SOLICITATION NOTICE
A -- Production and testing of select PET and SPECT radiopharmaceuticals - RFP S09-235
- Notice Date
- 10/21/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S09-235
- Archive Date
- 12/21/2009
- Point of Contact
- Kathy A. Scarzello, Phone: 3018461019, Shannon B Jackson, Phone: 301-228-4022
- E-Mail Address
-
scarzelloka@mail.nih.gov, sjackson@mail.ncifcrf.gov
(scarzelloka@mail.nih.gov, sjackson@mail.ncifcrf.gov)
- Small Business Set-Aside
- N/A
- Description
- RFP S09-235 Production and testing of select PET and SPECT radiopharmaceuticals SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK ARTICLE C.1. BOA STATEMENT OF WORK A. Background A goal of the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI) 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, therapy selection, and monitoring information. These efforts are broad in scope and include pre-clinical development, creation of standard operating procedures (SOPs) for Chemistry Manufacturing & Control (CMC) and quality control (QC)/quality assurance (QA), Investigational New Drug (IND) preparation and submission (including exploratory IND), supporting and conducting imaging clinical trials, and incorporating 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. B. Purposes and Objective of Procurement As a means to provide selected PET and SPECT radiopharmaceuticals to support non-clinical studies and both small early phase trials and larger trials, SAIC-F would like to engage subcontractors that are able to produce and distribute them on a unit dose basis to sites of special interest to SAIC-Frederick. A key requirement is the ability to produce doses to support preclinical studies and clinical trials conducted under authority of an IND or Radioactive Drug Research Committee (RDRC). The products may be produced employing the subcontractor's established procedure, a published procedure, the procedure submitted in an NCI IND, or by a subcontractor-developed procedure that synthesizes the desired product (see Attachment I for examples). The procedure must be provided for submission to the Food and Drug Administration (FDA) and accepted by the FDA if necessary. If distribution to additional sites is required, delivery will be handled by a separate subcontractor who can meet the unique requirements for shipping radiopharmaceuticals. Cost proposals for each Task Order shall be broken into five (5) separate budget lines: 1. Cost of development and implementation of synthesis if required; 2. Cost of needed animal studies if required; 3. Cost of required documentation and filing if required; 4. Ongoing administrative cost to maintain capability in an active status; 5. Unit dose cost (adjusted for volume) Some of the radiopharmaceuticals requested may already be routinely synthesized by the subcontractor, so portions of the budget lines listed here may not be necessary for a specific Task Order. SAIC-Frederick reserves the right to make site visits to subcontractor prior to the awarding of a basic ordering agreement and also reserves the right to inspect any sites and records as required. D. Subcontractor Requirements 1. Experience in the production of radiopharmaceuticals including alpha emitting, PET, and SPECT isotopes. 2. Ability to meet the requirements of United States Pharmacopeia (USP) <823>, and of the FDA for IND filing. 3. Ability to prepare and package for delivery unit doses of labeled compounds suitable for preclinical or clinical trial use. 4. A geographic location to allow delivery of short-lived radiopharmaceutical agents to Bethesda and Frederick, MD. 5. A positive ion cyclotron and experience in production of gas and liquid 18F, SPECT and alpha emitting nuclides. 6. A Small Animal Imaging capacity with high resolution PET, SPECT and CT scanners capable of auto-radiography, dosimetry, and surgery. 7. Adherence to and fulfillment of requirements of 1) The NIH Guide for Care and Use of Laboratory Animals (the Guide), 2) the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, 3) the Animal Welfare Act and 4) all applicable USDA laws and regulations for work conducted on animals. 8. Subcontractor must provide an NIH OLAW assurance number. 9. It is recommended that subcontractor adhere to the standards of and have accreditation to the Association of Assessment and Accreditation of Laboratory Animal Care International (AALAC, Int.). E. Anticipated Task Order Deliverables Although not required by this BOA, it is anticipated that the following types of deliverables will be required by any subsequent task orders. The subcontractor will work closely with DCTD and the SAIC-Frederick subcontract support personnel to complete the development work on the synthesis methods and quality control assays necessary to write and compile the manufacturing production records, standard operating procedures, and other information required for producing multi-dose radiopharmaceuticals. Specifically, this work will be done on a Task Order basis for a specific radiopharmaceutical, and will include the following: 1. Develop the synthesis of the radiopharmaceutical if necessary. 2. Provide a Small Animal Imaging capacity with high resolution PET, SPECT and CT scanners capable of auto-radiography, dosimetry, and surgery and perform preclinical studies as requested. 3. Once the methodology has been scaled up and optimized, the contractor will write appropriate documentation for producing the radiopharmaceutical at their facility in sufficient detail for IND with the FDA or to assure an RDRC that the quality is appropriate for administration to human subjects. This documentation will include the necessary background development information, the complete written compilation of chemistry and synthesis methods, and detailed QC/QA procedures and any required qualification data to assure that the synthesized compound is pure and acceptable for injection in human subjects. 4. Prepare the radiopharmaceutical on a unit dose basis for preclinical studies and clinical trials at the institution or to sites of special interest to SAIC-Frederick to support the program goals. If distribution to a separate site is necessary, it is anticipated that a separate vendor will be requested to ensure that distribution is being conducted as local, state, and federal laws mandate. 5. Provide a written plan for auditing and allowing outside auditors to visit the facility as appropriate. F. Meetings It is anticipated that meetings with the subcontractor shall occur as needed to keep the SAIC-F COTR and NCI Project Officer informed regarding the progress of the project. In the absence of formal meetings, contact with the subcontractor shall occur via phone, fax, or electronic mail.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/S09-235/listing.html)
- Place of Performance
- Address: Subcontractors location, United States
- Record
- SN01989553-W 20091023/091021235104-e9581569f637e27b7518221c2f08da80 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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