National Gene Vector Biorepository

NCRR replaced the National Gene Vector Laboratories in June 2008 with the National Gene Vector Biorepository and Coordinating Center to provide for storage and retrieval of vectors and biologic products associated with gene vector therapy trials and to establish and maintain a gene vector pharmacology and toxicology data repository. The biorepository also will support an information coordinating center and perform original research in gene vector toxicity.

National Gene Vector Biorepository and Coordinating Center

Indiana University
Medical Research & Library Bldg. IB 130
975 W. Walnut St.
Indianapolis, IN 46202-5167

Grant No. 1 P40 RR024928-01

Web site: www.ngvbcc.org

The National Gene Vector Biorepository at Indiana University will serve as a critical resource for academic investigators conducting gene therapy research. It also will seek to further improve safety for research subjects through education and compliance efforts.

Specifically, the biorepository will gather a wide variety of gene therapy reagents that will be made available to academic investigators for preclinical investigation. Along with supplying reagents, the biorepository will facilitate material transfer agreements through a Web-based system between researchers and those holding intellectual property rights. Once all parties have agreed to the terms, material will be dispensed by the biorepository to the investigator.

The biorepository also will seek to provide a safe and secure storage site for biospecimens that must be collected to maintain compliance with Food and Drug Administration (FDA) or other regulatory agencies. These include archived clinical samples, back-up and reserve vector final products, and GLP (Good Laboratory Practice) toxicology and pharmacology study samples.

The biorepository will also maintain a Web-based pharmacology and toxicology database, allowing investigators to view summaries of GLP studies submitted to the FDA that are relevant to their area of research. More importantly, it will facilitate letters of cross-reference to Investigational New Drug applications and Drug Master Files, in order to minimize duplication of costly pharm/tox studies on viral vectors. It also will expand gene therapy educational resources for designing pharm/tox studies.

Contact Information

For information about the biorepository and how to access its resources, please contact:

Program Manager
Lorraine Matheson
Telephone: 317-274-4519
E-mail: lrubin@iupui.edu

Director and Principal Investigator
Kenneth Cornetta
Telephone: 317-274-2240
E-mail: kcornett@iupui.edu

For program information, please contact:

Daniel Rosenblum, M.D.
Medical Officer
Division for Clinical Research Resources
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, Room 910
6701 Democracy Boulevard, MSC 4874
Bethesda, Maryland 20892-4874 (20817 for express mail)
Telephone: 301-435-4051
Fax: 301-480-3661
E-mail: RosenblumD@mail.nih.gov