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THIS REQUEST FOR INFORMATION (RFI)/ SOURCES SOUGHT IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. The purpose of this sources sought notice is to n... THIS REQUEST FOR INFORMATION (RFI)/ SOURCES SOUGHT IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. The purpose of this sources sought notice is to notify the industry that the Government is seeking any vendor that s capable of maintaining mice colonies and induce experimental autoimmune encephalomyelitis (EAE, RR-EAE) in selected animals to model MS ex vivo and in vivo. NOTICE This RFI does not constitute a Request for Quotation (RFQ) or a promise to issue an RFQ in the future. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are advised that the Government will not pay for any information or administrative costs incurred in response to this RFI. It is the responsibility of the responders to monitor this site for additional information pertaining to this requirement. Responses or questions concerning the composition and requirements to the RFI will not be returned. All capable contractors are welcome to respond to this notice and shall provide a brief capability statement that covers the information in the scope of work statement. The Capability Statement shall be limited to 10 pages and no more than 5MB. The Government will not review any other information or attachments included, that are more than the 10-page limit. The Government will not review generic marketing materials that do not address the information contained herein or the attached documents. GENERAL Your response must address capabilities specific to the services required in the performance work statement and must include the following: Request Company information to include: Company Name SAM CAGE/ Unique Entity ID under which the company is registered in Sam.gov/VetBiz.gov Company Address Point of contact name Telephone number Email address Socioeconomic data Company Business Size Status and representations of your business General pricing of your products/solution. Pricing will be used for the purpose of market research only. Names and types of current federal contracts and/or contract vehicles that can be utilized for the scope of the requirements. Background. This requirement directly relates to ongoing VA-approved, VA Merit Award-funded work at the Baltimore VA Medical Center to develop treatments for Multiple sclerosis (MS), a disease that occurs when a patient's immune system mistakenly attacks myelin in the brain, leading to slow loss of mobility over decades. The Principal Investigator (Pl), Dr. Jewell, utilizes a mouse model of Multiple Sclerosis to test new treatments to prevent the destruction of the myelin without the broad immune suppression that occurs with currently-approved drugs, and in collaboration with the VA's MS Center of Excellence, prepare the most promising materials for testing in pre-existing samples from human MS patients; these patient samples are managed with VA approval on-site by Dr. Jewell. Additionally, Dr. Jewell's lab utilizes highly specialized experimental models and techniques, which are acquired through extensive, unique training. One such technique, the development of vaccine like molecules assembled from novel biopolymers ("iPEMs") is not available at the Baltimore VA. Therefore, there is a need to contract for laboratory and biomaterial production and testing services from the FDB at the UMCP to support Dr. Jewell's VA-funded research. 4. Scope. The vendor will maintain mice colonies and induce experimental autoimmune encephalomyelitis (EAE, RR-EAE) in selected animals to model MS ex vivo and in vivo. They will also develop novel MS 'vaccine-like' molecules (nanostructured iPEMs") and test the ability of these molecules to stop autoimmune reaction in immune cells and during the in vivo mouse models. The work will take place at the on the UMCP campus A. James Clark Hall (8278 Paint Branch Drive), and the Central Animal Research Facility (8180 Engineering Drive) in College Park, MD. 5. Specific Tasks. The vendor will be tasked with maintaining animal colonies, inducing EAE/RR-EAE in experimental mouse groups, developing and testing the MS iPEM vaccines for animal studies, preparing iPEMs and characterizing the physicochemical properties, and testing iPEM samples from human MS patients (using the samples managed by Dr. Jewell). These activities will also require preparation of experimental protocols, maintaining logs of experimental activities, and communicating experimental results in oral and written form. 5.1 Task 1- Development and maintenance of research protocols and records 5.1.1 Subtask 1 - Assisting with Development of Experimental Protocols. The vendor will develop draft experimental protocols in digital form (e.g., Microsoft Word), with specific indication of experimental details, such as description of samples, reagents, procedures, interventions, substance volumes and concentrations, timing, power analysis, cohort sizes, and other pertinent details. 5.1.2 Subtask 2 - Keeping laboratory records. The vendor will keep thorough records of the experiments, including details of the work performed and detailed experimental observations. These will be reviewed by Dr. Jewell once a week, to clarify all ambiguous or missing details and to correct the notebook/logs. All data analysis will be carried out on laboratory computers and backed-up using the existing servers and infrastructure. Period of Performance: Base + 4 year option renewal years (5 years altogether) Deliverables: Microsoft Word files of experimental protocols and physical laboratory records (i.e., notebooks); Excel, Word, Powerpoint, Prism (statistics), and FCS (flow cytometry), images (histology), and Word files of experimental results. As requested, raw data from all directly relevant studies and colony records will be provided. 5.2 Task 2 - Production of iPEM MS vaccine molecules for mouse and human cell cultures studies, and for use in progressive and relapsing-remitting mouse models of MS 5.2.1 Subtask 1 - Assembling of iPEM Vaccine Panel. The vendor will produce the molecules by combining a bio-polymer material (e.g., nucleic acids) with other biological materials (e.g., myelin derived peptide) to produce a panel of candidate 'vaccine' molecules self-assembled from these different components. The vendor will characterize the molecules to quantify key physicochemical properties include surface charge, diameter, composition, and stability. These materials will be used for screening in in vitro mouse cells (Task 5.2.2) and in vivo mouse studies (Task 5.3). The iPEMs will also be used in cell cultures studies with pre-existing samples from human MS patients (mentioned above). 5.2.2 Subtask 2 - Screening of therapeutic vaccine molecules in mouse cells and human patient samples. The vendor will establish and use a mouse co-culture system based on primary antigen presenting cells isolated from mice and co-culture cultured with T cells isolated from transgenic mice engineered to generate T cells that recognize myelin antigen presented by antigen presenting cells, along with several features that allow tracking and reporting of function. Carrying out these studies will require the vendor to establish and maintain a breeding colony of the transgenic mice. The culture systems will be used to test each vaccine form the iPEM panel produced in Task 5.2.1 for the ability to control activation and inflammation in antigen presenting cells and in T cells, and to induce immune tolerance in these populations. The readouts for these studies will include surface, intracellular, and secreted signals (e.g., proteins and cytokines) measured by a combination of flow cytometry and antibody assays (e.g., ELISA) to indicate inflammatory and tolerogenic functions; the latter is a key goal to develop more effective therapies for MS. Gene expression analysis will also be used to define any modulation of TLR signaling. An analogous set of studies will be carried out in the pre-existing samples (PBMCs) from human MS patients. These cultures will be generally similar in goal, but will require treatment of the cells with iPEMs and restimulation with self-peptides to determine if the iPEMs reduce inflammatory recall response and promote tolerance. The analysis tools will be analogous to those describe for the mouse cell cultures. Subsets of these samples will also be isolated and analyzed in culture to isolate the role of specific subcompartments. Deliverables: Microsoft Word files of experimental protocols and laboratory records; Excel, Word, Powerpoint, Prism (statistics), and FCS (flow cytometry), images (histology), and Word files of experimental results. As requested, raw data from all directly related experiments and colony records will be provided. 5.3 Task 3-Testing of Vaccine Molecules in a Mouse Model of MS 5.3.1 - Subtask 1 - Maintenance of mouse colonies and induction of experimental MS. The vendor will induce and care for animals using two models of experimental MS (experimental autoimmune encephalomyelitis; EAE): i) a relapsing-remitting model (RR-EAE) that mimics late-stage disease, and ii) a progressive model (EAE) that mimics late-stage disease. These models will be induce using the established procedures and in selected animals. The vendor will perform daily checks using a detailed clinical scoring system that assesses body condition, weight loss, and impaired mobility of the animal (due to loss of neurologic function). 5.3.2 - Subtask 2 in vivo assessment of efficacy and mechanism of the iPEM vaccine panel. The vendor will test the most promising candidates from the iPEM vaccine panel by: 1) administering them in defined compositions, dosing regimens, and concentrations to the experimental mice, and 2) assessing the protective effects of the molecules on the mice, and 3) carrying out mechanistic studies to support efficacy and clinical translation. This will include early- and late-state interventions to assess the efficacy of the molecules in their ability to return mobility and function to the mice. In addition to these functional tests, the phenotype and signaling of treated and control groups will be assessed in antigen presenting cell and lymphocyte populations (e.g., inflammatory T cells vs. regulatory T cells) using surface and intracellular antibody staining, as well as cytokine secretion. Histology and lymph nodes, spleen, and the central nervous system will be used to ascertain organ/tissue-level changes in treated and control groups. Tissues will also be processed for analysis by gene expression using qRT-PCR. Further, the specificity of tolerance, and the ability efficacy to be transferred and achieve durability will be assessed using adoptive T cell transfer. The role of toll-like receptor signaling in disease and iPEM-driven therapeutic effects will be assessed using transgenic knock-out mice. Deliverables: Microsoft Word files of experimental protocols and laboratory records; Excel, Word, Powerpoint, Prism (statistics), and FCS (flow cytometry), images (histology), and Word files of experimental results. As requested, raw data from all directly related experiments and colony records will be provided. Period of Performance: Base + 4 option years (5 years althgother)