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FBO DAILY ISSUE OF JUNE 13, 2008 FBO #2391
SOURCES SOUGHT

A -- Radio-Synthesis of C-docetaxel

Notice Date

6/11/2008
 

Notice Type

Sources Sought
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

1043416
 

Point of Contact

Vida - Niles, Phone: 301-827-2476
 

E-Mail Address

vida.niles@fda.hhs.gov
 

Small Business Set-Aside

Total Small Business
 

Description

This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) that can provide the following analytical report: Project Title: Radio-Synthesis of 11C-docetaxel suitable for human administration Background: Docetaxel has value in the treatment of several tumors, including breast and lung cancer. It would be especially desirable to identify those tumors that are likely to be sensitive to docetaxel in a disease such as breast cancer, because there are many alternative drugs that could be used if docetaxel were ineffective. Several determinants for the antitumor activity of docetaxel are known. However, the most readily investigated mechanisms of sensitivity or resistance to docetaxel appear to be the steps of cellular uptake and efflux. Because the sensitivity of tumor cells to docetaxel is directly linked to the amount of drug that collects inside the cell, positron-labeled docetaxel might be useful as a probe for noninvasive external imaging of the uptake and retention of docetaxel. The ability of tracer amounts of radiolabeled docetaxel to evaluate the net effect of these two transport steps with this single probe is potentially a powerful tool to improve response rates and decrease unnecessary toxicity by matching drugs and tumors. The Laboratory of Clinical Pharmacology at FDA has developed a micro-synthesis using CO2 as the donor to form the tert-butylcarbonate group on the side chain connected to the main Baccatin moiety. 11C-CO2 is a common cyclotron product that can be used with this method to generate 11C-docetaxel. The contractor must have access to a cyclotron and have sufficient experience in 11C production and synthetic chemistry to generate the 11C starting material and 11C-docetaxel final product. Statement of Work: The contractor shall furnish the necessary personnel, services, materials, and otherwise perform all necessary functions, in the performance of the work as described below. The primary amine form of precursor is available from the Laboratory of Clinical Pharmacology at the FDA. I.Work closely with the project officer and study liaison throughout the lifespan of the contract. II.The contractor shall synthesize 11C-docetaxel based on the procedure developed by the Laboratory of Clinical Pharmacology (LCP) at FDA and at other sites. a.The contractor will perform the synthesis of 11C-docetaxel following the procedure developed by LCP. The procedure uses 11CO2 mixed with potassium tert-butoxide followed by the addition of methanesulfonyl chloride to produce 11C-di-tert-butyl dicarbonate (diBOC). The docetaxel precursor is reacted to complete the synthesis 11C-docetaxel. b.The contractor shall follow alternate synthesis methods of 11C-docetaxel from published literature or developed at their site to compare with the procedure described in 2a. The radiolabeled carbon may be in the form of 11CO2 or other forms of 11C. The synthetic process that is most facile with the least steps or shortest synthesis time and yields the most 11C-docetaxel will be used for isolation and purification steps suggested in 3 below. III.The contractor is required to purify the 11C-docetaxel after it is made. The suggestion is that the contractor follow procedure IIIa however the contractor may think of a better way to purify the 11C-docetaxel. IIIb allows the contractor to perform a different purification if the contractor so chooses. If it is confusing then IIIa and IIIb can be omitted keeping only III. a.The reaction mix from 2a or 2b is dried and then dissolved in a small volume of 40% ethyl alcohol. It is passed through a strong cation solid phase exchange column (SPE) followed by more 40% ethyl alcohol. The pooled elutions are diluted with water and passed through a C18 SPE, washed with water, and eluted with MeOH. The MeOH elution containing the 11C-docetaxel is dried and a final purification step is performed by peak collection from HPLC. b.The contractor may develop and follow alternate purification methods of the reaction mix from 2a or 2b. III.The contractor will optimize the full procedure from isotope generation to final injectable product while maintaining records of failed attempts and successful improvements. IV.Show that a sufficient quantity of final product can be produced with a specific activity and product quality required for patient imaging. The Period of Performance to be determined. The contract will be awarded for 1 year. Deliverables: The contractor shall issue monthly status reports to the project officer and study liaison indicating the progress since the last report. Due at the end of each month. At the completion of the project the contractor shall provide – I.Standard Operating Procedures (SOP) for the complete optimized production, synthesis, and purification processes under the Scope of Work above. Due 30 days after the completion of the project. II.Final report to include a summation of the results of the monthly reports and conclusions drawn from the findings. Due 30 days after the completion of the project. III. Reports shall be submitted in wordformat electronically via email upon due date. The performance period will be one year from the time of award. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents capacity and capability to provide the required specific instrument. Responses to this notice shall be limited to 15 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541712 (size standard, $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above) electronically to vida.niles@fda.hhs.gov. Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. THIS NOTICE IS FOR PLANNING PURPOSES ONLY, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses must be sent to this notice no later than 10:00 a.m. EST on June 26, 2008 submitted by email to vida.niles@fda.hhs.gov, Vida Niles, Contract Specialist for consideration. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=f490d56a4ebf37b38af9a463c998f01e&tab=core&_cview=1)
 

Place of Performance

Address: 10903 New Hampshire Avenue, Silver Spring MD 20993, United States

Zip Code: 20993
 

Record

SN01591161-W 20080613/080611221551-f490d56a4ebf37b38af9a463c998f01e (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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