A -- NHLBI Gene Therapy Resource Program (GTRP) - Clinical Coordinating Center

The National Heart, Lung, and Blood Institute anticipates that request for proposals (RFP) NHLBI-HV-07-01 will be available on or about December 9, 2005. The objective of the RFP is to establish a Clinical Coordinating Center (CCC) for a new five-year study, NHLBI Gene Therapy Resource Program (GTRP). The purpose of the Program is to facilitate the translation of basic research in gene therapy to clinical application in the areas of heart, lung, and blood diseases. The GTRP will provide resources in the areas of preclinical and clinical-grade vector production in accordance with Good Manufacturing Practices (GMP), and in the conduct of pharmacology/toxicology studies. In addition, the GTRP will provide funds and regulatory assistance to investigators wishing to conduct gene therapy clinical trials. The GTRP will consist of a clinical coordinating center that will oversee and coordinate the logistics of the core laboratories and provide regulatory assistance for clinical trials; a preclinical-grade vector production core laboratory; a clinical-grade vector production core laboratory for adeno-associated virus (AAV); a clinical-grade vector production core laboratory for lentivirus; and a pharmacology/toxicology core laboratory. The CCC will 1) participate in the Steering Committee (SC), and subcommittees as necessary, and attend SC meetings and participate in teleconferences, 2) schedule and coordinate the logistics of meetings, teleconferences, site visits and other face-to-face meetings between groups associated with conduct of the study, 3) develop, in collaboration with the SC, forms to be used by the Core Laboratories and investigators, 4) establish, in collaboration with the SC, and maintain an electronic database for use in capturing information conveyed to and from groups associated with the study, 5) develop, maintain and update a secure and password-protected Internet web site with pages for each of the Core Laboratories, 6) ensure that each Core Laboratory continually possesses all required certifications, inspections, and assurances, 7) develop and maintain a Manual of Procedures (MOP), 8) receive and process investigators? requests for vector production, pharmacological and/or toxicological studies, and clinical trials support services, 9) handle travel-related expense reimbursements for study-associated group members to attend meetings and site visits, 10) ensure that investigators have obtained, when necessary, regulatory approvals (i.e., IRB, IBC, RAC, NIH OBA) and had contact with or obtained Food and Drug Administration (FDA) approval, 11) act as the conduit for funding of clinical trials which have been approved by the NHLBI as part of the program, and 12) register all GTRP clinical trials on the ClinicalTrials.gov web site. This announcement is not a request for proposals (RFP) and, although one award is anticipated, the Government is not committed to award a contract pursuant to this announcement. The RFP will be available on the FedBizOpps web page at http://fedbizopps.gov. Prospective offerors are responsible for downloading the RFP and all attachments. It is also offerors? responsibility to monitor the FedBizOpps web page for the release of any amendments to the RFP. Letters of intent are due no later than January 31, 2006. This acquisition has been designated as full and open competition under the North American Industry Classification System (NAICS) code 541710.