The Clinical Coordinating Center (CCC) for the existing Gene Therapy Resource Program (GTRP) facilitates the translation of basic research in gene therapy to clinical application in the areas of heart, lung, and blood diseases. The GTRP renewal allows the program to continue providing resources in the areas of preclinical and clinical-grade vector production in accordance with Good Manufacturing Practices (GMP), and in the conduct of pharmacology/toxicology studies. In addition, the GTRP will continue to provide funds and regulatory assistance to investigators wishing to conduct gene therapy clinical trials. The GTRP consist of a clinical coordinating center that oversees and coordinates the logistics of the core laboratories and provides regulatory assistance for clinical trials;a preclinical-grade vector production core laboratory;a clinical-grade vector production core laboratory for adeno-associated virus (AAV);a clinical-grade vector production core laboratory for lentivirus;and a pharmacology/toxicology core laboratory.

Agency
National Institute of Health (NIH)
Type
Station Support Contracts (N03)
Project #
268201200002I-0-26800003-2
Application #
8755774
Study Section
Project Start
2012-06-01
Project End
2017-05-31
Budget Start
Budget End
Support Year
Fiscal Year
2013
Total Cost
$803,731
Indirect Cost
Name
Social and Scientific Systems, Inc.
Department
Type
DUNS #
091340943
City
Silver Spring
State
MD
Country
United States
Zip Code
20910