Forum on Regenerative Medicine

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Historical exclusion of women from basic, translational, and clinical research has led to an inadequate understanding of sex-based biological differences on health and disease burden and lack of therapies for women's health. In October 2024, the National Academies Forum on Regenerative Medicine and Forum on Temporomandibular Disorders hosted a public workshop to consider gaps within regenerative medicine research related to conditions that are female-specific and/or are more common in or differently impact women; explore emerging and potential regenerative medicine therapies and technologies for these conditions; and examine women's representation within the regenerative medicine workforce.

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14 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-09899-8
DOI: https://doi.org/10.17226/29088

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National Academies of Sciences, Engineering, and Medicine. 2025. The Intersection of Regenerative Medicine and Women's Health: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.

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The Forum on Regenerative Medicine aspires to spark exchange and inspire action among diverse interested parties to advance regenerative medicine for the benefit of all. During 2023, the forum members focused on three broad areas through their working groups: Diversity, Equity, and Inclusion; Manufacturing and Supply Chain; and Workforce Development. The members and staff also explored challenges and discussed possible solutions in a number of other areas relevant to the development of regenerative medicines, including communication, cost of and access to therapies, and regulatory and legislative affairs. This publication describes the activities of the forum during 2023.

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13 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-71849-X
DOI: https://doi.org/10.17226/27752

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National Academies of Sciences, Engineering, and Medicine. 2024. Forum on Regenerative Medicine: 2023 Annual Report. Washington, DC: The National Academies Press.

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As the number of regenerative medicines and therapies approved by the Food and Drug Administration (FDA) has grown to meet rising demand, the field of regenerative medicine has started to anticipate the potential of strategies such as artificial intelligence, decentralized manufacturing, and automation to accommodate this expansion. The National Academies Forum on Regenerative Medicine hosted a public workshop in October 2023 to explore emerging technologies, evolving manufacturing approaches, regulatory considerations, and diverse partnerships needed to increase regenerative medicine treatment capacity.

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15 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-71584-9
DOI: https://doi.org/10.17226/27483

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National Academies of Sciences, Engineering, and Medicine. 2024. Emerging Technologies and Innovation in Manufacturing Regenerative Medicine Therapies: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.

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Rapid growth in the regenerative medicine field is driving increased demand for skilled workers, highlighting the importance of considering how to shape the requisite workforce. The National Academies Forum on Regenerative Medicine hosted a November 2022 workshop to better understand gaps in workforce development and potential solutions, skillsets and other attributes needed for success in regenerative medicine, and incentives and disincentives for expanding the workforce. The workshop was intended to serve as an opportunity to catalyze engagement and development of the regenerative medicine workforce by exploring possibilities to expand participation. This proceedings document summarizes workshop discussions.

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15 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-70253-4
DOI: https://doi.org/10.17226/27013

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National Academies of Sciences, Engineering, and Medicine. 2023. Training the Regenerative Medicine Workforce for the Future: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.

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14 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-70216-X
DOI: https://doi.org/10.17226/26955

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National Academies of Sciences, Engineering, and Medicine. 2023. Forum on Regenerative Medicine: 2022 Annual Report. Washington, DC: The National Academies Press.

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The Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine convened a two-day virtual public workshop to address knowledge gaps in the understanding of promising approaches to manipulate the immune system and/or the regenerative medicine product to improve outcomes of tissue repair and regeneration in patients. The workshop, titled "Understanding the Role of the Immune System in Improving Tissue Regeneration," explored the role of the immune system in the success or failure of regenerative medicine therapies. Participants considered potential strategies to effectively "prepare" patients' immune systems to accept regenerative therapies and increase the likelihood of successful clinical outcomes and also discussed risks associated with modulating the immune system. This Proceedings of a Workshop highlights the presentations and discussions that occurred during the workshop.

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188 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-68817-5
ISBN Ebook: 0-309-68818-3
DOI: https://doi.org/10.17226/26551

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National Academies of Sciences, Engineering, and Medicine. 2022. Understanding the Role of the Immune System in Improving Tissue Regeneration: Proceedings of a Workshop. Washington, DC: The National Academies Press.

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The National Academies of Sciences, Engineering, and Medicine's Forum on Regenerative Medicine (the forum) provides a convening mechanism for interested parties from academia, industry, government, patient and provider organizations, regulatory bodies, foundations, societies, associations, and others. The forum identifies existing and potential barriers to scientific and therapeutic advances; discusses opportunities to assist in facilitating more effective partnerships among key stakeholders; examines the impact that current policies have on the discovery, development, and translation of regenerative medicine therapies; considers the unique challenges of identifying, validating, and bringing regenerative medicine applications to market; and explores the ethical, legal, and social issues posed by advances in regenerative medicine.

During 2021, the forum members continued to focus on two broad areas through their two working groups: Regenerative Engineering and Gene Therapy and Systems Thinking. The members and staff also continued to explore challenges and discuss possible solutions in a number of other areas relevant to the development of regenerative medicines, including communication, workforce development, cost of and access to therapies, and regulatory and legislative affairs. This publication describes the activities of the forum during 2021.

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9 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-68914-7
DOI: https://doi.org/10.17226/26583

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National Academies of Sciences, Engineering, and Medicine. 2022. Forum on Regenerative Medicine: 2021 Annual Report. Washington, DC: The National Academies Press.

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8 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-08751-1
DOI: https://doi.org/10.17226/26271

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National Academies of Sciences, Engineering, and Medicine. 2021. Forum on Regenerative Medicine: 2020 Annual Report. Washington, DC: The National Academies Press.

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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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170 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-15182-1
ISBN Ebook: 0-309-15252-6
DOI: https://doi.org/10.17226/26025

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National Academies of Sciences, Engineering, and Medicine. 2021. Applying Systems Thinking to Regenerative Medicine: Proceedings of a Workshop. Washington, DC: The National Academies Press.

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8 pages · 8.5 x 11 ·
ISBN Ebook: 0-309-08574-8
DOI: https://doi.org/10.17226/26247

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National Academies of Sciences, Engineering, and Medicine. 2020. Forum on Regenerative Medicine: 2018 and 2019 Program Activities. Washington, DC: The National Academies Press.

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8 pages · ·
ISBN Ebook: 0-309-08573-X
DOI: https://doi.org/10.17226/26246

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National Academies of Sciences, Engineering, and Medicine. 2018. Forum on Regenerative Medicine: 2016 and 2017 Program Activities. Washington, DC: The National Academies Press.

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Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.

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126 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-67298-8
ISBN Ebook: 0-309-67299-6
DOI: https://doi.org/10.17226/25712

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National Academies of Sciences, Engineering, and Medicine. 2020. Exploring Novel Clinical Trial Designs for Gene-Based Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press.

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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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132 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-48909-1
ISBN Ebook: 0-309-48910-5
DOI: https://doi.org/10.17226/25371

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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.

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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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124 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-46647-4
ISBN Ebook: 0-309-46648-2
DOI: https://doi.org/10.17226/24913

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National Academies of Sciences, Engineering, and Medicine. 2017. Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press.

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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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136 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-45508-1
ISBN Ebook: 0-309-45509-X
DOI: https://doi.org/10.17226/24671

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National Academies of Sciences, Engineering, and Medicine. 2017. Exploring the State of the Science in the Field of Regenerative Medicine: Challenges of and Opportunities for Cellular Therapies: Proceedings of a Workshop. Washington, DC: The National Academies Press.

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Forum on Regenerative Medicine

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Forum on Regenerative Medicine

The Intersection of Regenerative Medicine and Women's Health: Proceedings of a Workshop—in Brief

Publications

Perspectives

Annual Report/Review