Applying Systems Thinking to Regenerative Medicine : Proceedings of a Workshop.

Format:

Book

Author/Creator:

National Academies of Sciences, Engineering, and Medicine.

National Academies of Sciences, Engineering, and Medicine, author.

Health and Medicine Division, author.

Board on Health Sciences Policy, author.

Forum on Regenerative Medicine, author.

Contributor:

Division, Health and Medicine.

Policy, Board on Health Sciences.

Medicine, Forum on Regenerative.

Beachy, Sarah H.

Nicholson, Anna.

Teferra, Lydia.

Hackmann, Meredith.

Addie, Siobhan.

Health and Medicine Division, author.

Board on Health Sciences Policy, author.

Forum on Regenerative Medicine, author.

Language:

English

Subjects (All):

Regenerative medicine.

System theory.

Physical Description:

1 online resource (171 pages)

Edition:

1st ed.

Other Title:

Applying Systems Thinking to Regenerative Medicine

Place of Publication:

Washington, D.C. : National Academies Press, 2021.

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.

Contents:

Intro

FrontMatter

Reviewers

Acknowledgments

Contents

Boxes, Figures, and Tables

Acronyms and Abbreviations

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.

Notes:

Description based on publisher supplied metadata and other sources.

Part of the metadata in this record was created by AI, based on the text of the resource.

ISBN:

9780309154109

0309154103

9780309152525

0309152526

OCLC:

1262372628