SOLICITATION NOTICE
65 -- Two (2) Radium-224 Radioisotope Generators w/ Purification to remove stable Lead
- Notice Date
- 5/9/2011
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-110062-TG
- Archive Date
- 6/8/2011
- Point of Contact
- Terry Galloway, Phone: 301-402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
gallowaytl@mail.nih.gov, cr214i@nih.gov
(gallowaytl@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Description The National Cancer Institute (NCI), Cancer Center Research (CCR), Radiation Oncology Branch (ROB) plans to procure on a sole source basis the two (2) Radium-224 Radioisotope Generators with purification process for the removal of stable lead (Pb) from AlphaMed, Inc. P.O. Box 361, Sheldonville, MA 02070. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 325413 and the business size standard is 500 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Delivery Date: 120 days from date of award. The Radiation Oncology Branch (ROB) of the National Cancer Institute (NCI) focuses on the biologic and therapeutic effect of radiation therapy. The research clinical trials that the ROB develops and conducts involve novel technology and imaging based approaches to radiation therapy treatment. Currently, Ra-224 generators are required for on-site production of the daughter radionuclide from the decay process, Pb-212, that the NCI has been using to perform extensive pre-clinical studies on disseminated colorectal disease animal model system. These experiments have defined not only max. tolerated dose (MTD) in this model but also produced significant extension of survival, and defined the impact of combination therapy with gemcitabine. Most recently the NCI has demonstrated not only the beneficial effects of combination therapy with paclitaxel, but also that administration order is a critical variable that had to be arrived at empirically. This same variable was radionuclide dependent as opposed to being a direct biological factor. To this end, the NCI has now actively translated the results into a Phase 1 clinical trial in collaboration with the University of Alabama, Birmingham with our CRADA partner, AREVAMed with an IND approved by the FDA in Feb. 2011. From that same IND approval, the NCI now possesses requirements for further studies as well as periodic stability measurements required by the FDA as well as transchelation studies and protein stability studies requisite to maintain and continue that same Phase 1 trial. To execute those studies there is a significant need of generators to validate both the cGMP production antibody conjugate as well as to continue to validate both facilities and SOPs. AlphaMed has the exclusive contract from the Department of Energy (DOE) for marketing this radionuclide due to the parental being fissionable and not available from any commercial source in this country. AlphaMed was awarded this contract by the DOE in June of 2002 to privatize production of Bi-212 which is one of the daughters eluted from the Ra-224 generators. There are no other known sources which sell ready to use generators at greater than 2-5 mCi of Ra-224. The most critical characteristics and requirements of these generators is that they are consistent with those previously prepared for and used by the ROB for their animal model pre-clinical therapy studies. Activity levels of 15-20 mCi is a minimal amount of Ra-224 that has to be on the generators such that adequate amounts of Pb-212 can be provided. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received at the NCI Office of Acquisitions on or before 11:00 AM EST on May 23, 2011. No electronic capability statements will be accepted (i.e. email or fax), an original and one copy must be sent to the NCI Office of Acquisitions to the address stated above. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Terry Galloway, Contract Specialist at gallowaytl@mail.nih.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. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the Central Contractor Registration (CCR) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference solicitation number NCI-110062-TG on all correspondences.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-110062-TG/listing.html)
- Record
- SN02443349-W 20110511/110509234656-4631fedf3443a5b92a453d3d1176b3e2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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