SOURCES SOUGHT
A -- Scleroderma Cyclophosphamide or Transplantation Study (SCOT)
- Notice Date
- 2/9/2011
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- NIH-AI-2011117
- Archive Date
- 3/10/2011
- Point of Contact
- George Ralis, Phone: 301-496-0194, Donald E Collie, Phone: 301-496-0992
- E-Mail Address
-
ralisg@niaid.nih.gov, dcollie@niaid.nih.gov
(ralisg@niaid.nih.gov, dcollie@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SCLERODERMA CYCLOPHOSPHAMIDE OR TRANSPLANTATION STUDY (SCOT) Small Business Sources Sought Notice Solicitation Number: NIH-AI-2011117 Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background A trial entitled "A Randomized, Open-Label, Phase II Multi-Center Study of High Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation with Auto-CD34+HPC versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis" otherwise known as the SCOT (Scleroderma: Cyclophosphamide or Transplantation) trial was developed under the leadership of Dr. Sullivan at Duke University in response to a Broad Agency Announcement (BAA). Prior to the opening of the trial in 2005, a Drug Master File along with Standard Operating Procedures for the production of the cellular product, Auto-CD34+HPC were written and submitted to the FDA. These documents were created in order to ensure consistency in manufacturing across clinical sites. Transplant centers were inspected and qualified for participation in the trial. Version 1.0 of the clinical protocol was submitted to the FDA in August 2004; the first site (Duke) was opened for enrollment in May 2005. Ultimately 8 transplant centers and 23 rheumatology centers were qualified for participation in the clinical trial. Because of slow enrollment and new data regarding the treatments used in SCOT, the SCOT trial was redesigned in the fall of 2009. Results from recent updates to two previously completed studies were used to estimate the magnitude of the difference of the anticipated differences in survival and event free survival between the two treatment arms of SCOT. The new data revealed that group differences on the order of 20 percentage points could not be anticipated until 54 months following randomization. This analysis demonstrated that the trial as initially designed was underpowered to detect a difference between the arms at 44 months. In order to accommodate both the slow rate of enrollment and the new information on effect size, a hierarchical composite endpoint was developed. The study was amended to include the new endpoint at 54 months with a reduced sample size of 113 subjects. Purpose and Objectives The SCOT trial was originally designed as a phase III trial to determine whether event free survival would be greater in subjects with severe systemic sclerosis receiving high dose immunosuppressive therapy (HDIT) followed by Auto-CD34+HPC transplantation than in subjects who received a 12 month course of pulse intravenous cyclophosphamide at 44 months after randomization. Despite the barriers, the study has randomized 64 subjects to date. The purpose of this contract is to provide funds to complete the clinical study. Enrollment will be closed March 31, 2011. Subject follow up will be completed 54 months following the randomization of the last subject. A non randomized patient registry has been developed and is currently enrolling subjects. The collection of data from subjects eligible for participation in SCOT but who have declined to do so and are undergoing standard of care, will inform the rheumatology community about the progression of SSc in the current treatment climate. The registry will help to assess whether the outcomes for subjects enrolled in SCOT differ from those seen in individuals treated in the community. Other tasks to be completed include: flow cytometry studies, high resolution computer assisted tomography studies, and mechanistic studies evaluating the underlying immunologic basis of scleroderma, the effect of treatment on disease status and collection and management of a specimen repository. Project Requirements • The consortium of clinical sites developed by the contractor to perform this trial has been maintained and currently consists of 8 transplant centers across the US and Canada. In addition to the transplant centers, 11 rheumatology centers across the US and Canada work to treat and follow subjects from a wider geographic area. Clinical follow up for subjects participating in SCOT needs to be completed. • Follow up will continue for 54 months following the randomization of the last subject. This time period is essential in order to demonstrate efficacy given the sample size and statistical assumptions. Subjects will be seen on the schedule delineated in the clinical protocol. Data will be submitted to the Statistical and Clinical Coordinating Center and publications on the outcome of the trial need to be written. • Long term follow up of mortality and morbidity of subjects originally enrolled in the Scleroderma Lung Study will be obtained in order to understand the long term effectiveness of cyclophosphamide in the treatment of scleroderma lung disease. A repository has been established for future use and is collecting serum, plasma, RNA, DNA and peripheral blood mononuclear cells. • Mechanistic studies are ongoing including pharmacokinetics of cyclophosphamide relative to clinical outcome in both arms of SCOT, immunophenotying by flow cytometry, pulmonary response as measured by high resolution compute assisted tomography, molecular analysis of T cell recovery, and the role of endothelial progenitor cells in the pathogenesis of systemic sclerosis. Anticipated Period of Performance Base: June 1, 2011 - September 30, 2015 Option: October 1, 2015 - September 30, 2016 Other Important Considerations • The transplant sites have to conform to standards for cell processing mandated by the FDA. • Incumbent developed a website, advertising, and educational materials to aid in the conduct of the trial. All of these materials require IRB review before they can be made public. Capability Statement /Information Sought Offerors must demonstrate related experience, describe available facilities, list the staff qualified to support this effort, has appropriate financial resources and the ability to complete the work by the designated contract completion date. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIAID/NIH-AI-2011117/listing.html)
- Place of Performance
- Address: Contractor Site, United States
- Record
- SN02376223-W 20110211/110209234226-a893918bd27150fbd5ff22b94a6d0f32 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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