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

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

Article Information

vol. 4 no. 160 160cm14

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Author Information

  1. Glenn D. Prestwich1,*,
  2. Sangeeta Bhatia2,
  3. Christopher K. Breuer3,
  4. Shannon L. M. Dahl4,
  5. Chris Mason5,
  6. Richard McFarland6,
  7. David J. McQuillan4,
  8. Jonathan Sackner-Bernstein7,
  9. Jeffrey Schox8,
  10. William E. Tente4 and
  11. Alan Trounson9
  1. 1Department of Medicine, University of Utah, Salt Lake City, UT 84108, USA.
  2. 2Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA 02139, USA.
  3. 3Center for Regenerative Medicine and Cell-Based Therapies, Wexner Medical Center, Nationwide Children’s Hospital, Ohio State University, Columbus, OH 43205, USA.
  4. 4Humacyte, 7020 Kit Creek Road, Suite 110, Research Triangle Park, NC 27709, USA.
  5. 5Advanced Centre for Biochemical Engineering, University College London, London WC1E 6BT, UK.
  6. 6Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA.
  7. 7Neostem, New York, NY 10170, USA.
  8. 8Schox PLC, San Francisco, CA 94107, USA.
  9. 9California Institute for Regenerative Medicine, San Francisco, CA 94107, USA.
  1. *Corresponding author. E-mail: glenn.prestwich{at}pharm.utah.edu

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