SOLICITATION NOTICE
Q -- Assessing Drug Cardiac Safety with a 3D Engineered Cardiac Muscle Tissue Contractility Assay Platform
- Notice Date
- 5/3/2022 11:06:43 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95022Q00223
- Response Due
- 5/13/2022 8:00:00 AM
- Archive Date
- 05/28/2022
- Point of Contact
- Morgen Slager, Phone: 3014020952
- E-Mail Address
-
morgen.slager@nih.gov
(morgen.slager@nih.gov)
- Description
- (i)� �This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii)� The solicitation number is 75N95022Q00223 and the solicitation is issued as a request for quotation (RFQ). �This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13�Simplified Acquisition Procedures; �and FAR Part 12�Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).� The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition (including brand-name) to Curi Bio, 3000 Western Ave, Suite 400, Seattle, WA, 98121 for a service contract involving Screening of 17 cardiotoxic compounds at cMax in comparison to Untreated and Vehicle-treated Control. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). The rationale for the sole source justification is that ONLY Curi Bio provides both 2D and 3D drug toxicity testing services using their own platforms of cardiac tissue models in mid/high throughput formats. We have confirmed that this company has many experiences of testing drugs using their platforms. This unique platform will allow us for evaluating physiologically relevant functional outcomes of human cardiac muscle responding to drug compounds. NCATS previously obtained their measurement device for developing 3D skeletal muscle model (PO#: 75N95021P00371), which will allow for effective transfer of the 3D cardiac tissue assay from Curibio to NCATS in the future. To ensure continuity of science, we must test such an advanced cardiac tissue platform. (iii)� � The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-06dated May 1, 2022. (iv)� The associated NAICS code 541990, All Other Professional, Scientific and Technical Services. (v)� �The agreement will include depot hardware and software maintenance/support. Background: The LCSMS studies fundamental issues of synaptic transmission, Cardiac safety liabilities of new drugs including anti-viral and anti-cancer drugs are an important source of attrition during development as cardiac side effect is one of the leading causes of drug withdrawal in clinical trials. Therefore, there is a critical need to have in vitro physiologically relevant assays with medium throughput that can prospectively identify drug induced effects on myocardial function in early phase development and preferably prior to the in vivo testing of drug candidates. Drug-induced cardiotoxicity effects during drug development are typically assessed by cell-based human ether-a-go-go related gene (hERG) assays and in vivo animal studies, and then clinical studies, and are often conducted for drug clinical candidates at the late stage of preclinical drug development. However, hERG assays and animal studies sometimes fail to predict the clinical cardiotoxicity of drugs. Thus, there is still a critical need to develop and validate more clinically predictive assays for cardiotoxicity.� Physiologically relevant testing platforms with reasonably assay throughput, and affordable costs, would be very valuable to detect effects of compounds on cardiac function, including contraction. Such platforms could be used earlier in drug development to identify the best possible clinical drug candidates. These testing platforms might also provide mechanistic information on how a given drug affects cardiac contractility. We propose to do a pharmacological comparison of the Curibio 2D NanoSurface� vs MantarrayTM 3D Cardiac Contractibility assay platforms, as pre-clinical assays to assess potential drug cardiac liabilities. The compounds will be blind tested at one dose (Cmax when known, or otherwise at a dose where mitochondria toxicity effects were detected) in quadruplicates (n=4). Although the number of compounds to be tested is limited to keep the evaluation to a reasonable cost, this project is meant to be an initial assessment of the robustness, reproducibility, and differences in toxic effects of the compounds between the CuriBio 2D and 3D cardiac contractibility assay platforms. Purpose: Cardiovascular (CV) safety liabilities of new drugs including anti-viral and anti-cancer drugs are an important source of attrition during development. Therefore, there is a critical need to have in vitro assays with medium throughput that can predictively detect drug-induced effects on myocardial contractility as early as possible, and preferably prior to the in vivo testing of drug candidates. Curibio has developed a hiPSC-based 3D assay system for scalable cardiac safety screening. This unique technology uses the Curibio proprietary Mantarray� instrument to enable parallel measurements of 3D engineered cardiac muscle tissue contractility using magnetic sensing, in a 24-well plate system. We are planning to assess the predictability of this cardiac contractibility assay platform using a set of compounds with known cardiac liabilities. Project Requirements: Study Overview: Screening of 17 cardiotoxic compounds at cMax in comparison to Untreated and Vehicle-treated Control. Study Design WT iPSC-CM�s (Celogics CardioSight S) n=4 replicates per condition 17 compounds at cMax in 3D, and 4 doses in 2D 1 Vehicle control condition 1 untreated control condition 3 Mantarray (MA) plates 3 96 well NanoSurface plates Monitor MA outputs for 3 weeks of culture after week 1 Study Equipment Mantarray Beta Ver. 1.7 Nikon Ti2-E inverted optical microscope with a high-speed and high-sensitivity Hamamatsu ORCA-FUSION sCMOS camera Custom Environmental Control Unit Custom Engineered electrode stimulation system (Pacing for optional Ca2+ assay) Pulse 2D image analysis software Maestro Pro AxIS Navigator version: 2.0.4.21 DELIVERY OR DELIVERABLES Study Deliverables Collated Data Report of Full MA Outputs Collated Data Report of Pulse 2D Outputs Collated Data Report of MEA analysis Collated microscopy and imaging analysis of 3D-EHT�s Collated microscopy and imaging analysis of 2D treatments Fixed 2 endpoint 2D plates Fixed and frozen MA tissues (vi)���The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated period of performance is: Starting 9 approximately 9 weeks ARO. Base Year 5/30/2022 � 05/29/2023 (vii)� The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:� https://www.acquisition.gov/browse/index/far �� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html �� � (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) FAR 52.225-2, Buy American Certificate (Feb 2021) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text.� Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Jan 2022) NIH Invoice and Payment Provisions (Feb 2021) (viii)� The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. (ix)� �The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (x)� � The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xi)���There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xii)� �The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiii)� �Responses to this solicitation must include sufficient information to establish the interested parties� bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations. The Uique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All offers must be received by 11:00 a.m., Eastern Daylight/Standard Time, on Friday, May 13, 2022, and reference solicitation number 75N95022Q00223. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/69f98e2650ae48439d22b065e2f03ea5/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN06315200-F 20220505/220503230103 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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