Completed
The Forum on Regenerative Medicine hosted a public workshop to examine and discuss challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from examples of manufacturing of early generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes as well as designing and adhering to standards to help in the navigation of the scale-up process from a research laboratory to the manufacturing environment.
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Workshop
ยท2017
On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with d...
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Description
An ad hoc planning committee will plan and conduct a one-day public workshop to examine and discuss challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop will be to learn from existing examples of manufacturing of early generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes, as well as designing and adhering to standards to help navigate the scale-up process from a research laboratory to the manufacturing environment. Gathering this information will help inform and facilitate future Forum on Regenerative Medicine discussions around the issues of implementing regenerative medicine therapies and technologies, such as designing and implementing effective manufacturing processes, examining regulatory pathways, and considering bioethical matters. Discussions during this workshop will be held with a broad array of stakeholders, which may include research scientists, clinicians, patients, regulators, and representatives from pharmaceutical and biotech companies. The planning committee will develop the workshop agenda, select and invite speakers, and moderate the discussions. Proceedings from the workshop will be prepared by a designated rapporteur in accordance with institutional policies and procedures.
Collaborators
Committee
Steven Oh
Co-Chair
Claudia Zylberberg
Co-Chair
James Beck
Member
Rachel Haddock
Member
Cato T. Laurencin
Member
Thomas Petersen
Member
Anne Plant
Member
James Richardson
Member
Krishnendu Roy
Member
Krishanu Saha
Member
Martha Somerman
Member
Jiwen Zhang
Member
Sponsors
Department of Defense
Department of Health and Human Services
Other, Federal
Private: For Profit
Private: Non Profit
Major units and sub-units
Health and Medicine Division
Lead
Board on Health Sciences Policy
Lead