AWARD
A -- Artesunate for Injection Post-marketing Safety Studies and Clinical Trials
- Notice Date
- 9/16/2021 6:34:54 AM
- Notice Type
- Award Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH21C0105
- Archive Date
- 10/18/2021
- Point of Contact
- Matthew Teel
- E-Mail Address
-
matthew.d.teel.civ@mail.mil
(matthew.d.teel.civ@mail.mil)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Award Number
- W81XWH21C0105
- Award Date
- 09/03/2021
- Awardee
- Amivas (US), LLC MD 21702-5958 USA
- Award Amount
- 15285604.00
- Description
- This requirement is to conduct postmarketing safety studies and clinical trials to assess possible serious risks associated with Artesunate. Anticipated activities may include (but are not limited to): 1)�Conduct a single-arm descriptive international study collecting data in women exposed to IV Artesunate during pregnancy to assess risk of pregnancy and maternal complications and adverse effects on the fetus, neonate, and infant. Infant outcomes will be assessed through at least the first year of life. The study will collect information for a minimum of seven (7) years. 2) Conduct a five (5)-year surveillance study to evaluate the potential development of resistance to Artesunate and dihydroartesisinin as obtained from ongoing resistance monitoring programs on antimalarials. 3) Conduct a female fertility study in rats that tests the adverse effects of intravenous Artesunate when administered prior to mating and continued through mating and implantation in accordance with International Council for Harmonisation S5(A) and 21 Code of Federal Regulation 58 Good Laboratory Practice for Nonclinical Laboratory Studies. 4) Conduct a descriptive five (5)-year study on the use of Artesunate in the U.S. to describe the patterns of disease occurrence in relation to several variables such as demographics, treatment location and date of treatment. 5) Conduct a multiple-dose safety, tolerability, pharmacokinetic study in pediatric patients with severe malaria from 0 to 12 months of age receiving Artesunate. The majority of pediatric patients in this age group is to be six (6) months of age and younger. This contract action was not awarded competitively in accordance with FAR 6.302-1(a)(2). Reference the redacted Justification and Approval (J&A) for details.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/954b6a95d75349d3a2fbbb8667708b1a/view)
- Place of Performance
- Address: Frederick, MD 21702, USA
- Zip Code: 21702
- Country: USA
- Zip Code: 21702
- Record
- SN06134712-F 20210918/210916230114 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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