Performance of Good Clinical Practices (GCP) Compliant Clinical Trials of a Freeze Dried Plasma (FDP) Product of Support Efforts to Obtain Food and Drug Administration (FDA) Licensure
Award Notice Posted
- Solicitation number
- W81XWH14R0059
- Agency
-
Medical Command
Department of the Army, Department of Defense
- Awarded
- to Westat, Inc.
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- W81XWH15C0048 Federal contract award
- NAICS code
- 541711 Research and Development in Biotechnology
- PSC
- Not on record
- More information
Notice details come from SAM.gov. Updated .
Notice text
The US Army has a requirement to develop and license a FDP product in accordance with the Department of Defense (DoD) Acquisition System, FDA regulations and guidelines, and industry best practices. In direct support of the US Army product development effort, the Government is seeking to obtain clinical trial and regulatory support in the performance of GCP compliant clinical trials of a FDP product (Pre-clinical, Phase I, Phase II and Phase III).
The acquisition strategy for the FDP program will utilize a combination of a Cooperative Research and Development Agreement (CRADA) for manufacturing (CRADA partner will fund the manufacturing development) and a contract (subject of this solicitation notice) for conduct of clinical trials and regulatory/technical support. The CRADA partner will supply all clinical trial material for conduct of the clinical trials. The U.S. Army Office of The Surgeon General (OTSG) will be the regulatory sponsor of record for the Investigational New Drug (IND) application, but ultimately the CRADA partner will submit and manage the Biologics License Application (BLA).
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