Gene Therapy Resource Program (GTRP) Pharmacology-Toxicology Core Laboratory - Renewal
Added: Mar 17, 2011 9:27 am The National Heart, Lung, and Blood Institute anticipates posting a request for proposals (RFP) under NHLBI-HV-07-02, The Gene Therapy Resource Program (GTRP) Pharmacology/Toxicology Core Laboratory - Renewal, on or about March 14, 2011. The objective of the RFP is to continue Pharmacology/Toxicology Core Laboratory (PTCL) activities for five years. 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 provides 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 provides funds and regulatory assistance to investigators wishing to conduct gene therapy clinical trials. The GTRP consists of a clinical coordinating center that oversees and coordinates the logistics of the core laboratories and provides 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 PTCL will continue to 1) participate in the Steering Committee (SC), and subcommittees as necessary, and attend SC meetings and participate in teleconferences, 2) provide and maintain 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) conduct preclinical vector toxicology testing and biodistribution studies using all types of gene therapy vectors in accordance with Good Laboratory Practices (GLP) in small and/or large animals, and applicable Federal and State regulations, for use by NHLBI-funded investigators, 6) maintain an established facility to support rodent, non-human primate (NHP), and large animal pharmacology/toxicology and biodistribution studies 6) adhere to the treatment of animals in accordance with IACUC (Institutional Animal Care and Use Committee) guidelines, 7) monitor facilities to ensure quality control of pharmacology/toxicology studies and that a regulatory framework is established to ensure consistent data quality. Develop plans to facilitate rapid communication of adverse toxicological results to the CCC and NHLBI and maintain and make available for review, as necessary, records of monitoring activities, and 8) 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. A five-year "Cost-Reimbursement-Completion" type contract with a "Multi-year" FAR 17.1 funding mechanism, is being considered for this requirement. The ultimate contract type and funding mechanism will be determined by the NHLBI, based on what best fits the GTRP program goals and the available funding. 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 May 28, 2011. This acquisition has been designated as full and open competition under the North American Industry Classification System (NAICS) code 541711. NIH-NHLBI-HV-12-06 Department of Health and Human Services National Institutes of Health
3/17/11, 9:27 AM