell cultures and animal models, providing a promising alternative for more predictive preclinical testing (Tagle, 2019).

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1. Scalability and Integration Challenges: While MPS offer detailed biological insights, scaling these systems for high-throughput screening and integrating multiple organ systems for systemic responses remain challenging. These issues must be addressed to fully harness their potential in drug development pipelines (Andersen et al., 2014).

2. Technological and Operational Hurdles: MPS technologies face significant technical challenges, including the need for sophisticated equipment and specialized personnel. Additionally, the lack of standardized methodologies can hinder their broader adoption and acceptance in regulatory frameworks (Heringa et al., 2020).

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1. Livingston, C. A., Fabre, K. M., & Tagle, D. A. (2016). Facilitating the commercialization and use of organ platforms generated by the microphysiological systems (Tissue Chip) program through public-private partnerships. Computational and structural biotechnology journal, 14, 207–210. https://doi.org/10.1016/j.csbj.2016.04.003

2. Ewart L, Fabre K, Chakilam A, et al. Navigating tissue chips from development to dissemination: A pharmaceutical industry perspective. Experimental Biology and Medicine. 2017;242(16):1579-1585. doi:10.1177/1535370217715441

3. Heringa, M. B., Park, M. V. D. Z., Kienhuis, A. S., & Vandebriel, R. J. (2020). The value of organs-on-chip for regulatory safety assessment. ALTEX, 37(2), 208–222. https://doi.org/10.14573/altex.1910111

4. Tomlinson, L., Ramsden, D., Leite, S. B., Beken, S., Bonzo, J. A., Brown, P., Candarlioglu, P. L., Chan, T. S., Chen, E., Choi, C. K., David, R., Delrue, N., Devine, P. J., Ford, K., Garcia, M. I., Gosset, J. R., Hewitt, P., Homan, K., Irrechukwu, O., . . . Hardwick, R. N. (2024). 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, 8(8), 2300131. https://doi.org/10.1002/adbi.202300131

5. Baran, S. W., Brown, P. C., Baudy, A. R., Fitzpatrick, S. C., Frantz, C., Fullerton, A., Gan, J., Hardwick, R. N., Hillgren, K. M., Kopec, A. K., Liras, J. L., Mendrick, D. L., Nagao, R., Proctor, W. R., Ramsden, D., Ribeiro, A. J. S., Stresser, D., Sung, K. E., Sura, R., Tetsuka, K., … 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, 39(2), 297–314. https://doi.org/10.14573/altex.2112203

6. Hargrove-Grimes, P., Low, L. A., & Tagle, D. A. (2022). Microphysiological Systems: Stakeholder Challenges to Adoption in Drug Development. Cells, tissues, organs, 211(3), 269–281. https://doi.org/10.1159/000517422

7. Tagle, D. A. (2019). The NIH microphysiological systems program: developing in vitro tools for safety and efficacy in drug development. Current opinion in pharmacology, 48, 146-154.

8. Andersen, M. E., Betts, K., Dragan, Y., Fitzpatrick, S., Goodman, J. L., Hartung, T., Himmelfarb, J., Ingber, D. E., Jacobs, A., Kavlock, R., Kolaja, K., Stevens, J. L., Tagle, D., Lansing Taylor, D., & Throckmorton, D. (2014). Developing microphysiological systems for use as regulatory tools--challenges and opportunities. ALTEX, 31(3), 364–367. https://doi.org/10.14573/altex.1405151

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Successful Case Studies:

Instances where MPS data contributed to regulatory discussions, highlighting their potential to streamline drug development and safety assessments (Hargrove-Grimes et al., 2021).