SOURCES SOUGHT
B -- Clinical evaluation of Phenserine tartrate Extended Controlled Release Tablet (ECRT) formulation in early mild Alzheimer�s disease and mild to moderate traumatic brain injury
- Notice Date
- 3/15/2022 6:15:27 PM
- Notice Type
- Sources Sought
- 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
- HHS-NIH-NIDA(AG)-SBSS-75N95022R00041
- Response Due
- 3/30/2022 9:00:00 AM
- Point of Contact
- fred Ettehadieh
- E-Mail Address
-
fred.ettehadieh@nih.gov
(fred.ettehadieh@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 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:� There is a significant unmet need for Alzheimer�s disease therapeutics as well as drugs that favorably impact the consequences of brain injury as it can initiate cascades of biological events that may lead to long-term neurodegenerative disorders such as Alzheimer�s disease. The focus of this contract is to evaluate a promising candidate that may provide beneficial actions to both disorders. This contract is to evaluate pharmacokinetic and pharmacodynamic measures of (-)-Phenserine tartrate Extended Controlled Release Tablet (ECRT) formulation in subjects with early mild Alzheimer�s disease (AD) in a phase 1/2 clinical trial and in mild to moderate traumatic brain injury (TBI) subjects in a phase 1/2 clinical study. Specifically, the contract is to provide clinical services for the approved administration of drug to two well-characterized patient populations, and to obtain blood and other sample/measures from them under rigorously safe conditions for later evaluation of pharmacokinetic and pharmacodynamic measures associated with drug plasma concentrations, blood markers of drug action, tolerability and brain/blood markers of efficacy. Purpose and Objectives: The main objective of this Contract is to provide a service to perform a phase 1/2 clinical trial evaluation of Phenserine tartrate ECRT in subjects with early mild Alzheimer�s disease and in mild to moderate traumatic brain injury. Specifically, the Contract will perform clinical services to provide brain imaging, cognitive assessment as well as blood and other samples to support evaluation of pharmacokinetic and pharmacodynamic measures. This will involve a multiple ascending dose (MAD) study of Phenserine ECRT, and then the selection of the optimal dose of drug to carry forward into a longer-term analysis of early efficacy. Project requirements: �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 (SOW) attached to this Sources Sought notice through individual Task Orders. Anticipated period of performance: The anticipated period of performance is 30 months ordering period. Capability statement /information sought: 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, 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 requirements 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 Small Business Sources Sought Notice must be submitted to Fred Ettehadieh, Contracting Officer, by email at fred.ettehadieh@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 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 SAM.gov. 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://sam.gov/opp/eba41b5a0bc244d3a49c8001e20f694c/view)
- Place of Performance
- Address: MD, USA
- Country: USA
- Country: USA
- Record
- SN06267886-F 20220317/220315230106 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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