SOURCES SOUGHT
A -- Comprehensive Resources for HIV Microbicides and Biomedical Prevention
- Notice Date
- 7/31/2008
- 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 Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIAID-DAIDS-A0907
- Point of Contact
- Cassandra C Ellis,, Phone: 301-451-3691
- E-Mail Address
-
ellisca@niaid.nih.gov
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This SOURCES SOUGHT NOTICE is to determine the availability of potential small businesses (e.g., 8(a), service disabled veteran-owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) that can provide: There is a critical need to provide focused support of pipeline activities to assist in the advancement of potential topical microbicides (TM) and biomedical prevention (BP) products from discovery to initial clinical testing. The objective of this contract is to provide a resource of pre-clinical and non-clinical services to advance the development of TM/BP products into clinical testing for the prevention the sexual transmission of HIV. The information from this market research will help the National Institute of Allergy and Infectious Disease, Division of Acquired Immunodeficiency Syndrome (DAIDS) plan their acquisition strategy. Please be sure to indicate if you have a GSA schedule contract on GSA 8(a) STARS, or a contract on GSA VETS GWAC. THIS IS STRICLY MARKET RESEARCH. THE DAIDS, NIAID, WILL NOT ENTERTAIN QUESTIONS REGARDING THIS MARKET RESEARCH. BACKGROUND Topical microbicides (TM) and biomedical prevention (BP) interventions represent important strategies for preventing the sexual transmission of HIV. With current global HIV infection estimates exceeding 33 million people, the development of safe, effective, and acceptable TM/BP products to prevent the sexual transmission of HIV could play a major role in world-wide reduction of the over 9,000 new HIV infections per day, and potentially save millions of lives. The National Institute of Allergy and Infectious Diseases (NIAID) has recognized that the development of safe, effective and acceptable TM/BP products as a priority in the development of approaches to control the HIV/AIDS pandemic. In response to this priority, NIAID has developed a Topical Microbicide Strategic Plan http://www.niaid.nih.gov/publications/topical_microbicide_strategic_plan.pdf and is developing a similar plan for BP interventions. There is a critical need to promote discovery and transition of new strategies into clinical trials. This NIAID-sponsored contract focuses on promoting the development of strategies containing TM/BP as a means of addressing the NIAID and Division of AIDS (DAIDS) priority of controlling and preventing the HIV/AIDS epidemic worldwide. The development of sustainable pipelines for the discovery, development and implementation of TM/BP has suffered from limited pharmaceutical industry and private partnership participation, which has in turn resulted in delays in transitioning candidates from discovery to initial clinical testing. The lack of clinical evidence for proof-of concept for safety and efficacy of both TM/BP products has resulted in further delays. For TM, a Bill and Melinda Gates Foundation-sponsored Microbicide Development Strategy (MDS) http://www.microbicide.org/galleries/default-files/mds_final_10aug06.pdf has addressed these issues and provided a critical analysis of the topical microbicide field to identify and address critical gaps in development. Two critical process gaps were identified in the MDS: (i) the ability to advance compounds through FDA–required testing and (ii) the need to identify surrogate markers and standardize processes for the identification and measurement of safety and efficacy parameters. Similar gaps exist in the translation of BP products (i.e. Pre-Exposure Prophylaxis, PrEP) to clinical testing. There is a critical need to provide focused support of pipeline activities to assist in the advancement of potential TM/BP products from discovery to initial clinical testing. The objective of this contract is to provide a resource of pre-clinical and non-clinical services to advance the development of TM/BP products into clinical testing for the prevention of sexual transmission of HIV. Three (3) main areas of support are designed to achieve this objective: 1. Pre-clinical and non-clinical specific gap-filling services to advance the development of non-vaccine prevention strategies 2. Comprehensive pre-clinical and non-clinical services for advancing selected TM/BP products to initial clinical testing via Product Development Plans containing milestones, timelines, and Go/No Go decision points for completion of each milestone 3. Best Practices Working Groups (BPWG) to identify critical parameters for the standardization of TM/BP discovery and development assays, leading to the identification and development of surrogate biomarkers for safety and efficacy Achieving the objectives of the contract will require the Contractor to provide a broad range of activities that encompass many of the current standard development approaches and regulatory standards for testing and development of TM/BP products. The Contractor will be required to either directly or indirectly, through subcontracting, provide a wide range of pre-clinical and non-clinical support services for the advancement of TM/BP products from discovery to filing of Investigational New Drug (IND), Investigational Device Evaluation (IDE) and/or New Device Exception (NDE) applications with the Food and Drug Administration (FDA). The Contractor must be versant in the existing methodologies and processes used to discover and advance products in the TM/BP pipelines. SCOPE: This contract will provide pre-clinical and non-clinical development services of TM/BP products essential for advancement to clinical testing and for supporting activities required for IND, IDA and NDE applications to the FDA. TM/BP products for development services will be provided by or through the Project Officer and will be identified through NIAID-funded grants and contracts, the private sector, or other sources. The specific services required will depend on the status of the individual candidate(s), the need to prioritize potential candidates, and an overall product development plan and/or regulatory submission plan to the FDA. The Contractor shall carry out activities only upon approval by the Project Officer. The scope of pre-clinical and non-clinical services to be provided include: (1) Individual gap-filling services on a case-by-case basis, to advance TM/BP products in the development pathway toward clinical assessment (2) Comprehensive services for selected TM/BP products through a Go/No-Go milestone-driven pathway to accelerate a product toward clinical testing in the most efficient manner (3) Support for BPWGs composed of non-contract investigators to assess the critical processes and assays used to compare and advance products to clinical studies. This activity will ultimately lead to identification and validation of surrogate biomarkers for safety and efficacy testing in clinical trials. This contract will include an option to add additional BPWGs up to a total of 4 BPWGs during the period of contract performance that may be exercised at the discretion of the Government. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the pre-clinical and non-clinical services and support activities set forth in the Statement of Work (SOW). The Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants, and coordination of non-contract investigators in the BPWGs. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company’s experience and ability to perform this effort which includes the following: (1) a summary list of similar work previously performed or being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Project Director, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a.DUNS b.Company Name c.Company Address d.Company Point of Contact, Phone and Email address and FAX e.Current GSA Schedule appropriate to this Sources Sought. f.Do you have a Government approved accounting system? If so, please identify the agency that approved the system. g.Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index.asp Teaming Arrangements: All teaming arrangement should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. Responses must be submitted not later than 3:00 PM, August 15, 2008. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Cassandra Ellis, Contract Specialist. She can be emailed at the address provided below. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line Reference: NIH-NIAID-DAIDS-A0907. A paper copy can be sent via regular mail at the address provided below. National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions ATTN: Cassandra Ellis 6700 B Rockledge Drive, Room 3214 MSC 7612 Bethesda, Maryland 20892-7612 Email Address: ellisca@niaid.nih.gov GENERAL INFORMATION This Sources Sought Notice is for information and planning purposes only and should not be construed as a commitment by the Government. This is not a solicitation announcement for proposals and no contract will be awarded from this Notice. No reimbursement will be made for any costs associated with providing information in response to this Notice. Respondents will not be notified of the results of this evaluation. Capability statements will not be returned and will not be accepted after the due date. As previously stated, the Government will not entertain questions regarding this Market Research; however, general questions may be forwarded to the following: Contract Specialist: Cassandra Ellis Email Address: ellisca@niaid.nih.gov Contracting Officer: Eileen Webster-Cissel Email Address: webstere@niaid.nih.gov
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=59a0c45f9961a3987c3cd89959f15192&tab=core&_cview=1)
- Place of Performance
- Address: National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Drive, Room 3214 MSC 7612, Bethesda, Maryland, 20892-7612, United States
- Zip Code: 20892-7612
- Zip Code: 20892-7612
- Record
- SN01627564-W 20080802/080731221537-59a0c45f9961a3987c3cd89959f15192 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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