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

Author:

Prestwich Glenn D.1,Bhatia Sangeeta2,Breuer Christopher K.3,Dahl Shannon L. M.4,Mason Chris5,McFarland Richard6,McQuillan David J.4,Sackner-Bernstein Jonathan7,Schox Jeffrey8,Tente William E.4,Trounson Alan9

Affiliation:

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

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

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

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

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

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

7. Neostem, New York, NY 10170, USA.

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

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

Abstract

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

Publisher

American Association for the Advancement of Science (AAAS)

Subject

General Medicine

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