SOLICITATION NOTICE
B -- Support for clinical trials of Therion Vaccines
- Notice Date
- 6/29/2007
- Notice Type
- Solicitation Notice
- NAICS
- 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, MD, 20852, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-NCI-70078-NG
- Response Due
- 7/16/2007
- Archive Date
- 7/31/2007
- Description
- The National Cancer Institute (NCI) plans to procure, on a sole source basis with Dr. Alicia Gomez-Yafal; 599 Cambridge Street, Unit 302; Cambridge, MA 02141 regarding consulting support for 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 and planned NCI clinical trials 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) support for Investigational New Drugs (INDs). These vaccines are sponsored by the Cancer Therapy Evaluation Program (CTEP) clinical trials at the NCI. Contractor shall provide the following task: Stability testing, which includes identifying a facility capable of conducting plaque titration assays for vaccinia and fowlpox-based vaccines; provide assay procedures of the facility, consult and provide assays to facility, coordinate the handling of technical issue, audit and review, and approve test protocols. This requirement will allow NCI to continue vaccine clinical trials using the current schedule. Period of Performance shall be for a base period of four (4) months with two (2), one (1) month options. Dr. Alicia Gomez-Yafal is the only source known to the NCI that can provide the consulting service NCI requires to maintain the continuity of on-going and planned clinical trials using vaccines manufactured by the former Therion Biologics Corporation. Dr. Gomez-Yafal served as Director of Discovery Research and established the Cell Culture/Virology function at Therion. In addition, she was responsible for the generation of all vaccines, recombinant vectors and preclinical reagents including the development and characterization of complex vaccines all of which are currently being used in the NCI vaccine clinical trials. As a result, she was responsible for writing all pertinent standard operating procedures (SOPs) and performing the technology transfer to quality assurance (QA) and quality control (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 1:00 PM ET July 16, 2007. 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 and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA). Please reference solicitation number NCI-70078-NG on all correspondence.
- Record
- SN01331413-W 20070701/070629220455 (fbodaily.com)
- Source
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