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