National, Heart, Lung, and Blood Institute - Programs of Excellence in Gene Therapy

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PEGT Administrative Organization 

Inter-Program Steering Committee: Because of the PEGTs diverse scientific agendas and tasks to be accomplished, an Inter-Program Steering Committee has been established. The Inter-Program Steering Committee is comprised of representatives from each PEGT, outside non-PEGT investigators appointed by the NHLBI, and NHLBI program staff. The designated program officer for the PEGTs is the NHLBI voting representative on the Inter-Program Steering Committee. This Committee has the responsibility of overseeing the collaborative efforts of all the PEGTs, facilitating the conduct and monitoring of studies, and establishing policies and procedures for NHLBI investigators applying to the resources offered by the PEGTs. The Inter-Program Steering Committee is also involved in the review of new clinical protocols brought forth by the PEGTs. Also, the Inter-Program Steering Committee will discuss and advise NHLBI on emerging scientific opportunities and on needs or impediments that are relevant to the goals of the PEGTs. For example, the Committee will develop plans to integrate into the PEGTs any new vectors or related technologies that will optimize systems for gene therapy in humans for diseases of interest to the NHLBI.

Cornell Data and Coordinating Center: The Data and Coordinating Center serves a range of functions common to each PEGT such as arranging meetings, conference calls, and administering the provision of PEGT services to PEGT investigators and the wider NHLBI research community. Applications for services from all NHLBI-supported investigators doing gene transfer research will be processed through the Data and Coordinating Center. The Data and Coordinating Center will administer the review of each application for services through an External Scientific Panel made up of nominees generated by the Steering Committee and appointed by the NHLBI.

Another function of the Data and Coordinating Center is to establish a PEGT web site to inform the extramural community of services available through the PEGTs. Such information may include: technical information with updates on vectors and protocols for vector production and purification; adverse effects; and information on seminars and short courses being offered at various centers. 

Internal Advisory Committee: Each PEGT has established an Internal Advisory Committee to facilitate internal governance and operations, and to oversee the collaborative arrangements among investigators. This Committee is comprised of the PEGT Director and Principal Investigators of its various projects and cores. 

External Scientific Panel: The External Scientific Panel consists of non-PEGT affiliated scientists appointed by the NHLBI. This panel will provide scientific evaluation of the applications requesting services from the PEGT National Service Cores. Subsequently, the NHLBI program staff will prioritize these requests on the basis of scientific merit, NHLBI program relevance and availability of core resources.

NHLBI Data and Safety Monitoring Board: A Data and Safety Monitoring Board has been appointed by the Director, NHLBI to provide overall monitoring of interim data and safety issues. Meetings of the Data and Safety Monitoring Board will ordinarily be held in Bethesda, MD. The NHLBI Program Officer that oversees the PEGTs shall serve as Executive Secretary to the Board. 

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