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.
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Workshop
ยท2021
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 reg...
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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