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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26025.
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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.

Siobhan Addie, Meredith Hackmann, Lydia Teferra, Anna Nicholson, and Sarah H. Beachy, Rapporteurs Forum on Regenerative Medicine Board on Health Sciences Policy Health and Medicine Division PREPUBLICATION COPY—Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS   500 Fifth Street, NW   Washington, DC 20001 This activity was supported by contracts between the National Academy of Sciences and Advanced Regenerative Manufacturing Institute; Akron Biotech; Alliance for Regenerative Medicine; American Society of Gene & Cell Therapy; Burroughs Wellcome Fund (Grant No. 1021433); California Institute for Regenerative Medicine; Centre for Commercialization of Regenerative Medicine; Department of Veterans Affairs (Contract No. VA26816C0051P00004); Food and Drug Administration: Office of the Commissioner and Center for Biologics Evaluation and Research (Grant No. 1R13FD006614-02); International Society for Cellular Therapy; International Society for Stem Cell Research; Johnson & Johnson; The Michael J. Fox Foundation for Parkinson’s Research; National Institute of Standards and Technology; National Institutes of Health (Contract No. HHSN263201800029I; Order No. 75N98019F00847): National Center for Advancing Translational Sciences; National Eye Institute; National Heart, Lung, and Blood Institute; National Institute of Biomedical Imaging and Bioengineering; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Aging; The New York Stem Cell Foundation; and Sanofi (Contract No. 55630791). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/26025 Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2021 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2021. Applying systems thinking to regenerative medicine: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/26025. PREPUBLICATION COPY—Uncorrected Proofs

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. PREPUBLICATION COPY—Uncorrected Proofs

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. PREPUBLICATION COPY—Uncorrected Proofs

PLANNING COMMITTEE ON APPLYING SYSTEMS THINKING TO REGENERATIVE MEDICINE1 ANNE PLANT (Co-Chair), Fellow, National Institute of Standards and Technology KRISHNENDU ROY (Co-Chair), Robert A. Milton Chair and Professor; Technical Lead, National Cell Manufacturing Consortium, Georgia Institute of Technology TOM BOLLENBACH, Chief Technology Officer, Advanced Regenerative Manufacturing Institute JAMIE HAMILTON, (former) Senior Associate Director, Research Programs, The Michael J. Fox Foundation for Parkinson’s Research DEBORAH HOSHIZAKI, Program Director, Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health SADIK KASSIM, Chief Technology Officer, Vor Biopharma MALCOM MOOS, Medical Officer and Senior Investigator, Center for Biologics Evaluation and Research, Food and Drug Administration PHIL VANEK, Partner, Gamma Biosciences CLAUDIA ZYLBERBERG, Chief Executive Officer, Akron Biotech Forum on Regenerative Medicine Staff SARAH H. BEACHY, Senior Program Officer and Forum Director SIOBHAN ADDIE, Program Officer MEREDITH HACKMANN, Associate Program Officer LYDIA TEFERRA, Research Assistant Board on Health Sciences Policy Staff ANDREW M. POPE, Senior Board Director BRIDGET BOREL, Program Coordinator 1The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published proceedings of a workshop rests with the workshop rap- porteurs and the institution. v PREPUBLICATION COPY—Uncorrected Proofs

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FORUM ON REGENERATIVE MEDICINE1 TIM COETZEE (Co-Chair), Chief Advocacy, Services, and Science Officer, National Multiple Sclerosis Society KATHERINE TSOKAS (Co-Chair), Vice President, Regulatory, Quality, Risk Management and Drug Safety, Janssen Inc. Canada SANGEETA BHATIA, John J. and Dorothy Wilson Professor, Institute for Medical Engineering and Science, Electrical Engineering and Computer Science, Massachusetts Institute of Technology PHILIP JOHN BROOKS, Program Director, Office of Rare Disease Research, National Center for Advancing Translational Sciences, National Institutes of Health GEORGE Q. DALEY, Director, Stem Cell Transplantation Program, Boston Children’s Hospital and Dana-Farber Cancer Institute; Dean, Harvard Medical School BRIAN FISKE, Senior Vice President, Research Programs, The Michael J. Fox Foundation for Parkinson’s Research LAWRENCE GOLDSTEIN, Distinguished Professor, Department of Cellular and Molecular Medicine, Department of Neurosciences; Director, University of California, San Diego, Stem Cell Program; Scientific Director, Sanford Consortium for Regenerative Medicine; Director, Sanford Stem Cell Clinical Center, University of California, San Diego, School of Medicine CANDACE KERR, Program Officer, Stem Cell Program, Aging Physiology Branch Division of Aging Biology, National Institute on Aging, National Institutes of Health ROBERT S. LANGER, David H. Koch Institute Professor, Massachusetts Institute of Technology CATO T. LAURENCIN, University Professor, Albert and Wilda Van Dusen Distinguished Professor of Orthopaedic Surgery, Professor of Chemical, Materials Science, and Biomedical Engineering; Director, The Raymond and Beverly Sackler Center for Biomedical, Biological, Physical, and Engineering Sciences; Chief Executive Officer, The Connecticut Convergence Institute for Translation in Regenerative Engineering, University of Connecticut TERRY MAGNUSON, Sarah Graham Kenan Professor, Vice Chancellor for Research, University of North Carolina at Chapel Hill MICHAEL MAY, President and Chief Executive Officer, Centre for Commercialization of Regenerative Medicine 1The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published proceedings of a workshop rests with the workshop rapporteurs and the institution. vii PREPUBLICATION COPY—Uncorrected Proofs

RICHARD McFARLAND, Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute JACK MOSHER, Senior Manager, Scientific Affairs, International Society for Stem Cell Research DAVID OWENS, Acting Deputy Director, Division of Extramural Research, National Institute of Neurological Disorders and Stroke, National Institutes of Health AMY PATTERSON, Chief Science Advisor and Director of Scientific Research Programs, National Heart, Lung, and Blood Institute, National Institutes of Health DUANQING PEI, Director General, Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences ANNE PLANT, Chief of the Biosystems and Biomaterials Division, National Institute of Standards and Technology KIMBERLEE POTTER, Scientific Program Manager, Biomedical Laboratory R&D Service, Office of Research and Development, Department of Veterans Affairs DAVID RAMPULLA, Director, Division of Discovery Science and Technology (Bioengineering), Delivery Systems and Devices for Drugs and Biologics Synthetic Biological Systems, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health DEREK ROBERTSON, Co-Founder and President, Maryland Sickle Cell Disease Association KELLY ROSE, Program Officer, Burroughs Wellcome Fund KRISHNENDU ROY, Robert A. Milton Chair and Professor in Biomedical Engineering; Technical Lead, National Cell Manufacturing Consortium; Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology KRISHANU SAHA, Associate Professor and Retina Research Foundation Kathryn and Latimer Murfee Chair, Department of Biomedical Engineering, University of Wisconsin–Madison RACHEL SALZMAN, Society Officer, American Society of Gene & Cell Therapy IVONNE SCHULMAN, Program Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health JAY P. SIEGEL, (retired) Chief Biotechnology Officer and Head, Scientific Strategy and Policy, Johnson & Johnson LANA SKIRBOLL, Vice President, Science Policy, Sanofi MARTHA SOMERMAN, Director, National Institute of Dental and Craniofacial Research, National Institutes of Health MICHAEL STEINMETZ, Director, Division of Extramural Science Programs, National Eye Institute, National Institutes of Health viii PREPUBLICATION COPY—Uncorrected Proofs

SUSAN L. SOLOMAN, Founder and Chief Executive Officer, The New York Stem Cell Foundation SOHEL TALIB, Associate Director of Therapeutics and Industry Alliance, California Institute for Regenerative Medicine DANIEL WEISS, Chief Scientific Officer, International Society for Cellular Therapy MICHAEL WERNER, Co-Founder and Senior Policy Counsel, Alliance for Regenerative Medicine CELIA WITTEN, Deputy Director, Center for Biologics Evaluation and Research, Food and Drug Administration CLAUDIA ZYLBERBERG, Founder and Chief Executive Officer, Akron Biotech Forum on Regenerative Medicine Staff SARAH H. BEACHY, Senior Program Officer and Forum Director SIOBHAN ADDIE, Program Officer MEREDITH HACKMANN, Associate Program Officer LYDIA TEFERRA, Research Assistant Board on Health Sciences Policy Staff ANDREW M. POPE, Senior Board Director BRIDGET BOREL, Program Coordinator ix PREPUBLICATION COPY—Uncorrected Proofs

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Reviewers This Proceedings of a Workshop was reviewed in draft form by indi- viduals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical com- ments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We thank the following individuals for their review of this proceedings: MARTHA LUNDBERG, National Heart, Lung, and Blood Institute RYAN MURPHY, National Academies of Sciences, Engineering, and Medicine GUNARETNAM RAJAGOPAL, Johnson & Johnson Although the reviewers listed above provided many constructive com- ments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by LINDA DEGUTIS, Henry M. Jackson Foundation. She was responsible for making certain that an independent examination of this proceedings was carried out in accordance with stan- dards of the National Academies and that all review comments were care- fully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies. xi PREPUBLICATION COPY—Uncorrected Proofs

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Acknowledgments The support of the sponsors of the Forum on Regenerative Medicine was crucial to the planning and conduct of the workshop Applying Systems Thinking to Regenerative Medicine and for the development of this Pro- ceedings of a Workshop. Federal sponsors were the Department of Veterans Affairs; Food and Drug Administration: Office of the Commissioner and Center for Biologics Evaluation and Research; National Institute of Stan- dards and Technology; and National Institutes of Health: National Center for Advancing Translational Sciences; National Eye Institute; National Heart, Lung, and Blood Institute; National Institute of Biomedical Imaging and Bioengineering; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Aging. Nonfederal sponsorship was provided by Advanced Regenerative Manu- facturing Institute; Akron Biotech; Alliance for Regenerative Medicine; American Society of Gene & Cell Therapy; Burroughs Wellcome Fund; California Institute for Regenerative Medicine; Centre for Commercializa- tion of Regenerative Medicine; International Society for Cellular Therapy; International Society for Stem Cell Research; Johnson & Johnson; The Michael J. Fox Foundation for Parkinson’s Research; The New York Stem Cell Foundation; and Sanofi. The Forum on Regenerative Medicine wishes to express gratitude to the expert speakers who explored how cross-disciplinary systems thinking xiii PREPUBLICATION COPY—Uncorrected Proofs

xiv ACKNOWLEDGMENTS approaches can support the development of safe and effective regenerative medicine therapies. The forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda. The project director would like to thank the project staff who worked diligently to develop both the workshop and the resulting Proceed- ings of a Workshop. PREPUBLICATION COPY—Uncorrected Proofs

Contents ACRONYMS AND ABBREVIATIONS xix 1 INTRODUCTION 1 Organization of the Proceedings, 7 2 INTRODUCTION TO SYSTEMS THINKING CONCEPTS 9 An Introduction to Systems Thinking, 10 Applying Systems Thinking to the Development of Regenerative Medicines, 16 System Dynamics of Cell-State Transitions: Relevance for Regenerative Medicine, 20 Discussion, 24 3 EXPLORING THE CHALLENGES OF CRITICAL QUALITY ATTRIBUTES: THE ROLE OF SYSTEMS THINKING 29 Systems Thinking and the Regulation of Regenerative Medicine Products, 31 Using Systems Thinking Approaches for Cell Therapy Product Development, 37 Discussion, 41 xv PREPUBLICATION COPY—Uncorrected Proofs

xvi CONTENTS 4 CHALLENGES ASSOCIATED WITH DATA COLLECTION, AGGREGATION, AND SHARING 47 Toward Open Science in Omics Analysis and Disease Modeling, 48 Using Big Data for Clinical Stratification of Patients, 53 Discussion, 58 5 CHALLENGES AND OPPORTUNITIES ASSOCIATED WITH SYSTEMS-LEVEL ANALYSIS AND MODELING 65 Developing Algorithms for Single-Cell Genomics, 66 Modeling Dynamic Data to Identify a Latent Space, 70 Adopting Metabolic Modeling Tools in Biopharmaceutical Drug Development, 74 Discussion, 78 6 ADDRESSING REGENERATIVE MEDICINE MANUFACTURING AND SUPPLY CHAIN CHALLENGES WITH SYSTEMS-LEVEL APPROACHES 85 Artificial Intelligence in Cell and Gene Therapies, 86 Modeling the Manufacturing Process in Regenerative Medicine, 91 Novel Supply Chain and Cost Modeling for Cell Therapies, 98 Discussion, 103 7 EXPLORING ISSUES OF WORKFORCE DEVELOPMENT RELATED TO SYSTEMS THINKING 109 Education and Workforce Development to Advance Systems Thinking, 110 Reflections on the Workshop, 116 Final Words on Models and Data, 118 REFERENCES 121 APPENDIXES A WORKSHOP AGENDA 127 B SPEAKER BIOGRAPHICAL SKETCHES 137 C STATEMENT OF TASK 149 PREPUBLICATION COPY—Uncorrected Proofs

Boxes, Figures, and Tables BOXES 1-1 Workshop Statement of Task, 3 6-1 Grand Challenges in Cell Manufacturing, 92 6-2 Questions to Consider in Determining Analysis Objectives, 97 FIGURES 1-1 Cell therapy: interaction of multi-scale dynamic complex systems, 5 1-2 A systems approach to inform the regenerative medicine field, 6 2-1 Fruit fly early development: from maternal inputs to larva, 12 3-1 Process of cell therapy development as a system, 39 6-1 Complexity of regenerative medicine supply chain ecosystem, 99 TABLES 4-1 Use Cases for Real-World Data, 59 6-1 Factors Influencing Each Stage in the Development of Autologous Cell Therapies, 90 xvii PREPUBLICATION COPY—Uncorrected Proofs

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Acronyms and Abbreviations ACO accountable care organization AD Alzheimer’s disease AI artificial intelligence AMP-AD Accelerating Medicines Partnership—Alzheimer’s Disease APC antigen-presenting cells AUC area under the curve CAR chimeric antigen receptor CMaT Center for Cell Manufacturing Technologies CoGAPS Coordinated Gene Activity in Pattern Sets CPP critical process parameters CQA critical quality attribute CRS cytokine release syndrome EHR electronic health record ERC engineering research center (NSF) FDA Food and Drug Administration FHIR Fast Healthcare Interoperability Resources GMP good manufacturing practice HIPAA Health Insurance Portability and Accountability Act xix PREPUBLICATION COPY—Uncorrected Proofs

xx ACRONYMS AND ABBREVIATIONS iPS induced pluripotent stem NIH National Institutes of Health NLP natural language processing NMR nuclear magnetic resonance NSF National Science Foundation OMOP Observational Medical Outcomes Partnership PCORI Patient-Centered Outcomes Research Institute TCR T cell receptor UCH University of California Health (System) UMAP Uniform Manifold Approximation and Projection PREPUBLICATION COPY—Uncorrected Proofs

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Regenerative medicine products, which are intended to repair or replace damaged cells or tissues in the body, include a range of therapeutic approaches such as cell- and gene-based therapies, engineered tissues, and non-biologic constructs. The current approach to characterizing the quality of a regenerative medicine product and the manufacturing process often involves measuring as many endpoints as possible, but this approach has proved to be inadequate and unsustainable.

The Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine convened experts across disciplines for a 2-day virtual public workshop to explore systems thinking approaches and how they may be applied to support the identification of relevant quality attributes that can help in the optimization of manufacturing and streamline regulatory processes for regenerative medicine. A broad array of stakeholders, including data scientists, physical scientists, industry researchers, regulatory officials, clinicians, and patient representatives, discussed new advances in data acquisition, data analysis and theoretical frameworks, and how systems approaches can be applied to the development of regenerative medicine products that can address the unmet needs of patients. This publication summarizes the presentation and discussion of the workshop.

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