AWARD
A -- OrbeShield Development Program
- Notice Date
- 9/23/2013
- Notice Type
- Award Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Point of Contact
- Thomas P. Hastings,
- E-Mail Address
-
phil.hastings@hhs.gov
(phil.hastings@hhs.gov)
- Small Business Set-Aside
- N/A
- Award Number
- HHSO100201300023C
- Award Date
- 9/18/2013
- Awardee
- Soligenix, Inc., 29 Emmons Drive, Suite C-10, Princeton, New Jersey 08540, United States
- Award Amount
- $10,686,683 (plus options, total not to exceed $26,311,094)
- Description
- The work plan will detail the key studies in the OrbeShield TM (oral beclomethasone 17,21-dipropionate or BDP) development program. The focus of the work plan is the evaluation of OrbeShield TM in pre-clinical and non-clinical studies. A rhesus macaque non-human primate (NHP) total body irradiation (TBI) model of the gastrointestinal acute radiation syndrome (GI-ARS) will be established and will be used to test the efficacy of OrbeShield TM in support of Food and Drug Administration (FDA) regulatory approval under the animal Rule. An option of the work plan proposes to conduct additional pre-clinical and non-clinical studies, drug product manufacturing, as well as establish and study OrbeShield TM in a rhesus NHP partial body irradiation (PBI) model of the GI-ARS as additional support for FDA regulatory approval.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/Awards/HHSO100201300023C.html)
- Record
- SN03198859-W 20130925/130923235448-c43533b9826d7695e10612d18f455785 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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