SPECIAL NOTICE
99 -- Request for Information (RFI) - NINDS Division Translational Research � Continuous Rodent and Non-Rodent Pharmacokinetic (PK) Assessments
- Notice Date
- 3/11/2024 1:12:29 PM
- Notice Type
- Special Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95024R00062
- Response Due
- 4/15/2024 8:00:00 AM
- Archive Date
- 04/30/2024
- Point of Contact
- Sneha Singh
- E-Mail Address
-
sneha.singh@nih.gov
(sneha.singh@nih.gov)
- Description
- See Attached PDF.� REQUEST FOR INFORMATION Solicitation Number: 75N95024R00062 Title:� NINDS Division Translational Research � Continuous Rodent and Non-Rodent Pharmacokinetic (PK) Assessments Classification Code:� Q301 Medical � Laboratory Testing NAICS Code:� 541380 Testing Laboratories and Services Size Standard: $19M Description:� This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for programs planning purposes. The Government is also considering NAICS 325414 Biological Product (except Diagnostic) Manufacturing, Size Standard 1,250 employees. Background:� The National Institute of Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm) have established a �virtual pharma' network of contract service providers and consultants with extensive industry experience to enable therapeutic (e.g., small molecule, peptide, biologic) development in the NIH research community. This network has a need to run routine pharmacokinetic studies in support of the program.� Studies are mostly iv/po rodent studies but information on capabilities to run other routes of administration and other species is also of interest. Purpose and Objectives: The NINDS is interested in identifying commercial sources with capabilities and qualifications that could run routine rodents pharmacokinetic (PK) testing for the purposes of new therapeutics developments. �Additionally, information capabilities to run dog PK and other routes of administration is also sought. Requirements: (See Attached PDF ) Please describe your organization�s ability to perform the following tasks and answer the following questions: Is your organization a small business as defined by the SBA? What are your general capabilities to provide commercial pharmacokinetic (PK) studies to support drug discovery? What species do you typically offer to your commercial customers e.g. mouse/rat/dog/primate etc? What routes besides IV and oral can you provide (e.g. IT, ocular etc)? Where would the work be performed? For each of study types below please answer the following: State your organization ability and track record offering these types of studies as a commercial option to the scientific community? Do your organization�s standard designs differ? What are the usual timelines for individual study completion, from study request, assuming compound is available for immediate shipment, to study initiation and delivery of interim and final reports? What is your organization�s ability to run multiple studies in parallel? What is the approximate expected cost of the proposed studies at your organization (note #1, 3, 4 and 5 cost with and without brain level determination is desired)? Sample Designs for Consideration: Rat Pharmacokinetic with or without brain level determination A design for a rat PK study is presented below.� It is anticipated that a similar study design will be used for the majority of studies to be completed.� Group Test Compound Dose (mmol/kg) Route # of Animals Plasma Collection (hr) Brain Collection (hr) 1 A TBD IV 3 0,.083,.25,.5,1,2,4,8,12,24 - 2 A TBD PO 3 0,.25,.5,1,2,4,8,12,24 - 3 A TBD IV 3 1 1 3 male rodents per group, 1 PO and 2IV groups. Blood (plasma) collected via jugular catheters Assume that a bioanalytic method is unavailable and must be developed for each study.� Study results are intended to support chemistry optimization, thus rapid turnaround is essential to meet the needs of the iterative drug design cycle. Reports should include: �A detailed rat PK study protocol based on the design used and data report including graphical representation of the data and separate data table. �Rodent Brain Pharmacokinetics Analysis The contractor shall administer BPN-supplied compounds to rodents (rat or mouse) and assess blood and brain levels of at various time points.� A design for a rat brain PK study is presented below, as a starting point for protocol development, subject to modification.� It is anticipated that a similar study design will be used for the majority of studies to be completed, but minor modifications may be needed based on the requirements of each project.� Group Test Compound Dose (mmol/kg) Route # of Animals Plasma Collection (hr) Brain Collection (hr) 1 A TBD IV or oral 3 0.5 0.5 2 A TBD IV or oral 3 1 1 3 A TBD IV or oral 3 2 2 4 A TBD IV or oral 3 6 6 5 A TBD IV or oral 3 12 12 6 A TBD IV or oral 3 24 24 3 male rats per time point, 6 time points.� Blood (plasma) and brain collections at 0.5,1,2,6, and 12 h, 24h post administration. Assume that a bioanalytic methods are available from prior study. Study results are intended to support chemistry optimization, thus rapid turnaround is essential to meet the needs of the iterative drug design cycle. Reports should include: �A detailed rat PK study protocol based on the design used and data report including graphical representation of the data and separate data table. Rodent Plasma Sample Pharmacokinetic Analysis The contractor shall analyze rodent plasma and brain samples supplied by the NIH to measure levels of the compound being studied to support pharmacokinetic assessment of samples collected off-site, as a component of in vivo activity studies in rodent models of disease.� It is anticipated that samples will be obtained at 6 time points, from 3 animals per time point, for a total of 36 samples.� Assume that a bioanalytic method is unavailable and must be developed for each study.� Study results are intended to support chemistry optimization, thus rapid turnaround is essential to meet the needs of the iterative drug design cycle. Mouse Pharmacokinetic with or without brain level determination Group Test Compound Dose Route Dose� (mg/kg) Sub-group No. of Animals Blood (Plasma) Collection Timepoint (hr) Brain Collection Timepoint (hr) 1 A IV 1 A 3 0.083, 1 1 B 3 0.25, 4 4 C 3 0.5, 8 8 D 3 2, 24 24 2 A PO 5 A 3 1 1 B 3 0.25, 4 4 C 3 0.5, 8 8 D 3 2, 24 24 Assume that a bioanalytic method is unavailable and must be developed for each study.� Study results are intended to support chemistry optimization, thus rapid turnaround is essential to meet the needs of the iterative drug design cycle. Dog Pharmacokinetic determination Group Test Article Dose Route Dose Level (mg/kg) Dose Conc. (mg/ml) Dosing Volume (ml/kg) No. of Animals Blood & Plasma Collection Time Point (hr) 1 A iv 1 0.2 5 3 Pre-dose, 0.083, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 2 A po 5 1 5 3 Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 �Species and Strain: Beagle dog Assume that a bioanalytic method is unavailable for dog and must be developed for each study, but mouse and/or rat bioanalytical will available.� Study results are intended to support chemistry optimization, thus rapid turnaround is essential to meet the needs of the iterative drug design cycle. Other Important Considerations: In case domestic sources are available and capable of fulfilling the Government�s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25. NIH has policies, regulations, and guidance that protect animals used in research, training, and testing. Offerors must meet regulatory compliances and safety requirements. Please describe how your organization complies with these requirements. Information Sought: 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 twenty (20) page limit.� The 20-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist.� Facsimile responses are NOT accepted. The response must be submitted to Sneha Singh, Contract Specialist, at e-mail address sneha.singh@nih.gov The response must be received on or before April 15, 2024, at 11:00 a.m., Eastern Time. 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. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. 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. Any solicitation resulting from the analysis of information obtained will be announced to the public in www.sam.gov in accordance with the FAR Part 5. 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/b6722b66e96d4fb48d486018cc8a84b2/view)
- Place of Performance
- Address: Bethesda, MD, USA
- Country: USA
- Country: USA
- Record
- SN06992152-F 20240313/240311230038 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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