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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. Access

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https://www.hbs.edu/faculty/Pages/item.aspx?num=35037 (October 2007). Download references ACKNOWLEDGEMENTS The authors acknowledge all participants of the Wellcome Leap HOPE-meets-Industry

event (7 December 2022) for the discussion on catalyzing bioengineering innovations. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Human Organs, Physiology and Engineering (HOPE), Wellcome

Leap, Los Angeles, CA, USA Annie Moisan * Flagship Pioneering, Cambridge, MA, USA David Kolesky * 3D Systems, Houston, TX, USA Jordan Miller * Rice University, Houston, TX, USA Jordan Miller

* Complex in vitro Systems, Safety Assessment, Genentech, South San Francisco, CA, USA Kimberly Homan Authors * Annie Moisan View author publications You can also search for this author

inPubMed Google Scholar * David Kolesky View author publications You can also search for this author inPubMed Google Scholar * Jordan Miller View author publications You can also search for

this author inPubMed Google Scholar * Kimberly Homan View author publications You can also search for this author inPubMed Google Scholar 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. ETHICS DECLARATIONS COMPETING INTERESTS The authors declare no competing interests. ADDITIONAL INFORMATION 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/ RIGHTS AND PERMISSIONS Reprints

and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE 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 Download citation * Published: 04 September 2023 * Issue Date: December 2023 * DOI:

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