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Applying Systems Thinking to Regenerative Medicine - Proceedings of a Workshop (Paperback)
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Applying Systems Thinking to Regenerative Medicine - Proceedings of a Workshop (Paperback)
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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. Table of Contents Front Matter 1
Introduction 2 Introduction to Systems Thinking Concepts 3
Exploring the Challenges of Critical Quality Attributes: The Role
of Systems Thinking 4 Challenges Associated with Data Collection,
Aggregation, and Sharing 5 Challenges and Opportunities Associated
with Systems-Level Analysis and Modeling 6 Addressing Regenerative
Medicine Manufacturing and Supply Chain Challenges with
Systems-Level Approaches 7 Exploring Issues of Workforce
Development Related to Systems Thinking References Appendix A:
Workshop Agenda Appendix B: Speaker Biographical Sketches Appendix
C: Statement of Task
General
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