SOURCES SOUGHT
Q -- Method Development and Determination of Levels of (2R,6R)-hydroxynorketamine in Human CSF and Human Plasma Pharmacokinetics to Support Phase II (2R,6R)-hydroxynorketamine Trials.
- Notice Date
- 1/28/2022 12:24:19 PM
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95022Q00100
- Response Due
- 2/14/2022 6:00:00 AM
- Archive Date
- 02/15/2022
- Point of Contact
- Kimberly Espinosa, Phone: 3018273546
- E-Mail Address
-
kimberly.espinosa@nih.gov
(kimberly.espinosa@nih.gov)
- Description
- PURPOSE OF NOTICE: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. 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 tremendously 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. � PURPOSE AND OBJECTIVES: The National Center for Advancing Translational Sciences (NCATS) is seeking information about vendor capabilities for pharmacokinetics data acquisition, sample analysis, and reporting to support a phase I and phase II clinical trial in human patients. (2R,6R)-Hydroxynorketamine is currently in phase 1 trials for treatment-resistant depression. While animal models have demonstrated that 2R,6R-HNK easily penetrates the blood-brain barrier (BBB), there is always the potential for humans to have differential relative BBB penetration when compared to animal models. The �only way to ensure that 2R,6R-HNK achieves cerebrospinal fluid (CSF) concentrations within humans is to measure the CSF levels in humans who have been dosed with 2R,6R-HNK. In addition, it is critical that accurate levels of 2R,6R-HNK be assessed in the human plasma in order to accurately correlate these levels to the human CSF levels. Thus, the objectives of this potential acquisition �are to: 1 � Accurately assess the levels of 2R,6R-HNK in CSF after administration in humans; 2: - Accurately assess the levels of 2R,6R-HNK in plasma after administration in humans. � PROJECT REQUIREMENTS: The potential acquisition is for the method development and determination of levels of (2R,6R)- hydroxynorketamine in human CSF and plasma. �Specific activities to be performed include: 1.��� Re-establishment of a bioanalytical method for the detection and quantification of the small molecule in plasma. NCATS currently has a bioanalytical method for the detection and quantification of the small molecule in rat, dog, and human plasma. The CRO will transfer this method to its own laboratories and perform the necessary tests and assessments in order to ensure the accuracy and precision of the method within its labs for analysis of the small molecule within human plasma. The CRO will then validate the method within its laboratories. The CRO will provide a comprehensive, signed, report on the method transfer, development, and validation of the bioanalytical method. 2.��� Establishment of the bioanalytical method for CSF (cerebrospinal fluid) The CRO will develop a method for the detection and quantification of the small molecule of interest within human CSF via LC-MS/MS. The CRO will perform the necessary tests and assessments in order to assure the accuracy and precision of the method within its labs for the analysis of the small molecule within its laboratories. The CRO will then validate the method within its laboratories. The CRO will provide a comprehensive, signed, report on the method transfer, development, and validation of the bioanalytical method. 3.��� Review and align data analysis methods The CRO is expected to perform a comprehensive review of the current clinical and non-clinical pharmacokinetics reports developed for the small molecule of interest. It is then expected to align its current developed methods for the analysis and quantification of the data against the current clinical and non-clinical reports, in order to provide a transition between the two data sets as best as possible. 4.��� Review the Single Ascending Dose (SAD) trial data The CRO will provide a comprehensive review of the clinical pharmacokinetics for the existing data around the Phase 1 SAD trial for the small molecule of interest. 5.��� Conduct the Multiple Ascending Dose (MAD) trial pharmacokinetics support for the Phase II trial The CRO is expected to take delivery of human blood samples or human plasma samples shipped from the clinical site. It would then separate the human plasma from the human blood, if needed, or directly use the human plasma samples. The CRO would measure and analyze the levels of the small molecule in each of the plasma samples, via the LC-MS/MS bioanalytical method previously transferred and developed. The CRO would then provide a comprehensive pharmacokinetic analysis and report on the levels of the small molecule. As needed, the CRO would provide a level of reporting and rigor required for submission of these pharmacokinetic reports to the United States Food and Drug Administration. 6.��� Conduct the CSF study The CRO will take delivery of human CSF samples delivered from the clinical site. The CRO would then measure and analyze the levels of the small molecule in each of the� CSF samples via the LC-MS/MS bioanalytical method previously transferred and developed. The CRO would then provide a comprehensive pharmacokinetic analysis and report on the levels of the small molecule. As needed, the CRO would provide a level of reporting and rigor required for submission of these pharmacokinetic reports to the United States Food and Drug Administration. CONTRACTOR REQUIREMENTS: The contractor shall be compliant with applicable domestic or international regulations. The contractor must also: 1. �� Be capable of operating under Good Laboratory Practice (GLP). 2. �� Be compliant with the Federal Information Security Modernization Act (FISMA). 3. �� Currently possess or have access to the necessary equipment to perform the work, specifically LC MS/MS machines. 4.��� Have certification for dealing with human tissue samples such as blood and CSF. The contractor must be capable of performing clinical work. ANTICIPATED PERIOD OF PERFORMANCE: This potential acquisition is anticipated to have a period of performance of 16 months from the date of award. � INFORMATION REQUESTED: Vendors should provide a capability statement that addresses their capability and experience in performing the Project Requirements listed above, and their ability to meet the Contractor Requirements listed above. Specifically, capability statements should: 1.��� Include a general overview statement about the vendor�s history of pharmacokinetics support for phase I and phase II human clinical trials, including direct analysis of small molecule within human tissue samples via LC-MS/MS (Liquid chromatography-mass spectrometry), and developing and writing pharmacokinetics reports intended for submission to the United States Food and Drug administration. 2.��� Address the vendor�s capability and experience in each of the six Project Requirements; general capability statements will not be reviewed. Vendors with prior, similar experience should clearly demonstrate that experience and include information on the size and scope of that experience. If prior experience was gained with the Government as a prime or subcontractor, describe the size and scope of the work and provide the contract number. 3. �� Address the vendor�s current or future capability to comply with each of the four Contractor Requirements. Vendors seeking to respond to this Notice as part of a teaming arrangement should include the requested information from each vendor in the proposed team. RESPONSE INSTRUCTIONS: Responses are required no later than 9:00am Eastern Time on February 14, 2022. Responses must be submitted via email to Kimberly.espinosa@nih.gov and should include the following: 1.� � Capability statement 2.��� Cover Page that includes the following: DUNS number Company Name Company Address Company Point of Contact, Phone, and Email address Company Size / Socio Economic status under NAICS code 541380 (Small Business respondents only) Acknowledgment of compliance with FAR Clause 52.219-14. As noted below, FAR Clause 52.219-14 will apply to this acquisition if set aside for Small Business. Small Business respondents must acknowledge they will comply with this clause if they receive an award for this requirement under a Small Business Set-Aside. Small Business respondents who fail to acknowledge this will not be considered a Small Business for the purposes of this Sources Sought. 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 pre-solicitation synopsis and solicitation may be published in SAM. However, responses to this notice will not be considered adequate responses to a solicitation. If any portion of the potential acquisition is set aside for Small Business, FAR Clause 52.219-14, Limitations on Subcontracting, will apply to the portion that is set aside. This clause states the prime Small Business contractor cannot subcontract more than 50% of the work to a non-similarly situated entity. The full text of the clause is available at https://www.acquisition.gov/far/part-52#FAR_52_219_14. Respondents are advised that having an active registration within the System for Award Management (SAM) is required to be eligible for any contract with the United States Government. In addition, contractors are required to maintain an active registration in SAM throughout the life of the contract. 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/c6de93f8ad0b4e709bc76b952be817f7/view)
- Record
- SN06227792-F 20220130/220129201527 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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