FBODaily.com | FedBizOpps: SRCSGT | B | Kinetic Image Analysis

FBO DAILY - FEDBIZOPPS ISSUE OF JULY 23, 2015 FBO #4990
SOURCES SOUGHT

B -- Kinetic Image Analysis

Notice Date: 7/21/2015
Notice Type: Sources Sought
NAICS: 541690 — Other Scientific and Technical Consulting Services
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
ZIP Code: 72079
Solicitation Number: FDA1151961
Archive Date: 8/12/2015
Point of Contact: Nicholas E Sartain, Phone: 870-543-7370
E-Mail Address: nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
Small Business Set-Aside: N/A
Description: MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for kinetic image analysis of calcium transient and action potential of induced pluripotent stem cell-derived human cardiomyocytes (iPSC-CMs, from both male and female donors)to be cultured in monolayer and analyzed by the Contractor. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required services. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is-541690- Other Scientific and Technical Consulting Services; Small Business Size Standard is $15 million. The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires the Contractor to analyze iPSC-CMs using high-resolution imaging assays to survey for compound effects against the full complement of cardiac ion channels in a physiologically relevant model. Part I: General Introduction The US FDA Office of Women's Health (OWH) has funded NCTR in establishing in vitro (cell culture) screening assays to study gender differences in drug-induced arrhythmia. As part of the study, NCTR will use high-resolution imaging assay services to evaluate gender differences in the proarrhythmic response of a pair of iPSC-hCMs cell lines, male and female, to three compounds for which there exist extensive animal and human data and for which their mechanisms of action are well understood. A. Background QT interval (the space between the start of the Q wave and the end of the T wave) prolongation at surface electrocardiogram ECG is a biomarker for assessing the risk of torsade de pointes (TdP). Although, in general, torsadogenic potential is correlated with the extent of QT prolongation, it is not always true for some drugs. Many of the risk factors, including sex, need to be considered in risk assessments of drug-induced TdP. Besides, TdP is not always initiated by blocking Herg (the human Ether-à-go-go-Related Gene) channel, the simultaneous effects on other ion channels may compensate the Herg blocking effects. Recently, iPSC-hCMshave become a popular model because they largely resemble the electrophysiological behavior of human ventricular myocytes. However, iPSC-hCMs are derived from individuals with diverse genetic backgrounds, no single line is optimal for detecting all arrhythmogenic mechanisms. It would thus be critical to understand the particular characteristics, such as gender difference, of any lines NCTR would routinely use for characterizing compounds. B. Scope When observed at the cellular level contraction of the heart is a three step process where: 1) Currents generated by the intrinsic pacemaker tissues of the heart stimulate an action potential in the cell; 2) The action potential stimulates the generation of the cardiac calcium transient, a rapid rise and fall of intracellular calcium levels which 3) regulates the activity of the contractile machinery of the cell. Compounds altering the activity of any of the steps mentioned above may in turn induce arrhythmias. Thus, analyzing compound induced alterations in both the action potential and calcium transients of stem cell derived cardiomyocytes using high-resolution imaging assays provides an integrated assay to survey for compound effects against the full complement of cardiac ion channels in a physiologically relevant model. Part II: Work Requirements A. Technical Requirements for Contractor: • Contractor shall be required to culture male and female hiPSC iCell® cardiomyocytes produced by Cellular Dynamics International in monolayer for two weeks then switch the CDI normal culture medium to a hormone-free medium ((These cells and media shall be provided by NCTR) • The Contractor shall be requested to apply one physiological concentration of testosterone (5α-dihydrotestosterone, DHT) on male cells and one physiological concentration of 17-estradiol (E2) on female cells • Contractor shall be required to perform a calcium transient assay and an action potential (e.g. integrated membrane potential) assay under electrical stimulation (1Hz or as discussed with NCTR Technical Representative). The measured data will include transient/action potential duration at 25%, 50%,75%, and 90% of full transient/action potential duration, changes in transient/action potential shape (triangulation or T75-25), amplitude, maximal upstroke and decay/contraction and relaxation velocity, ensemble average of Ca-transient /action potential profiles, and occurrence of proarrhythmia such as early after depolarization (EAD). • The Contractor shall measure the effects of three compounds (four concentrations each), which will be provided in stock solution form by researchers at NCTR. Names of compounds will not be provided as the contractor will perform a blinded study. • A reference compound and a negative control also will be run on the same plate for quality assurance purposes. Fluorescent markers, reference compound, imaging solutions, DMSO, and compound dose preparation shall be provided by the Contractor. • The Contractor shall compare baseline measurements and response (30 min post drug addition, or specified duration discussed with NCTR Technical Representative) to chemical treatment between male and female cardiomyocytes with/without hormone treatment in at least triplicated wells. B. US Government Laboratory will conduct the following during this study: • Researchers at NCTR will ship four (4) vials (>4 millions cells/vial) of cells from each gender to the contractor for processing and data analysis. The cells, hormones, and compounds will be shipped to the Contractor within three (3) months after contract award. An additional vial of cells can be provided within four (4) months after contract award if needed. C. Deliverables • The contractor shall update Technical Representative (TR) (to be identified at award) each month on the status of the project and discuss the result with the TR. A full data report in PDF format shall be provided to the TR. This report shall be completed within 3 months of receiving the biological samples from the FDA. Contractor shall send a draft final report for TR review/comments prior to submission of the final full data report. Contractor shall incorporate TR comments or make appropriate changes as required to the final data report. The data report shall contain effects of different culture conditions, gender of cells studied and drug effects on action potential duration, maximum rate of rise and fallEnsemble average of action potential profiles, and changes in calcium release and re-uptake, such as Ca-transient duration, amplitude, maximal upstroke velocity, and maximal decay velocity and ensemble average of Ca-transient profiles. D. Place of Performance: • Biological samples analysis shall be conducted at the Contractor's laboratory. Laboratory shall be equipped to perform high-resolution imaging analysis. • The Contractor will receive the payment for the service after FDA/NCTR receives and accepts the final report. • Biological samples will be shipped from the NCTR laboratory address listed below to the contractor. Dr. to be identified at time of award FDA/NCTR 3900 NCTR Rd. Bldg.__, Room ___ Jefferson, AR 72079 FOB Point Destination. All items shall include shipping and handling to the destination identified herein. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • Three (3) years of past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar service solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 28, 2015 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1151961. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. 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 FedBizOpps. 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).
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1151961/listing.html)
Place of Performance: Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States; Zip Code: 72079
Record: SN03805359-W 20150723/150722000037-3ffe05a806e82479b2087ed425560807 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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B -- Kinetic Image Analysis