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Applying Systems Thinking to Regenerative Medicine: A Workshop

Completed

Manufacturing and characterizing the quality of regenerative medicine products often involve measuring as many endpoints as possible, but this approach has proved to be inadequate and unsustainable. Accordingly, an ad hoc planning committee of the National Academies of Sciences, Engineering, and Medicine was assembled to hold a public workshop on the topic. This workshop explored how cross-disciplinary systems thinking approaches can support the identification of relevant quality attributes and streamline manufacturing and regulatory processes of regenerative medicine products.

Description

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 one-day 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.

Contributors

Committee

Anne Plant

Co-Chair

Krishnendu Roy

Co-Chair

Tom Bollenbach

Member

Jamie Hamilton

Member

Deborah K. Hoshizaki

Member

Sadik Kassim

Member

Malcolm Moos

Member

Phil Vanek

Member

Claudia Zylberberg

Member

Sponsors

Department of Health and Human Services

Other, Federal

Private: For Profit

Private: Non Profit

Staff

Sarah Beachy

Lead

Meredith Hackmann

Siobhan Addie

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