SOURCES SOUGHT NOTICE # FDA_SSN_1227128 for an instrument capable of enabling maturation of hiPSC-cardiomyocytes using electrical pacing Posted Date: May 29, 2020 Response Date: June 12, 2020 by no later than 2:00 pm CDT Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the imaging equipment described below. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a Small Business Set-Aside is possible. The appropriate NAICS code for the acquisition is 334516 – Analytical laboratory Instrument Manufacturing; Small Business Size Standards – 1,000 employees. Requirement and Background The U. S. Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) Division of Systems Biology (DSB) requires an instrument capable of (1) high-throughput screening, (2) simultaneous and real-time monitoring of viability and contraction, and (3) directed electrical pacing, of human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). Drug-induced cardiotoxicity is the leading cause of late stage drug attrition and drug withdraw. Because many of the cardiotoxicities are often discovered in late-stage clinical trials or even years after drug approval, there is an urgent need to develop translational and sensitive preclinical methods to assess potential drug-induced cardiotoxicities early in drug development and well before human clinical trials are initiated. hiPSC-CMs are gaining recognition for in vitro cardiac toxicity screening of new drug candidates and have been used to support investigational new drug applications and to reveal mechanisms of drug actions. A current project supported by CDER and NCTR uses patient-specific iPSC-CMs to predict anticancer drug induced cardiotoxicity. We are in the process of screening drug-induced cardiotoxicity over 250 lines of iPSC-CMs with doxorubicin and 12 tyrosine kinase inhibitors. A high-throughput assay platform will greatly speed up the progress of the project. Human iPSC-CMs generated with current protocols display immature phenotypes that are not shared with adult human cardiomyocytes, which have made it difficult to interpret the responses to therapeutic compounds. For example, adult human cardiomyocytes display positive force-frequency relationship whereas hiPSC-CMs showed negative force-frequency relationship. As several studies have reported that chronic pacing improved the maturation of iPSC-CMs, an assay platform that is capable of chronic pacing in a highly flexible format and high-throughput manor may improve the accuracy in predicting drug-induced cardiotoxicity. Minimum Technical Requirements The required instrument shall include and meet the following technical requirements: 1. Capable of chronic electrical pacing of hiPSC-CMs to improve the maturation of cardiomyocytes as demonstrated by the enhanced contractility to an increase of pacing frequency (the positive force-frequency relationship); 2. Precise control of beating rate of hiPSC-CMs over different time durations; 3. Simultaneous pacing of cardiomyocytes from a few columns to up to six 96-well plates; 4. Consistent data acquisition from a few columns to up to six 96-well plates to enable more high-throughput experiments; 5. Compatible with different types of workflows, such as plate readers, calcium measurements, high content microscopy, and voltage sensitive dyes; 6. Software capable of tunable pacing and stimulus settings that can be independently applied based on individual columns or across different plates; 7. Include built-in algorithm capability that automatically generates relationship curves to evaluate cell maturation; 8. Software capable of real-time monitoring and off-line data analysis of cell viability and contractility; 9. Include laptop computer-based control unit pre-installed with all software listed above; 10. Minimum 1-yr. full warranty to include unlimited e-mail and telephone support from manufacturer; 11. Include all shipping charges FOB Destination. Delivery Address: U.S. Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079-9501 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the required electrical pacing instrument described herein and meeting the technical requirements set forth above. Although the target audience is small businesses or small businesses capable of providing these systems from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following: Business name and bio, 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 again if responding with the capability of providing an instrument offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the instrument and equipment (to include consumables) which the responding firm is regularly engaged in providing; Information on available service/maintenance plans for the identified equipment; If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN’s that are applicable to this potential requirement are also requested. If a large business, provide documentation if subcontracting opportunities exist for small business concerns; 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. Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on June 12, 2020, to Tim Walbert, Contract Specialist, at the following address:
[email protected]. 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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality and Proprietary Information 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).