SOURCES SOUGHT
A -- PHARMACEUTICAL AND CHEMICAL RESOURCES FOR AIDS DRUG DEVELOPMENT
- Notice Date
- 12/29/2005
- 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 Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIH-NIAID-DAIDS-07-22
- Response Due
- 1/5/2006
- Archive Date
- 1/20/2006
- 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 novel agents for the prevention and treatment of infections caused by human immunodeficiency virus (HIV) and AIDS-associated opportunistic pathogens, including tuberculosis. Investigators at academic and small biotechnology institutions 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. DAIDS thus also maintains a portfolio of 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 and include (a) In Vitro Testing Resources for AIDS Therapeutics Development; (b) Tissue-Based Small Animal Model for HIV Drug Discovery; (c) Safety Evaluation of Anti-AIDS Agents; and (d) Management of Information Resources for AIDS Drugs. Contracts for formulation and manufacture of dosage formulations, and analytical chemistry evaluation also are being recompeted and are the topic of this specific solicitation. 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 to either 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: Formulations and Clinical Trial Materials for AIDS Therapeutics shall address all issues presented below pertaining to Part A only. Similarly, capability statements for Part B: Analytical Chemistry Evaluation of AIDS Therapeutics 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. PART A: FORMULATIONS & CLINICAL TRIAL MATERIALS FOR AIDS THERAPEUTICS Potential sources are required to demonstrate relevant experience in conducting preformulation and formulation development studies for anti-infective therapeutic agents including agents which possess delivery challenges related to physical/chemical properties, bioavailability, administration route, administration schedule, etc. Potential sources will be required to show experience in formulating, manufacturing, packaging and shipping dosage forms in a timely manner, in both pilot and production scale, and in performing requisite quality control and other analyses of bulk substances and manufactured dosage forms. Potential sources must have senior staff with adequate experience and qualifications to manage projects and/or conduct studies relevant to preformulation and formulation development needs, and to have experience manufacturing clinical dosage forms in compliance with Federal regulations 21 CFR parts 210 and 211. Section M of the solicitation will include Mandatory Qualification Criteria. The Mandatory Qualification Criteria must be met at the time of the original proposal submission. Copies of licenses and registration numbers to support compliance must be provided for the prime Contractor or any proposed subcontractor who will manufacture clinical supplies in compliance with 21 CFR sections 210 and 211, current Good Manufacturing Practices (GMPs). All Potential sources or their subcontractors who manufacture clinical dosage forms must be registered with the FDA as a pharmaceutical manufacturer and hold requisite state and/or local drug product manufacturing licenses, copies of which must be included in the capability statement. Potential sources must have adequate, suitable, and immediately available all necessary facilities, equipment, and resources to conduct preformulation and formulation development studies and to manufacture clinical dosage forms in compliance with GMPs. Furthermore, Potential sources must demonstrate: experience in coordinating essential tasks involved in dosage form manufacture; willingness to prioritize Government projects within the organization's overall scheduling framework; and the ability to maintain confidentiality of data. PART B: ANALYTICAL CHEMISTRY EVALUATION OF AIDS THERAPEUTICS Potential sources will be required to demonstrate relevant experience in: confirming the identity and evaluating the purity of bulk drug substances and generating Certificates of Analysis; determining the physical and chemical properties of bulk drug substances and pharmaceutical dosage formulations; developing and validating new analytical assays; initiating shelf life studies of pharmaceutical dosage formulations; and quantitating levels of active drug and degradation products or metabolites in pharmaceutical dosage formulations or physiologic fluids. Potential sources must have adequate and suitable personnel, facilities, equipment, and other resources to conduct all work suggested above in compliance with the FDA?s current GLP and GMP regulations. The potential source will be required to maintain confidentiality of data, conduct work in compliance with all applicable Federal, state, and local guidelines and regulations regarding the safe handling of chemicals, and effectively communicate with NIAID staff. Interested organizations shall submit five (5) copies of their capability statement addressing each of the areas cited above. Written capability statements shall be received by the NIAID Contract Specialist by January 5, 2006. Please reference the Sources Sought 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 small business size status.
- Place of Performance
- Address: Place of performance is unknown at this time
- Record
- SN00959370-W 20051231/051229211708 (fbodaily.com)
- Source
-
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