SOURCES SOUGHT
Q -- Evaluating Pharmacokinetics of Compounds from Dystonia Project
- Notice Date
- 6/23/2021 7:41:16 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
- 75N95021Q00256
- Response Due
- 7/8/2021 12:00:00 PM
- Archive Date
- 07/23/2021
- Point of Contact
- Scott Bredow, Phone: 3014807503
- E-Mail Address
-
scott.bredow@nih.gov
(scott.bredow@nih.gov)
- 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 NAICS code 541380 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 and Objectives: � In DYT1 dystonia, there is a delta E mutation in the torsin A protein that leads to its mislocalization, that is, instead of having a diffuse distribution it forms dots (puncta) with cells. With the National Center for Advancing Translational Sciences (NCATS) collaborators at Duke University, we embarked on a high throughput screening campaign followed by the identification of hit compounds that were further optimized by medicinal chemistry into compounds that are able to rectify a torsion mislocalization at less than 100 nanomolar concentrations. In vitro, these compounds have a range of stabilities in mouse liver microsomes and a range of permeabilities as determined by a PAMPA BBB assay. However, we need to determine their actual levels in mice in order to discover a compound that is ready for proof of concept in a relevant dystonia animal model. This also seeks to determine the partition coefficient of the free fractions in brain versus free fraction in plasma which is an important parameter to rank order compounds that are predicted to have better efficacy specially in neurological diseases such as dystonia. Project Requirements: Contractor will be required to perform the following: 1. Receive compounds over a period of 12 months from NCATS and dose male C57/BL6 mice at a predetermined dose, route of administration, and formulation. 2. Harvest plasma, brain, heart, kidney, and liver after dosing at 8 time points (5 min, 15 min, 30 min, 1, 2, 4, 8, 24 hr) with N=3 per time point. 3. Develop a method to determine concentration of compounds in all tissues. 4. Plot concentration vs time graphs, calculate PK parameters, note in life clinical observation, and provide them in a report to NCATS. 5. Perform Kpuu studies on an ad hoc basis, if needed. 6. The Contractor shall be required to have an active NIH OLAW Animal Welfare Assurance and AALAC accreditation. Do not provide the actual assurance with your response but indicate whether you possess these qualifications. Note: NCATS will supply compounds from the dystonia project and a study design to the contractor. Anticipated Period of Performance:� The anticipated period of performance is 12 months from the date of award. Capability Statement: Small business concerns that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.� Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Small businesses must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested small businesses are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. 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 an 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) pages.� The 10-page limit does not include the cover page, executive summary, or references, if requested. All capability statements sent in response to this Sources Sought Notice must be submitted to Scott Bredow, Contracting Officer, via email at scott.bredow@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Facsimile responses are not acceptable. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response.� No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities.� However, responses to this notice will not be considered adequate responses to a solicitation.� The solicitation release date is pending.� 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
-
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- Record
- SN06040844-F 20210625/210623230114 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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