SOURCES SOUGHT
A -- Gene Therapy Resource Program - Adeno-associated Virus Vector Production Core Laboratory Renewal
- Notice Date
- 12/20/2010
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HV-12-08
- Archive Date
- 1/19/2011
- Point of Contact
- Nora I Rivera, Phone: (301) 435-0712, Stacy C Turner, Phone: (301) 435-6676
- E-Mail Address
-
nr85c@nih.gov, turners@nhlbi.nih.gov
(nr85c@nih.gov, turners@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Market Survey Gene Therapy Resource Program –Renewal Adeno-associated Virus (AAV) Vector Production Core Laboratory (AAVCL) NHLBI-SS-12-08 December 20, 2010 The NHLBI is seeking any small business with the ability to serve as an Adeno-associated Virus (AAV) Vector Production Core Laboratory (AAVCL) for the existing Gene Therapy Resource Program (GTRP). The program facilitates the translation of basic research in gene therapy to clinical application in the areas of heart, lung, and blood diseases. The GTRP renewal allows the program to continue providing 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 continue to provide funds and regulatory assistance to investigators wishing to conduct gene therapy clinical trials. The GTRP 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 AAVCL 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 adeno-associated virus (AAV) 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 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 possess the capabilities necessary to undertake this study renewal 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 laboratory and 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 renewal 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HV-12-08/listing.html)
- Place of Performance
- Address: Within the USA, United States
- Record
- SN02347414-W 20101222/101220234000-8e1ffc595737e472585f4da32c324a5d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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