Abstract

Microphysiological systems (organs-on-chips, tissue chips) are devices designed to recapitulate human physiology that could be used to better understand drug responses not easily addressed using other in vivo systems or in vitro animal models. Although still in development, initial results seem promising as tissue chips exhibit in vivo systems-like functional responses. The National Center for Advancing Translation Science (NCATS) identifies this technology as a potential tool that could improve the process of getting safer, more effective treatments to patients, and has led to the Tissue Chip Program, which aims to develop, integrate and validate major organ systems for testing. In addition to organ chip development, NCATS emphasizes disseminating the technology to researchers. Commercialization has become an important issue, reflecting the difficulty of translation from discovery to adoption and wide availability. Therefore, NCATS issued a Request for Information (RFI) targeted to existing partnerships for commercializing tissue chips. The goal was to identify successes, failures and the best practices that could provide useful guidance for future partnerships aiming to make tissue chip technology widely available.

Highlights

  • National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20892, United States article info

  • National Center for Advancing Translation Science (NCATS) issued a Request for Information (RFI) targeted to existing partnerships for commercializing tissue chips

  • To foster additional partnerships and to identify factors contributing to their success, NCATS issued a Request for Information (NOT-TR-14-008, Public–Private Partnerships for Organ Systems and Platforms Developed by Microphysiological Systems (MPS) Investigators)

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Summary

Characteristics of successful public–private partnerships

Many partnerships within the TC Program include academic and private sector scientists with mutual interests in the development of the organ systems and in advancing the design of the bioengineered platforms. Proximity of leadership and private sector partners to basic and clinical scientists is advantageous in the early stages of development, as this facilitates discussion, testing, access to clinical resources, and can eliminate “middlemen.” Ongoing feedback from private sector partners based on their knowledge of manufacturing and marketing is critical for later stages of development The integration of this feedback and that from publically funded biomedical scientists is essential to achieving long-term objectives. During early translation of the organ systems and platforms to consumers, it is advantageous to anticipate an extended period of technical support and discussion This facilitates closer collaboration between engineers and biologists, and between developers and consumers, leading to more rapid improvements in design and assurance that the devices meet requirements. Once a good legal plan is established, it can serve as a general model for future partnership agreements

Regulatory considerations
Roles of the NIH and Tissue Chip Consortium
Scenario for commercialization
Partnerships associated with the Tissue Chip program
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