SOLICITATION NOTICE
Q -- Synthesis of 20 grams of RDEA-119
- Notice Date
- 6/22/2010
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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-PB-(HG)-2010-198-DLM
- Archive Date
- 7/13/2010
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) intends to negotiate and award a purchase order on a noncompetitive sole source basis to Organix Incorporated, 240 Salem Street, Woburn, Massachusetts 01801-2029 for the synthesis of 20 grams of the Mek inhibitor RDEA-119. The sole source determination is based on the fact that National Institute of Health (NIH) is the nation’s medical research agency and the primary Federal agency conducting and supporting making medical discoveries that improve people’s health and save lives. The NIH Chemical Genomics Center (NCGC) and the Therapeutics for Rare and Neglected Disease program (TRND) of the National Human Genome Research Institute (NHGRI) in collaboration with Dietz Laboratory at John Hopkins Medical School are working on a collaborative study in advance understanding of the MEK/ERK pathway in Marfan pathology. The collaboration with NCGC/TRND and Dietz Laboratory has been able to show that the clinically used MEK inhibitor RDEA-119 is capable of altering disease progression in mouse models of Marfans syndrome and it is critical for NCGC/TRND to expand the studies with RDEA-119 to judge the ability of the agent to enter clinical trials. Additionally, the synthesis is required to extend studies of RDEA-119 in Marfan models, additional models such as Loeys-Dietz syndrome and extend the NHGRI’s knowledge of this agent as a potential therapy for both Marfan and Loeys-Dietz syndrome patients. Organix has synthesized 1 gram of RDEA-119 for preliminary studies for NHGRI. Organix has the ability to construct molecules of this base scaffold and has the previous experience to provide a unique understanding of the synthetic challenges. The contract with Organix will keep NHGRI personnel from having to spend their effort on a scale-up synthesis and will allow them to concentrate their efforts on new programs rather than the consistent scale up of this reagent for collaborative purposes. Only one responsible source and no other supplies or services will satisfy agency requirements. The delivery point is the National Institutes of Health (NIH), National Human Genome Research Institute, NHGRI), 9800 Medical Center Drive, Building B, Room 2B-2, Rockville, Maryland 20850. Statement of Work • The contractor shall conduct an assessment of the purified material. No material will be sent without purity and characterization requirements that meet the accepted standards for publication (H1 NMR, C13 NMR, HRMS). • The contractor shall identify the synthetic techniques that are not previously recorded in the published literature and forward such methods. • The contractor shall address alterations to the procedure of synthesis as well as abnormalities in the characterization of the material. • The primary task is the synthesis and timely delivery of the material. • The project timeline is variable based upon unforeseen issues with the synthesis. The project will be initiated within four weeks of receipt of purchase order and weekly updates will be required during the duration of the project. Government Furnished Information • The final report of the project shall include consistent NMR and mass spectral data, and shall have an elemental analysis within 0.4% for C, H, and N. The product will be shipped together with a Data Sheet and copies of all spectra taken. Deliverables • The contractor shall provide bi-weekly updates by phone, fax, or email. • The contractor shall provide the synthesized material as a homogenous sample. • The contractor shall provide a print ready master final report included with the above deliverables. Industry Classification (NAICS) Code is 541711, Research and Development in Biotechnology, with size standard of 500 employees, this is a small business set-aside. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001).and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-41 (May 13, 2010). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by June 28, 2010, 7:30 a.m. Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurement. Inquires to this announcement, referencing synopsis number NHLBI-PB-(HG)-2010-198-DLM, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition, Procurement Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB-(HG)-2010-198-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02184982-W 20100624/100622235809-6e74adc08483b7cab819cba6701ef3ef (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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