NATIONAL GENE VECTOR LABORATORY
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Indiana Univ-purdue Univ At Indianapolis 620 Union Drive, Room 618 Indianapolis, In 462025167
Grant 3U42RR011148-05S1 from National Center For Research Resources IRG: SRC
Abstract: Adapted from s ) IU presents an excellent environment for the development of a NGVL. The institution has built a strong gene therapy program with over eleven NIH-funded researchers pursuing clinical gene therapy. The close collaborative efforts of the gene therapy investigators has led to the successful competition for two program projects and the designation as a Centers of Excellence in Molecular Hematology. A Vector Production Facility is currently funded as a core for two existing program grants. s are proposing to expand the current facility to provide viral vectors to outside investigators as a member of the NGVL. The NGVL at IU will 1) provide a mechanism for review, generation and distribution of clinical grade vector to investigators in the gene therapy field; 2) generate vector producer cell lines and supernate intended for clinical use; 3) certify vectors for clinical use based on Food and Drug Administration (FDA) guidelines under good manufacturing practice (GMP) and good laboratory practice (GLP) specifications; and 4) provide regulatory support for investigators using vectors generated in the NGVL.
Keywords: biomedical facility, gene therapy, transfection /expression vector, Retroviridae, adeno associated virus group, chemical standardization, cooperative study
Project start date: 1995-08-01
Project end date: 2001-09-29
3U42RR011148-05S1 (2000): $2622303
Sponsored Links Excellgen http://Excellgen.com
NATIONAL GENE VECTOR LABORATORY AT INDIANA UNIVERSITY
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Indiana Univ-purdue Univ At Indianapolis 620 Union Drive, Room 618 Indianapolis, In 462025167
Grant 3U42RR011148-10S4 from National Center For Research Resources IRG: ZRR1
Project start date: 1995-08-01
Project end date: 2007-08-31
3U42RR011148-10S4 (2007): $56046
3U42RR011148-10S1 (2006): $442875
3U42RR011148-10S2 (2006): $1265524
3U42RR011148-10S3 (2006): $1842795
NATIONAL GENE VECTOR LABORATORY
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Medicineindiana Univ-purdue Univ At Indianapolis
620 Union Drive, Room 518
indianapolis, In 462025167
Grant 3U42RR011148-03S1 from National Center For Research Resources IRG: SRC
Project start date: 1995-08-01
Project end date: 2000-07-31
3U42RR011148-03S1 (1998): $18000
3U42RR011148-02S1 (1997): $150000
Grants awarded to Kenneth G Cornetta
NATIONAL GENE VECTOR BIORESPOSITORY AND COORDINATING CENTER AT INDIANA UNIVERSIT
Kenneth G Cornetta, Joe C. Christian Professor & Chairman
Indiana Univ-purdue Univ At Indianapolis, 620 Union Drive, Room 518, Indianapolis, In 46202-5167
Abstract: This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. To enable researchers at the National Gene Vector Biorespository to have access to the most current technology
Keywords: CRISP; Computer Retrieval of Information on Scientific Projects Database; Funding; Genes; Grant; Indiana; Institution; Investigators; NIH; National Institutes of Health; National Institutes of Health (U.S.); Research; Research Personnel; Research Resources; Researchers; Resources; Source; Technology; United States National Institutes of Health; Universities; vector
Project start date: 2009-08-13
Project end date: 2011-08-12
Budget start date: 13-AUG-2009
Budget end date: 12-AUG-2011
PFA/PA: RFA-RR-07-002
3P40RR024928-02S1_8265 (2009): $249620
AUTOMATED NUCLEIC ACID EXTRACTOR SYSTEM:AUTOGENFLEX STAR/AUTOGEN QUICK-GENE 810
Kenneth G Cornetta, Joe C. Christian Professor & Chairman
Indiana Univ-purdue Univ At Indianapolis, 620 Union Drive, Room 518, Indianapolis, In 46202-5167
Grant 1S10RR027710-01 from National Center For Research Resources
Abstract: This request is for funds to purchase a nucleic acid extraction system consisting of an AutoGenFlex Star automated DNA isolation system and the AutoGen Quick-Gene 810 RNA isolation unit. The instruments will be housed, managed, and maintained by the Indiana Clinical and Translational Sciences Institute (CTSI) within the IndianaCTSI Specimen Storage Facility. Biobanking has become an integral part of translational research. The rapid developments in high throughput sequencing along with novel bioinformatic analytical tools has led to an increase in the number of investigators performing novel genetic analysis. With this increase in analytical capacity, the limiting step has become the collection and isolation of nucleic acids. The equipment will facilitate health research for the CTSI member institutions Indiana University (IU), Purdue University and the University of Notre Dame. All three members of the Indiana CTSI will share a common state-of-the-art repository that was built, in part, through a NCRR construction grant (C06-RR020128-01, 09/30/04 - 09/29/08, R.S. Fife, PI, K. Cornetta, Co-I). The facility will be housed at the IU School of Medicine. In addition to supporting individual investigators, the IU Simon Cancer Center (2P30CA082709), the National Cell Repository for Alzheimer Disease (5U24AG021886; PI T. Foroud), the National Gene Vector Biorepository (P40 RR024928; PI K. Cornetta), and the Susan G. Komen for the Cure Tissue Bank at the IU Simon Cancer Center work closely with the Indiana CTSI repository efforts. As a result, the instrument system will have an impact on a much larger group of NIH funded investigators than those located in Indiana. The facility will serve as a recharge center for users and the service contract and reagent costs will be included in user fees. The CTSI will provide support for a technician dedicated to repository activities including DNA processing and equipment maintenance. By developing a common facility, the Indiana CTSI will facilitate sample collection and processing, promote sharing of samples, and assure compliance with international biobanking standards. The equipment requested in this proposal will improve consistency of biospecimens, increase capacity, and free up technician time for analytical work. Furthermore, the diverse group of investigators who will utilize this equipment will ensure the investment will facilitate basic and clinical research in almost every area of medicine. Understanding the genetic basis of disease continues to foster the development of new treatments for both common and rare diseases. Automated extraction of DNA can facilitates genetic analysis, a benefit that will positively affect almost every area of clinical medicine and the capacity to provide RNA will allow Indiana investigators to pursue this rapidly expanding field. The equipment requested will improve the research for R01 funded investigators, national biobanking efforts, and Indiana CTSI investigators engaged in basic and clinical research
Keywords: Affect; Alzheimer; Alzheimer disease; Alzheimer sclerosis; Alzheimer syndrome; Alzheimer`s; Alzheimer`s Disease; Alzheimers Dementia; Alzheimers disease; Area; Arts; Banking, Tissue; Bio-Informatics; Bioinformatics; Cancer Center; Cells; Clinical; Clinical Medicine; Clinical Research; Clinical Study; Collection; Contract Services; DNA; Dementia, Alzheimer Type; Dementia, Primary Senile Degenerative; Dementia, Senile; Deoxyribonucleic Acid; Development; Disease; Disorder; Ensure; Equipment; Fees; Fostering; Funding; Gene Products, RNA; Genes; Genetic; Genetic analyses; Grant; Health; Housing; Indiana; Individual; Institutes; Institution; International; Investigators; Investments; Maintenance; Maintenances; Medical Sciences, Clinical; Medicine; NCRR; NIH; National Center for Research Resources; National Institutes of Health; National Institutes of Health (U.S.); Nucleic Acids; Primary Senile Degenerative Dementia; Process; RNA; RNA, Non-Polyadenylated; Rare Diseases; Rare Disorder; Reagent; Research; Research Personnel; Research Specimen; Researchers; Ribonucleic Acid; Sampling; Schools, Medical; Science of Medicine; Specimen; System; System, LOINC Axis 4; Time; Tissue Banking; Tissue Banks; Tissue Collection; Tissue/Specimen Collection; Translational Research; Translational Research Enterprise; Translational Science; United States National Institutes of Health; Universities; Work; analytical tool; base; biobank; cost; dementia of the Alzheimer type; disease/disorder; genetic analysis; improved; instrument; medical schools; member; novel; primary degenerative dementia; repository; sample collection; senile dementia of the Alzheimer type; specimen collection; translation research enterprise; vector
Project start date: 2010-02-20
Project end date: 2011-02-19
Budget start date: 20-FEB-2010
Budget end date: 19-FEB-2011
PFA/PA: PAR-09-028
1S10RR027710-01 (2010): $159460
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Indiana Univ-purdue Univ At Indianapolis 620 Union Drive, Room 618 Indianapolis, In 462025167
Grant 5P30DK049218-099002 from National Institute Of Diabetes And Digestive And Kidney Diseases
Abstract: The Vector Cores is designed to facilitate gene therapy research and was established during the first funding period. This shared facility has allowed consolidated of resources and promoted interactions among thje gene therapy investigators at IU. During the initial funding period, the Vector Core sought to facilitate basic retroviral gene therapy research by supplying certified packaging of cell lines and supernate. The components of the Vector Core are (1) A production laboratory capable of generating retroviral vectors using certified packaging cell lines. Funds are requested to support generation of packaging cell lines for basic science efforts of the CCEMH, including production of retroviral and lentiviral material. CCEMH funds are not requested to support the clinical production efforts of the Vector Core; (2) a Vector Testing Laboratory which can assay packaging cell lines or other material used by CCEMH investigators to insure they are pathogen free; and (3) a Molecular Diagnostic Laboratory which provides CCEMH investigators to insure they are pathogen free; and (3) a Molecular Diagnostic Laboratory which provides CCEMH investigators with rapid vector determinations and estimation of gene transfer using quantitative PCR. In addition, the laboratory is skilled at assessing gene transfer into hematopoietic progenitors using PCR of individual progenitor colonies. The Molecular Diagnostic Laboratory is also involved with sample processing for clinical gene therapy samples. For the upcoming funding period, the core will (1) provide investigators with high titer retroviral and lentiviral packaging cell lines, (2) provide molecular diagnostic services, including quantitative PCR, and (3) provide consistent handling of clinical samples from patients participating in gene therapy trials and provide safety testing of clinical samples as mandated by the FDA.
Keywords: biomedical facility, hematology, transfection /expression vector, biological product, cell line, polymerase chain reaction, Retroviridae, human tissue
Kenneth G Cornetta, Joe C. Christian Professor & Chairman
Indiana Univ-purdue Univ At Indianapolis, 620 Union Drive, Room 518, Indianapolis, In 46202-5167
Abstract: The Vector Core is designed to facilitate gene therapy research and has been an active part of this PPG throughout its funding. It has met and exceeded the specific aims during prior funding periods. This shared facility has allowed consolidation of resources and promoted interactions among the gene therapy investigators at IU. While the Core initially provided support for retroviral gene transfer, it has been heavily invovled with the development of lentiviral vectors for PPG investigators. The core will continue to provide PPG investigators with the following services (1) Access to plasmid, cell lines, and other reagents used in the generation of gene transfer vectors, (2) Generation and characterization of retroviral and lentiviral vectors for preclinical work, (3) Molecular Diagnostics Services, and (4) Access to BL3 Facilities and assistance with regulatory requirements. The objectives include new services such as LAM-PCR and production of foamy viral vectors
Keywords: Blood Precursor Cell; Cell Line; Cell Lines, Strains; CellLine; Clinical; Clinical Trials; Clinical Trials, Unspecified; Development; Diagnostic Services; Funding; Gene Transfer; Gene Transfer Clinical; Gene Transfer Procedure; Gene-Tx; Generations; Genetic Intervention; Hematopoietic stem cells; Intervention, Genetic; Investigators; Lentiviral Vector; Lentivirus Vector; Molecular; Molecular Biology, Gene Therapy; Plasmids; Production; Progenitor Cells, Hematopoietic; Reagent; Research Personnel; Research Resources; Researchers; Resources; Retroviral Vector; Retrovirus Vector; Services; Therapeutic Studies; Therapy Research; Therapy, DNA; Viral Vector; Work; clinical investigation; cultured cell line; design; designing; diagnosis service; gene replacement therapy; gene therapy; gene transfer vector; genetic therapy; meetings; pre-clinical; preclinical; transfer of a gene; vector
Budget start date: 1-JUL-2009
Budget end date: 30-JUN-2010
5P01HL053586-15_9002 (2009): $164160
NATIONAL GENE VECTOR LABORATORY AT INDIANA UNIVERSITY
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Medical And Molecular Geneticsindiana Univ-purdue Univ At Indianapolis
620 Union Drive, Room 618
indianapolis, In 462025167
Grant 5U42RR011148-10 from National Center For Research Resources IRG: ZRR1
Abstract: The purpose of this grant application is to allow IU to continue as a NGVL production center. The investigators wish to provide service to the gene therapy community by producing and distributing clinical grade vectors for Phase I/II gene transfer protocols. They also propose to continue as the NGVL Coordinating Center. The aims of this application include generate and certify retroviral vectors intended for clinical use; generate and certify lentiviral vectors intended for clinical use; and provide scientific and regulatory support for investigators using vectors generated in the NGVL. They will facilitate clinical investigators in preparing their clinically-based Investigational New Drug Application (IND), allowing cross-reference to the IU Vector Production Drug Master File. They will provide relevant safety tests services to other NGVL centers generating clinical grade material. The IU vector production facility has an extensive experience in the certification of vectors and offers a variety of safety tests performed under Good Laboratory Practice. They will make these assays available to other NGVL centers who might otherwise need to outsource this work. Finally, they will administer the NGVL Coordinating Center. The Coordinating Center will coordinate the meetings of the NGVL Review Committee and Steering Committee, process investigator requests for NGVL services, oversee compliance with investigators responsibilities as described in the NGVL Policy and Procedures Manual, maintain the NGVL Toxicology Master File(s), and collect post-distribution monitoring data from all NGVL-funded investigators
Keywords: Lentivirus, biomedical facility, gene delivery system, transfection /expression vector cooperative study microorganism culture
Project start date: 1995-08-01
Project end date: 2008-08-31
5U42RR011148-10 (2005): $1609334
5U42RR011148-09 (2004): $1259004
5U42RR011148-08 (2003): $1251902
5U42RR011148-07 (2002): $1694989
Sponsored Links Excellgen http://Excellgen.com
NATIONAL GENE VECTOR LABORATORY
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Medicineindiana Univ-purdue Univ At Indianapolis
620 Union Drive, Room 518
indianapolis, In 462025167
Grant 2U42RR011148-06 from National Center For Research Resources IRG: ZRR1
Abstract: The purpose of this grant application is to allow IU to continue as a NGVL production center. The investigators wish to provide service to the gene therapy community by producing and distributing clinical grade vectors for Phase I/II gene transfer protocols. They also propose to continue as the NGVL Coordinating Center. The aims of this application include generate and certify retroviral vectors intended for clinical use; generate and certify lentiviral vectors intended for clinical use; and provide scientific and regulatory support for investigators using vectors generated in the NGVL. They will facilitate clinical investigators in preparing their clinically-based Investigational New Drug Application (IND), allowing cross-reference to the IU Vector Production Drug Master File. They will provide relevant safety tests services to other NGVL centers generating clinical grade material. The IU vector production facility has an extensive experience in the certification of vectors and offers a variety of safety tests performed under Good Laboratory Practice. They will make these assays available to other NGVL centers who might otherwise need to outsource this work. Finally, they will administer the NGVL Coordinating Center. The Coordinating Center will coordinate the meetings of the NGVL Review Committee and Steering Committee, process investigator requests for NGVL services, oversee compliance with investigators responsibilities as described in the NGVL Policy and Procedures Manual, maintain the NGVL Toxicology Master File(s), and collect post-distribution monitoring data from all NGVL-funded investigators
Keywords: Lentivirus, biomedical facility, gene delivery system, transfection /expression vector cooperative study microorganism culture
Project start date: 1995-08-01
Project end date: 2006-08-31
2U42RR011148-06 (2001): $1049938
NEW FACULTY RECRUITMENT TO THE INDIANA UNIVERSITY GENE THERAPY PROGRAM
Kenneth G Cornetta, Joe C. Christian Professor & Chairman
Indiana Univ-purdue Univ At Indianapolis, 620 Union Drive, Room 518, Indianapolis, In 46202-5167
Grant 1P30HL101337-01 from National Heart, Lung, And Blood Institute
Abstract: The Gene and Cell Therapy Program (GCTP) at Indiana University is a highly interactive group of investigators with a 15-year history of multi-departmental interaction and collaborative research. The program has a focus on the genetic manipulation of stem cells and is home to a world-class facility for the manufacture of clinical gene therapy products (funded by a NCRR construction grant). Indiana University is the NHLBI designated site for clinical lentiviral vector production through its Gene Therapy Resources Program. Indiana University is also the site of the National Gene Vector Biorepository funded by the NCRR/NIH. A NHLBI funded Program Project Grant (PI Dinauer) has facilitated the collaborations in the GCTP. Moreover, a NHLBI funded training grant in gene therapy has trained 5 pre-doctoral students and 22 post-doctoral fellows. An NIDDK training grant in hematopoiesis has trained 22 pre-doctoral students and 26 post-doctoral fellows. This P30 application will enhance this interactive group of gene and cell therapy experts while providing a proven, productive environment for the development of junior faculty. Specific Aim The aim of this proposal is to fund recruitment of a junior faculty with expertise in gene transfer that can facilitate clinical trial and develop novel production methodology. The individual we seek to move to a tenure track position is Scott Witting, Ph.D. This P30 grant will enhance the Gene and Cell Therapy Program at Indiana University. Dr. Scott Witting will be hired as an Assistant Professor tenure track and develop an independent research program aimed at identifying the optimal, clinically relevant, gene transfer methodology for transduction of hematopoieitic and other stem cell products. This will facilitate clinical trials proposed by the GCTP members
Keywords: Cancer Grant Supplements; Cancer Grant Supplements (P30); Cell Therapy; Clinical; Clinical Trials; Clinical Trials, Unspecified; Collaborations; Development; Doctor of Philosophy; Environment; Faculty; Funding; Gene Transfer; Gene Transfer Clinical; Gene Transfer Procedure; Gene-Tx; Genes; Genetic Intervention; Grant; Hematopoiesis; Hematopoietic Cellular Control Mechanisms; History; Home; Home environment; Indiana; Individual; Intervention, Genetic; Investigators; Lentiviral Vector; Lentivirus Vector; Method LOINC Axis 6; Methodology; Molecular Biology, Gene Therapy; Mother Cells; NCRR; NIDDK; National Center for Research Resources; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Digestive Diseases and Kidney Disorders; P-30; P-30 Protein; P01 Mechanism; P01 Program; P30; P30 Award; P30 Grant; P30 Protein; Ph.D.; PhD; Position; Positioning Attribute; Postdoc; Postdoctoral Fellow; Production; Progenitor Cells; Program Project Grant; Program Research Project Grants; Programs (PT); Programs [Publication Type]; Recording of previous events; Research; Research Associate; Research Personnel; Research Program Projects; Research Resources; Researchers; Resources; Site; Stem cells; Students; Therapy, Cell; Therapy, DNA; Training; Universities; biobank; cell-based therapy; clinical investigation; clinical relevance; clinical research site; clinical site; clinically relevant; gene therapy; genetic manipulation; genetic therapy; manufacturing facility; member; novel; post-doc; post-doctoral; pre-doc; pre-doctoral; predoc; predoctoral; professor; programs; ranpirnase; transfer of a gene; vector
Relevance: This P30 grant will enhance the Gene and Cell Therapy Program at Indiana University. Dr. Scott Witting will be hired as an Assistant Professor tenure track and develop an independent research program aimed at identifying the optimal, clinically relevant, gene transfer methodology for transduction of hematopoieitic and other stem cell products. This will faciliate clinical trials proposed by the GCTP members
Project start date: 2009-09-30
Project end date: 2011-08-31
Budget start date: 30-SEP-2009
Budget end date: 31-AUG-2010
PFA/PA: RFA-OD-09-005
1P30HL101337-01 (2009): $407810
AMERICAN SOCIETY OF GENE THERAPY ANNUAL MEETING (2009-2013)
Kenneth G Cornetta, Joe C. Christian Professor & Chairman
American Society Of Gene Therapy, Suite 1100, Milwaukee, Wi 53202
Grant 1R13HL097543-01 from National Heart, Lung, And Blood Institute
Abstract: The American Society of Gene Therapy was founded in 1996 and is dedicated to the development of gene and cell therapies with a particular focus on professional and public education. Our Annual Meeting represents the major educational initiative of the Society and has been CME accredited for all of our prior 11 meetings. This R13 proposal requests support for travel grants and an educational program for trainees. Over 1/4 of our members are scientists in training working to develop clinically applicable gene-based technologies. Trainee participation in the Annual Meeting is fostered by an outstanding educational program, trainee travel awards, and recognition of outstanding scientific accomplishments through peer-reviewed trainee Excellence in Research Awards. Over the past decade, the ASGT has offered 470 travel grants and 63 Research Awards, with 20 travel grants per year for the past 5 years made possible by an R13 grant from the NHLBI. Educational opportunities for travel awardees include outstanding plenary speakers, state-of-the-art scientific symposia, and educational sessions that review current thinking on a variety of topics. In addition to leading scientists and clinicians, the program includes ethicists and representatives from the FDA, OBA, and NIH so young scientists may gain insight into the compliance and ethical issues related to human gene therapy. Trainees are active presenters in oral and poster presentations and the top trainee s are recognized at the Presidential Symposium. This proposal also requests partial support of a novel "Meet the Expert" program that allows trainees to interact with gene therapy leaders in a small group setting. The size of the ASGT meeting (approximately 2,000 participants) is ideally suited to expose young scientists to leaders in the field, yet provide opportunities for trainees to present their work at the premier meeting in the field of gene and cell therapy. Continued NIH support for the ASGT Annual Meeting will allow continued educational and professional advancement of trainees in the field of cell and gene therapy. (End of )
Keywords: American; Arts; Award; Cell Therapy; Cells; Development; Educational Grants; Ethical Issues; Ethicists; Ethics Consultants; Fostering; Funding; Gene Transfer Clinical; Gene Transfer Procedure; Gene-Tx; Genes; Genetic Intervention; Grant; Grants, Educational; Human; Human, General; Intervention, Genetic; Investigators; Issues, Ethical; Man (Taxonomy); Man, Modern; Molecular Biology, Gene Therapy; NIH; National Heart, Lung, and Blood Institute; National Institutes of Health; National Institutes of Health (U.S.); Oral; Participant; Peer Review; Postdoc; Postdoctoral Fellow; Posters; Posters [Publication Type]; Programs (PT); Programs [Publication Type]; RFP; Request for Proposals; Research; Research Associate; Research Personnel; Researchers; Scientific Advances and Accomplishments; Scientist; Senior Scientist; Societies; Students; Technology; Therapy, Cell; Therapy, DNA; Thinking; Thinking, function; Training; Travel; United States National Institutes of Health; Work; ing; base; cell-based therapy; conference; gene therapy; genetic therapy; innovate; innovation; innovative; insight; meetings; member; novel; post-doc; post-doctoral; posters; programs; public education; scientific accomplishments; scientific advances; symposium
Relevance: The American Society of Gene Therapy (ASGT) is seeking funding for 30 travel awards for post- doctoral fellows and students for each year of the project. In addition, ASGT is seeking funding to support each year for the innovative "Meet-the-Investigator" sessions which enable post- doctoral fellows and students in the field to interact with high profile, senior scientists in the field of gene and cell therapy
Project start date: 2010-05-01
Project end date: 2011-04-30
Budget start date: 1-MAY-2010
Budget end date: 30-APR-2011
PFA/PA: PA-08-149
1R13HL097543-01 (2010): $10000
NATIONAL GENE VECTOR BIORESPOSITORY AND COORDINATING CENTER AT INDIANA UNIVERSITY
Kenneth G Cornetta, Joe C. Christian Professor & Chairman
Indiana Univ-purdue Univ At Indianapolis, 620 Union Drive, Room 518, Indianapolis, In 46202-5167
Grant 5P40RR024928-03 from National Center For Research Resources
Abstract: In this application, we propose a comprehensive National Gene Vector Repository (NGVB) which meets all the goals stated in RFA-RR-07-002.The Specific Aims of the NGVB are Specific Aim 1. Develop and Oversee a Repository of Gene Therapy Reagents. The NGVB will gather a wide variety of gene therapy reagents that will be made available to academic investigators for preclinical investigation. Specific Aim 2. Archive Samples Collected in the Performance of Clinical Trials or Pharmacology/Toxicology Studies. The NGVB will seek to provide a safe and secure storage site for biospecimens that must be collected to maintain compliance with FDA or other regulatory agencies. Specific Aim 3. Expansion of a Pharmacology/Toxicology Database. Indiana University has maintained a web-based Pharmacology/Toxicology Database that allows investigators to search for studies that are relevant to their area of research. The unique resource will become the model for NGVB database and allow investigators to view the design of studies already on file with the FDA. Specific Aim 4. Serve as a Coordinating Center. The NGVB Coordinating Center will facilitate the activities within Specific Aims 1-3. In addition, it will (1) organize an External Advisory Boards; (2) develop a Policy and Procedure Manual that defines the activities of the NGVB; (3) conduct outreach activities; (4) provide a "help-desk" function for investigators seeking gene therapy reagents; (5) host a new and unique bioinformatics tool that aids in vector insertion site analysis, SeqMap. Specific Aim 5. Research on Insertional Mutagenesis. To address the research requirements of the RFA, we will build on our ongoing work in a murine gene therapy model and will compare the lentiviral vector insertion pattern with our existing database of retroviral insertions. If this system proves to be a predictor of clonal selection, it can be used to validate other, ideally in vitro, models of risk
Keywords: Address; Animal Model; Animal Models and Related Studies; Archives; Area; Arts; Bio-Informatics; Bioinformatics; Biological; Biotechnology; Clinical Trials; Clinical Trials, Unspecified; Data; Data Banks; Data Bases; Databank, Electronic; Databanks; Database, Electronic; Databases; Drugs; Education; Educational aspects; Gene Transfer Clinical; Gene Transfer Procedure; Gene-Tx; Genes; Genetic Intervention; Goals; Grant; Housing; Human; Human Resources; Human, General; In Vitro; Indiana; Insertional Mutagenesis; Intellectual Property; Intervention, Genetic; Investigation; Investigational New Drug Application; Investigators; Lentiviral Vector; Lentivirus Vector; Letters; Mammals, Mice; Man (Taxonomy); Man, Modern; Manpower; Manuals; Medication; Mice; Modeling; Molecular Biology, Gene Therapy; Murine; Mus; Mutagenesis, Insertional; NCRR; NIH; National Center for Research Resources; National Institutes of Health; National Institutes of Health (U.S.); On-Line Systems; Online Systems; Pattern; Performance; Pharmaceutic Preparations; Pharmaceutical Preparations; Pharmacology and Toxicology; Policies; Procedures; Reagent; Research; Research Design; Research Personnel; Research Resources; Research Subjects; Researchers; Resources; Risk; Safety; Sampling; Secure; Site; Study Type; System; System, LOINC Axis 4; Therapeutic Studies; Therapy Research; Therapy, DNA; United States National Institutes of Health; Universities; Work; biobank; clinical data repository; clinical data warehouse; clinical investigation; data repository; drug/agent; educational resource design; gene therapy; genetic therapy; improved; in vitro Model; material transfer agreement; meetings; member; model organism; online computer; outreach; patient safety; personnel; pre-clinical; preclinical; relational database; repository; study design; tool; vector; web based
Project start date: 2008-06-15
Project end date: 2011-03-31
Budget start date: 1-APR-2010
Budget end date: 31-MAR-2011
PFA/PA: RFA-RR-07-002
5P40RR024928-03 (2010): $1042555
3P40RR024928-02S1 (2009): $249620
NATIONAL GENE VECTOR LABORATORY
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Indiana Univ-purdue Univ At Indianapolis 620 Union Drive, Room 618 Indianapolis, In 462025167
Grant 5U42RR011148-04 from National Center For Research Resources IRG: SRC
Abstract: Adapted from s ) IU presents an excellent environment for the development of a NGVL. The institution has built a strong gene therapy program with over eleven NIH-funded researchers pursuing clinical gene therapy. The close collaborative efforts of the gene therapy investigators has led to the successful competition for two program projects and the designation as a Centers of Excellence in Molecular Hematology. A Vector Production Facility is currently funded as a core for two existing program grants. s are proposing to expand the current facility to provide viral vectors to outside investigators as a member of the NGVL. The NGVL at IU will 1) provide a mechanism for review, generation and distribution of clinical grade vector to investigators in the gene therapy field; 2) generate vector producer cell lines and supernate intended for clinical use; 3) certify vectors for clinical use based on Food and Drug Administration (FDA) guidelines under good manufacturing practice (GMP) and good laboratory practice (GLP) specifications; and 4) provide regulatory support for investigators using vectors generated in the NGVL.
Keywords: biomedical facility, gene therapy, transfection vector, Retroviridae, adeno associated virus group, chemical standardization, cooperative study
Project start date: 1995-08-01
Project end date: 2000-07-31
5U42RR011148-04 (1998): $1508069
5U42RR011148-05 (1999): $1941324
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Indiana Univ-purdue Univ At Indianapolis 620 Union Drive, Room 618 Indianapolis, In 462025167
Grant 5P01HL053586-109002 from National Heart, Lung, And Blood Institute
Abstract: A shared vector production facility is proposed which will supply clinical grade viral vector for the projects participating in this program. The core will also supply FDA and RAC required safety testing for patients participating in clinical gene therapy trials. A facility capable of producing and testing retroviral and adeno-associated viral vectors will be housed in the Cancer Research Building and will occupy 1800 sq. feet of space. The laboratory is specifically designed for the production of clinical grade viral vector under Good Laboratory and Good Manufacturing Practice criteria. Clinical grade supernate will be produced by a technician with experience in GMP production and a technician with experience in retroviral vector testing. The facility will be overseen by an investigator who has successfully written Investigational New Drug (IND) applications for retroviral vectors and is currently conducting clinical trials using retroviral vectors. The laboratory will play a critical role in bringing the viral vectors developed in this project to clinical trial.
Keywords: biomedical facility, biotechnology, transfection /expression vector, Lentivirus, Retroviridae, cell line, genetic transduction, germ free condition, microorganism growth, polymerase chain reaction
Project start date: 2004-02-29
Project end date: 2005-02-28
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Indiana Univ-purdue Univ At Indianapolis 620 Union Drive, Room 618 Indianapolis, In 462025167
Grant 5P01HL053586-099002 from National Heart, Lung, And Blood Institute
Abstract: A shared vector production facility is proposed which will supply clinical grade viral vector for the projects participating in this program. The core will also supply FDA and RAC required safety testing for patients participating in clinical gene therapy trials. A facility capable of producing and testing retroviral and adeno-associated viral vectors will be housed in the Cancer Research Building and will occupy 1800 sq. feet of space. The laboratory is specifically designed for the production of clinical grade viral vector under Good Laboratory and Good Manufacturing Practice criteria. Clinical grade supernate will be produced by a technician with experience in GMP production and a technician with experience in retroviral vector testing. The facility will be overseen by an investigator who has successfully written Investigational New Drug (IND) applications for retroviral vectors and is currently conducting clinical trials using retroviral vectors. The laboratory will play a critical role in bringing the viral vectors developed in this project to clinical trial.
Keywords: biomedical facility, biotechnology, transfection /expression vector, Lentivirus, Retroviridae, cell line, genetic transduction, germ free condition, microorganism growth, polymerase chain reaction
National Gene Vector Biorespository And Coordinating Center At Indiana University
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Medical And Molecular Geneticsindiana Univ-purdue Univ At Indianapolis
Grant 5P40RR024928-02 from National Center For Research Resources IRG: ZRR1
Project start date: 2008-06-15
Project end date: 2011-03-31
Sponsored Links Excellgen http://Excellgen.com
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Indiana Univ-purdue Univ At Indianapolis 620 Union Drive, Room 618 Indianapolis, In 462025167
Grant 5P01HL053586-139002 from National Heart, Lung, And Blood Institute IRG: HLBP
Project start date: 2007-07-01
Project end date: 2010-06-30
NATIONAL GENE VECTOR LABORATORY
Kenneth G Cornetta, Joe C. Christian Professor And Chair
Medicineindiana Univ-purdue Univ At Indianapolis
620 Union Drive, Room 518
indianapolis, In 462025167
Grant 5U42RR011148-03 from National Center For Research Resources IRG: SRC
Keywords: biomedical facility, gene therapy, transfection vector Retroviridae, adeno associated virus group, chemical standardization, cooperative study
Project start date: 1995-08-01
Project end date: 2000-07-31
5U42RR011148-03 (1997): $1502805
5U42RR011148-02 (1996): $1070305
GTRP- LENTIVIRUS VECTOR PRODUCTION CORE LABORATORY
Kenneth G Cornetta, Joe C. Christian Professor & Chairman
N/a
Keywords: No Project Terms available
N01HV78204-1-0-0 (0000): $0