Considerations from an International Regulatory and Pharmaceutical Industry (IQ MPS Affiliate) Workshop on the Standardization of Complex In Vitro Models in Drug Development

• Published in: Advanced biology Vol. 8; no. 8; pp. e2300131 - n/a
• Main Authors: Tomlinson, Lindsay, Ramsden, Diane, Leite, Sofia Batista, Beken, Sonja, Bonzo, Jessica A., Brown, Paul, Candarlioglu, Pelin L., Chan, Tom S., Chen, Eugene, Choi, Colin K., David, Rhiannon, Delrue, Nathalie, Devine, Patrick J., Ford, Kevin, Garcia, Martha Iveth, Gosset, James R., Hewitt, Philip, Homan, Kimberly, Irrechukwu, Onyi, Kopec, Anna K., Liras, Jennifer L., Mandlekar, Sandhya, Raczynski, Arek, Sadrieh, Nakissa, Sakatis, Melanie Z., Siegel, Jeffrey, Sung, Kyung, Sunyovszki, Ilona, Van Vleet, Terry R., Ekert, Jason E., Hardwick, Rhiannon N.
• Format: Journal Article
• Language: English
• Published: Germany 01-08-2024
• Subjects: complex in vitro models; drug development; Drug Development - legislation & jurisprudence; Drug Development - standards; Drug Industry - legislation & jurisprudence; Drug Industry - standards; Humans; microphysiological systems; standardization; United States; United States Food and Drug Administration - legislation & jurisprudence; United States Food and Drug Administration - standards; United States; drug development; standardization; complex in vitro models; microphysiological systems
• DOI: 10.1002/adbi.202300131
• EISSN: 2701-0198

In May 2022, there is an International Regulatory and Pharmaceutical Industry (Innovation and Quality [IQ] Microphysiological Systems [MPS] Affiliate) Workshop on the standardization of complex in vitro models (CIVMs) in drug development. This manuscript summarizes the discussions and conclusions of this joint workshop organized and executed by the IQ MPS Affiliate and the United States Food and Drug Administration (FDA). A key objective of the workshop is to facilitate discussions around opportunities and/or needs for standardization of MPS and chart potential pathways to increase model utilization in the context of regulatory decision making. Participation in the workshop included 200 attendees from the FDA, IQ MPS Affiliate, and 26 global regulatory organizations and affiliated parties representing Europe, Japan, and Canada. It is agreed that understanding global perspectives regarding the readiness of CIVM/MPS models for regulatory decision making and potential pathways to gaining acceptance is useful to align on globally. The obstacles are currently too great to develop standards for every context of use (COU). Instead, it is suggested that a more tractable approach may be to think of broadly applicable standards that can be applied regardless of COU and/or organ system. Considerations and next steps for this effort are described.
There is a strong need for standardization of microphysiological systems in order to increase model utilization and incorporation into the existing paradigm of drug development. These models must also be deemed acceptable to regulators. The results of a workshop with Industry and Global Regulatory participants are shared.