ngvbcc.org
NGVB - Archiving Services
https://www.ngvbcc.org/ArchivingServices.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. As gene therapy products are developed and brought to clinical trials, the US FDA requires collection and storage of materials that can be accessed, as needed, at later time points ( PDF. Pharmacology and Toxicology Archive. If you have performed Pharm/Tox studies submitted to the FDA and have material that must be maintained under GLP conditions, the NGVB will store the...
ngvbcc.org
NGVB - What's New
https://www.ngvbcc.org/WhatsNew.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. What's New at the NGVB. August 1, 2016. We have observed a heightened interest in insertional site/clonal analysis. In response to this, we have developed a testing pipeline that will utilize nrLAM PCR and next generation sequence technology (see http:/ www.ncbi.nlm.nih.gov/pubmed/20671722. We now offer nrLAM PCR as a service. Support Gene Therapy Research!
ngvbcc.org
NGVB - Pharm/Tox Archive Request Process
https://www.ngvbcc.org/PharmToxArchiveRequestProcess.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. Application Process for Pharm/Tox Archive Services. The NGVB will maintain samples from any gene therapy related Pharmacology or Toxicology study that has been submitted to the FDA by a U.S. academic investigator that require storage under Good Laboratory Practices. Investigators seeking NGVB Archiving Services must:. Log-in to the NGVB. Through a grant to the.
ngvbcc.org
NGVB - Clinical Trial Sample Archive Studies
https://www.ngvbcc.org/ListPostTrialStudies.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. Get user name and password. Can't remember your password? The NGVB is supported by the NIH's National Heart, Lung, and Blood Institute. Through a grant to the. Indiana University School of Medicine. Department of Medical and Molecular Genetics.
ngvbcc.org
NGVB - Insertion Site Analysis
https://www.ngvbcc.org/InsertionSiteAnalysis.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. For certain gene therapy clinical trials, the FDA has required post-trial monitoring of patients, evaluating clinical samples for evidence of clonal expansion of cells ( PDF. To help academic investigators comply with this FDA recommendation, the NGVB offers assistance with clonal analysis using nrLAM PCR. Technology. Contact the NGVB Coordinating Center.
ngvbcc.org
NGVB - Clinical Trial Testing Request Process
https://www.ngvbcc.org/ClinicalSampleTestingRequestProcess.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. Clinical Trial Testing with/without Archiving. Application Process for Clinical Trial Testing (with/without archiving). The NGVB will test and archive (if requested) clinical samples from gene therapy studies to help academic investigators meet FDA monitoring requirements ( FDA Guidelines. Investigators seeking NGVB Testing Services must:. Log-in to the NGVB.
ngvbcc.org
NGVB - Policy and Procedure Manual
https://www.ngvbcc.org/PolicyAndProcedureManual.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. National Gene Vector Biorepository. POLICY AND PROCEDURE MANUAL. Version 4 - June 19, 2015. Eligibility Requirements for Receiving NGVB Resources. NGVB External and Internal Advisory Boards. Advertising of NGVB Resources. Responsibility of the Investigator. Criteria for Termination of Support. NGVB Coordinating Center Responsibilities. 10 STATEMENT OF PURPOSE. The NGVB I...
ngvbcc.org
NGVB - Toxicology Database
https://www.ngvbcc.org/ToxDatabase.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. Investigators have agreed to allow submission of their data into this database. The database is also accessible to any investigator in the gene therapy field who would like to share their data. To access the database click here. The NGVB is supported by the NIH's National Heart, Lung, and Blood Institute. Through a grant to the. Indiana University School of Medicine.
ngvbcc.org
NGVB - Error
https://www.ngvbcc.org/ArchivingSOPs.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. Archive user access required. You need to be a registered archive user to access the SOPs. The NGVB is supported by the NIH's National Heart, Lung, and Blood Institute. Through a grant to the. Indiana University School of Medicine. Department of Medical and Molecular Genetics.
ngvbcc.org
NGVB - IU-KSOB/VPF Costing Tool
https://www.ngvbcc.org/CostingTool.action
Apply for a new study. Clinical Grade Vector and Cell Lines. Apply for a new study. Clonal Analysis (nrLAM PCR). Apply for a new study. IU KSOB/VPF Costing Tool. Information on the use of the tool is provided in the Instructions tab of the Excel file. It is important only to provide data into colored cells as cells in white are locked to protect the cost calculation formulae. IU KSOB/VPF Costing Tool. IU KSOB/VPF Costing Tool with Simulation. ANDERSON SR, KAPLAN RS. (2004). Time-driven activity-b...FARBE...
