SOURCES SOUGHT
Q -- In vitro metabolic stability and metabolite identification of 14C-Benserazide
- Notice Date
- 8/22/2018
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIHDA201800490
- Archive Date
- 9/13/2018
- Point of Contact
- Hunter A Tjugum, Phone: 3018275304
- E-Mail Address
-
hunter.tjugum@nih.gov
(hunter.tjugum@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This is a Small Business Sources Sought (SBSS) 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 and type of qualified Small Business companies technically capable of meeting this potential 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. The notice is strictly for research and information purposes only. The information requested will assist the Government in determining the appropriate acquisition method including small business socio-economic set-aside possibilities and to determine the availability of qualified Small Business companies technically capable of meeting the Government's potential requirement. All Small Business companies with the capability and availability to perform the requirement under the applicable NAICS code are invited to submit a response to this notice. NORTH AMERICAN CLASSIFICATION SYSTEM (NAICS) CODE The NAICS code applicable to this requirement is 541990- All Other Professional, Scientific and Technical Services with associated small business size standard of $15.0 million. BACKGROUND The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) was officially established in fiscal year 2012 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS, one of 27 Institutes and Centers (ICs) at NIH, strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients. The Division of Pre-Clinical Innovation (DPI) at NCATS plans, conducts and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum. Specifically, this division: Plans, conducts and collaborates on research to develop new methods and technologies to enhance pre-clinical processes; Plans, conducts and collaborates on research to evaluate existing and developing approaches, technologies, and processes in the pre-clinical spectrum; Supports training programs relevant to pre-clinical phases of translational science; Allocates DPI resources to pre-clinical extramural and intramural investigators; Collaborates with other NIH Institutes and Centers and the scientists they support; Consults with stakeholders, including patients, industry and regulators. NCATS and Boston University are jointly developing Benserazide as a drug candidate for the treatment of β-hemoglobinopathies. In a previous study in mice, in vivo pharmacokinetics, biodistribution, metabolism and excretion of 14C-labeled benserazide were determined. The current potential requirement is for contractor services to conduct a study of in vitro metabolic stability test and metabolite identification (MetID) of 14C-Benserazide in hepatocytes of mouse, rat, dog and human to compare in vitro drug metabolism among different species prior to Phase I clinical trials. PURPOSE AND OBJECTIVES The purpose of this potential requirement is to obtain contractor results of testing of differncees in vitro drug metabolism among different species prior to Phase I clinical trials in studying in vitro metabolic stability test and metabolite identification (MetID) of 14C-Benserazide in hepatocytes of mouse, rat, dog and human. Results from this study will be used to: 1. Correlate in vitro and in vivo metabolic stability rates and metabolite formation profiles in mice, and 2. Compare in vitro metabolic stability and metabolite formation profiles among lab animal species and humans prior to the clinical trial in human subjects. For benserazide project, a mouse disease model is used to evaluate the drug efficacy, and rat (rodent) and dog (non-rodent) are used as safety evaluation species. PROJECT REQUIREMENTS This Small Business Sources Sought notice seeks responses from qualified sources that are capable of providing the following salient service requirements of this potential government requirement deemed as the essential features needing to be achieved. Offerors to this Sources Sought notice shall possess the capability of achieving the following requirements. Statement of Work: 14C-Benserazide will be added to hepatocytes of mouse, rat, dog and human at a concentration of 1 uM for the metabolic stability test and 10 uM for the MetID study. After incubation at 37oC, aliquots of samples will be collected over 2 hours. The metabolic stability will be assessed by the disappearance rate of parent drug over time. The metabolic profiles will be generated by HPLC with a radioactivity detector. The mass spectrum characterization will also be conducted for major metabolite peaks to elucidate possible structures of these metabolites for each species. Controls with known metabolic rates and metabolic pathways should be used. Although it is not a GLP study, the company SOP for in vitro metabolic stability and MetID study with a 14C labeled drug should be followed. 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 following specific tasks involved in this study: 1.Protocol generation 2.Dosing solution preparation 3.Conducting in vitro metabolic stability test in hepatocytes of mouse, rat, dog and human 4.Determine metabolic stability of 14C-benserazide 5.Generate metabolic profiles of 14C-benserazide from samples collected from hepatocytes of 4 species 6.Characterize the major metabolite structures for each species by mass spectrometry 7.Additional services include study scheduling, record keeping, in vitro study report generation. Period of Performance The in vitro metabolic stability and MetID study in hepatocytes of 4 species should be completed in 2 months after contractor receipt of order. GOVERNMENT RESPONSIBILITIES NCATS will provide the materials to be profiled. NCATS will provide the study outline, review study protocol, provide test article, and communicate with Study Director or Staff Scientist during the study period to ensure that the study is conducted according to the protocol. DELIVERY OR DELIVERABLES 1.In vitro metabolic stability of benserazide in hepatocytes of 4 species (mouse, rat, dog and human). 2.Structure identification of major benserazide metabolites generated from hepatocytes of 4 species (mouse, rat, dog and human). 3.In vitro metabolic stability and MetID study report. 4.Contractor will confirm that the remaining 14C-benerazide solution will be discarded per NCATS' instruction. CAPABILITY STATEMENT / INFORMATION SOUGHT Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. Respondents must provide clear and convincing evidence of possessing the knowedge, skills, abilities and experience to successfully perform the requirements described in this announcement. Detailed past experience in implementing similar requirements to the requirement described in this announcement must be clearly delineated in any response provided. Respondents must provide clear and convincing documentation of their capability in providing analytical quality control and any other requirements and services specified in this notice. Respondents must provide a general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. The Respondent must also provide information in sufficient detail of the 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. 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 response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, CV's or references, if requested. The information submitted must be must be in and outline format that addresses each of the elements of the product requirement. A cover page and an executive summary may be included but is not required. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response MUST reference the solicitation number and be submitted electronically to Mr. Hunter Tjugum at hunter.tjugum@nih.gov prior to the closing date specified in this announcement. The response must be received on or before the closting date/time specified in this announcement. CONCLUDING STATEMENTS 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 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).
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- Record
- SN05050819-W 20180824/180822231256-8b6ff244dd71ba593fa1ca2f1d48c006 (fbodaily.com)
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