SOURCES SOUGHT
R -- Define the Optimal Parameters and Target Cell for In-Vitro Assay Method
- Notice Date
- 5/21/2009
- Notice Type
- Sources Sought
- NAICS
- 561410
— Document Preparation Services
- 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
- FDA-09-1056211
- Point of Contact
- Karen R. Petty, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Solicitation: FDA-09-1056211 Agency/Office: Food and Drug Administration Project Title: Expansion and Validation of Invitro Assays Request for Information (RFI): This is a RFI in accordance with FAR 15.201 (e) to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication that the Government will contract for the items contained herein. This notice 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 notice. This RFI is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for or award a competitive contract. It is emphasized that this is a notice for planning and information purposes only and is not be construed as a commitment by the government to enter into a contractual agreement, nor will the government pay for information solicited. The Government does 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 RFI. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is seeking to identify any sources with capabilities or prior experience that can perform the following: Background: Identified Public Health Gap & Critical Path Need: Children in a gene therapy clinical protocol for X-linked Severe Combined Immunodeficiency Disease (X-SCID) have developed leukemia as a result of insertion and subsequent activation of known human oncogenes by the retroviral vector used to treat their disease. This tragic outcome has led many investigators in the gene therapy field to develop novel retroviral vectors with the expectation that they may provide the therapeutic benefit that the gammaretroviral vector used in France provided to the children with X-SCID but with a reduced risk of tumorigenesis. In an effort to develop and validate an animal model that can be used to assess the relative tumorigenic risks associated with new vectors, FDA and academic investigators will assess various vectors that are under development. While the animal model that will be used in the study can reproducibly detect retroviral vector-mediated tumorigenic events, it is time-consuming (6-14 months before tumorigenic events are detected), expensive, and requires use of animals. In an effort to develop a method that would be faster, higher throughput, less expensive, and not require animals, we have shown that ex vivo transduction of primary cultures of murine hematopoietic stem cells can be used to detect immortalization events when subject to prolonged in vitro culture, depending on the vector structure. We propose that the in vitro assay would not substitute for an in vivo tumorigenicity assay, but may be suitable as an initial screen of new vector types, and if the new vector was negative or had a low rate in the in vitro assay, it would then be reasonable to proceed with the more rigorous and most relevant in vivo assay to look for tumorigenicity in the mouse model. However, prior to instituting this type of approach, the in vitro method needs to be further studied and the assay needs to be optimized and developed in order to demonstrate its reproducibility, sensitivity, and ability to be sufficiently quantitative for comparison of different vector types that may transform primary cells by different mechanisms. The goal would be to complement the ongoing study by performing the immortalization assay on the same sets of transduced cells that are going into the mice, and in this way, one could obtain side-by-side comparisons of the relative sensitivity of each assay, as well as obtain data to define the reproducibility and reliability of the in vitro method. If the assay proves to be suitable, then future sponsors would have a relatively inexpensive and rapid (weeks vs. months-year) assay method to perform an initial screen of novel vector constructions for assessment of relative risk. The additional advantage of using the in vitro assay for initial screens is the reduction in the use of animals for tumorigenicity testing. Availability of an in vitro method to assess the tumorigenic likelihood of new retroviral vectors in hematopoietic cells may ultimately translate into a reduced risk to clinical trial participants, along with economic savings to the sponsors developing these novel products, and a reduction in the number of animals used for safety testing. FDA Objectives: Define the optimal parameters and target cell for an in vitro assay method that is reproducible, sensitive, and quantifiable in detection of retroviral vector-mediated cell transformation. RFI Submission Instructions: FDA will not award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA’s use of such information. Responses will be separated from, and have no bearing on subsequent evaluations of proposals submitted in response to any resulting formal RFP. Eligibility in participating in a future acquisition does not depend upon a response to this notice. Proprietary information is not being solicited. Information considered proprietary, if any, should be identified as such. Responses will be reviewed only by FDA personnel and will be held in a confidential manner. Responses to the RFI should address the following: Companies are encouraged to respond if they have the capability and capacity to provide the services with little or no disruption of services to the current users at the FDA. However, be advised that generic capability statements are not sufficient for effective analysis of respondents' capacity and capability to enable FDA to examine, analyze, review, verify, improve upon existing and develop, if necessary, mechanisms related to food safety and defense (protection) to protect, promote and preserve the public’s health and well-being. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Part A: Technical and Capabilities--Provide a capability statement describing how your institution would define the optimal parameters and target cell for an in vitro assay method that is reproducible, sensitive, and quantifiable in detection of retroviral vector-mediated cell transformation. Part B: Cost Estimate--Provide a cost estimate for the services and the number of hours to define the optimal parameters and target cell for an in vitro assay method that is reproducible, sensitive, and quantifiable in detection of retroviral vector-mediated cell transformation. Part C: Organizational Conflict of Interest--If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest to define the optimal parameters and target cell for an in vitro assay method that is reproducible, sensitive, and quantifiable in detection of retroviral vector-mediated cell transformation. Part D: Security Requirements--At project completion, while the generated data, information and recommendations are considered public property, describe your ability to provide cleared contractor personnel for the project ensuring data accuracy and integrity. Part E: Business Size—Provide your business size, ie. Small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. Although anticipated NAICS code is identified in the Fedbizopps posting, all NAICS codes will be reviewed. Part F: Small Business--Describe your ability to meet the requirements in accordance with 52.219.14—Limitation on Subcontracting. Responses shall be: 1.Identified with the RFI number; and include: Company’s 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.No more than ten (10) pages in length; 3.NOT submitted using the marketing materials; 4.Submitted to the email as indicated above. SUBMISSIONS ARE DUE no later than 5:00pm, on Thursday, May 28, 2009, Eastern Standard Time. The RFI response shall be e-mailed to: Karen.petty@fda.hhs.gov. All information received in response to this notice that is marked proprietary will be handled accordingly. FDA makes no implied or in fact contracts by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Do not send any material that requires a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1056211/listing.html)
- Place of Performance
- Address: 5600 Fishers Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01824777-W 20090523/090521235328-91a139ce0bfdbf986d79f3308bb2286f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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