NATIONAL GENE VECTOR BIOREPOSITORY
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1 NATIONAL GENE VECTOR BIOREPOSITORY A NHLBI FUNDED GENE THERAPY RESOURCE at Indiana University Funded by the NHLBI P40 RR024928
2 Spectrum of NGVB Services Clinical Trial Development Basic Research Preclinical Studies Clinical Trial Long-Term Follow-up Barriers Access to Novel Reagents Pharm/Tox Studies Access to GMP Reagents and Testing Archiving and patient monitoring NGVB Solutions Reagent repository Ph/Tox Database Ph/Tox Archive GMP Reagents RCR/RCL Testing Sample Archive RCR/RCL Testing LAM-PCR SeqMap Tool
3 Policy and Procedure Manual Non-for-profit eligible to receive NIH funding Follow regulatory guidelines acknowledge the NGVB on all relevant publications agree to indemnification of the NGVB and NIH
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5 Reagent Repository AAV vector plasmids (courtesy of Jude Samulski) Adenoviral vector stocks (Lowenstein/Castro) Retroviral vectors Lentiviral packaging line (J. Gray) Certified Cell Lines HEK293 HEK293T Phoenix cell lines PG13 G7b-1
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10 Reagents dispensed over time 300 Reagents Shipped To Date 250 Cumulative Total YTD Cell Lines Plasmids
11 Archiving Services Over 13,000 samples from GLP Pharm/Tox studies Back-up of GMP grade vectors and cell lines Archive patient samples to comply with FDA requirements for post-trial monitoring
12 GLP Pharm/tox Archive GLP Pharm/Tox Archive Total Jan 2009 Total Jan 2010 Current Histo Wet Tissue DNA Tissue Fluids Blood Lysate Paraffin Tissue and Blood Bone Marrow Serum Other Total
13 Post-Trial Monitoring RCR and RCL testing on clinical cell products RCR and RCL testing of patient samples LAM-PCR or other insertion site analysis SeqMap 2.0 a bioinformatics tool to help analyze LAM-PCR and other integration analysis.
14 Testing RCR/RCL qpcr MD Anderson Univ Penn Harvard Robert Williams 200 NHGRI/NIH UCLA St Jude Childrens Cincinnati Childrens UCLA NIH NCI Baylor College MSSK FHCRC
15 RCR/RCL Biologic Assays 45 Biologic Assays: Samples Tested YTD RCR RCL
16 SeqMap Submitted sequences are represented graphically Chaos Censor Each sequence is mapped to the genome, using the following three-step protocol: BLAT DNA sequences are displayed, colored to match the graphical representation to aid in distinguishing its sections
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18 Pharm/Tox Database Detailed description of Pharm/Tox studies submitted to the FDA in support of gene therapy INDs Foster letters of cross-reference Educational tool
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21 Cost Resource Reagents Pharm/Tox Database Info Archiving Services SeqMap Insertion Site (ex. LAM-PCR) RCR/RCL Testing Post-Trial Monitoring Cost FREE to academic investigators FREE to all FREE to academic US investigators FREE to all FREE to academic investigators FREE to academic investigators
22 NGVB Supports 160 Extramural Grants Jan-11 Aug AG AI AR CA DK ES EY FD GM HD HL MH NS RR NIH DOD FND NSF
23 DONATE REAGENTS!!!!!!
24 Not NGVB.org!!!!
25 Lorraine Matheson Hongyu Gao, PhD Aparna Jasti Lisa Duffy Lilith Reeves Erol Cetinok Daniela Bischof, PhD Sue Koop Jing Yao Lina Sego Alisha Auberry Anna Leath Aaron Shaw Support by NHLBI, HHSN ) NHLBI P40 HL Lilly Endowment: Indiana Genomics Initiative
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