SOURCES SOUGHT
A -- PRECLINICAL-GRADE VECTOR PRODUCTION CORE LABORATORY 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-07-03
- Response Due
- 10/21/2005
- Point of Contact
- Pamela Lew, Chief, HLV Section, Phone (301) 435-0340, Fax (301) 480-3338, - Joanne Deshler, Contracting Officer, Phone (301) 435-0340, Fax (301) 480-3338,
- E-Mail Address
-
pl116x@nih.gov, jd52g@nih.gov
- Description
- The NHLBI is seeking a small business with the ability to serve as a Preclinical-Grade Vector Production Core Laboratory (PCL) 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 PCL will 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) produce large-scale, preclinical-grade vectors (both viral and non-viral), in accordance with Good Laboratory Practices (GLP) and applicable State and Federal regulations, for use by NHLBI-funded investigators. Vectors may include, but are not limited to, retroviruses, lentiviruses, adenoviruses, adeno-associated viruses, and non-viral plasmid vectors. Preclinical vectors shall be highly characterized in terms of physical and biological titer, amount of replication competent virus, and other quality control tests including but not limited to sterility, mycoplasma, endotoxin, and cell DNA, 6) maintain, in a secure and confidential manner, an electronic database of all orders made for vector production and submit data, as defined and called for in the MOP, 7) prepare and ship vectors, in accordance with the MOP and state and Federal guidelines, upon completion of production and testing, 8) maintain product-related inventories in a secure and confidential manner, 9) 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 10) 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 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 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 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. NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (13-OCT-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 14-MAR-2007, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HV-07-03/listing.html)
- Record
- SN01251420-F 20070316/070314223854 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |