SPECIAL NOTICE
A -- Notice of Intent to Sole Source a Contract to Biopath Clinical Diagnostics Inc. to Support Dengue Vaccine Clinical Study
- Notice Date
- 11/3/2011
- Notice Type
- Special Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W806YH11882002
- Archive Date
- 2/1/2012
- Point of Contact
- John Niziolek, 301-619-1348
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(john.niziolek@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Date: 03 November 2011 Year: 2011 Contracting Office Zip Code: 21702-9232 Classification Code - 5411690 - Research and Development in Biotechnology Contracting Office Address - USA Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702-5014 Subject: Notice of Intent to Sole Source a Contract to Biopath Clinical Diagnostics Inc. to Support Dengue Vaccine Clinical Study Solicitation Number: W81XWH-12-R-0006 Closing Response Date: Notice of Intent - 20 November 2011, Solicitation - 22 December 2011. Contact Point: John Niziolek at john.niziolek@amedd.army.mil or 301-619-1348. Contract Award Dollar Amount: $2,627,371.41 over 5 years Contract Award Date: 13 January 2012 Contractor: Biopath Clinical Diagnostics Inc., Cebu City, Philippines Description: The Government intends to award a sole source contract to Biopath Clinical Diagnostics Inc. (Biopath) to perform a Phase 3 efficacy trial involving a leading dengue vaccine candidate. Over the past 18 months, BioPath successfully performed a preparatory study to evaluate their ability to adequately perform a large scale phase 3 efficacy studies in Cebu City, Philippines. As a result of this performance, the U. S. Government has selected BioPath for continued support of this phase 3 efficacy trial. Subsequently, the phase 3 efficacy study protocol has been approved by all Institutional Review Boards (IRBs), the US Food and Drug Administration, and all applicable Government IRBs. This is a continuation of the effort conducted over the prior 18 months. Award to another contractor would result in significant delays and additional costs. Ultimately, these delays would result in clinical hold, potentially cancelation of the study and additional costs. Aside from being cost prohibited to the U.S. Government and potentially dangerous to subjects, switching contractors could jeopardize the relationships the U.S. Government has with the Philippines MOPH and Cebu City government as well as jeopardize the validity of the research results obtained thus far in the early stages of the phase 3 efficacy trial. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. Place of Contract Performance - Cebu City, Philippines Set-aside Status: Unrestricted
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W806YH11882002/listing.html)
- Record
- SN02617608-W 20111105/111103234256-489938cc4f928b2356f78ed779e062a1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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