SOLICITATION NOTICE
68 -- Two (2) Ra-224 Isotope Generators
- Notice Date
- 8/19/2009
- Notice Type
- Presolicitation
- NAICS
- 325412
— Pharmaceutical Preparation 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-90202-AV
- Archive Date
- 9/12/2009
- Point of Contact
- Ashley L. Virts,
- E-Mail Address
-
virtsa@mail.nih.gov
(virtsa@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Research Oncology Branch (ROB) plans to procure as a sole source two (2) Ra-224 Isotope Generators from AlphaMed Incorporated; PO Box 607; Acton, MA 01720-0607. This acquisition will be conducted under the authority to use simplified acquisition procedures in accordance with FAR 13.106-1(b)(1). The North American Industry Classification System code is 325412 and the business size standard is 750 employees. Delivery will be sixty (60) days from date of award. This is not a solicitation for competitive quotations. However, if any interested party believes it can perform the requirement as detailed they may submit a statement of capabilities. All information furnished shall 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 in the contracting office by 11:00 am EST, on August 28, 2009. All questions must be in writing and must be emailed to Ashley Virts at virtsa@mail.nih.gov faxed to (301) 402-4513. 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 from the NCI contractors must be registered in the Online Representations and Certifications Applications (ORCA). Please refer to http://orca.bpn.gov In addition; contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. Please reference NCI-90202-AV on all correspondence. Part I: Background information and description of requirements: The ROB proposes to procure two (2) Ra-224 generators required for on-site production of the daughter radionuclide from the decay process, Bi-212, used to perform extensive pre-clinical studies of the disseminated colorectal disease animal model system. These experiments produced significant extension of survival, and defined the impact of combination therapy with gemcitabine. Most recently this laboratory 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 laboratory is now actively pursuing translation of these results into a Phase 1 clinical trial in collaboration with the University of Alabama, Birmingham (UAB) having very recently had a pre-IND meeting with the FDA. From that same meeting the ROB now possesses the requirements for the toxicology studies requisite to move this effort forward to that same Phase 1 trial. To execute those studies, the ROB is in significant need of two generators to validate the cGMP production antibody conjugate, facilities and SOPs; also to facilitate transferal of that same information and ability to the clinical trial site at UAB. This information is needed not only for operational reasons, but also to be documented for inclusion within the IND filing. Therein resides an element of urgency to execute these requested studies such that the IND might be filed in a timely manner to support efforts at both the NCI and those of extramural partners. JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION: Part II: Facts and Reasons to Justify Other than Full and Open Competition: Statutory Authority Statute: This justification has been prepared under simplified acquisition procedures as set forth in 13.106-1 (b)(1). Justification: AlphaMed holds an exclusive contract from the Department of Energy (DOE) for marketing this radionuclide and was awarded this contract by the DOE in June of 2002 to privatize production of Bi-212, a daughter eluted by Ra-224 generators. The lab uses the parental radionuclide, Pb-212, in their studies. There are no other known sources to sell ready to use generators at greater than 2 mCi of Ra-224. The lab requires that the Ra-224 generators are consistent with those previously prepared for and used by the lab for animal model pre-clinical therapy studies; they originate from the same nuclear feedstock materials which insure consistent chemical and radiochemical behavior and purity of the eluted Pb-212. Activity levels of 15-20 mCi is the minimal amount of Ra-224 to be on the generators such that adequate amounts of Pb-212 can be provided. The design and plumbing of the generators must be compatible with the generators previously prepared for and used by the lab. The process to remove stable Pb-212 is critical to operational generators for animal model pre-clinical therapy studies. The presence of stable Pb interferes and competes with the use of the radioactive Pb-212 generated from the Ra-224. As there is only one source of the Ra-224 which resides with AlphaMed, it is impossible to have this process performed be anyone else. Additionally, in the 25 year history of the development of Ra-224 generators, no other entity has performed this process. The process was created by AlphaMed and the combination that the source materials and this process both reside with AlphaMed defines that no other entity could perform said process.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/NCI-90202-AV/listing.html)
- Record
- SN01918253-W 20090821/090820001111-7b47a036014d2276c47aa2f2f3313040 (fbodaily.com)
- Source
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