SOURCES SOUGHT
A -- An Integrated Approach to Understanding Host-Pathogen Interactions
- Notice Date
- 11/13/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID-RDSS-16-NIHAI2016HP1
- Archive Date
- 12/19/2015
- Point of Contact
- Tiffany Chadwick, Phone: 240-669-5171, George Kennedy, Phone: 240-669-5170
- E-Mail Address
-
tiffany.chadwick@nih.gov, kennedyg@mail.nih.gov
(tiffany.chadwick@nih.gov, kennedyg@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This is a Research and Development (R & D) 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 including small and small disadvantaged businesses to perform a potential R & D requirement. BACKGROUND This National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) project is for work related to the contract below: - An Integrated Approach to Understanding Host-Pathogen Interactions, Emory University (Contract HHSN272201200031C) This contract was awarded on a competitive basis for a five year period (inclusive of options) in 2012 for the provision of services utilizing multiple high-throughput “omics” technologies to generate diverse experimental data, with the goal of developing and or validating computational models of host-pathogen molecular interaction networks and pathways through the analysis and integration of the experimental datasets generated by the high-throughput technologies. The contract was awarded with an initial Base Period of September 30, 2012 to September 29, 2013; and included four one-year Option Periods for a total potential performance period through September 29, 2017. The total potential value of the contract, inclusive of Options, is $19,458,981. During the course of this contract, comprehensive systems biology studies involving active experimental malaria infections in non-human primates (NHPs) using several host-parasite combinations over time have been conducted. These studies included the following components: physiological and clinical monitoring, innate and adaptive immune profiling, genomics, transcriptomics, proteomics, metabolomics, lipidomics, pathogenesis, informatics and computational systems biology and mathematical modeling. Infections were initiated by intravenous inoculation of infectious sporozoites, and the development of blood-stage parasitemia, illness, and recovery stages upon treatment was monitored along with the development and impact of the immune response. Novel assays and procedures have been developed, optimized and implemented to assess NHP immune response to both simian and human malaria parasites in relevant NHP models, including small-new world monkeys (Aotus sp. and Saimiri sp.) and old world monkeys (M. mulatta and M. fascicularis). Comprehensive immunological assays performed in diverse sample types (e.g. bone marrow aspirates, whole blood, peripheral blood mononuclear cells) have been established to identify and functional characterize 20-30 cellular subsets comprised of monocytes, dendritic cells, T-cells, B-cells, eosinophils, basophils, and neutrophils, and to monitor their potential contribution to the ongoing immune responses observed during the infection. Computational infrastructures for acquiring, analyzing, integrating, and modeling large datasets from omics technologies and immune profiling assays for studying malaria host-pathogen interactions using NHPs have been established. This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NIAID. PURPOSE AND OBJECTIVES The purpose of this Research and Development Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this R & D Sources Sought Notice, the NIAID may issue a Request for Proposal (RFP) if it deems this necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID’s use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement. The objective of this acquisition is to increase the quantity of labor hours delivered to the Government through the remainder of the current contract, increasing the effort available to demonstrate the utility and value of systems vaccinology for malaria vaccine development with the benefits of established non-human primate (NHP) model systems, validated assays for in-depth immune profiling, and established computational infrastructures for large scale systems biology data analysis and modeling. PROJECT REQUIREMENTS The NIAID intends to modify the existing Emory University contract to provide an increase to the required Level of Effort by 7,800 hours. This project aims to demonstrate the utility and value of systems vaccinology for malaria vaccine development with the benefits of established non-human primate (NHP) model systems. This work will build upon: 1) a large body of systems biology data generated on this contract on the natural course of infection, immunity and pathogenesis in Macaca mulatta (rhesus monkeys) infected with Plasmodium cynomolgi sporozoites (multiple strains) as a model for the widespread human malaria pathogen, P. vivax; 2) assays and panels established and validated on this contract for in-depth immune profiling, including panels for assessing cellular phenotypes in macaques, innate cells and multiplex cytokine assays with a panel of custom-defined molecules; and 3) ready access to cohorts of healthy malaria naïve rhesus macaques on a daily basis and at selected times for blood testing of clinical, parasitological and immune response parameters. This work will consist of experiments that involve immunizing M. mulatta with irradiation-attenuated P. cynomolgi sporozoites to identify molecular signatures associated with immunity and protection. Clinical baseline, immunization and post-challenge data using multiple high-throughput omics technologies will be generated. Omics data analysis and integration will be performed as well as in-depth immune profiling to assess changes in frequencies and activation status of approximately 30 cellular subsets comprised of neutrophils, monocytes, B-cells, dendritic cells, and T-cells. ANTICIPATED PERIOD OF PERFORMANCE The increase in Labor Hours is anticipated to be applied to Option Period 3 (September 30, 2015 – September 29, 2016) and Option Period 4 (September 30, 2016 – September 29, 2017), of the current contract. OTHER IMPORTANT CONSIDERATIONS CAPABILITY STATEMENT/INFORMATION SOUGHT Tailored Capability Statements submitted as a result of this announcement should demonstrate the offerors’ facilities, qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following areas: 1. Ready access to cohorts of healthy, male and female malaria naïve rhesus macaques on a daily basis and at selected times for daily clinical bleeds as well as collecting samples for immunological assays by highly experienced animal research staff and veterinarians in monitoring malaria infections and assisting with vaccine trials. 2. Ready access to a customized multiplex cytokine array designed for NHP testing based on a panel of 45 defined molecules including pro-inflammatory, anti-inflammatory, regulatory, chemokines, and growth factors. This array must have been rigorously tested and is ready for use with the lowest amount of sample to monitor presence and changes in cytokine abundance during malaria infection in non-human primates. 3. Established methodologies for in-depth monitoring of immune responses in macaques through cellular immunophenotyping by flow cytometry, cell sorting for functional analyses of specific subsets, cytokine production via multiplex cytokine arrays, antibody responses via ELISPOTs, among others. 4. Experience with challenge studies involving sporozoite or blood-stage inoculums. This involves generating the infectious agents & preparing the inoculums; administering the infectious inoculums; evaluating efficacy/protection; and relating the efficacy results to the host response data. 5. Extensive knowledge developing novel assays using cutting-edge technologies to address specific questions identified through system biology-based approaches. 6. Access to equipment, expertise and facilities for performing the work required above, with particular focus on an established systems biology infrastructure for studying malaria host-pathogen interactions using NHPs as a model, including setting up NHP trials, acquiring and analyzing large datasets using omic technologies, applying bioinformatics to individual and combined datasets, developing and testing mathematical models, and making informed decisions based on such analysis and modelling efforts. Sources are expected to have the necessary skills and tools to meet the requirements of this project. Capability statements must include the following: 1. Respondents’ DUNS number, organization name, address, and point of contact. 2. Respondents’ opinions about the difficulty and/or feasibility of the potential proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts. 3. Information regarding respondents’ a. Staff expertise, including their availability, experience, and formal or other training b. Current in-house capability and capacity to perform the work c. Prior completed projects of similar nature 4. Any other information that may be helpful in developing or finalizing the acquisition requirements. SUBMISSION INSTRUCTIONS This sources sought notice requires interested parties to submit a capability statement via the NIAID electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov/NIAID. For directions on using eCPS, go to https://ecps.nih.gov/NIAID/home/howto. Submissions should be in PDF format, no smaller than 10 pt. font and 10 pages or less. 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).
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