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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 |
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
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The National Gene Vector Laboratories (NGVLs) help researchers
obtain adequate quantities of clinical-grade vectors for human
gene transfer protocols. The NGVLs consist of three vector
production centers at Baylor College of Medicine; City of Hope
National Medical Center and Beckman Research Institute; and
Indiana University, which also is the Coordinating Center for
the activities of all the laboratories. In addition, two other
laboratories conduct toxicology studies for investigators upon
approval by the NGVL steering committee. These centers are
located at the Southern Research Institute and the
University of Florida.
Application packages are available from the Project Coordinator
listed above. 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.
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
Special Services, Facilities, or Instruments
- Coordinating center houses the public toxicology databases.
- Facilities are compliant with Good Manufacturing Practice
(GMP)/Good Laboratory Practice (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
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