SOLICITATION NOTICE
B -- NCI Clinical Trials of Therion Vaccines
- Notice Date
- 6/28/2007
- 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-70076-NG
- Response Due
- 7/13/2007
- Archive Date
- 7/28/2007
- Description
- The National Cancer Institute (NCI) plans to procure, on a sole source basis with Ms. Mary Lou Horzempa, 4 Marions Way Georgetown, MA 01833 regarding consulting support services for 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 and planned NCI clinical trails 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 requirements: 1) Stability testing, 2) Vaccine inventory, 3) CMC amendment for Vaccines and; 4) Regulatory Submission Maintenance. These requirements will allow the continuity of the vaccine clinical trials, CMC project, and allow the NCI to continue with the current schedule of clinical trials. These requirements will help to ensure that NCI capitalizes on the enormous potential these trials offer and the opportunity to lead discovery efforts in cancer vaccine research. Period of Performance shall be for a base period of four (4) months with two (2), one (1) month options. Ms. Mary Lou Horzempa is the only source known to the NCI that can provide the consulting services NCI requires to maintain the continuity of on-going and planned clinical trials using vaccines manufactured by the former Therion Biologics Corporation. Ms. Horzempa served as the Vice President of Regulatory Affairs and established the Regulatory Affairs function at Therion which was responsible for all regulatory submissions and communication with the FDA pertinent to the clinical research of Therion?s vaccines. In addition, she is the only source that can maintain the continuity of the CMC project, has access to Therion?s related INDs and Master Files, all of which contain data that is required for uninterrupted research regarding the NCI vaccine clinical trials. In addition, Ms. Horzempa was also responsible for the quality assurance and quality groups at Therion Biologics Corporation which included contract test facilities. 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 13, 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-70076-NG on all correspondence.
- Record
- SN01330175-W 20070630/070628220708 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |