Abstract

NIH Translational Centers for Microphysiological Systems (TraCe MPS)

Danilo Tagle, Associate Director for Special Initiatives, National Institutes of Health

Over the last decade, the National Center for Advancing Translational Sciences (NCATS) as part of the US National Institutes of Health (NIH) have supported the development and use of microphysiological systems (MPS) or tissue chips in testing candidate therapies for safety and efficacy, in modeling human diseases, in designing clinical trials, and in applications for precision medicine. Recently, NCATS has established four Translational Centers for Microphysiological Systems (TraCe MPS) in the US to support the widespread adoption and use of tissue chip technology, especially in drug discovery and development. These Centers aims to support research that will accelerate the translational use of MPS in drug (both human pharmacological and biological products) development through regulatory acceptance and adoption for industrial use, by establishing MPS that are fit-for-purpose for industry needs and have specific defined context-of-use (CoU) and will be developed with consideration of applicable expectations to achieve regulatory approval. The TraCe MPS program is in partnership with the US Food and Drug Administration (FDA) and the Critical Path. The four centers will focus on qualification of MPSs developed for liver, kidney, barrier-function, and pregnancy and women’s health. The These Centers will further the development of these MPSs as drug development tools (DDTs) that, once qualified, will be made commercially available to fill unmet needs in drug development.