A -- SubPopulations and InteRmediate Outcome Measures In COPD Study: Genomics and Informatics Center

The NHLBI is seeking a small business with the ability to serve as a Genomics and Informatics Center (GIC) for a new six-year multi-center clinical research study entitled, SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS). This observational study will collect and analyze phenotypic, biomarker, genetic, genomic, and clinical data from several thousand research subjects with COPD. Baseline data will be analyzed in a cross-sectional manner to identify subpopulations of patients with similar molecular abnormalities. Longitudinal data will be used to identify and validate intermediate outcome measures, such as x-ray computed tomographic (CT) image, biomarker, and genomic measures whose spontaneous changes over a period of 9-12 months correlate with long-term (3 year) outcomes of mortality, frequency of hospitalizations, change in spirometry, and change in quality of life. Secondary aims are to develop a bioinformatic infrastructure that will enable the utilization and sharing of pulmonary research data and to create a collection of clinical, biomarker, radiographic, and genetic data that can be used by external investigators for other studies of COPD. Research subjects will be enrolled, phenotyped, and followed at approximately eight Clinical Centers (CCs) solicited under a separate request for proposals. High throughput genetic, genomic, and proteomic analyses of biospecimens will be performed by core laboratories contracted separately. The GIC will have primary responsibility for operating a repository of biospecimens; developing bioinformatic resources; designing and implementing a strategy for data collection and analysis to identify subpopulations and intermediate outcome measures which includes molecular phenotypic data obtained with high throughput genetic and genomic assays; training CC staff; managing study data; providing overall management and oversight of the study; and disseminating study results. Specifically, the GIC will: 1) provide expertise in genetic, genomic, and proteomic analyses; 2) provide expertise in bioinformatics, including development of controlled vocabularies and metadata elements; 3) provide biostatistical support for study design and protocol development, including sample size calculations or simulations; 4) analyze the study data; 5) provide administrative support and oversight for the study as a whole; 6) process and store biospecimens collected at the CCs; 7) coordinate, plan, make arrangements for, and participate in meetings of the study committees and boards; 8) develop and maintain web sites for study investigators; 9) establish and maintain a computer system and software needed for the storage and analysis of study data; 10) prepare and distribute periodic technical and statistical reports of study activities and progress; and 11) coordinate and track the reporting of adverse events. GIC staff must possess strong scientific qualifications related to bioinformatics, biostatistics, genetics, genomics, and proteomics. The GIC must have pulmonary medical expertise, experience in the supervision of complex multi-center clinical studies, and experience in the statistical analysis of high volume genetic, genomic, proteomic, and phenotypic data. Small business concerns that believe they possess the capabilities necessary to undertake this study should submit documentation of their capabilities to the Contracting Officer. The capability statement submitted should include: 1) the total number of employees, 2) the professional qualifications of scientist, and technical personnel, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) an outline of previous research projects in which the small business organization and the proposed personnel have participated and any other information relevant to this program. The capabilities statement must not exceed 8 single sided or 4 double sided pages in length. Interested small business organizations submitting a capability statement are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in response to this RFI. However, responses to this RFI that indicate that the information therein is propriety will be properly safeguarded for Government use only. Questions, concerns and responses should be emailed to Ms. Joanne Deshler at contact@example.gov. Responses shall be submitted in Adobe Acrobat PDF format by 3p.m. eastern standard time June 27, 2007, and include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. When submitting this information, please reference the solicitation notice number. Responses received after the due date may not be reviewed. This is not a request for proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. If this program is approved for implementation and it is determined to be a small business set aside, then a competitive RFP will be available in FedBizOpps.