SOURCES SOUGHT
A -- GMP Production and Distribution of Investigational Radiopharmaceutical FLT for NCI Supported Multi-Center Clinical Trials
- Notice Date
- 12/5/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, MD, 21702
- ZIP Code
- 21702
- Solicitation Number
- S05-119
- Response Due
- 1/3/2006
- Archive Date
- 1/18/2006
- Description
- A key goal of the Cancer Imaging Program (CIP) in the Division of Cancer Treatment and Diagnosis of the National Cancer Institute is to facilitate the development of promising imaging agents so they can be safely and effectively used in clinical trials to provide unique diagnostic, staging, and therapy selection and monitoring information. These facilitative efforts are broad in scope including pre-clinical development, creation of SOPs for CMC and QC, IND preparation and submission (including exploratory IND), supporting and conducting imaging clinical trials, and incorporating imaging into therapeutic trials. To support these activities, there are several specific resources including DCIDE for pre-clinical development, SAIC contract resources to assist in IND preparation, and a competitively selected core of 4 institutions contracted to perform Phase I/II Clinical Trials of new imaging agents. In addition the NCI supports a number of cooperative groups including the American College of Radiology Imaging Network (ACRIN) for the performance of larger multi-center trials both of imaging agents and integrating imaging into therapeutic trials. In addition to developing agents for use in NCI sponsored clinical trials, it is hoped that such development will progress to provision of a useful agent for other investigational trials including commercial therapeutic drug development and eventually to a commercial imaging agent product. In order to provide 18 FLT to support larger multi-center trials, NCI would like to engage a vendor that would be able to produce and distribute 18FLT on a unit dose basis to regional and national sites to support clinical trials. The key requirement would be for multi-dose production capability to the standards set in the QA and acceptance SOPs to support the existing IND. The product may be produced employing the CMC developed by NCI and submitted with the IND 71,260 or by an alternative CMC process that produces equivalent product. If an alternative CMC is employed it must be provided for submission to the FDA and accepted by the FDA. In the alternative a DMF may be filed but also must be accepted by the FDA. The successful proposal may be by a single vendor proposal or a subcontract among entities including academic institutions however the capability to produce the tracer under cGMP conditions and to distribute in a timely manner must be in evidence. The distribution coverage should be defined and will be evaluated in the selection of vendors. Cost proposal should be broken into 5 separate budget lines: 1) Cost of development and implementation of synthesis; 2) Cost of required documentation and filing; 3) Ongoing administrative cost to maintain capability in an active status; 4) Unit dose cost (adjusted for volume); and 5) delivery cost (may be broken into zones). Vendors will be provided copies of the FLT SOPs for CMC and QA as well as product acceptance criteria under a confidentiality agreement. These materials are to assist the potential vendors in responding to the RFP and cannot be copied and must be returned. SAIC reserves the right to make site visits to bidding vendors prior to the awarding of the contract and also reserves the right to inspection of the sites and records as required.
- Place of Performance
- Address: Contractor's facility
- Record
- SN00944697-W 20051207/051205211805 (fbodaily.com)
- Source
-
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