A -- NHLBI Gene Therapy Resource Program (GTRP) - Lentivirus Vector Production Core Laboratory

The National Heart, Lung, and Blood Institute anticipates that request for proposals (RFP) NHLBI-HV-07-05 will be available on or about December 9, 2005. The objective of the RFP is to establish a Lentivirus Vector Production Core Laboratory (LCL) 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 LCL will 1) participate in the Steering Committee (SC), and subcommittees as necessary, and attend SC meetings and participate in teleconferences, 2) provide, maintain and update a Manual of Procedures (MOP), 3) develop, in collaboration with the SC, a customer satisfaction survey for investigators to evaluate the quality and acceptability of the product and timeliness of the service provided, 4) develop, in collaboration with the Clinical Coordinating Center (CCC), maintain and update a secure and password protected web site page and provide updates to the CCC as needed, 5) produce scalable clinical grade lentiviral vectors, in accordance with Good Manufacturing Practices (GMP), as defined by the Food and Drug Administration (FDA), and applicable Federal and State regulations, for use by NHLBI-funded investigators, 6) prepare and ship vectors, in accordance with the MOP and Federal and State guidelines, upon completion of GMP production and testing, 7) maintain product-related inventories in a secure and confidential manner, 8) monitor facilities to ensure quality control of vector production and accuracy and completeness of production data, and maintain and make available for review, as necessary, records of monitoring activities, and 9) prepare materials for and participate in site visits to the contractor?s facilities and ensure that up-to-date versions of all required certifications, inspections, and assurances are available for review during site visits. 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.