75N94024Q00019.SOURCES SOUGHT NOTICE.pdf

SOURCES SOUGHT NOTICE

(Acquisition of Services of a Contract Inflammatory and Vascular Diseases

Scientist)

AGENCY: The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)

TITLE: Acquisition of Services of a Contract Inflammatory and Vascular Diseases Scientist

PROPOSED SOLICITATION NUMBER: 75N94024Q00019

PROJECT SERVICE CODE: R499 – SUPPORTPROFESSIONAL:

OTHER

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of all 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 according 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:

Much of the work carried out in the Biomedical and Metabolic Imaging Branch focuses on developing noninvasive imaging approaches with high spatial (micro-millimeter) and temporal (milliseconds) resolution that allow multi-organ evaluation and analysis to better understand the interplay between atherogenesis and metabolic syndrome in humans. This is being achieved through new chemical spectroscopic techniques of involved organs (e.g. liver, heart and muscles) and improved imaging methodologies such as the development of free breathing methods (important for kids and adolescents) and high contrast techniques without the use of contrast agents. The Biomedical and Metabolic Imaging Branch has championed the creation of a multidisciplinary team of imaging physicists, spectroscopists, and biologists.

In recent years, the scientific community has turned its attention towards the intricate role of exosomes in patients grappling with Cushing syndrome and metabolic syndrome, conditions often characterized by significant metabolic and immunological dysregulations. These nano-sized vesicles have emerged as pivotal players in the complex network of interactions that underpin multi-organ diseases, including atherogenesis, a condition frequently encountered in these patients.

Notably, individuals with rare genetic mutations such as hyper immunoglobulin E (Job's) syndrome, Turner's syndrome, lipodystrophy, or HIV infection exhibit a spectrum of dysregulations that mirror those seen in obesity, particularly affecting leptin metabolism and T-cell function. As these subjects are known to acquire accelerated atherosclerosis, a deeper understanding of the early signaling events mediated by exosomes could pave the way for innovative therapeutic strategies.

The goal, therefore, is to isolate and scrutinize these defects, fostering a new frontier in the battle against the devastating cardiovascular consequences associated with these syndromes.

Taking advantage of the effects of deregulation of metabolism, inflammation, and immunity that play a key role in multi-organ disease progression of atherosclerosis in obesity and metabolic syndrome necessitates an in-depth understanding of the molecular basis of inflammatory diseases and studying their associated pro-inflammatory cytokines. In this complex landscape, the roll of extracellular vesicles and their diverse subpopulations emerges as a focal point of research. These vesicles, including exosomes, are instrumental in mediating the intricate communications between various cellular entities, significantly influencing the dysregulation of metabolism and inflammation seen in these conditions.

Particularly, their cargo of microRNAs serves as molecular messengers, modulating pathways that are central to the inflammatory response and metabolic homeostasis. By dissecting the nuanced interactions of these microRNAs and their target molecules, researchers can unravel the complex molecular bases underlying the accelerated progression of atherosclerosis. Consequently, a deeper exploration into the world of extracellular vesicles and their microRNA cargos not only sheds light on the mechanistic intricacies of metabolic and immunological dysregulations but also paves the way for the development of targeted therapeutic strategies, offering a beacon of hope in the comprehensive management of these debilitating conditions.

The novel role of microRNA within the mitochondrial and vascular domains has been spotlighted as a critical factor in the pathogenesis of autoinflammatory diseases, including those with significant mitochondrial dysfunction such as Type 2 diabetes and obesity. These microRNAs are pivotal in orchestrating complex cellular dialogues, influencing both mitochondrial dynamics and vascular function, thereby playing a substantial role in the progression of these diseases.

Consequently, a deeper comprehension of the intricate relationships between microRNAs and mitochondrial as well as vascular dysfunctions could significantly propel the development of novel therapeutic strategies to combat inflammatory diseases. To this end, research endeavors are increasingly leveraging cutting-edge techniques such as induced pluripotent stem cells (iPSC) technology and microarray analyses. These approaches, coupled with the study of various subpopulations of extracellular vesicles, aim to pinpoint the precise origins of these vesicles, thereby providing a more granular understanding of their roles in disease progression. By employing a synergistic combination of these advanced methodologies, researchers aspire to unveil the nuanced mechanisms that govern the mitochondrial regulation of inflammatory diseases, paving the way for a new era of targeted and effective treatments.

In order to accomplish the goals of this program, The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Biomedical and Metabolic Imaging Branch has a requirement to obtain services of a scientist with extensive expertise in innate immunology and hereditary autoinflammatory diseases. This scientist should have a demonstrated understanding of, and ability to apply principles, concepts, practices, and standards associated with patient sample testing in a laboratory setting. Moreover, the scientist must be proficient in a range of advanced techniques including cloning, exosome engineering, microRNA and siRNA transfection, and processing of induced pluripotent stem cells (iPSCs), which are directly applicable to the research conducted by the Biomedical and Metabolic Imaging Branch. Their skill set should also encompass traditional molecular and cellular biological techniques such as PCR, flow cytometry, and immunohistochemistry (IHC). The candidate must be self- motivated and driven, capable of achieving milestones and exceeding goals with minimal direction. Furthermore, they must possess a PhD with 15+ years of demonstrated expertise in immunology and/or inflammation research, showcasing a deep and comprehensive understanding of the complex dynamics involved in these fields.

OBJECTIVE:

The objective of this request is to procure the services of a scientist with specialized skills beyond what our current resources can provide in order to accomplish the goals of this program. The contractor will work 40 hours per week, Monday through Friday, totaling 2080 hours per year.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS:

The contractor must have:

• Doctorate degree with over 15 years of specialized experience in the realms of immunology or inflammation research, with a proven track record of leading innovative studies.

• Expertise in the isolation and characterization of various subpopulations of extracellular vesicles, including a deep understanding of their biogenesis, secretion mechanisms, and functional roles in intercellular communication and disease progression.

• Mastery in cellular culture techniques, particularly focusing on the cultivation and manipulation of human cells, including primary cells, stem cells, and immune cells, to facilitate in-depth studies on disease mechanisms and potential therapeutic interventions.

• Proficiency in advanced molecular biology techniques, including microRNA analysis, western blotting, quantitative PCR, and multiplex ELISA, complemented by hands-on experience in microarray analyses and proteomics to facilitate comprehensive molecular studies.

• In-depth knowledge of microRNA biology, including their functional roles in regulating cellular signaling pathways, and their potential as biomarkers and therapeutic targets, with a focus on their involvement in mitochondrial and vascular dysfunction.

• Expertise in nucleic acid isolation techniques, along with adeptness in T-cell isolation and the development of innovative cell assays.

• Hands-on experience with animal models, including mouse and rabbit handling and organ isolation, particularly within the context of autoimmune and inflammatory disease research.

• Comprehensive knowledge in exosome research, including purification, characterization, and engineering, with a focus on understanding the role of microRNA cargos and their implications in intercellular communication and disease progression.

• Proficiency in cutting-edge technologies such as microRNA analysis, facilitating detailed insights into cellular heterogeneity, and enabling the identification and study of rare cell populations.

• A keen interest in metabolomics, with the ability to integrate findings into a broader understanding of immune responses and inflammatory processes, complemented by a strong foundation in proteomics for detailed protein expression analyses.

• Demonstrated ability to contribute both creatively and strategically to the design and optimization of in vitro assays, with a focus on deriving actionable biological insights and developing novel therapeutic strategies.

• Experience with induced pluripotent stem cell (iPSC) technology, including cloning and processing, to support groundbreaking research initiatives and develop disease models for studying complex biological systems.

• Capacity to conceptualize and implement critical studies that bolster hypothesis-driven research, with a focus on innovative approaches in the field of exosome research and microRNA biology.

• Proficiency in drafting protocols and study reports, coupled with the ability to maintain accurate and detailed records, facilitating transparent and reproducible research.

• Expertise in data analysis using software platforms such as Excel and GraphPad Prism, along with skills in analyzing high-throughput sequencing data, facilitating the integration of large datasets into coherent research findings.

• Exceptional verbal and written communication skills, with the ability to articulate complex scientific concepts in a clear and concise manner, facilitating effective collaboration and knowledge dissemination.

• Strategic thinking abilities, with the capacity to distill complex scientific challenges into coherent strategies and tactics, fostering innovation and advancing the field of immunology and inflammation research.

• Familiarity with various operating systems including Microsoft and Mac, and proficiency in software applications such as PowerPoint, Excel, Word, Adobe Photoshop, and Access, facilitating effective data presentation and report generation.

• Outstanding interpersonal skills, complemented by analytical, organizational, and time management abilities, with a proven track record in managing complex research projects and leading multidisciplinary teams.

The contractor is expected to spearhead and deliver groundbreaking scientific data and results, fulfilling the following responsibilities:

• Tissue processing and purification of immune cells, alongside the development of in vitro cell-based bioassays, encompassing tissue cell culture techniques with primary mouse and human cells and established cell lines.

• Establishing induced pluripotent stem cell (iPSC) models and co-culture systems to facilitate the comprehensive study of vascular function, leveraging imaging techniques such as MRI to glean detailed insights into the underlying mechanisms.

• Multicolor flow cytometry (FACS), and ELISA assays, complemented by advanced techniques to study the role and implications of exosomes and exosomal microRNAs in disease progression and therapy.

• Implementation of basic and advanced molecular biology techniques, including cloning, viral transductions, and the development of novel approaches to study exosomal cargo, particularly focusing on microRNA functionalities.

• Analyzing biological data utilizing a range of software platforms including FlowJo, Microsoft Excel, and GraphPad Prism, with the ability to integrate data from various sources to derive coherent insights.

• Interpreting, analyzing, and presenting data in a dynamic, fast-paced, and result- oriented research environment, fostering collaboration and knowledge exchange.

• Contributing to project advancement by developing new methods or technologies, troubleshooting existing protocols, and spearheading translational research initiatives to bridge the gap between laboratory findings and clinical applications.

• Writing detailed protocols and study reports, producing and maintaining accurate records to ensure transparency and reproducibility in research endeavors.

• Preparing manuscripts for journal publications, with a focus on disseminating findings related to the role of exosomes and microRNAs in disease mechanisms and potential therapeutic interventions.

TASK AREAS:

Task Area 1 – Drive discovery and translational research aimed at identifying, characterizing, and interpreting results for novel diagnosis for inflammatory diseases. The candidate must be able to create their own research plans with minimum support from the principal investigator. The candidate must be able to run research plans independently. Weekly/as needed meetings will be held to evaluate the work and provide directions for next steps.

Task Area 2 – Define and implement critical studies needed to support hypothesis-based research. The candidate’s progress will be parodically evaluated and the candidate will be provided with feedback and directions.

Task Area 3 – Make contributions to scientific literature and conferences through publication and presentation of research results. The candidate will be evaluated based on preparing manuscripts and abstracts for scientific publications.

Task Area 4 – Identify and evaluate a wide variety of in vitro assays to test immunological, inflammatory , metabolic, and various disease mechanisms.

Task Area 5 – Contribute creatively and strategically to in vitro assay design, optimization, and derive actionable biological conclusions.

Task Area 6 – Perform assay development, qualification and validations as needed.

Task Area 7 – Conduct cell-based assays including, but not limited to, microRNA, qPCR, ELISA and Flow Cytometry.

Task Area 8 – Separate, isolate and cryopreserve primary cells peripheral blood mononuclear cells (PBMCs).

Task Area 9 – Organize data prior to scientific publication submission. The data will be reviewed and evaluated by the principal investigator.

Task Area 10 – Ensure lab maintenance activities and equipment calibration are performed according to schedule.

Task Area 11 – Ensure lab maintenance activities and maintain a clean and safe lab environment.

PERIOD OF PERFORMANCE:

Period of Performance: 1/1/2024 - 12/31/2024

INVOICE PROCESSING PLATFORM (IPP):

Vendor/Contractor Must be able to accept payments via IPP (Invoice Processing Platform) The contractor may submit a request for an exception. See below for IPP, IPP helpdesk information and applicable Health and Human Services addendum clause.

INVOICING PROCESSING PLATFORM (IPP) In compliance with the Office of Management and Budget (OMB) M-15-19 memorandum "Improving Government Efficiency and Saving Taxpayer Dollars through Electronic Invoicing" directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award resulting from this solicitation will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests" IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury's Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date. The IPP website address is: https://www.ipp.gov If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov Note: Should an Offeror feel that use of the IPP would be unduly burdensome, the response to this solicitation should include an explanation of this position for a determination by the contracting officer.

HHSAR 352.232-71 Electronic Submission of Invoice Payment Requests (Feb 2022) will apply when this requirement is solicited and awarded. As stated: (a) Definitions. As used in this clause, Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

SPECIAL INSTRUCTIONS:

This Sources Sought is for an organization or institution to provide the NIDDK with the Services of a Contract Inflammatory and Vascular Diseases Scientist.

All qualified small businesses, 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; interested in submitting a corporate capability statement should demonstrate their capability to provide equipment that meets the characteristics above.

The vendor will be evaluated on their quoted supplies meeting the specifications under section SALIENT / REQUIRED FEATURES AND SPECIFICATIONS.

If you or your firm/business has an interest and possess the required expertise, we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502- 2(b) whether or not this procurement will be set-aside for any of the programs described above. The associated NAICS code is 541690, with the small business size standard of $19.0. All respondents are requested to identify their firm's size and type of business.

Interested firms responding to this Sources Sought Notice should adhere to the following:

(a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities. The capability statement should not exceed 15 pages using a font size 10 or larger.

(b) Small business concerns that possess the capabilities necessary to undertake the efforts should submit complete documentation of their capabilities to the Contracting Officer. This capability statement should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented.

Further, Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations shall be provided. References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of government Contracting Officer Representative and Contracting Officers.

(c) All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Point of Contact below in MS Word or Adobe Portable Document Format (PDF). The subject line must specify 75N94024Q00019. Facsimile responses will not be accepted.

Electronically submitted capability statements are due no later than 9:00 AM (Eastern Prevailing Time) seven (7) calendar days (including date of submission to https://sam.gov) after posting of the Small Business Sources Sought Notice.

CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL

NOT BE CONSIDERED

This notice is for information and planning purposes only and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.

https://sam.gov/