National Gene Vector Laboratories
NCRR provides core funding for a group of National Gene Vector Laboratories (NVGL) that serve
as a resource for researchers seeking adequate quantities of clinical-grade
vectors for human gene transfer protocols.
The labs include three vector production centers at Baylor College of Medicine,
City of Hope National Medical Center and Beckman Research Institute, and Indiana
University, which also serves as the coordinating center for all the laboratories.
Two additional laboratories conduct toxicology studies for approved investigators.
These laboratories are located at the Southern Research Institute and the University
of Florida.
More information about how to request vector production or
pharmacology and toxicology support is available on National Gene Vector Laboratories Web site
.
Program Guidelines
(PDF files require free Acrobat Reader)
Guidelines for National Gene Vector Laboratories (297KB PDF) describes the goals of the NGVL, the application and review process for obtaining NGVL resources, and the responsibilities of NGVL members and investigators. Investigators must agree to follow these guidelines to be considered for NGVL resources.
Policy and Procedures Manual for National Gene Vector Laboratories (359KB PDF) provides information about the management and operation of the NGVLs and prescribes procedures for eligible investigators to apply for and receive NGVL resources.
Coordinating Center for the National Gene Vector
Laboratories
Department of Medical and Molecular Genetics
Medical Science Building, University of Indiana
635 Barnhill Drive, MS 205
Indianapolis, IN 46202-5121
Grant No. U42 RR11148
Web site: www.ngvl.org
Special Services, Facilities, or Instruments
- Coordinating center houses the public toxicology databases.
- Facilities are compliant with Good Manufacturing Practice/Good Laboratory Practice (GMP/GLP) guidelines for the production
of retrovirus, adenovirus, adeno-associated virus, herpes virus,
lentivirus, and DNA plasmid vectors for use in Phase I and II
clinical gene therapy trials.
- GLP laboratories provide safety testing and certification.
- GMP/GLP laboratories and animal facilities provide
toxicology services
Resource Applications
Application packages are available from the project coordinator
listed below. Completed applications should be received at the
Coordinating Center by March 1 or September 15. However, an expedited
review process is available to investigators who have both obtained
provisional IRB approval and registered with the NIH Office of
Biotechnology Activities. Such requests can be submitted at any time.
The NGVL Scientific Review Board will evaluate applications for
preclinical data; understanding of the molecular mechanism of the
targeted disease; protocol design; qualifications of the investigator
and the laboratory and clinical facilities; ethical implications
of the proposed research; plans to protect human subjects; and
compliance with regulatory, minority and gender guidelines.
The NGVL Prioritization Committee will evaluate completed reviews,
assign priority scores, and rank applications. Its recommendations
are then conveyed to the NGVL Steering Committee for final
disposition.
Contact Information
For information about these
resources and how to access them, please contact:
Project Coordinator
Lorraine Matheson
317-274-4519; Fax: 317-274-4518
E-mail:
lrubin@iupui.edu
Program Director and Principal Investigator
Kenneth Cornetta, M.D.
317-274-2240; Fax: 317-274-2387
E-mail: kcornetta@iupui.edu
Production Laboratory Manager
Christopher Ballas, Ph.D.
317-278-1628; Fax: 317-278-3327
e-mail: cballas@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 915
6701 Democracy Boulevard, MSC 4874
Bethesda, Maryland 20892-4874 (20817 for express mail)
Telephone: 301-435-0451
Fax: 301-480-3661
E-mail: RosenblumD@mail.nih.gov
