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B -- Consulting Support for Clinical Trials of Therion Vaccines

Notice Date
Notice Type
541690 — Other Scientific and Technical Consulting Services
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
ZIP Code
Solicitation Number
Point of Contact
Malinda L Holdcraft,, Phone: (301) 402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
E-Mail Address
holdcram@exchange.nih.gov, cr214i@nih.gov
Small Business Set-Aside
The National Cancer Institute (NCI) plans to procure on a sole source basis with Dr. James Monroe 80 Randall Street, Worcester, MA 01606, for support services regarding the NCI Clinical Trials of Therion Vaccines. The North American Industry Classification System Code is 541690 and the business size standard is $6.5M. The supplies and services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13.106. The purpose of this procurement is to support on-going planned NCI clinical studies of vaccines manufactured by the former Therion Biologics Corporation. These vaccines were manufactured by Therion and are in good standing with the Food and Drug Administration (FDA) and provide the necessary Chemistry, Manufacturing, and Control (CMC) information required for FDA approval to conduct clinical trials of these vaccines. Contractor requirements: Stability testing in which the contractor shall provide recommendations and guidance in the technical transfer of stability tests assays to the test facility, review test facility protocols, batch records and Standard Operating Procedures (SOP's) for technical content to name a few. This will allow the continuity of the vaccine clinical trials, CMC project, and allow the NCI to continue with the current schedule of clinical trials. It will also help to ensure that NCI capitalizes on the enormous potential these clinical trials offer and the opportunity to lead discovery efforts in cancer vaccine research. Period of Performance shall be for six (6) months from date of award; FAR Clause 52.217-8 Option to Extend Services. Dr. James Monroe is the only source known to the NCI that can provide the services required to maintain the continuity of on-going and planned clinical trials using vaccines manufactured by the former Therion Biologics Corporation. He served first as Scientist in the Cell Culture/Virology Department, and then as a Scientist in the BioAnalytical Department. In the Cell Culture/Virology Department at Therion he was responsible for the generation of vaccines, recombinant vectors and preclinical reagents, including the development and characterization of complex vaccines for Phase I, II and III clinical trials. In addition, he developed and performed the assays to test the stability of Therion vaccines, was responsible for writing all pertinent SOPs and for performing the technology transfer to QA/QC. This is not a request for competitive quotation. However, if any interested party believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform this requirement. Capability statements must be received in the contracting office by 11:00 AM ET June 5, 2008. Questions must be submitted in writing to Malinda Holdcraft, Contract Specialist, at holdcram@exchange.nih.gov or by fax 301-402-4513. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered in and have valid certifications in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Please reference solicitation number NCI-80081-NG on all correspondence.
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