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Coordination of a Multi-site Cell and Gene Therapy Study in an Academic Medical Center: A Success Story

Time

Wed, Jun 18 7:15AM
W 05

Title

Coordination of a Multi-site Cell and Gene Therapy Study in an Academic Medical Center: A Success Story

Abstract Summary

A Memorandum of Understanding(MOU) was developed and signed that outlined regulatory and data management responsibilities of the Academic Medical Center(PI) and a CRO. The MOU was sent to the Food and Drug Administration(FDA) as part of the IND submission to codify the roles and responsibilities.

Poster Presenter

Bambi Grilley
RAC,
Director, Clinical Research & Early Product Dev., Center for Cell & Gene Therapy,
Baylor College of Medicine
United States