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Suggested Citation:"Appendix D: Registered Attendees." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Page 105
Suggested Citation:"Appendix D: Registered Attendees." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×
Page 106
Suggested Citation:"Appendix D: Registered Attendees." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×
Page 107
Suggested Citation:"Appendix D: Registered Attendees." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×
Page 108
Suggested Citation:"Appendix D: Registered Attendees." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
×
Page 109
Suggested Citation:"Appendix D: Registered Attendees." National Academies of Sciences, Engineering, and Medicine. 2019. Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25371.
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Page 110

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Appendix D Registered Attendees Guillermo Ameer Steven Bauer Northwestern University U.S. Food and Drug Administration Khaled Amer Jeannie Baumann Armed Services Center for Bloomberg Law Regenerative Medicine Steven Becker Rachael Anatol National Eye Institute U.S. Food and Drug Administration Angie Botto-van Bemden Megan Anderson Brooks Musculoskeletal Research CRD Associates International Judith Arcidiacono Jim Bowman U.S. Food and Drug Administration Health Resources and Services Administration Deepika Arora National Institute of Standards Kelvin Brockbank and Technology Tissue Testing Technologies, LLC Stephen Badylak Wilson Bryan McGowan Institute for U.S. Food and Drug Administration Regenerative Medicine Carl Burke Janssen Pharmaceuticals 105 PREPUBLICATION COPY­ Uncorrected Proofs —

106 EXPLORING VARIABILITY IN REGENERATIVE ENGINEERING PRODUCTS Karen Christman Rachel Haddock University of California, San Diego GlaxoSmithKline Michelle Cortes Wenzheng Hu National Institute of Dental and RxGen, Inc. Craniofacial Research Allison Hubel Reid D’Amico University of Minnesota U.S. Food and Drug Administration Deborah Hursh Cynthia Dunbar U.S. Food and Drug Administration American Society of Gene & Cell Therapy Laarni Ibenana Emmes Corporation Jennifer Elisseeff Johns Hopkins University Aminul Islam National Heart, Lung, and Blood Andrew Fesnak Institute University of Pennsylvania Seigo Izumo Erik Finger Takeda Pharmaceutical Company University of Minnesota Limited Brian Fiske Shekhar Jha The Michael J. Fox Foundation for National Institutes of Health Parkinson’s Research Ping Jin Flagg Flanagan National Institutes of Health DiscGenics Norma Johnston John Gardenier American Society of Mechanical Independent Engineers Turkan Gardenier Wendy Knosp Pragmatica Corporation National Institute of Dental and Craniofacial Research Julia Goldstein National Institute of Allergy and Audrey Kusiak Infectious Diseases Department of Veterans Affairs Andrea Gray Edward Kwee U.S. Food and Drug Administration National Institute of Standards and Technology PREPUBLICATION COPY­ Uncorrected Proofs —

APPENDIX D 107 Cato Laurencin Peter Marks University of Connecticut Health U.S. Food and Drug Administration Center Lisa McClain Moss Albert Lee Longeveron, LLC National Heart, Lung, and Blood Institute Mary Clare McCorry Advanced Regenerative Bo Yeon Lee Manufacturing Institute National Center for Advancing Translational Sciences Racheal Mezynski North Carolina State University Marilyn Levi Health Resources and Services Andra Miller Administration VectorCell Bio Consulting Sheng Lin-Gibson George Muschler National Institute of Standards Cleveland Clinic and Technology Michele Myers Shutong Liu GlaxoSmithKline National Institutes of Health Anne Nadler Kathy Loper American Society of Mechanical AABB Engineers Nadya Lumelsky Arely Navarrete Valazquez National Institute of Dental and National Migrant and Seasonal Craniofacial Research Head Start Association Martha Lundberg Lisa Neuhold National Heart, Lung, and Blood National Eye Institute Institute Bao-Ngoc Nguyen Arin Maercks U.S. Food and Drug Administration Longeveron, LLC Anne Nicholas Terry Magnuson International Society for Stem Cell University of North Carolina at Research Chapel Hill Kim O’Connor Elizabeth Maldonado Tulane University DBH and CAN PREPUBLICATION COPY­ Uncorrected Proofs —

108 EXPLORING VARIABILITY IN REGENERATIVE ENGINEERING PRODUCTS Morgan O’Hayre Kelley Rogers National Institute of Dental and National Institute of Standards Craniofacial Research and Technology Steven Oh Krishnendu Roy U.S. Food and Drug Administration Georgia Institute of Technology Khadijah Onanuga Krishanu Saha Neural Stem Cell Institute University of Wisconsin–Madison David Owens Sumona Sarkar National Institute of Neurological National Institute of Standards Disorders and Stroke and Technology Suzanne Page Ivonne Schulman Longeveron, LLC University of Miami Miller School of Medicine Amy Patterson National Institutes of Health Elizabeth Schwarzbach New York Stem Cell Foundation Julie Perlin International Society for Stem Cell Allan Shipp Research National Heart, Lung, and Blood Institute Anne Plant National Institute of Standards Jay Siegel and Technology Tycho Therapeutics Kimberlee Potter Carl Simon Department of Veterans Affairs National Institute of Standards and Technology Raj Puri U.S. Food and Drug Administration Kay Smith Harvard Medical School Peter Reczek Centrala Strategic Solutions Martha Somerman National Institute of Dental and Laura Ricles Craniofacial Research U.S. Food and Drug Administration Sandeep Srivastava Derek Robertson National Institutes of Health Maryland Sickle Cell Disease Association PREPUBLICATION COPY­ Uncorrected Proofs —

APPENDIX D 109 Michael Steinmetz Carolyn Wilson National Eye Institute U.S. Food and Drug Administration David Stroncek Celia Witten National Institutes of Health U.S. Food and Drug Administration Clive Svendsen Theresa Wizemann Cedars-Sinai Medical Center Wizemann Scientific Communications, LLC Sohel Talib California Institute for Regenerative Joseph Wu Medicine Stanford University Zehra Tosun Yu-Chung Yang U.S. Food and Drug Administration National Heart, Lung, and Blood Institute Kathy Tsokas Johnson & Johnson Carolyn Yong U.S. Food and Drug Administration Santa Tumminia National Eye Institute Shimian Zou National Heart, Lung, and Blood Fei Wang Institute National Institutes of Health Claudia Zylberberg Dan Weiss Akron Biotech International Society for Cellular Therapy Michael Werner Alliance for Regenerative Medicine PREPUBLICATION COPY­ Uncorrected Proofs —

PREPUBLICATION COPY­ Uncorrected Proofs —

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The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results.

The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop.

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