This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI).
The purpose of this Small Business Sources Sought Notice is to identify qualified small business concerns, including 8(a), HUBZone or Service-Disabled Veteran-owned business concerns, that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract based on responses received nor otherwise pay for the preparation of any information submitted. 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 requirement is assigned North American Industry Classification System (NAICS) code 541990 with a size standard of $15 million is being considered.
NCI may issue a request for quotation (RFQ) as a result of this Small Business Sources Sought Notice. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Small Business Sources Sought Notice or the NCI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.
BACKGROUND
The National Cancer Institute (NCI), Surgery Branch (SB) is developing immune-based therapies to treat patients with metastatic cancer. One of the branch’s current major therapeutic strategies is to use tumor mutation-reactive T cells to treat patients with cancer. This is based on data from the SB clinical trials demonstrating that the curative responses seen in patients with melanoma treated with T cells are likely mediated by mutation-reactive T cells. Moreover, the NCI treated a patient with metastatic bile duct cancer with a highly pure population of mutation-reactive T cells and are observing ongoing tumor regression at 16+ months after therapy. The SB is thus attempting to treat more patients with mutation-reactive T cells. In order to do this, the SB first has to identify mutation- reactive T cells from patients. The reagents that the branch requires to identify mutation-reactive T cells are custom genes and custom peptides that encode for tumor mutations. Since the SB is using these reagents in “real time” to develop therapies to treat patients with late stage cancer, the branch requires that these reagents be synthesized quickly, be error-free and that the product sequences are of high quality.
OBJECTIVE
The patients being treated at the SB are late-stage patients with no other therapeutic options, thus the NCI requires that all these reagents be synthesized in an expeditious manner as time is of the essence. This process is required for every single patient on the SB protocol (i.e., this is highly personalized medicine/therapy).
SCOPE
Independently, and not as an agent of the Government, the Contractor shall furnish all necessary supplies, equipment, labor, and services to perform gene synthesis/cloning, peptide synthesis, and QC analysis of peptides and mammalian expression constructs for the Government's use in the conduct of cancer-related clinical research/trials.
CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS
Contractor shall conduct gene synthesis/cloning, peptide synthesis, and QC analysis of peptides and mammalian expression constructs for 125 cases. Detailed requirements for each of these services are as follows:
4.1 - Gene Synthesis/Cloning and Peptide Synthesis:
The contractor shall produce crude or HPLC purified peptides or peptide pools that encode normal endogenous protein sequences and those with tumor mutations embedded. They will use the sequence file that researchers provide to them from the NGS sequencing done on clinical trial patient tumor samples associated with one of many trials under The National Cancer Institute (NCI), Surgery Branch (SB). Additionally, the contractor shall provide tandem minigene fragments that encode normal endogenous gene sequences and those with tumor mutations embedded in tandem. Gene fragments will be cloned into mammalian expression vectors provided by the researcher. The contractor shall provide purified TMG constructs at varying concentrations dependent upon what the researcher requestors. The contractor shall provide retroviral mammalian expression vectors containing antigen specific T-cell receptor (TCR) inserts for the TCR-alpha/beta chains (TCRa/b). Constructs shall be purified at varying concentrations dependent upon what the researcher requestors. Importantly, the contractor shall provide advice on the codon optimization of mammalian expression inserts to ensure that all constructs will have a good chance of working in vitro and in vivo.
4.2 - QC Analysis of peptides and mammalian expression constructs:
The contractor shall perform QC analysis of crude or HPLC purified peptides or peptide pools that encode normal endogenous protein sequences and those with tumor mutations embedded using Mass Spectrometry (MS) to determine the amino acid composition of said peptides. Documentation shall be sent with the peptides or via email to the specific researcher. Additionally, the contractor shall Sanger sequence every construct that the researchers request to determine that either the TMG insert is correct in sequence or that the TCRa/b molecule is correct in sequence. The sequencing file for all constructs shall be made available via mail or email.
TYPE OF ORDER
This will be issued as a firm fixed price purchase order.
PERIOD OF PERFORMANCE
The period of performance is for twelve (12) months with two (2) twelve (12) month option periods.
PLACE OF PERFORMANCE
All work shall be performed at the Contractor’s facility.
REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE
The Contractor shall provide the following:
The aforementioned deliverables and any ancillary reports containing relevant data items, per above, will be scrutinized and subsequently accepted within thirty (30) calendar days of receipt,
The Government’s Technical Point of Contact (TPC), who will be named upon award, will be responsible for reviewing the work done by the Contractor, making sure that it is consistent with the terms of the Contract, and approving the reports/deliverables provided by the contractor.
The TPC is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Government may unilaterally change its TPC designation.
All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."
PAYMENT
Payment shall be made in full upon delivery and acceptance by the Government. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the attached payment provisions listed below:
The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:
NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.
The Contractor shall submit a copy of the electronic invoice to the following Technical Point of Contact (TPOC):
Technical Point of Contact (TPOC)
Name- ___________________Email Address-
For inquiries regarding the status of invoices, contact OFM Customer Service via email at [email protected] or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.
Note: The OFM Customer Service is open Eastern Standard Time Monday – Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.
SUBMISSION INFORMATION
Capability statements shall be submitted via email to Contracting Officer, Miguel Diaz, at [email protected] no later than 12:00 P.M. EST on August 2, 2021 (08/02/2021). All information furnished must be in writing and must contain enough detail to allow the NCI to determine if it can meet the unique specifications described herein. Please reference number 75N91021Q00179 on all correspondence.
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 capability. 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, an RFQ may be published. However, responses to this notice will not be considered adequate responses to a solicitation(s).