MODIFICATION
R -- TRND Malaria Williamson Profiling from lead optimization and safety profiling panels
- Notice Date
- 7/24/2018
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIHDA201800287
- Archive Date
- 8/10/2018
- Point of Contact
- Hunter A Tjugum, Phone: 3018275304
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The purpose of Amendment one (1) is to extend the due date for accepting quotations from July 24, 2018 to July 26, 2018. All other terms and provisions remain unchanged. (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 NIHDA201800287 and the solicitation is issued as a Request for Quotation (RFQ) on a Full and Open competitive basis. 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; FAR Subpart 13.5- Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is NOT expected to exceed the simplified acquisition threshold (SAT). A Fixed-Price type of Purchase Order contract is contemplated for any resulting contract entered into as a result of this solicitation. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC Number/Effective Date: 2005-99-1 / 07-16-2018. (iv) The North American Industry Classification System (NAICS) code for this procurement is 541990- All Other Professional, Scientific and Technical Services with associated small business size standard of $15.0 million. (v) Background The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) was officially established in fiscal year 2012 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS, one of 27 Institutes and Centers (ICs) at NIH, strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients. The Therapeutics for Rare and Neglected Diseases (TRND) program at NCATS supports pre-clinical development of therapeutic candidates intended to treat rare or neglected disorders, with the goal of enabling Investigational New Drug (IND) candidates. TRND projects are selected based on their potential to move forward into human trials and transform patient care for rare and neglected diseases. Each project has the potential for success and ability to teach important lessons about rare and neglected disease drug development. Plasmodium falciparum malaria remains a major threat to the public health, especially in tropical and subtropical areas of the world's poorest countries. The life cycle of Plasmodium falciparum malaria comprises an exogenous sexual phase with multiplication in certain mosquitoes corresponding to the vector of the disease and an endogenous asexual phase with multiplication in the human host. During a blood meal, a malaria-infected female Anopheles mosquito inoculates sporozoites into the human host. After several asexual cycles in the blood following the hepatic cycle, some merozoites can differentiate into sexual forms known as macro (female) or micro (male) gametocytes. This production of gametocytes from asexual parasites is named gametocytogenesis. Ingestion of these gametocytes by the invertebrate host allows for the following gametocytogenesis process and the continuation of the parasite cycle. Although the malaria illness is caused by the asexual blood stages, the presence of gametocytes is directly responsible for the infection of the anopheline vector, thus perpetuating the plasmodial cycle. Thus, identifying drugs which can kill gametocytes is an essential strategy in antimalarial drug development. Recently NCATS has identified a series of (quinolin-3-yl)benzo[h][1,6]naphthyridin-2(1H)-ones with gametocytes killing activity. Since similar compounds were reported as cancer treatments with potential adverse effects, it is important to measure our compound's inhibitory activity against common safety pharmacology targets so that we can develop a strategy to keep the gametocyte killing activity and reduce the safety-related attrition. Purpose and Objective: The purpose of this requirement is to obtain contractor results of compound testing from profiling panels that provide early identification of significant off-target interactions for the optimization of safety margins of various compounds. Contractor shall provide safety profiling to check the potential off-target toxicity of the Government's lead compounds. The selected targets are common targets associated with toxicity observed in drug discovery, and they were recommended by major pharmaceutical companies in the drug discovery process (see attached list of safety targets). This project is to determine percent inhibition values of 10 compounds in lead optimization and safety profiling panels using 44 selected targets and 2 compounds in lead optimization and safety profiling panels using 87 selected targets. Product Description: This requirement includes obtaining contractor support that will fulfill the following salient characteristics deemed essential to achieve. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: 1.Determine percent inhibition values of 10 compounds in the lead optimization and safety profiling panels of 44 selected targets and 2 compounds in the lead optimization and safety profiling panels of 87 selected targets. Safety targets are listed in the attached file. 2.The selected targets shall be gathered in a cost-effective panel that brings together both robustness (each assay is HTS-compatible) and the strategic choice of information-rich targets in the drug discovery process. 3.Item description includes Assay mode using Single Point, 2 compounds, 1 concentration, 2 replicates, quantity two (2), batch consisting of default test Con. 10 uM. 4.Profiling panels used shall provide the early identification of significant off-target interactions for the optimization of safety margins required. Contractors shall possess the technical capability to achieve the salient government essential features of this requirement and document evidence of being able to provide the subject requirement that will allow for the essential features described herein to be accomplished. Period of Performance Project Initiation Date: receipt of purchase order and the compounds Project Completion Date: 2 weeks after receipt of the compounds The projected award date is July 31, 2018. All compounds and testing results need to be completed not later than September 30, 2018. GOVERNMENT RESPONSIBILITIES NCATS will provide the compounds to be profiled. DELIVERY OR DELIVERABLES Reporting of results should be delivered electronically to NCATS within two (2) weeks of receipt of compounds. Confidentiality of Information: All data is the property of NCATS unless otherwise specified. Inspection and Acceptance Offerors must indicate an estimated delivery time in full after receipt of an order and compounds to be analyzed. Inspection and acceptance of delivery or deliverables will be performed at NCATS, located at 9800 Medical Center Drive, Rockville, MD 20850. (vi) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. The following is provided as an addendum to FAR clause 52.212-1, Instructions to Offerors: Offerors must indicate an estimated delivery time in full after receipt of material to be tested. (vii) The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. The following is an addendum to 52.212-2. Responses received to this RFQ will be evaluated on the basis of Lowest Price Technically Acceptable (LPTA). Offeror's submitting a response must provide a completed Price Quote to be evaluated and considered for award. Price quotes must indicate fixed unit pricing and total cost, including shipping cost and estimated time of delivery after receipt of order, and warranty or training considerations as applicable. Responses will be evaluated based on contractor's ability to meet the government's essential requirements stated in this notice and on ability to deliver required supplies. Responses to this solicitation must include clear and convincing evidence of the Offeror's capability of fulfilling the requirement as it relates to the essential government requirements stated in this solicitation. Under the lowest-price technically acceptable (LPTA) process, Offerors' will be determined to be "technically acceptable" or "technically unacceptable" based on the evaluation of responses to determine if, as submitted, the proposal is technically acceptable. Technical Acceptability will be determined on the offeror's Technical Capability: Offerors shall clearly indicate possessing the technical capability to achieve the salient characteristics of this requirement. The Offeror must indicate in its quotation the ability to provide all essential features of this requirement. The Offeror must indicate in its quotation the ability to meet the delivery requirements. Offerors submitting a response with documented technical specifications and evidence of possessing the technical capability, technical knowledge, qualifications and capability and management structure needed in successfully achieving this requirement will be determined to be technically acceptable. Respondents that believe that they are manufacturers or authorized resellers of any BRAND-NAME product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. (viii) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition. (ix) The provision at FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. An addendum to FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items, Offeror Representations and Certifications Commercial Items, applies to this acquisition. The addendum includes the following FAR Clauses: non-applicable. (x) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items applies to this acquisition. See attached document. (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. Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria and a price proposal. Offerors are requested to submit historical pricing information ESSENTIALLY EQUAL to a commercial item price list or redacted contract or invoice containing the price offered to a commercial or public entity for the same or similar subject requirement. Offerors must include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, or provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror's cover sheet. In addition the Dun & Bradstreet Number (DUNS), 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 responses must be received no later than the date specified in this announcement. Late responses will not be accepted. All responses must reference the solicitation number NIHDA201800287. Responses to this Request for Quotation solicitation must be submitted electronically to Hunter Tjugum, Contracting Officer, at hunter.tjugum@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, please contact Mr. Tjugum by email at hunter.tjugum@nih.gov
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