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This group was created out of the first cell therapy liaison meeting. It is being chaired by Liz Cardwell and falls under the Commercialization and Translational Research Committee. The Group has a sister Advisory Group chaired by Shelly Heimfeld which was struck to give advice and feedback to the Working Group as needed. The intent of this working group is to create a draft guidance that will be submitted to the FDA on this issue. The Group meets by teleconference and is making steady progress.
History: The leadership and membership of the International Society of Cell Therapy have determined that the interpretation and application of the new 21 CFR 1271 regulations need further clarity, specifically 21 CFR 1271.3(c). To that end, ISCT, working with the FDA CBER Office of Cells, Tissue, and Gene Therapies and interested stakeholder organizations, has organized a Working Group and Advisory Panel to present potential clarifications. It is called the Homologous Use Working Group or HuWG.
Working Group Chair:
Liz Cardwell, MT(ASCP), MBA
Seattle, USA
lcardwell5@comcast.net
Working Group Core Group Members:
Lizabeth J. Cardwell, MT(ASCP), MBA Quality Management)
Seattle, USA
Shelly Heimfeld, PhD
Seattle, USA
Armand Keating, MD,FRCP©
Toronto, Canada
Zbigniew Szczepiorkowski, MD, PhD, FCAP
Lebanon
Becky Haley, MD
Durham, USA
Camillo Ricordi, MD
Miami, USA
Onder Alpdogan, MD
New York, USA
C. Randal Mills, PhD
Baltimore, USA
J. Wade Atkins, MT(ASCP)SBB
Bethesda, USA
Christine Czarniecki, PhD
Bethesda, USA
Connie Garrison, MBA, MT
Woburn, USA
Janet Macpherson, PhD
Sydney, Australia
Dale Peterson, PhD
Summit, New Jersey
Darin Weber, PhD
Seattle, USA
Advisory Group Chair:
Shelly Heimfeld, PhD
Seattle, USA
sheimfel@fhcrc.org
Advisory Group Members:
Shelly Heimfeld, PhD
Seattle, USA
Liz Cardwell, MT(ASCP), MBA
Seattle, USA
Mark Brecher, MD
Chapel Hill, USA
EJ Read, MD
Bethesda, USA
John McMannis, PhD
Houston, USA
Leslie Silberstein, MD
Boston, USA
Dennis Gastineau, MD
Rochester, USA
Joyce L. Frey-Vasconcells, PhD
Washington, USA
Helen Heslop, MD
Houston, USA
Celia Witten PhD, MD
Rockville, USA
Working Group Chair:
The Working Group Chair is responsible for managing the Group's function, and deliverable within the parameters of the Group’s Terms of Reference and at the instruction of the overseeing ISCT Committee and Executive Committee.
Working Group Members:
Appointees that are the committed, have the required expertise, and are collectively representative of a wide spectrum of stakeholders
Advisory Group Chair:
The Advisory Group Chair is responsible for managing the Group's function, and input requested by the Working Group and liaising between the overseeing ISCT Committee and Executive Committee
Advisory Members:
Appointees that are committed, have the required expertise, and are widely representative of the spectrum of stakeholders to provide required input at various critical stages from outside the expertise represented in the Working Group Members
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