SOLICITATION NOTICE
R -- Metformin for Cancer Chemoprevention in Li-Fraumeni Syndrome
- Notice Date
- 9/2/2016
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-HL-2016-302-KMA
- Archive Date
- 9/27/2016
- Point of Contact
- Kevin Alvarez,
- E-Mail Address
-
kevin.alvarez@nih.gov
(kevin.alvarez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to The George Washington University, 2121 I St NW Ste 601, Washington, DC, 20052-0001, to launch a phase II, double-blinded, randomized, placebo controlled trial with metformin to determine if treatment with metformin decreases the incidence of cancer in patients with germline TP53 mutations and a clinical diagnosis of Li-Fraumeni Syndrome. BACKGROUND Li-Fraumeni Syndrome (LFS) is a highly penetrant, autosomal dominant cancer predisposition syndrome that typically manifests prior to age 45. It is estimated that 60-80% of LFS families have detectable germline mutations in TP53. We recently reported evidence of increased oxidative mitochondrial metabolism both in humans with LFS and in a mouse model of LFS. There is growing evidence that mitochondria play an important role in tumorigenesis. Another site of action of metformin is the mitochondria, where it inhibits complex 1 of the respiratory chain and increases cellular levels of AMP by inhibiting oxidative phosphorylation. Metformin can modulate the balance between glycolytic and oxidative phosphorylation pathways that are also regulated by TP53. Wild-type p53 promotes growth arrest during cellular stress but mutations in TP53 may cause loss of this inhibitory function, allowing cellular proliferation to progress unchecked. Inhibition of mitochondrial function by metformin in such a setting may induce an energy crisis and result in cell death. In our ongoing phase I pilot study of metformin treatment in LFS patients (NCI 14-C-0005, Walcott, F et al); we have preliminary evidence of in vivo and in vitro oxidative metabolism inhibition that serves as proof of concept that it is possible to modulate mitochondrial function in humans. Whether this alteration in metabolic function can prevent or delay cancer development in the LFS patient population remains to be determined. The Bench-to-Bedside (B2B) Program funds research teams seeking to translate basic scientific findings into therapeutic interventions for patients and to increase understanding of important disease processes. The B2B Program accomplishes this mission by addressing barriers, such as the traditional silos between basic and clinical researchers in biomedical research, which can hinder progress toward finding new therapeutics for patients in need. B2B teams involve basic and clinical researchers, often from different NIH Institutes and Centers. In 2006, the B2B program's charge was expanded to unite the efforts of intramural and extramural NIH researchers. Intramural science refers to research that takes place on an NIH campus under the auspices of federal employees, while extramural research is funded by NIH and conducted by investigators and institutions outside of NIH. Each B2B award provides up to $135,000 a year for two years. Projects, which are funded by various NIH offices and Institutes, have represented several research categories: AIDS, rare diseases, behavioral and social sciences, minority health and health disparities, women's health, rare diseases drug development, pharmacogenomics, and general. To date, approximately 800 principal and associate investigators have collaborated on 238 funded projects with approximately $53million distributed in total Bench-to-Bedside funding. The introduction of extramural collaborations in 2006 has resulted in 157 partnerships at 90 institutions. Ninety-seven percent of B2B awards spanning the three most recent review cycles have involved extramural partners. PURPOSE NIH's Dr. Paul Hwang, and his collaborator Dr. Farzana Walcott of George Washington University, recently received a NIH Bench to Bedside (B2B) award. Dr. Walcott will launch a phase II, double-blinded, randomized, placebo controlled trial with metformin to determine if treatment with metformin decreases the incidence of cancer in patients with germline TP53 mutations and a clinical diagnosis of Li-Fraumeni Syndrome. The purpose of this acquisition is to enter into a formal agreement with George Washington University to conduct the study. JUSTIFICATION The sole source determination is based on the fact that Dr. Paul Hwang (of NHLBI) and his collaborator Dr. Farzana Walcott (of GWU) were recipients of an NIH Bench to Bedside (B2B) award. As such, only George Washington University has the capability to meet the Government's need in performing this study. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b), soliciting from a single source (for purchases not exceeding the simplified acquisition threshold) and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 541990, All Other Professional, Scientific, and Technical Services, and the Small Business Size Standard is $15.0 million. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable (FAR Part 6.001). The resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-89 (August 15th, 2016). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 12, 2016 at 9:00AM EST and must reference synopsis number NHLBI-CSB-HL-2016-302-KMA. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6127, Bethesda, Maryland 20892-7902, Attention: Kevin Alvarez. Responses may be submitted electronically to kevin.alvarez@nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-HL-2016-302-KMA/listing.html)
- Record
- SN04253973-W 20160904/160902235022-fb1f2dff1b63a761ccfb6cb609afe5d5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |