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FBO DAILY ISSUE OF MAY 31, 2009 FBO #2743
SOLICITATION NOTICE

R -- Define the Optimal Parameters and Target Cell for In-Vitro Assay Method - Past Performance Questionnaire

Notice Date

5/29/2009
 

Notice Type

Combined Synopsis/Solicitation
 

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-KP
 

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

N/A
 

Description

Past Performance Questionnaire Synopsis: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 561410, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-32. This synopsis is designated for full and open competition for a Labor hour purchase order. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This combined synopsis solicitation is issued as a Request for Quotations (RFQ). The FDA intends to award a purchase order for the expansion and validation of invitro assays for detection of events predictive of leukemogenic potential of retroviral vector from pre-clinical or clinical samples. The Statement of Work is as follows: Objective: 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. 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. The animal model that we are using was initially developed by Dr. Christopher Baum (co-affiliated with the Hannover Medical School in Germany as well as Cincinnati Children’s Hospital Medical Center). 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, Dr. Baum has 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. Scope of Work: The methodological approach: Indentify the target cell type, in three (3) steps. 1) Identify the primary hematopoietic cell source that provides a reliable and sensitive measure of transformation due to vector-mediated insertional mutagenesis. Different hematopoietic cell lineages will be analyzed for their relative sensitivity to transformation after vector transduction in an established replating assay. 2) Using different retroviral vectors varying in the types of regulatory elements included in backbone, the mechanism of transformation as a function of vector backbone will be determined. Analysis of frequency of transformation events in the optimized assay and mapping of genomic integration sites will be used to elucidate the mechanism associated with different regulatory elements. The results will be used to rationally design various types of integrating vectors that can circumvent the mechanisms indentified as primary drivers of transformation events. 3) Clonal lines (murine or human) carrying specific oncogenes will be established and tested for reversion of transformation due to down-regulated expression of the oncogene using inducible promoters, thus making the transformation phenotype conditional. These cells will be examined for resistance to oncogene down-regulation as a result of insertional mutagenesis – perhaps leading to an unrestricted, highly reproducible cell line for the transformation assay. DELIVERABLES: Deliverables for Base Year: 1) Analyze the mechanism of transformation by vector type: By December 31, 2009, initial work will be done in the current assay to identify the characteristics of the vector that correlate to in vitro immortalization Deliverable: report to FDA/CBER on results of the preliminary analysis 2) Define target cell type: By March 31, 2010, the target cell type should be identified Deliverable: report to FDA/CBER on results of the analysis and findings Deliverables for Option Year #1: 3) Develop conditionally immortal cell lines that may replace primary cells By March 31, 2011, conditionally immortal cell lines will be identified Deliverable: report to FDA/CBER on results Deliverables for Option Year #2: By March 31, 2012, confirmatory work of findings will be completed in the final assay format (determined in #3) Deliverable: report to FDA/CBER on results of confirmatory findings and publication of research results in a peer-reviewed scientific journal By March 2012, confirmatory work to show that the immortal cell lines give the same results with the same panel of retroviral vectors will be completed. Deliverable: report to FDA/CBER on results of confirmatory findings and publication of research results in a peer-reviewed scientific journal Period of Performance: Period of performance shall be for a base year and two (2) option years. Place of Performance: Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: karen.petty@fda.hhs.gov, no later than 5:00pm, EST on or before Thursday June 4, 2009. QUOTATIONS DUE: All quotations must be received by email to: karen.petty@fda.hhs.gov, no later than 5:00pm, EST on or before, Friday, June 12, 2009. Telephone calls will not be accepted. EVALUATION AND AWARD: Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: Each Offeror must submit a proposal, which consists of three (3) parts: (1)Demonstrated Technical Approach The Offeror shall describe its proposed technical approach demonstrating it fully understands the requirements set forth in the Statement of Work and its overall approach for achieving the requirements set forth in the Statement of Work. The technical approach shall include: •The Offeror’s proposed approach to managing the tasks set forth in the Statement of Work. •The proposed personnel will be evaluated on their qualifications and experience as they relate to the tasks described in the Statement of Work. All personnel must meet the required education and experience requirements as set forth in the Statement of Work. The contractor must have personnel with specific experience in the development for each of the deliverables listed in the Statement of Work. •The contractor shall establish a clear understanding of the issues faced in the SOW. •The contractor shall show a clear understanding of the intent of the project, a clear awareness of the contract objectives. •The contractor’s technical approach shall be representative of the broad disciplines described in the Statement of Work. •The contractor’s technical approach shall demonstrate a logical progressive step-by-step path to the completion. •The contractor’s technical approach shall address each of the program objectives and deliverables listed in the Statement of Work. •The contractor shall provide evidence that the designated personnel are competent and experienced in the skills required in the Statement of Work. Resumes of personnel and consultants reflect not only academic qualifications, but also length and variety of experiences in similar tasks. (2)Past Performance Information The Offeror shall describe previous experience in performance of technical projects similar in size, scope, technical difficulty, and complexity to the requirement being competed. Past performance information must include: •A demonstrated historical relationship performing the tasks referenced in the SOW. •Evidence of prior experience in education / curriculum development for the disciplines represented in the Statement of Work. The Government’s evaluation of past performance shall examine: the services delivered, timeliness of performance, and cost effectiveness. The Offeror shall request completion of past performance questionnaires (see Attachment 1) from a total of three (3) references. In order to facilitate the evaluation of the Offeror’s past performance, the Offeror shall present the following information for its three (3) references: a)Name and Address of Customer b)Contract Number c)Brief Description of Contract d)Brief Description of Services provided and Technologies Used e)Name, address, and current phone number for the Customer’s Business Manager (Contracting Officer) f)Name, address, and current phone number for the Customer’s Technical Manager. The Past Performance Questionnaire attached to this RFQ must be submitted by the Offeror’s references and submitted directly to FDA/OAGS at the address shown in the questionnaire no later than the close of business on or before the date proposals are due. It is the Offeror’s responsibility to forward the past performance questionnaires to the references and to have those references complete the questionnaires and fax them in a timely manner. Offerors shall not submit past performance questionnaires with their proposals. If the Offeror has no past performance, the Offeror shall submit a certification indicating the Offeror has no past performance. The certification shall be in a separately sealed envelope clearly marked with a notation indicating past performance certification and the solicitation number, and accompanied with the RFQ volumes. (3)Pricing Information The Offeror shall prepare a Price Proposal that contains all information necessary to allow for a comprehensive evaluation of the prices proposed by the Offeror. The Price Proposal shall consist of pricing discounts with the proposed labor categories and hours, and an accompanying narrative that fully describes all assumptions made by the Offeror. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-09-1056211-KP/listing.html)
 

Place of Performance

Address: 5600 Fishers Lane, Rockville, Maryland, 20857, United States

Zip Code: 20857
 

Record

SN01830654-W 20090531/090529235832-8b1e8fe44cfd503ffb1e0b1217d05c29 (fbodaily.com)
 

Source

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

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