SOURCES SOUGHT
A -- Collaborative Program to Accelerate SMA Therapeutics Development
- Notice Date
- 12/17/2002
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, MD, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- Reference-Number-NS03005
- Archive Date
- 2/16/2003
- Point of Contact
- Patricia Denney, Contracting Officer, Phone 301 496-1813, Fax 301 402-4225, - Helene Braun, Contract Specialist, Phone 301 496-1813, Fax 301 402-4225,
- E-Mail Address
-
pd22n@nih.gov, braunh@ninds.nih.gov
- Description
- The National Institute for Neurological Disorders and Stroke (NINDS) is considering issuing a contract that would provide resources and expertise to help us accelerate therapeutics development for Spinal Muscular Atrophy (SMA). NINDS is attempting to identify competent sources to establish and coordinate pre-clinical research activities leading to a new treatment for SMA, and is seeking input from experienced sources into the design of a proposed statement of work for the project. Background The NINDS wishes to develop a treatment for SMA, a devastating neurological disease of childhood. SMA is an ideal candidate for targeted therapeutics development for two reasons. First, it is caused by the loss of function of a known gene product. Thus, there are tractable strategies for developing treatments based on replacement of the lost function. Second, SMA is the most severe of the common genetically recessive neurological diseases. Currently, no effective treatment for SMA exists. The overall objective of the proposed contract is to accelerate the development of a treatment for SMA through the establishment of an innovative SMA translational research program. This program will pursue parallel research avenues for therapeutics development in a coordinated, rapid, milestone-driven process to identify a testable therapy suitable for clinical trials. Clinical trials will not be undertaken as part of this program. The contract will establish the SMA research program and coordinate its progress, implementing a fast and focused process in response to the NINDS strategic plan. Organizations capable of fulfilling this effort must be able to: 1) Establish an SMA Research Program consisting of institutions capable of providing the scientific and administrative expertise necessary to perform therapeutics development studies for SMA. 2) Manage a strategic plan that must include processes for a) establishing research priorities; b) reviewing, modifying, approving and disapproving research studies; c) allocating resources; d) monitoring and evaluating progress and maintaining effective working relationships. 3) Provide input on research progress to a Program Oversight Committee. Information Requested Information and advice in the following areas will aid in the design of a statement of work and solicitation for establishment and oversight of the SMA research program. We ask that organizations that have performed such services identify critical criteria to include in the solicitation and describe their capabilities to meet these criteria. This information can address performance measures, standards and incentives, as well as possible criteria for judging success. The information supplied in response to this request need not be limited to these areas. 1. Establishing the SMA Research Program The SMA research program will be established through subcontracts, awarded by the contractor, to individual research laboratories. The requirements for these subcontracts will be defined by the NINDS strategic plan for SMA therapeutics development. The contractor will be responsible for soliciting and reviewing research proposals with a targeted review and award cycle of approximately 4 months. We anticipate 3 standard application receipt dates per year. At the discretion of NINDS, up to 6-10 solicitations may be released per year, with 5-30 research proposals submitted per solicitation. The contractor will establish a scientific review committee(s) that could meet as often as 3 times per year. Based on the results of the scientific reviews and the priorities of the program, final award selection recommendations would be forwarded to NINDS. The NINDS will ultimately be responsible for final award selection (or: for approving all award selection recommendations). With respect to the establishment of the research program: i. Describe your capabilities for the efficient and fair solicitation and review of research proposals for a pre-clinical therapeutics development program. ii. Describe the criteria and strategies you would apply in establishing a peer review committee and in managing data related to the reviews. iii. Describe the expertise and level of effort of personnel necessary to solicit and review proposals according to the above schedule. 2. Subcontract Award and Management Research conducted by the SMA network will be funded through awards issued by the contractor as subcontracts. It is anticipated that up to 6-12 subcontracts may be issued each year. i. Describe the personnel and database requirements associated with awarding and managing multiple subcontracts, including quality control procedures. ii. Describe your capabilities for evaluating the budgets of subcontract proposals. iii. Describe your strategies for insuring that subcontracted research projects are completed on schedule and within budget. 3. Program Management and Evaluation To maximize the rate of progress, researchers in the SMA network will be required to interact and collaborate with each other and to report progress regularly to an oversight committee selected by NINDS. The contractor will be required to develop a meeting schedule to facilitate these interactions. In addition, the contractor will be required to evaluate the progress of the subcontracted research against the goals of the NINDS strategic plan and communicate these evaluations to the oversight committee. i. Describe your experience with strategic planning efforts. ii. Describe your experience with the evaluation of the success or failure of scientific programs. iii. Describe your experience with planning and conducting meetings. 4. Personnel Please provide an overall assessment of the number and mix of personnel required to accomplish the tasks outlined above and the approximate level of effort required for each. Include a description of the scientific and technical expertise required. This Request for Information is for planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government?s use of such information. Respondents will not be notified of the Government?s evaluation of the information received. Should a proposed solicitation materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government?s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Responses will be held in a confidential manner. Any proprietary information should be so marked. All respondents are asked to indicate the type and size of your business or organization, e.g., Large Business, Small Business, Hubzone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, or other profit or non-profit organization. Responses should be limited to 20 pages, should be identified with RFI No. NS-03-005, and are due by February 1, 2003. Please submit three (3) copies of your response to: Patricia S. Denney Contracting Officer Contracts Management Branch National Institute of Neurological Disorders and Stroke NIH 6001 Executive Boulevard, Room 3287 Bethesda, MD 20892-9531 (For Fedex or courier, use: Rockville, MD 20852) (The telephone number for the Contracts Management Branch is (301) 496-1813.) Email responses will also be accepted at: pd22n@nih.gov. NO FAXES PLEASE.
- Record
- SN00225196-W 20021219/021217213503 (fbodaily.com)
- Source
-
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