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

In May 2022, there was 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 was 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 was agreed upon that understanding the global perspective regarding the readiness of CIVM/MPS models for regulatory decision making and potential pathways to gaining acceptance would be useful to align on globally. It was also determined that it the obstacles are currently too great to develop standards for every context of use (COU). Instead, it was 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.

TOMLINSON Lindsay;  RAMSDEN Diane;  BATISTA LEITE Sofia;  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 A.;  GARCIA Martha Iveth;  GOSSETT James R.;  HEWITT Philip;  HOMAN Kimberly;  IRRECHUKWU Onyi;  KOPEC Anna K.;  LIRAS Jennifer L.;  MANDELKAR Sandhya;  RACZYNSKI Arek;  SADRIEH Nakissa;  SAKATIS Melanie Z.;  SIEGEL Jeffrey;  SUNG Kyung;  SUNYOVSZKI Ilona;  VAN VLEET Terry R.;  EKERT Jason E.;  HARDWICK Rhiannon; 

2024-09-24

WILEY-V C H VERLAG GMBH

JRC132974

2701-0198 (online),   

https://onlinelibrary.wiley.com/doi/10.1002/adbi.202300131,    https://publications.jrc.ec.europa.eu/repository/handle/JRC132974,   

10.1002/adbi.202300131 (online),