SOURCES SOUGHT
B -- Quantitative Imaging Biomarkers Alliance (QIBA)
- Notice Date
- 4/18/2013
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-SS-EB-2013-109-JES
- Archive Date
- 5/18/2013
- Point of Contact
- Jennifer Swift, Phone: 3014350358
- E-Mail Address
-
swiftje@mail.nih.gov
(swiftje@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- HHS-NIH-NHLBI-SS-EB-2013-109-JES Title: Quantitative Imaging Biomarkers Alliance (QIBA) This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. (1) Background: Professional societies and regulatory and non-regulatory government groups have identified biomarker evaluation, validation and qualification (by the FDA) as major priorities. For example, the FDA's "Critical Path Initiative" calls for modernizing drug development by incorporating recent scientific advances, such as genomics and advanced imaging technologies, into the process. An important part of the Critical Path initiative is the use of public-private partnerships and consortia to accomplish the needed research. Studies to validate and qualify known biomarkers are required, with clearly defined milestones, measurable (ideally quantitative) outcomes and research methodology accepted by regulatory authorities. (2) Purpose and Objectives QIBA is an initiative to advance quantitative imaging and the use of imaging biomarkers in clinical trials and clinical practice by engaging researchers, healthcare professionals and industry. This involves: • collaborating to identify needs, barriers, and solutions to develop and test consistent, reliable, valid, and achievable quantitative imaging results across imaging platforms, clinical sites, and time; and • accelerating the development and adoption of hardware and software standards needed to achieve accurate and reproducible quantitative results from imaging methods. (3) Project Requirements The Contractor will perform the tasks and/or projects necessary to (1) develop and validate a model for quantitative imaging biomarker development to meet the requirements of clinical trials, and (2) following the model, develop and implement QIBA Profiles for imaging biomarkers in active clinical trials and/or clinical practice. In addition, the Contractor shall continue to manage a coordinated process structured to meet the scientific needs for quantitative imaging biomarkers, thereby enabling users and developers of healthcare imaging technology to achieve repeatable and accurate quantitative imaging results through the precise definition of clinical contexts, delineation of standards-based equipment specifications and protocol designs, and the conformance testing of systems to determine that they adhere to the specifications. The Contractor shall determine the methodology to be followed, the specific workplan, and the administrative management requirements for performing these tasks and projects. The workplan shall address imaging biomarkers in those areas already under development and/or identified as high priority by the broad, inclusive membership of the QIBA. (4) Anticipated period of performance 1 Twelve (12) month base with a 12 month option period (5) Other important considerations None (6) Capability statement/Information sought The contract applicants must demonstrate an understanding of the needs for the development and qualification of imaging biomarkers, the groundwork, infrastructure, and methodology whereby multiple stakeholders collaborate to achieve the objectives of this acquisition. The contract applicants must provide strong evidence that they are an entity recognized nationally and internationally, with a productive overall structure for integrated activity by the collective industries wherein stakeholders would collaborate on the methodology to qualify candidate quantitative imaging biomarkers. This includes the following: • an understanding of the needs for the development and qualification of imaging biomarkers for use in clinical trials, drug development and clinical decision-making; • an understanding of the complexity of establishing the groundwork, infrastructure, and methodology whereby multiple stakeholders collaborate to achieve the objectives of this program; and, • capability of collaboration with multi-stakeholders (the clinical research community, imaging equipment manufacturers, the pharmaceutical industry, government, and medical informatics companies) to achieve cross-industry consensus on and adoption of quantitative imaging biomarkers. (7) Information Submission Instructions Capability Statements should be received by 3:30PM EDT, May 1, 2013 via email to Jennifer Swift, Contract Specialist, Jennifer.Swift@nih.gov. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SS-EB-2013-109-JES/listing.html)
- Record
- SN03039767-W 20130420/130418234211-5300ca093003d115645a37b009ba4b1a (fbodaily.com)
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-
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