Forum on Regenerative Medicine's Books

Applying Systems Thinking to Regenerative Medicine

Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,National Academies Of Sciences Engineeri,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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Applying Systems Thinking to Regenerative Medicine

Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,National Academies Of Sciences Engineeri,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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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170

Published Date

ISBN 10

0309151821

ISBN 13

9780309151825

Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies

Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies

Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment. This publication summarizes the presentations and discussions from the workshop.

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125

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National Academies Press

Published Date

ISBN 10

0309466474

ISBN 13

9780309466479

Exploring the State of the Science in the Field of Regenerative Medicine

Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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Exploring the State of the Science in the Field of Regenerative Medicine

Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

Regenerative medicine holds the potential to create living, functional cells and tissues that can be used to repair or replace those that have suffered potentially irreparable damage due to disease, age, traumatic injury, or genetic and congenital defects. The field of regenerative medicine is broad and includes research and development components of gene and cell therapies, tissue engineering, and non-biologic constructs. Although regenerative medicine has the potential to improve health and deliver economic benefits, this relatively new field faces challenges to developing policies and procedures to support the development of novel therapies are both safe and effective. In October 2016, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop with the goal of developing a broad understanding of the opportunities and challenges associated with regenerative medicine cellular therapies and related technologies. Participants explored the state of the science of cell-based regenerative therapies within the larger context of patient care and policy. This publication summarizes the presentations and discussions from the workshop.

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137

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National Academies Press

Published Date

ISBN 10

0309455081

ISBN 13

9780309455084

Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies

Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies

Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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Solve jigsaw puzzle

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125

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National Academies Press

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ISBN 10

0309466474

ISBN 13

9780309466479

Exploring the State of the Science in the Field of Regenerative Medicine

Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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Exploring the State of the Science in the Field of Regenerative Medicine

Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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137

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National Academies Press

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ISBN 10

0309455081

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9780309455084

Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products

Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products

Proceedings of a Workshop

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

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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133

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National Academies Press

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ISBN 10

0309489091

ISBN 13

9780309489096

Book's by Forum on Regenerative Medicine

Applying Systems Thinking to Regenerative Medicine

Applying Systems Thinking to Regenerative Medicine

Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies

Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies

Exploring the State of the Science in the Field of Regenerative Medicine

Exploring the State of the Science in the Field of Regenerative Medicine

Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies

Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies

Exploring the State of the Science in the Field of Regenerative Medicine

Exploring the State of the Science in the Field of Regenerative Medicine

Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products

Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products

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