CommentaryINSIDER VIEWS
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