SOURCES SOUGHT
Q -- Testing of compounds in rat pharmacokinetic experiments
- Notice Date
- 12/21/2020 9:22:53 AM
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95021Q00039
- Response Due
- 12/31/2020 8:00:00 AM
- Archive Date
- 01/15/2021
- Point of Contact
- Renato Gomes, Phone: 3014512596
- E-Mail Address
-
renato.gomes@nih.gov
(renato.gomes@nih.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made as a result of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. Background:� The National Institutes of Health (NIH) is the nation�s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people�s health and save lives.� The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people�s lives. Included in this process is the development of unique small molecules as potential anticancer agents. Prior work at NCATS has produced a series of small molecule inhibitors, including NCGC00371481 and its structural analogs. Compounds such as �1481 have shown promising results in cellular and mouse models of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).� Further optimization of the biochemical, physiochemical and pharmacokinetic properties of these compounds is required, and may eventually produce a clinical candidate that could be used to treat cancers such as MDS and / or AML. In order for a candidate compound to advance into clinical trials, it must display a wide range of acceptable properties.� For this program, a potential clinical candidate must display potent inhibition of the desired targets.� It must also display suitable pharmacokinetic (PK) properties in a range of preclinical species, including at least one rodent species (mouse or rat), as well as at least one higher preclinical species (dog or monkey).� Good PK profiles in these species are required 1) in order to build models that predict good pharmacokinetic properties in humans, and 2) so that compounds can be given at high doses and high plasma exposure levels in preclinical safety studies. In order to characterize and optimize the pharmacokinetic properties of NCAT�s compounds in rat, the Program need to run a series of rat pharmacokinetic experiments.� Testing a set of 20 small molecule compounds in rat PK experiments will provide critical data that identify the strengths and weaknesses of NCATS current compounds� PK profiles, and will help optimize those profiles so that the program can identify a suitable candidate for clinical trials. Purpose and Objectives: This order provides for testing of 20 small molecule compounds in rat pharmacokinetic experiments. These compounds are drug molecules being evaluated for a kinase inhibitor program. Testing of the compounds for their pharmacokinetic properties in rat will provide critical information on compound clearance, exposure, and bioavailability. Project requirements: 1. Test each of 20 small molecule compounds in rat pharmacokinetic studies comprised of two dosing arms (one oral, one IV, n = 3 rats per arm). Test compounds shall be administered as a single doses (either oral or IV, depending on the study arm), and in each study arm, 8 serial blood draws will be taken at 8 different time points covering a range of at least 8 hours, and up to 24 hours, post-dose.� Plasma samples shall be analyzed by LCMS to determine the concentration of test compound at each time point. 2. Provide a comprehensive report for each of the 20 compounds detailing results from the pharmacokinetic experiment. The report must contain the following: A graphical plot of plasma concentration of test compound vs. time; A table of raw data showing the plasma concentration of test compound at each time point in each rat, as well as the average or mean concentration across all 3 rats, and the standard deviation or standard error for each mean value; Calculated oral bioavailability (F%), clearance rate (Clp), half-life (t1/2), area under the curve (AUC), maximal concentration (Cmax), and volume of distribution (Vd) for the compound. 3. Contractor shall run the assays using scientists that have significant experience (>3 years) in the testing of small molecule compounds in rat pharmacokinetic experiments. 4. Contractor shall be required to have an active OLAW Animal Welfare Assurance and AALAC accreditation. Do not provide the actual assurance with your response, but indicate whether you possess these qualifications. 5. Contractor shall have significant experience (>3 years) in running rat pharmacokinetic experiments. Level of Effort: Estimated personnel: 1 (one) PhD level-Manager. 1 (one) Ph.D. level scientist. 1-2 months total. Government Responsibilities: Government will not furnish property, facilities, workspace, computers, or other equipment. Contractor will not use federal facilities. Government will have the responsibility to review and approve the final report. Government will have the responsibility to provide sufficient quantities of the lead compound in order to contractor to accomplish the necessary work. Delivery or Deliverables: Contractor shall provide the data analysis and reports for the contents of the performed services. Reporting Requirements: Contractor shall provide monthly updates on the progress of the project, or more often as deemed appropriate. Anticipated period of performance: Period of performance shall be 12 months from the contract award and receipt of first batch of material. Other important considerations: N/A. Capability statement /information sought. Respondents must provide clear and convincing documentation of their capability of providing the products specified in this notice. Moreover, responders must provide a capability statement for: respondents� opinions about the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; information regarding respondents�: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; The respondent must also provide their� DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. Submission Instructions: � One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2� x 11� paper size, with 1� top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.� A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit.� The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Submit responses by email to Renato Gomes, Contract Specialist, at Renato.gomes@nih.gov. �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 presolicitation 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: 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
-
SAM.gov Permalink
(https://beta.sam.gov/opp/873e93e72dad4a2ab6328dff0a43a7a4/view)
- Place of Performance
- Address: Bethesda, MD 20892, USA
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN05878955-F 20201223/201221230112 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |