SOURCES SOUGHT
R -- Regulatory Support for Clinical Trials of Therion Produced Vaccines
- Notice Date
- 9/14/2007
- Notice Type
- Sources Sought
- 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
- N02-RC-81007-32
- Response Due
- 10/30/2007
- Archive Date
- 11/13/2007
- Description
- The National Cancer Institute (NCI) plans to procure, on a sole source basis with May Lou Horzempa, 4 Marions Way, Georgetown, MA 01833 for regulatory support for clinical trials of Therion produced 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 tasks: monitoring of stability testing of vaccines, vaccine inventory management, maintenance of Investigational New Drug Applications for vaccines developed under CRADA with Therion Biologics Corporation (Therion) and assistance in transitioning vaccine development to a third party partner. Any contractor performing this work must have knowledge of the assay procedures and Investigational New Drug applications held in conjunction with vaccines developed by Therion. In addition, the contractor must monitor transfer and inventory of current vaccine inventory from a third party contractor to a Government repository. NCI This requirement will allow the continuity of the vaccine clinical trials within the NCI and to continue with the current schedule of these clinical trials. Period of Performance shall be for a base period of six (6) months with two (2), three (3) month options. Ms. Horzempa is the only source known to the NCI that can provide the service NCI requires to maintain the continuity of on-going and planned clinical trials using vaccines manufactured by the former Therion Biologics Corporation. The contactor, Mary Lou Horzempa, is uniquely qualified to meet the needs for the proposed contract. Ms. Horzempa was employed by Therion Biologics Corporation during its entire 15-year history. She served first as Manager, then Director, and, most recently, Vice President of Regulatory Affairs. She established the Regulatory Affairs function at Therion and was responsible for all regulatory submissions and communications with the FDA pertinent to the clinical research of Therion?s vaccines. 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 October 30, 2007. Questions must be submitted in writing to Richard Hartmann, Contracting Officer, at hartmari@mail.nih.gov or by fax 301-402-6699. 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 N02-RC-81007-32 on all correspondence.
- Place of Performance
- Address: 4 Marions Way, Georgetown, MA
- Zip Code: 01833
- Country: UNITED STATES
- Zip Code: 01833
- Record
- SN01406955-W 20070916/070915193403 (fbodaily.com)
- Source
-
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