The University of Louisville Division of Thoracic and Cardiovascular Surgery began the development of its Good Laboratory Practices (GLP) program in 1998.  Under the direction of Quality Assurance (QA) manager, Lauren Unger, Ph.D., these efforts contributed to the world’s first two clinical implants of the AbioCor® Total Replacement Heart at Jewish Hospital.

From 2000-2006, the GLP program supported testing of cardiac assist devices for several corporate sponsors with 3 FDA approved cardiovascular systems being introduced clinically.  The GLP program, its facilities and documentation have been repeatedly evaluated by outside auditors including the FDA.

Now a part of the CII Translational Research Division, the GLP program is gearing up to provide expanded QA support in new areas including cardiovascular therapeutics.  Ensuring regulatory compliance from protocol development through to the final report for preclinical studies is vital to the success of the CII and its research mission.