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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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Appendix D

Registered Attendees

Guillermo Ameer

Northwestern University

Khaled Amer

Armed Services Center for Regenerative Medicine

Rachael Anatol

U.S. Food and Drug Administration

Megan Anderson Brooks

CRD Associates

Judith Arcidiacono

U.S. Food and Drug Administration

Deepika Arora

National Institute of Standards and Technology

Stephen Badylak

McGowan Institute for Regenerative Medicine

Steven Bauer

U.S. Food and Drug Administration

Jeannie Baumann

Bloomberg Law

Steven Becker

National Eye Institute

Angie Botto-van Bemden

Musculoskeletal Research International

Jim Bowman

Health Resources & Services Administration

Kelvin Brockbank

Tissue Testing Technologies, LLC

Wilson Bryan

U.S. Food and Drug Administration

Carl Burke

Janssen Pharmaceuticals

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.
×

Karen Christman

University of California, San Diego

Michelle Cortes

National Institute of Dental and Craniofacial Research

Reid D’Amico

U.S. Food and Drug Administration

Cynthia Dunbar

American Society of Gene & Cell Therapy

Jennifer Elisseeff

Johns Hopkins University

Andrew Fesnak

University of Pennsylvania

Erik Finger

University of Minnesota

Brian Fiske

The Michael J. Fox Foundation for Parkinson’s Research

Flagg Flanagan

DiscGenics

John Gardenier

Independent

Turkan Gardenier

Pragmatica Corporation

Julia Goldstein

National Institute of Allergy and Infectious Diseases

Andrea Gray

U.S. Food and Drug Administration

Rachel Haddock

GlaxoSmithKline

Wenzheng Hu

RxGen, Inc.

Allison Hubel

University of Minnesota

Deborah Hursh

U.S. Food and Drug Administration

Laarni Ibenana

Emmes Corporation

Aminul Islam

National Heart, Lung, and Blood Institute

Seigo Izumo

Takeda Pharmaceutical Company Limited

Shekhar Jha

National Institutes of Health

Ping Jin

National Institutes of Health

Norma Johnston

American Society of Mechanical Engineers

Wendy Knosp

National Institute of Dental and Craniofacial Research

Audrey Kusiak

Department of Veterans Affairs

Edward Kwee

National Institute of Standards and Technology

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.
×

Cato Laurencin

University of Connecticut Health Center

Albert Lee

National Heart, Lung, and Blood Institute

Bo Yeon Lee

National Center for Advancing Translational Sciences

Marilyn Levi

Health Resources & Services Administration

Sheng Lin-Gibson

National Institute of Standards and Technology

Shutong Liu

National Institutes of Health

Kathy Loper

AABB

Nadya Lumelsky

National Institute of Dental and Craniofacial Research

Martha Lundberg

National Heart, Lung, and Blood Institute

Arin Maercks

Longeveron, LLC

Terry Magnuson

University of North Carolina at Chapel Hill

Elizabeth Maldonado

DBH and CAN

Peter Marks

U.S. Food and Drug Administration

Lisa McClain Moss

Longeveron, LLC

Mary Clare McCorry

Advanced Regenerative Manufacturing Institute

Racheal Mezynski

North Carolina State University

Andra Miller

VectorCell Bio Consulting

George Muschler

Cleveland Clinic

Michele Myers

GlaxoSmithKline

Anne Nadler

American Society of Mechanical Engineers

Arely Navarrete Valazquez

National Migrant and Seasonal Head Start Association

Lisa Neuhold

National Eye Institute

Bao-Ngoc Nguyen

U.S. Food and Drug Administration

Anne Nicholas

International Society for Stem Cell Research

Kim O’Connor

Tulane University

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.
×

Morgan O’Hayre

National Institute of Dental and Craniofacial Research

Steven Oh

U.S. Food and Drug Administration

Khadijah Onanuga

Neural Stem Cell Institute

David Owens

National Institute of Neurological Disorders and Stroke

Suzanne Page

Longeveron, LLC

Amy Patterson

National Institutes of Health

Julie Perlin

International Society for Stem Cell Research

Anne Plant

National Institute of Standards and Technology

Kimberlee Potter

Department of Veterans Affairs

Raj Puri

U.S. Food and Drug Administration

Peter Reczek

Centrala Strategic Solutions

Laura Ricles

U.S. Food and Drug Administration

Derek Robertson

Maryland Sickle Cell Disease Association

Kelley Rogers

National Institute of Standards and Technology

Krishnendu Roy

Georgia Institute of Technology

Krishanu Saha

University of Wisconsin–Madison

Sumona Sarkar

National Institute of Standards and Technology

Ivonne Schulman

University of Miami Miller School of Medicine

Elizabeth Schwarzbach

New York Stem Cell Foundation

Allan Shipp

National Heart, Lung, and Blood Institute

Jay Siegel

Tycho Therapeutics

Carl Simon

National Institute of Standards and Technology

Kay Smith

Harvard Medical School

Martha Somerman

National Institute of Dental and Craniofacial Research

Sandeep Srivastava

National Institutes of Health

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.
×

Michael Steinmetz

National Eye Institute

David Stroncek

National Institutes of Health

Clive Svendsen

Cedars-Sinai Medical Center

Sohel Talib

California Institute for Regenerative Medicine

Zehra Tosun

U.S. Food and Drug Administration

Kathy Tsokas

Johnson & Johnson

Santa Tumminia

National Eye Institute

Fei Wang

National Institutes of Health

Dan Weiss

International Society for Cellular Therapy

Michael Werner

Alliance for Regenerative Medicine

Carolyn Wilson

U.S. Food and Drug Administration

Celia Witten

U.S. Food and Drug Administration

Theresa Wizemann

Wizemann Scientific Communications, LLC

Joseph Wu

Stanford University

Yu-Chung Yang

National Heart, Lung, and Blood Institute

Carolyn Yong

U.S. Food and Drug Administration

Shimian Zou

National Heart, Lung, and Blood Institute

Claudia Zylberberg

Akron Biotech

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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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.
×
Page 110
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 111
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 112
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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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