SOURCES SOUGHT
A -- In Vitro Testing Resources For AIDS Therapeutics Development
- Notice Date
- 7/21/2006
- 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 Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIH-NIAID-DAIDS-07-25
- Archive Date
- 9/30/2006
- Description
- The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), funds a comprehensive portfolio of grant and contract resources to discover and develop novel agents for the prevention and treatment of infections caused by the human immunodeficiency virus (HIV) and AIDS-associated opportunistic pathogens, including tuberculosis. Investigators at academic institutions and small biotechnology/pharmaceutical companies who identify new therapeutic or prevention agents frequently do not have the expertise or financial resources to conduct many of the additional studies needed to convert promising leads into pharmaceutical agents suitable for Phase I clinical evaluation. To facilitate further development of promising leads, DAIDS supports a portfolio of in vitro, animal model, and drug development contracts to assist these investigators by providing the pharmaceutical-grade materials and preclinical data needed to support submission of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). Several contracts in this research and development portfolio are being recompeted for award in fiscal year 2007, including: (a) Tissue-based Small Animal Model for HIV Drug Discovery; (b) Pharmaceutical and Chemical Resources for AIDS Drug Development; (c) Safety Evaluation of Anti-AIDS Agents; and (d) Management of Information Resources for AIDS Drugs. Through this Request for Proposals (RFP), DAIDS is recompeting contracts for the development and conduct of in vitro assays to assess the potential of drug substances for further development as anti-HIV agents. There are two separate parts to this project and separate capability statements are required for each part. The two parts are described in more detail below. Potential sources may respond either to Part A or Part B, or to both, but a separate stand alone capability statement must be submitted for either part. Capability statements for Part A: Confirmatory In Vitro Evaluations of HIV Therapeutics shall address all issues presented below pertaining to Part A only. Similarly, capability statements for Part B: Specialized In Vitro Virological Assays for HIV Therapeutics and Topical Microbicides shall address all issues presented below pertaining to Part B only. Any submission which combines both Part A and Part B in the same capability statement will be returned to the potential source without review or further consideration. SOURCES SOUGHT NOTICE INFORMATION Type of Requirement Re-competition (Contract Nos.: N01-AI-25478 and N01-AI-05415) Place of Performance Place of performance is unknown at this time Potential sources must demonstrate and document the following in their capability statements: PART A: CONFIRMATORY IN VITRO EVALUATIONS OF HIV THERAPEUTICS Potential sources must demonstrate and document each of the following: 1. Ability to evaluate drug substances as single agents in cell-based in vitro assays for antiviral efficacy against HIV and for cytotoxicity; 2. Ability to evaluate drug substances in combination with FDA-approved drugs in cell-based in vitro assays for antiviral efficacy against HIV and for cytotoxicity; 3. Ability to evaluate drug substances against a wide range of primary and laboratory isolates of HIV including subtype representative isolates, coreceptor-specific isolates, and drug-resistant isolates; 4. Ability to develop drug-resistant isolates of HIV via in vitro passage of virus in the presence of increasing concentrations of drug substance and ability to characterize these isolates for genotypic and phenotypic changes from the parent virus isolate; 5. Ability to conduct each of the tasks mentioned above in all three of the following human cell types: established cells lines, peripheral blood mononuclear cells, and macrophages; 6. Ability to provide a secure, reliable and efficient database system and to manage and quality control all contract-generated data for compilation and analysis; 7. Ability to conduct all work in accordance with applicable Federal, state, and local guidelines and regulations regarding biohazards and potentially toxic chemicals; and, 8. Ability to utilize efficient and effective procedures for receiving, storing, shipping, and tracking drug substances, viruses and other reagents. In addition, potential sources must provide: 9. A summary of previous experience in conducting antiviral drug substance evaluation projects of the scope and complexity detailed above; 10. Names and professional qualifications of key personnel proposed to staff the contract; and, 11. A description of the facilities, resources, and equipment available to conduct antiviral drug substance evaluation projects of the scope and complexity detailed above. PART B: SPECIALIZED IN VITRO VIROLOGICAL ASSAYS Potential sources must demonstrate and document each of the following: 1. Ability to evaluate drug substances as potential topical microbicides and anti-HIV therapeutics in relevant primary cells, established cell lines, and human tissue/organ explant cultures; 2. Ability to conduct HTS of at least 10,000 drug substances in cell-based anti-HIV assays; 3. Ability to conduct mechanism of action studies on potential topical microbicides and anti-HIV therapeutics; 4. Ability to conduct cellular and tissue cytotoxicity assays to evaluate potential topical microbicides and anti-HIV therapeutics; 5. Ability to conduct assays to determine the suitability of potential topical microbicides in seminal plasma, Lactobacillus and pH transition assays; 6. Ability to provide a secure, reliable and efficient data management system and to manage and quality control all contract-generated data for compilation and analysis; 7. Ability to work in accordance with applicable Federal, state, and local guidelines and regulations regarding biohazards and potentially toxic chemicals; and, 8. Ability to utilize efficient and effective procedures for receiving, storing, shipping, and tracking drug substances, viruses and other reagents. In addition, potential sources must provide: 9. A summary of previous experience in conducting antiviral drug substance evaluation projects of the scope and complexity detailed above; 10. Names and professional qualifications of key personnel proposed to staff the contract; and 11. A description of the facilities, resources, and equipment available to conduct antiviral drug substance evaluation projects of the scope and complexity detailed above. The following legend will be added to the bottom of all Sources Sought announcements: Interested Small Business organizations shall submit five (5) copies of their capability statement for each of the areas cited above. Potential sources may respond either to Part A or Part B, or to both, but a separate stand alone capability statement must be submitted for either part. Any submission which combines both Part A and Part B in the same capability statement will be returned to the potential source without review or further consideration. Written capability statements shall be received by the NIAID Contracting Officer at 3:30 PM Eastern time by August 8, 2006. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. No facsimile transmissions will be accepted. This notice is for information and planning purposes only and does not commit the Government to award a contract now or in the future. This is not a request for proposals. The Government does not intend to award a contract based on responses under this announcement. Any proprietary information shall be so marked. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. Point of Contact Nancy M. Hershey, Contract Specialist, Phone 301-496-0193, Email nhershey@niaid.nih.gov ? Eileen Webster-Cissel, Contracting Officer, Phone 301-496-0349, Fax 302-402-0972, Email ewebstercissel@niaid.nih.gov.
- Record
- SN01094807-W 20060723/060721220507 (fbodaily.com)
- Source
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