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Translation of tissue-engineering innovations requires a connected ecosystem

The potential of tissue engineering to deliver clinical advances hinges on a connected ecosystem that includes academics, funding agencies, entrepreneurs, investors, the pharmaceutical industry and regulatory bodies. Open dialog on goals and risks across these stakeholders is key to implementing bioengineered tissue models in drug development and tissue therapies.

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Acknowledgements

The authors acknowledge all participants of the Wellcome Leap HOPE-meets-Industry event (7 December 2022) for the discussion on catalyzing bioengineering innovations.

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Contributions

All authors contributed to researching data, discussing content and writing the manuscript. A.M. and K.A.H. reviewed and edited the manuscript for submission and publication.

Corresponding authors

Correspondence to Annie Moisan or Kimberly Homan.

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The authors declare no competing interests.

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Related links

Advanced Regenerative Manufacturing Institute: https://www.armiusa.org/

Advanced Research and Invention Agency (Aria): https://www.aria.org.uk/

Advanced Research Projects Agency for Health (ARPA-H): https://arpa-h.gov/

American Society for Testing and Materials: https://www.astm.org/

Defense Advanced Research Projects Agency (DARPA): https://www.darpa.mil/

EMA strategic vision: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf

Emergency Use Authorization: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

European Organ-on-Chip Society: https://euroocs.eu/

FDA Alternative Methods working group: https://www.fda.gov/science-research/about-science-research-fda/advancing-alternative-methods-fda

FDA Modernization Act 2.0: https://www.nabr.org/about-nabr/news/nabrs-press-statement-fda-modernization-act-20

Federal Agency for Disruptive Innovations (SPRIN-D): https://www.sprind.org/en/

Innovative Science and Technology Approaches for New Drugs: https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program

Institute of Human Biology: https://institutehumanbiology.com/

IQ Microphysiological Systems Affiliate: https://www.iqmps.org/

International Microphysiological System Society: https://impss.org/

Moonshot Research and Development Program: https://www8.cao.go.jp/cstp/english/moonshot/top.html

National Centre for Advancing Translational Sciences: https://ncats.nih.gov/

Partnership between Semma Therapeutics and the Juvenile Diabetes Research Foundation: https://t1dfund.org/news/semma-therapeutics-receives-investment-from-jdrf-t1d-fund/

Right to Try Act: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try

Tissue Chip for Drug Screening program: https://ncats.nih.gov/tissuechip

Tissue chip testing centers: https://ncats.nih.gov/tissuechip/projects/centers

Wellcome Leap: https://wellcomeleap.org/

Wellcome Leap HOPE Program: https://wellcomeleap.org/hope/

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Moisan, A., Kolesky, D., Miller, J. et al. Translation of tissue-engineering innovations requires a connected ecosystem. Nat Rev Bioeng 1, 879–881 (2023). https://doi.org/10.1038/s44222-023-00111-y

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