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Upcoming Meetings
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Safety and Scientific Symposia |
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Scientific Symposium - December 9-10, 2010
NIH RAC and CliniGene Scientific Symposium on "Retroviral and Lentiviral Vectors for Long-Term Gene Correction: Clinical Challenges in Vector and Trial Design"
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Safety Symposium - June 15, 2010
Gene-Modified T Cells: Challenges in Clinical Trial Design
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Safety Symposium on a Serious Adverse Event on OBA Protocol 705
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Safety Symposium - March 15, 2005
Current Perspectives on Gene Transfer for X-SCID
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Safety Symposium - September 21-22, 2004
Safety Considerations in Recombinant DNA Research with Pathogenic Viruses
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Safety Symposium - March 7, 2001
Safety Considerations in the Use of AAV Vectors in Gene Transfer Clinical Trials
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Safety Symposium - December 14, 2000
Safety Considerations in Cardiovascular Gene Transfer Clinical Research
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Safety Symposium - March 8, 2000
Internally Deleted, Helper-Dependent Adenoviral Vectors
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Biosafety Considerations for Research with Lentiviral Vectors |
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Policy Conferences |
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Gene Transfer and Rare Diseases Workshop (September 13, 2012)
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RNA Oligonucleotides: Emerging Clinical Applications (December 15-16,2011)
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Sham Neurological Procedures in Clinical Trials for Neurodegenerative Diseases: Scientific and Ethical Considerations (June 30, 2010 - July 1, 2010) |
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NIH Public Consultation on Proposed Changes to the NIH Guidelines for Synthetic Nucleic Acids (June 23, 2009) |
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Summaries and Reports of the Gene Therapy Policy Conferences (1998-Present)
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Upcoming Meetings |
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Gene Therapy: Charting a Future Course - April 12, 2013 - NIH Campus, Building 31C, 6th Floor, Room 10, 9000 Rockville Pike, Bethesda, MD |
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OBA will be hosting a meeting with mid-career gene therapy investigators to examine the key scientific, biosafety and policy issues facing the field in the next decade. |
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The meeting is open to the public and no preregistration is required. |
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Agenda |
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Events of Interest to IBCs and Others |
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OBA will be participating in several key meetings in the next few months, sponsoring exhibits and training sessions that will offer information about the oversight of recombinant DNA research, as well as promote awareness about dual use life sciences research. Please take note of the following events: |
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Yale University IBC Training, April 12, 2013, New Haven, Connecticut
OBA will be conducting an IBC training workshop at Yale University. The session will cover all that IBCs, investigators, and biosafety professionals should know about implementing the
NIH Guidelines.
For further information and registration information, contact Benjamin Fontes.
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American Society of Gene and Cell Therapy (ASGCT) 16th Annual Meeting, May 15 - 18, 2013, Salt Lake City, Utah
OBA staff will also be available to answer questions at an exhibit booth during the conference. The exhibit will display educational material relating to the oversight of research involving recombinant DNA, For more information about this event, visit the conference registration website. |
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IBC Professional Development Conference - June 16-19, 2013, Seattle, Washington
The Eagleson Institute, with the participation of OBA staff, the American Biological Safety Association (ABSA) and the Campus Safety, Health, and Environmental Management Association (CSHEMA), will host the 2013 biannual professional development conference for Institutional Biosafety Committees. The conference, titled "Facilitating Safety and Secure Science: Practical Approaches for IBCs", will take place at the Renaissance Hotel in Seattle, Washington. For more information visit Eagleson Institute. |
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Questions about OBA activities at any of the above events may be directed to Dr. Kathryn Harris, Senior Outreach and Education Specialist (Contractor), NIH OBA, at 301-435-2195 or email.
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Policy Conference - September 13, 2012: |
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Gene Transfer and Rare Diseases Workshop |
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The NIH Office of Biotechnology Activities and Office of Rare Disease Research, NCATS, co-sponsored a workshop to discuss the advances in and challenges of gene transfer for rare diseases. There have been recent promising clinical successes in gene transfer protocols for rare diseases, such as retinal degeneration, hemophilia, and immune disorders. Investigators discussed their results to date and opportunities and challenges for extending these successes to other similar rare diseases. The panel discussions focused on strategies for maximizing opportunities for data sharing or platform development. |
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Agenda (with links to briefings) |
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Webcast |
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Policy Conference - December 15-16, 2011: |
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RNA Oligonucleotides: Emerging Clinical Applications |
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Agenda (with links to briefings) |
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Webcast- December 15, 2011 - Day 1 |
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Webcast- December 16, 2011 - Day 2 |
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Scientific Symposium - December 9-10, 2010: |
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NIH RAC and CliniGene Scientific Symposium on "Retroviral and Lentiviral Vectors for Long-Term Gene Correction: Clinical Challenges in Vector and Trial Design"
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Agenda (with links to briefings) |
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Webcast- December 9, 2010 - Day 1 |
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Webcast- December 10, 2010 - Day 2 |
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Safety Symposium - June 15, 2010: |
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Gene-Modified T Cells: Challenges in Clinical Trial Design
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Agenda |
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Participant List |
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Webcast |
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RAC Points to Consider |
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Meeting Publication: Cancer Research |
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Reference Materials |
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Safety Symposium |
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Safety Symposium on a Serious Adverse Event on OBA Protocol 705:
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A Phase I/II Study of Repeat Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:FC Fusion Gene in Inflammatory Arthritis with and without Concurrent TNF-a Antagonist
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Safety Symposium on a Serious Adverse Event on OBA Protocol 705 |
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Safety Symposium - March 15, 2005: |
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Current Perspectives on Gene Transfer for X-SCID
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Webcast - Morning session before break |
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Webcast - Morning session after break |
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Webcast - Afternoon session before break |
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Webcast - Afternoon session after break |
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Current Perspectives on Gene Transfer for X-linked Severe Combined Immunodeficiency Disease (X-SCID) |
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Safety Symposium - September 21-22, 2004: |
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Safety Considerations in Recombinant DNA Research with Pathogenic Viruses
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On September 21-22, 2004, NIH OBA held a safety symposium in conjunction with the meeting of the Recombinant DNA Advisory Committee (RAC). The symposium addressed safety considerations for recombinant DNA research with pathogenic viruses, focusing on containment issues for research with such viruses as 1918 influenza virus, highly pathogenic avian influenza viruses, and SARS Co-V. A major goal of the symposium was to develop a Points to Consider document and other resources to assist IBCs in conducting risk assessments and determining appropriate containment.
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Agenda and Participant List |
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Webcast - Day one - Morning session before break |
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Webcast - Day one - Morning session after break |
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Webcast - Day one - Afternoon session before break |
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Webcast - Day one - Afternoon session after break |
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Reference Information |
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Safety Symposium - March 7, 2001: |
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Safety Considerations in the Use of AAV Vectors in Gene Transfer Clinical Trials
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Transcript |
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Safety Symposium - December 14, 2000: |
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Safety Considerations in Cardiovascular Gene Transfer Clinical Research
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Transcript |
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Safety Symposium - March 8, 2000: |
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Internally Deleted, Helper-Dependent Adenoviral Vectors
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Transcript |
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Summary |
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Summaries and Reports of the Gene Therapy Policy Conferences (1998-Present) |
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Prenatal Gene Therapy: Scientific, Medical, & Ethical Issues - January 7-8, 1999 |
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Full Report |
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Summary |
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RAC Statement Regarding In Utero Gene Transfer Research |
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Lentiviral Vectors for Gene Delivery - March 9, 1998 |
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Summary |
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Preclinical Safety Evaluation of Lentivirus Vectors: FDA Regulatory Expectations - Anne M. Pilaro, Ph.D. |
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