Appendix C
Statement of Task
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. To explore how cross-disciplinary systems thinking approaches can support the identification of relevant quality attributes and streamline manufacturing and regulatory processes of regenerative medicine products, a planning committee of the National Academies of Sciences, Engineering, and Medicine will hold a public workshop. Speakers at the workshop may be asked to discuss 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. Discussions may explore how systems thinking is currently being applied in clinical and manufacturing settings. The planning committee will develop the workshop agenda, select and invite speakers and discussants, and may moderate the discussions. A proceedings of the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.
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