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History: One of the significant challenges facing both manufacturers and users of devices and equipment involved in the manufacturing of cell-based therapeutic products is the current lack of clarity around their regulatory requirements and possible avenues for commercial approval. ISCT has been asked to assist in addressing this topic by pulling together interested parties to produce issues and recommendations for the appropriate regulation of such devices. FDA has stated they would welcome information about such issues, which could serve as the basis for development of guidance documents and new strategies to enhance clinical development and regulatory approval.
ISCT has committed to forming and supporting a Devices Working Group (DWG) to address this issue. The DWG will be facilitated through ISCT’s North American Legal and Regulatory Affairs Committee, and held their initial meeting to discuss the formation of the DWG at the 6th Annual Somatic Cell Therapy Symposium.
Draft Mission Statement: The Cell Therapy Devices Working Group (DWG) is dedicated to defining issues and recommendations for improved regulatory frameworks for devices, equipment, and their reagents, as they are used in cell therapy product manufacturing and treatment. The Group is comprised of cell therapy professionals from industry and academia representing both users and builders of such devices. The Group will fulfill its mission by utilizing a representative core group of members that seek the advice of a larger Advisory Group and stakeholders in industry and academia to discuss issues and produce and propose regulatory frameworks. The group will operate through the facilitation of discussions, meetings, surveys, and educational events as well as the publication of papers, best practices, and recommendations. The Group reports to ISCT through the ISCT North American Legal and Regulatory Committee and derives support from both that committee and the ISCT Cell Therapy Commercialization Committee.
Next Meeting:
The next meeting of the DWG will take place at the Somatic Cell Therapy Symposium in the Cabinet Suite (Hyatt Regency Bethesda) on Sept 26th from 5:00pm - 7:00pm EST.
Working Group Chair:
John Gilbert Ph.D.
Boston, MA
john-gilbert@piconomics.com
Working Group Administrative Contact:
Audrey Le
Audrey@celltherapysociety.org
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