PROCEEDINGS FROM THE WORKSHOP ON BIOMEDICAL MATERIALS AT THE EDGE

Challenges in the Convergence of Technologies

Presentation to the

Roundtable on Biomedical Engineering Materials and Applications

Crystal M. Cunanan ,

ReVision Optics

Bonnie A. Scarborough ,

National Research Council

National Materials Advisory Board

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies PROCEEDINGS FROM THE WORKSHOP ON BIOMEDICAL MATERIALS AT THE EDGE Challenges in the Convergence of TechnologiesPresentation to the Roundtable on Biomedical Engineering Materials and Applications Crystal M. Cunanan , ReVision Optics Bonnie A. Scarborough , National Research Council National Materials Advisory Board NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by Alfred University, American Academy of Orthopaedic Surgeons, Bose Corporation, Boston Scientific Corporation, California State University Program for Education and Research in Biotechnology, Center for Integration of Medicine and Innovative Technology, DuPont Bio-Based Materials, Edwards Lifesciences Corporation, Genzyme Corporation, Medtronic, Inc., National Institutes of Health, National Science Foundation, University of Florida, and U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. Available in limited quantities from the National Materials Advisory Board, 500 Fifth Street, N.W., Washington, DC 20001; Internet, http://www.nationalacademies.org/nmab. Additional copies are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2006 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies ROUNDTABLE ON BIOMEDICAL ENGINEERING MATERIALS AND APPLICATIONS BUDDY D. RATNER, Chair, University of Washington CRYSTAL M. CUNANAN, Vice Chair, ReVision Optics, Lake Forest, California PAUL CITRON, NAE Liaison, Medtronic, Inc. (retired), Minneapolis, Minnesota SCOTT E. ANDERSON, Bose Corporation, Minnetonka, Minnesota REBECCA BERGMAN, Medtronic, Inc., Minneapolis, Minnesota JAMES W. BURNS, Genzyme Corporation, Cambridge, Massachusetts HENGCHU CAO, Edwards Lifesciences Corporation, Irvine, California A. STEPHEN DAHMS, California State University Program for Education and Research in Biotechnology, San Diego ROBERT R. DORSCH, DuPont Bio-Based Materials, Wilmington, Delaware ALAN GOLDSTEIN, Alfred University, Alfred, New York JOSHUA J. JACOBS, American Academy of Orthopaedic Surgeons, Rosemont, Illinois WINFRED M. PHILLIPS, University of Florida, Gainesville SOHI RASTEGAR, National Science Foundation, Arlington, Virginia JONATHAN JAY ROSEN, Center for Integration of Medicine and Innovative Technology, Boston, Massachusetts RONALD SAHATJIAN, Boston Scientific Corporation, Natick, Massachusetts RICHARD E. SWAJA, National Institute of Biomedical Imaging and Bioengineering, Bethesda, Maryland TERRY O. WOODS, U.S. Food and Drug Administration, Rockville, Maryland NRC Staff BONNIE A. SCARBOROUGH, Program Officer JAMIE L. OSTROHA, Research Associate TERI THOROWGOOD, Administrative Coordinator COLLEEN BRENNAN, Program Associate LAURA TÓTH, Senior Project Assistant

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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies NATIONAL MATERIALS ADVISORY BOARD KATHARINE G. FRASE, Chair, IBM, Hopewell Junction, New York LYLE H. SCHWARTZ, Vice Chair, Consultant, Chevy Chase, Maryland JOHN E. ALLISON, Ford Motor Company, Dearborn, Michigan PAUL F. BECHER, Oak Ridge National Laboratory, Oak Ridge, Tennessee CHERYL R. BLANCHARD, Zimmer, Inc., Warsaw, Indiana EVERETT E. BLOOM, Oak Ridge National Laboratory (retired), Oak Ridge, Tennessee BARBARA D. BOYAN, Georgia Institute of Technology, Atlanta L. CATHERINE BRINSON, Northwestern University, Evanston, Illinois DIANNE CHONG, The Boeing Company, Bellevue, Washington PAUL CITRON, Medtronic, Inc. (retired), Minneapolis, Minnesota FIONA DOYLE, University of California, Berkeley SOSSINA M. HAILE, California Institute of Technology, Pasadena CAROL A. HANDWERKER, Purdue University, West Lafayette, Indiana ELIZABETH A. HOLM, Sandia National Laboratories, Albuquerque, New Mexico ANDREW T. HUNT, nGimat Company, Atlanta, Georgia DAVID W. JOHNSON, JR., Stevens Institute of Technology, Bedminster, New Jersey FRANK E. KARASZ, University of Massachusetts, Amherst CONILEE G. KIRKPATRICK, HRL Laboratories, Malibu, California TERRY C. LOWE, Los Alamos National Laboratory, Los Alamos, New Mexico KENNETH H. SANDHAGE, Georgia Institute of Technology, Atlanta LINDA S. SCHADLER, Rensselaer Polytechnic Institute, Troy, New York ROBERT E. SCHAFRIK, GE Aircraft Engines, Cincinnati, Ohio JAMES C. SEFERIS, University of Washington, Seattle SHARON L. SMITH, Lockheed Martin Corporation, Bethesda, Maryland NRC Staff GARY FISCHMAN, Director DENNIS CHAMOT, Acting Director (October 2004 to March 2005) TONI MARÉCHAUX, Director (to October 2004)

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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies Preface Recent advances in biomedical materials technology, such as the use of stem cells as biomaterials, the development of biomolecular materials composites, and supramolecular/nanoscale biomaterials engineering and design, hold the promise of a revolution in clinical medicine. Potential applications of these technologies include treatments for cancer, AIDS, congenital diseases, orthopedic problems, and cardiovascular disease. Despite their promise for clinical applications, however, there are many barriers to the development, manufacture, regulatory approval, and commercialization of these materials. ROUNDTABLE ON BIOMEDICAL ENGINEERING MATERIALS AND APPLICATIONS The Roundtable on Biomedical Engineering Materials and Applications (BEMA) is an activity of the National Research Council (NRC) convened with the objective of bringing together government officials, industry representatives, academics, and others to discuss research, development, applications, and regulation of biomedical materials and devices. BEMA provides a forum for participants to identify opportunities for applying engineering principles to create and improve the clinical performance of medically useful materials and devices. In addition, the roundtable discusses strategies for overcoming the technical, legal, and cultural obstacles that impede the transition of new materials and devices to clinical application. BEMA achieves these objectives by three means: Providing a neutral setting for the exchange of information about issues related to biomaterials science, research, and practice; Identifying and discussing priority issues in the general area of biomaterials and their application in the development, manufacture, and use of medical devices; and Conducting problem-solving and issue-identification activities such as workshops that address these issues in greater depth. WORKSHOP ON BIOMEDICAL MATERIALS AT THE EDGE A workshop entitled “Biomedical Materials at the Edge: Challenges in the

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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies Convergence of Technologies” was held on September 30 and October 1, 2004, at the National Academies in Washington, D.C. (the theme was identified in BEMA meetings held earlier that year). The purpose of the workshop was to discuss breakthrough biomedical materials technologies that could be used in the development of future treatments and the manufacture of future medical devices. To facilitate discussion, the workshop was organized into sessions on three emerging technologies: stem cells as biomaterials of the future, biomolecular materials composites, and supramolecular/nanoscale biomaterials engineering and design. Each session, and the resulting discussion, is summarized in this report, and abstracts of the individual presentations are offered. The agenda for the workshop is included as Appendix A and biographical sketches of the speakers are given in Appendix B. The viewgraphs presented by the speakers are reproduced, as originally supplied, on the accompanying CD-ROM. NRC roundtables are established solely to provide open forums for discussion of emerging issues. They are prohibited by NRC policy from producing conclusions and recommendations or from offering advice to government agencies. As such, the primary purpose of this workshop was to educate the individuals who attended so that they might take this information back to their organizations and use it in their daily planning and decision making. This proceedings therefore serves primarily as a guide for those participants to remembering the content of the discussions. The abstracts of the workshop presentations and the unedited viewgraphs represent the viewpoints of the presenters only. ACKNOWLEDGMENTS The BEMA roundtable has no head and no foot. While prohibited from providing advice or recommendations, the BEMA roundtable was formed so that its members might learn, analyze, freely exchange ideas, identify challenges, suggest the need for more formal NRC meetings and publications, and publish workshop proceedings such as these. On behalf of BEMA, I would like to thank the speakers for their informative presentations, the session chairs for keeping the discussions focused and on time, and the workshop participants for taking the time to join with BEMA members for a day and a half of lively discussion. I would also like to thank the BEMA members who volunteered their time to organize this workshop, especially Jim Burns, Alan Goldstein, Josh Jacobs, and Sohi Rastegar. Crystal Cunanan deserves special recognition for her role as program chair. She and Bonnie Scarborough did a terrific job of putting together the workshop summary. In addition, I would like to thank

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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies the following NRC staff members for their assistance and support in making this workshop and proceedings possible: Jamie Ostroha, Colleen Brennan, Teri Thorowgood, and Laura Tóth. Thanks are extended to the following individuals, who reviewed the contents of this proceedings volume: Ray A. Gsell, Zimmer, Inc.; Jack E. Lemons, University of Alabama; Martha S. Lundberg, National Heart, Lung, and Blood Institute; and Scott G. McNamee, U.S. Food and Drug Administration. The review of this proceedings was overseen by Howard Freese, Allvac Incorporated. Appointed by the National Research Council, he was responsible for making certain that an independent examination of this proceedings volume was carried out in accordance with institutional procedures and that all review comments were carefully considered. The individual presenters and the summary authors are responsible for the substance of this proceedings. Buddy D. Ratner, Chair Roundtable on Biomedical Engineering Materials and Applications

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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies Contents     WORKSHOP SUMMARY   2     ABSTRACTS          CONTEXT FOR NEW BIOMEDICAL MATERIALS   14      Can Public Policy Be as Innovative as Science and Technology?, Susan B. Foote, University of Minnesota   14      U.S. Department of Health and Human Services’ Medical Innovation Task Force, Larry G. Kessler, U.S. Food and Drug Administration   15      Dialogue on Innovation and Risk, Annabelle R. Hett, Swiss Re   15      Convergent Calling: MG Biotherapeutics, a Rational Joint Venture Between the Device and Biotechnology Worlds, Stephen N. Oesterle, Medtronic, Inc.   16      STEM CELLS AS BIOMATERIALS OF THE FUTURE   18      Stem Cells as Biomaterials of the Future: An Overview of Some Stem Cell Issues, Philip H. Schwartz, National Human Neural Stem Cell Resource   18      Propagating and Differentiating Human Embryonic Stem Cells, Steven L. Stice, University of Georgia   18      Cardiac Regenerative Strategies Using Hematopoietic and Human Embryonic Stem Cells, Michael A. Laflamme, University of Washington   19      New Tissues from Human Mesenchymal Stem Cells, Mark F. Pittenger, Osiris Therapeutics, Inc.   20      BIOMOLECULAR MATERIALS COMPOSITES   21      Not Merely the Secret of Life: DNA and Nanotechnology, Nadrian C. Seeman, New York University   21      Helical Porous Protein Mimics, Virgil Percec, University of Pennsylvania   22      Engineering Proteins for Biomaterials Applications: Prospects and Challenges, James L. Harden, Johns Hopkins University   22

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Proceedings from the Workshop on Biomedical Materials at the Edge: Challenges in the Convergence of Technologies      SUPRAMOLECULAR BIOMATERIALS ENGINEERING AND DESIGN   23      National Nanotechnology Initiative, James S. Murday, Office of Naval Research   23      Nanotechnology and Biomaterials: Venture Capital Investment and Emerging Business Issues, Edward K. Moran, Deloitte & Touche   24      Globalization: Challenges for Trade Organizations, Nik Rokop, Chicago Microtechnology and Nanotechnology Community   25      Engineering Biocompatible Nanostructures, Vicki L. Colvin, Rice University   25      Bioconjugated Nanotubes for Biosensing and Bioseparations, Charles R. Martin, University of Florida   26      Metal Nanoshells: Diagnostic and Therapeutic Applications of Nanotechnology, Jennifer L. West, Rice University   26     APPENDIXES         A  Workshop Agenda   30     B  Biographical Sketches of Speakers and Summary Authors   34