Inactive 8(a) Sole Source (FAR 19.8)

Title: Establishing organ-chip models for studying radiation-induced normal tissue injury and identifying RNA biomarkers for radiation biodosimetry Document Type: Sources Sought Notice Solicitation Nu... Title: Establishing organ-chip models for studying radiation-induced normal tissue injury and identifying RNA biomarkers for radiation biodosimetry Document Type: Sources Sought Notice Solicitation Number: 75N91020R00010 Posted Date: 01/28/2020 Response Date: 02/14/2020 Classification Code: 6505 – Biological and Reagent Material – Direct Use NAICS Code: 334517 – Irradiation Apparatus Manufacturing(1000 employees). Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Bethesda, MD 20892. Description This is a sources-sought to determine the availability of potential sources having the skills and capabilities necessary to perform/provide the SPECIFIED REQUIREMENT. All interested vendors are invited to provide information to contribute to this market survey/sources sought synopsis only. Questions should be submitted by email to william.neal@nih.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub-zone, 8(a), small, small disadvantage, woman-owned small business, or large business) relative to 334517 – Irradiation Apparatus Manufacturing (1000 employees). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources-sought synopsis, a solicitation announcement may be published on the FBO website. Responses to this sources-sought synopsis are not considered adequate responses to any future solicitation announcements. All interested offerors will have to respond to the solicitation announcement in addition to responding to this sources-sought announcement. Background Partial or total body irradiation (TBI) causes damage to the vascular endothelium and in effect, injury to vital organs such as the lungs, liver, kidneys, heart, and brain. Current models for studying acute radiation injury and its biomarkers include animal models (e.g. mouse, non-human primate) and static in vitro cell cultures. Mice are the most frequently used animal models because they’ve been well characterized and are advantageous in terms of space, time, and cost; however, they do not mimic human physiology or organ structure, and fail to recapitulate all radiation-responses observed in humans. By contrast, two- and three-dimensional in vitro cell cultures address the human aspect that animal models lack, but do not mimic cell behavior in the body and thus sacrifice key biological interactions required to understand the molecular mechanisms of radiation response. The DHHS, NIH, National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB) recently conducted extensive research in a mouse model after whole body irradiation to see if non-coding RNAs and coding RNAs can be used as biomarkers for radiation biodosimetry. The NCI has also been assessing the role of the radiation induced miRNAs in prostate carcinoma cells, normal prostate epithelial cells (RWPE-1), and in human coronary artery endothelial cells (HCAEC) as potential molecular therapeutic targets in radiotherapy. To bridge the gap between previously studied animal models and static in vitro cell cultures, an automated microfluidic cell culture system of human organ-chips is necessary. This system will incorporate mechanical stretch of and continuous fluid flow through the organ-chips to recreate the tissue-tissue interfaces of human organs. Previous work demonstrates not only that organ-chips grown in this automated culture system mimic the microenvironment, structure, and cellular interactions of human organs, but that irradiating the organ-chips leads to the same structural damage seen in humans after radiation. By recapitulating key radiation-induced responses seen in humans, the automated organ-chip culture system provides a more advance in vitro model for studying radiation-induced normal tissue injury and identifying radiation induced RNA biomarkers. SPECIAL ORDER REQUIREMENT PRODUCT FEATURES/SALIENT CHARACTERISTICS For this requirement, the NCI’s organ-chip platform must meet the following criteria: The cell culture system must contain microfluidic chips made from silicone polymer with a 7µm membrane separating the endothelial and epithelial chambers. This allows the culture to be subject to specific mechanical forces, i.e. fluid flow and stretch, that recapitulate the microenvironment of cells in the human body. Additionally, separate endothelial and epithelial chambers allow isolation of each cell type independently of the other, which is critical to study response of the endothelium to radiation and observe its interactions with other key cell types such as organ-specific epithelial cells The chips shall also be available in forms suitable for culture of various organ-specific cells (basic research and liver co-culture kits). The chips shall connect to a holder (pod) that enables the addition and replenishment of fluid to the epithelial and endothelial chambers independently, without the need for peristaltic pumps, tubing, or syringes. The flow and stretch applied to the chip-pod system shall range from 0µl/hr – 1000µl/hr and 0.01Hz to Max 0.4Hz or a maximum of 10%, respectively. These conditions shall be user-selectable through a digital interface. The chips shall reside in the pod and be placed inside a controlling instrument (culture module) that holds 12 chips and is able to be housed in an incubator. This incubator shall be pre-programmed by the user to enable treatment and culture of the cells in the epithelial and endothelial chambers independently. The system shall be designed so that individual chip-pod systems can be removed from the culture module, analyzed with live cell imaging via a microscope, and placed back into the culture module within the incubator. Furthermore, this removal of the chip-pod system from the culture module shall be easy and the pod shall contain 4 fluid reservoirs: 2 for the endothelial and epithelial inlet chambers and 2 for the outlet flow from each chamber. This will enable collection of effluent from the chip at any time while it is in the incubator. The instruments that supply power and forces to the chip-pod systems (culture and power modules) shall do so via internal pressure, thus eliminating the need for a pumping system. A system with the aforementioned specifications is necessary for reproducibility of experiments, for compatibility with downstream analysis instruments (e.g. imagers), and to fit within the dimensions of the current incubator and lab space. Each component of the system must have the following key specifications: Culture Module: System controls flow in the organ-chip: Min= 0ul/hr to Max=1000ul/hr System controls stretch frequency: Min=0.01Hz to Max=0.4Hz System has a maximum organ-chip Stretch = 10% System controls flow of up to 12 organ-chips independently System operating temperature 20-37.5°C Power Source: Connects and supplies power to up to two culture modules Provides gas, power, and stretch required by culture modules Organ-chips: Organ-chip contains Epithelial Chamber and Endothelial Chamber separated by 7um Flexible membrane Organ-chip is high clarity & optically transparent to allow high content imaging Organ-chip holder, known as a Pod, contains 2 reservoirs for inlet and 2 reservoirs for collection off effluent Pods and organ-chips are self-contained with 0.2um filters to ensure no cross contamination while in instrument. Pods and organ-chips are supplied sterile for cell culture All responses and questions shall be emailed to William Neal, Contracting Officer, via electronic mail at william.neal@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through SAM.gov. Reference: 75N91020R00010 on all correspondence. This notice is not a request for competitive quotation. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received via electronic mail at william.neal@nih.gov by 3:00 PM EST, on February 7, 2020. Responses should include both the STATEMENT OF CAPABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained below. This notice is to assist with determining sources only. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. REQUESTED INFORMATION: (1) STATEMENT OF CAPABILITY: Submit a brief description [ten (10) pages or less] that includes product specifications. Include past experience with performing this type of service for Government (Federal or State) agencies, or for a private medical facility. Please indicate your address (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB)(g) Include the DUNS number of your firm. (h) State whether your firm is registered with SAM System for Award Management www.sam.gov/. If not, please NOTE: any future solicitation can only be awarded to a contractor who is registered in SAM.