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Forum on Regenerative Medicine: 2021 Annual Report (2022)

Chapter:Working Groups and Areas of Interest

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Suggested Citation:"Working Groups and Areas of Interest." National Academies of Sciences, Engineering, and Medicine. 2022. Forum on Regenerative Medicine: 2021 Annual Report. Washington, DC: The National Academies Press. doi: 10.17226/26583.
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Working Groups and Areas of Interest During 2021, the forum members continued to focus on two broad areas through their two working groups: Regenerative Engineering & 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. A more detailed description of the current working groups and areas of interest is below. Regenerative Engineering & Gene Therapy Systems Thinking The forum’s working group on regenerative engineering The forum’s working group on systems thinking is interested in and gene therapy explores barriers impeding the advancing the field of regenerative medicine by exploring new successful translation of regenerative and gene-based technologies and theoretical models that may improve product therapies and forward-thinking approaches aimed at characterization, manufacturing processes, and patient improving clinical outcomes. The group held a public stratification, resulting in greater clinical success of new therapies. workshop in November 2021 to explore promising The forum also seeks to understand what skillsets methods to modulate the patient immune system and/or are needed by the workforce now and in the future to discover, the regenerative medicine product to promote develop, and manufacture regenerative medicines. In 2021, the regeneration in individuals. The workshop was highly working group on systems thinking continued to examine the interdisciplinary and sought to apply lessons from fields importance of training (or retraining) the future and current such as immune tolerance, graft acceptance, and wound regenerative medicine workforce in data science and other cross- healing to improve tissue repair and regeneration. disciplinary areas. A subset of forum members from this group is developing a perspective paper on training opportunities in data science and quantitative analytical methods to be submitted for publication in 2022. ADDITIONAL AREAS OF INTEREST Cost of and Access to Regulatory and Communication Therapies Legislative Affairs The forum members remain invested in Forum members continue to track Forum members are regularly updated exploring how patients can become barriers for patients in accessing on regulatory developments, including more involved in the research and regenerative therapies with the goal of standards and potential roles for development process of new therapies understanding the various factors that various regulatory bodies at the state and how experts in the field can better may contribute to cost and access issues. and national levels involved in communicate about regenerative enforcing regulations related to medicine with the public. unproven therapies. 2021 Annual Report | 1

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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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