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A -- Rituximab Therapy in Refractory Adult and Juvenile Idiopathic Inflammatory Myopathies

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NIH-NIAMS-04-05Federal

Contract Overview

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AI Contract Overview

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) plans to negotiate a sole source contract with the University of Pittsburgh to conduct a multi-center, six-month randomized, double-blind, placebo-controlled trial assessing the efficacy of intravenous Rituximab for refractory myositis in both adults and children. The trial will involve rheumatologists and neurologists specializing in inflammatory myopathies, using disease activity and damage measures developed by the International Myositis Assessment and Clinical Study Group (IMACS). Rituximab is an FDA-approved monoclonal antibody targeting CD20 antigen, leading to B cell elimination, and is being investigated as a potential therapeutic advance for these myositis conditions. The University of Pittsburgh is uniquely qualified to perform this research due to their established collaboration with most major myositis research centers, approval and cooperation from the drug manufacturer, and prior experience including a planning grant and development of outcome measures in partnership with IMACS. Because of this unique expertise and existing infrastructure, the NIAMS determined competition is not feasible due to potential duplication of costs and delays. While this is not a Request for Proposals, responses from responsible sources will be considered, but the final decision to proceed without competition rests with the Contracting Officer. The contract is associated with NAICS code 541710 and is managed through contact with Eileen D Webster-Cissel, Chief Contracting Officer at NIAMS.

General Info

NIAMS will sole-source a six-month Rituximab trial for refractory myositis with University of Pittsburgh.

Agency

N/A

NAICS

541710 - Research and Development in the Physical, Engineering, and Life Sciences

Place of Performance

Not specified

Set-Aside

NONE

Documents

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Timeline

PostedJun 8

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Organization & Contact Information

AgencyN/A

Contacts1 person available

OfficeN/A

Organization / Agency

N/A

Office AddressN/A

Contacts

Eileen D Webster-CisselChief Contracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to negotiate on a sole source basis with the University of Pittsburgh, Pittsburgh, Pennsylvania, to carry out a study to assess the efficacy of intravenous Rituximab in a multi center 6-month randomized, double-blind, placebo-controlled trial of refractory myositis in adults and children. The trial will be conducted among adult and pediatric rheumatologists and neurologists implementing the newly defined disease activity and damage measures (developed by the International Myositis Assessment and Clinical Study Group (IMACS) in childhood and adult inflammatory myopathy. The goal is to examine the efficacy of Rituximab as a potentially important new therapeutic advance for these diseases. Rituximab is a monoclonal antibody directed against the CD20 antigen that results in elimination of circulating B cells and is currently FDA-approved for use in B cell lymphomas. A determination for the use of other than full and open competition has been made in accordance with 41 U.S.C. 253(c)(1) as set forth in FAR 6.302-1. The University of Pittsburgh is determined to be the only responsible source for the following reasons: (1) They have organized the effort to conduct the study in full collaboration with the majority of myositis research centers in the U.S. and internationally; 2) They have obtained approval and collaboration of the drug manufacturer to conduct the study; 3) They were awarded and carried out a planning grant to organize the study and to develop and test the primary outcomes instrument in collaboration with the IMACS. Therefore, the University of Pittsburgh has the unique capability to perform this work. This is not an announcement of the availability of a Request for Proposals. Inherent duplication of cost to the Government and unacceptable delays in performance make competition for this work unfeasible. All responsible sources may submit a proposal which will be considered by the NIAMS. A determination not to compete the proposed work based upon responses to this notice is solely within the discretion of the Contracting Officer. The North American Industry Classification System (NAICS) Code is 541710. This notice of intent is not an announcement of the availability of a Request for Proposals (RFP), nor is an RFP available. See Numbered Note 22.