Scientific Support Services for Conversion of Fibroblasts to Induced Pluripotent Stem Cells

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 business size standard $15,000,000.00. BACKGROUND The National Institute of Mental Health (NIMH) Child Psychiatry Branch studies neurobiology of sex chromosome aneuploidies (SCAs) and the way such conditions impact the human brain and behavior. The NIMH is establishing for the first time how SCAs impact the biology of human neurons, which is a foundational step in the link between altered sex chromosome dosage and altered brain structure/function. Support converting fibroblasts to induce pluripotent stem cell (iPSCs) types will provide NIMH the starting point for making neuronal cells in vitro. PURPOSE AND OBJECTIVES The purpose of this potential requirement is to to acquire scientific support services for the conversion of fibroblasts to Induced Pluripotent Stem Cells (iPSCs). The objective is to conduct an analysis of single-cell RNA sequencing analysis of gene-expression in iPSC-derived tissues from patients with sex chromosome aneuploidy, in comparison with the globally-unique set of StemBancc controls at University of Oxford. To complete this objective, we have to ensure our patient samples are specifically matched with these uniquely-derived control cells at Oxford, which have been reprogrammed, passaged, quality controlled, differentiated and sequenced according to a proprietary pipeline at Oxford university. The required stage of cellular phenotyping and RNAseq analysis must be done on patient and control cells which have all been through exactly the same reprogramming/differentiation pathway. In particular, the NIMH DNU requires this specific protocol chain, and only this specific chain for 2 specific reasons: (i) the protocol chain is established to support differentiation of iPSC-derived neurons with our required cortical layer identity markings (Handel at al, Human Molecular Genetics 2016), and (ii) the protocol chain permits direct comparison with publically available data from StemBANCC tissues generated by identical protocols to enable the NIMH DNU to test specificity of SCA effects on genome function (Morrison et al, Stem Cell Rev, 2015). 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 through the following tasks: 1. The contractor will convert fibroblast samples provided by the Government into induced pluripotent stem cell (iPSC) lines. Conversion shall be performed using the Sendai virus system 2. The contractor will identify pluripotency markers in iPSC lines using Pluritest and genome-wide SNP typing. 3. The contractor shall confirm clearance of Sendai from the iPSCs using RT-qPCR. 4. The contractor shall extract RNA from iPSCS and fibroblasts 5. The contractor shall confirm iPSC lines test negative for mycoplasma using MycoAlert. Period of Performance The anticipated Peroid of Performance of this potential requirement for 12 months shall become effective on or around September 30, 2017. 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, including a Curriculum Vitea (CV). Evidence of published manuscripts or other documentation produced must be used to support past experience. 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 to Ms. Zenab Chowdhry at zenab.chowdhry@nih.gov and NIDASSSAPurchaseRequ@mail.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).