What Is the Greatest Regulatory Challenge in the Translation of Biomaterials to the Clinic?

Glenn D. Prestwich; Sangeeta Bhatia; Christopher K. Breuer; Shannon L. M. Dahl; Chris Mason; Richard McFarland; David J. McQuillan; Jonathan Sackner-Bernstein; Jeffrey Schox; William E. Tente; Alan Trounson

doi:10.1126/scitranslmed.3004915

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What Is the Greatest Regulatory Challenge in the Translation of Biomaterials to the Clinic?

Glenn D. Prestwich¹,*,
Sangeeta Bhatia²,
Christopher K. Breuer³,
Shannon L. M. Dahl⁴,
Chris Mason⁵,
Richard McFarland⁶,
David J. McQuillan⁴,
Jonathan Sackner-Bernstein⁷,
Jeffrey Schox⁸,
William E. Tente⁴ and
Alan Trounson⁹

¹Department of Medicine, University of Utah, Salt Lake City, UT 84108, USA.
²Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA 02139, USA.
³Center for Regenerative Medicine and Cell-Based Therapies, Wexner Medical Center, Nationwide Children’s Hospital, Ohio State University, Columbus, OH 43205, USA.
⁴Humacyte, 7020 Kit Creek Road, Suite 110, Research Triangle Park, NC 27709, USA.
⁵Advanced Centre for Biochemical Engineering, University College London, London WC1E 6BT, UK.
⁶Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA.
⁷Neostem, New York, NY 10170, USA.
⁸Schox PLC, San Francisco, CA 94107, USA.
⁹California Institute for Regenerative Medicine, San Francisco, CA 94107, USA.

↵*Corresponding author. E-mail: glenn.prestwich{at}pharm.utah.edu

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Science Translational Medicine 14 Nov 2012:
Vol. 4, Issue 160, pp. 160cm14
DOI: 10.1126/scitranslmed.3004915

Glenn D. Prestwich

1Department of Medicine, University of Utah, Salt Lake City, UT 84108, USA.

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For correspondence: glenn.prestwich@pharm.utah.edu

Sangeeta Bhatia

2Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA 02139, USA.

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Christopher K. Breuer

3Center for Regenerative Medicine and Cell-Based Therapies, Wexner Medical Center, Nationwide Children’s Hospital, Ohio State University, Columbus, OH 43205, USA.

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Shannon L. M. Dahl

4Humacyte, 7020 Kit Creek Road, Suite 110, Research Triangle Park, NC 27709, USA.

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Chris Mason

5Advanced Centre for Biochemical Engineering, University College London, London WC1E 6BT, UK.

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Richard McFarland

6Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA.

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David J. McQuillan

4Humacyte, 7020 Kit Creek Road, Suite 110, Research Triangle Park, NC 27709, USA.

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Jonathan Sackner-Bernstein

7Neostem, New York, NY 10170, USA.

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Jeffrey Schox

8Schox PLC, San Francisco, CA 94107, USA.

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William E. Tente

4Humacyte, 7020 Kit Creek Road, Suite 110, Research Triangle Park, NC 27709, USA.

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Alan Trounson

9California Institute for Regenerative Medicine, San Francisco, CA 94107, USA.

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Abstract

Leaders in the field comment on what they perceive to be the greatest barriers to biomaterial translation.

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What Is the Greatest Regulatory Challenge in the Translation of Biomaterials to the Clinic?

Abstract

Science Translational Medicine

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