SOURCES SOUGHT
A -- CLINICAL COORDINATING CENTER FOR THE GENE THERAPY RESOURCE PROGRAM
- Notice Date
- 10/13/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HV-07-01
- Response Due
- 10/21/2005
- Archive Date
- 11/4/2005
- Description
- The NHLBI is seeking a small business with the ability to serve as a Clinical Coordinating Center (CCC) for a new five-year study, 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 is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. Small business concerns that believe they possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the Contracting Officer at the above noted address. The capabilities statement shall include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) an outline of previous research projects in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The information provided must also establish the organization?s status as a small business. Three copies of the capabilities statement must be received at the address listed in this announcement. If this program is approved for implementation and it is determined to be a small business set aside, then a competitive RFP will be set aside for small business concerns. The RFP will be available in FedBizOpps and electronically via the NHLBI web site.
- Record
- SN00915173-W 20051015/051013211745 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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