Hidden Bibliographic Details
| Other authors / contributors: | Hackmann, Meredith, rapporteur.
Teferra, Lydia, rapporteur.
Nicholson, Anna, rapporteur.
Beachy, Sarah H., rapporteur.
National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Regenerative Medicine. issuing body.
Applying Systems Thinking to Regenerative Medicine (Workshop) (2020 : Online)
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| ISBN: | 9780309151825
0309151821
9780309152525
0309152526
9780309154109
0309154103
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| Notes: | Includes bibliographical references.
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.
Description based on online resource; title from PDF title page (viewed December 20, 2021).
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| Summary: | 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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| Other form: | Print version: National Academies of Sciences, Engineering, and Medicine. Applying Systems Thinking to Regenerative Medicine. Washington, D.C. : National Academies Press, 2021 9780309152525
Print version: 0309151821 9780309151825
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