CIVICs Statistical, Data Management and Coordination Center (SDMCC)

Sources Sought Notice Information Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. As part of this research program, NIAID supports a comprehensive portfolio covering basic, translational and clinical studies to improve the efficacy of seasonal influenza vaccines, including development of a universal vaccine that will provide broad, durable protection against group I and II influenza A viruses. NIAID also provides resources, including animal models, research reagents and testing of candidate products, to investigators worldwide to facilitate biomedical research and help move drugs, vaccines and diagnostics closer to clinical use. In addition, NIAID supports a robust program in basic immunology that includes detailed analyses of human immune responses to pathogenic infections and/or vaccines. The NIAID Divisions of Allergy, Immunology and Transplantation (DAIT) and Microbiology and Infectious Diseases (DMID) have jointly developed the Collaborative Influenza Vaccine Innovation Center network to advance the production of improved seasonal and universal influenza vaccines that provide durable, broadly cross-protective immunity. NIAID plans to establish the CIVICs network in 2019. This network will consist of at least two (2) Vaccine Centers, responsible for design/development and comprehensive immunologic evaluation of candidate influenza vaccines both preclinically and clinically; a Clinical Core, which will conduct vaccine and human challenge trials; and a Vaccine Manufacturing and Toxicology Core, which manufacture, formulate, optimize, and evaluate the safety and toxicity of the innovative vaccine platforms and approaches developed by the Vaccine Centers. Purpose and Objectives This request is for establishment of the CIVICs Statistical, Data Management and Coordination Center (SDMCC). The SDMCC will provide sophisticated statistical support and state-of-the art statistical and data analysis capabilities for pre-clinical and clinical studies, including numerous systems immunology, genetic and virologic experiments; state-of-the art data management and sharing solutions; and monitoring initiation, conduct and tracking of seasonal and universal influenza vaccine clinical trials and human challenge studies. The SDMCC will include the following components: - Statistical Design and Analysis - Data Management and Analysis - CIVICs Network Data Access and Resource Sharing - CIVICs Network Coordination Services Project requirements Activities conducted by the SDMCC components include, and are not limited to: - Statistical Design and Analysis o Statistically sound preclinical and clinical study design o State-of-the-art statistical analyses for CIVICs pre-clinical and clinical studies o Provision of statistical analyses and manuscript/presentation review for CIVICs network publications and presentations - Data Management and Analysis o Software tools/systems to facilitate collection, harmonization, tracking, updating, query, visualization and analysis of metadata, experimental data and information generated across the CIVICs network o Data Quality Control o Management of clinical trial and human challenge data, include tracking and reporting of Serious Adverse Events (SAEs) o Sophisticated data and metadata analyses and sharing across the CIVICs network - CIVICs Network Data Access and Resource Sharing o Establish, maintain and update one portal capable of privately sharing research data and information with the COR, other relevant NIAID staff, and the CIVICs network, and for providing public access to information about the CIVICs network o Submission of CIVICs data and metadata to NIAID-designated public repositories - CIVICs Network Coordination Services o Tracking, sharing and reporting of CIVICs-generated samples, reagents, resources, and standard operating procedures (SOPs) across the CIVICs network and with the broader research community; and managing o CIVICs site training, assessment and technical assistance o Clinical Study Initiation and Training of Clinical Site Personnel covering regulatory requirements and standard practices for human subject research o Develop and implement Clinical Trial SOPs governing all aspects of the support to be provided to the CIVICs clinical sites Anticipated period of performance Initial period of performance is expected to be from August 2019 - August 2020, with 6 option years Other important considerations Respondents are expected to have expertise in the following areas: i. viral genome sequences; vaccine composition and formulation; serologic and immunologic data, including hemagglutination and neuraminidase inhibition, microneutralization, immune receptor repertoire analyses, multi-parameter flow cytometry, CyTOF, proteomics, metabolomics, transcriptomics, RNA-seq; clinical trial and human challenge study data, and all relevant metadata; ii. advanced analysis and integration of complex systems immunology, functional analyses of T cell responses, serum proteomic analyses in combination with B cell clonal profiling to establish the clonal origin of serum antibodies, and a wide range of diverse datasets, including importing data from related projects to facilitate data mining and analyses and keeping abreast of emerging technologies and data analysis and integration tools; iii. vaccine manufacturing, formulation and toxicology iv. conduct and management of clinical trials and influenza human challenge studies (domestic and foreign sites), including monitoring and reporting Capability statement / information sought Potential sources should demonstrate their qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with attention to the following: - Demonstrate that they have the organizational experience and expertise to manage a Statistical, Data Management, and Coordination Center (SDMCC), that has provided statistical support, data management and analysis, and preclinical/clinical study coordination services within a network of multiple Vaccine Centers. - Potential sources should demonstrate their capability to provide and analyze preclinical and clinical studies and develop and refine study designs and statistical analysis plans. - Demonstrate that they have the organizational experience and expertise to operate and maintain a scalable data management system for the collection, management, storage, quality control, analysis, sharing and query/retrieval of all preclinical and clinical data generated by the CIVICs network. - Demonstrate how they have managed clinical trial and human challenge data. - Potential sources should demonstrate that they have the adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. - Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 10 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: - DUNS. - Company Name. - Company Address. - Company Point of Contact, Phone and Email address - Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. - Do you have a Government approved accounting system? If so, please identify the agency that approved the system. - Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Tom Bahrami, Contracting Officer, at bahramit@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID(AI)-SBSS-18-018. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00PM (Eastern Prevailing Time) on 7/6/2018. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. 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)."