This Government Contract opportunity from Department Of Defense was posted on September 16, 2021. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Artesunate for Injection Post-marketing Safety Studies and Clinical Trials

Awarded

W81XWH21C0105Federal

Submission Closed09/03/2021, 12:00:00 AM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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AI Contract Overview

This non-competitive, firm-fixed-price contract awarded to Amivas (US) LLC by the Department of Defense, specifically the USA Medical Research Acquisition Activity, focuses on conducting postmarketing safety studies and clinical trials for Artesunate for Injection. The primary objective is to assess serious risks associated with the drug in support of the USAMMDA Warfighter Protection and Acute Care project. The scope of work includes a seven-year international study on women exposed to IV Artesunate during pregnancy to monitor maternal and fetal outcomes, a five-year surveillance study on drug resistance, and a five-year descriptive study on disease occurrence patterns within the United States. Additionally, the contract mandates a female fertility study in rats conducted under Good Laboratory Practice standards and a pharmacokinetic study focusing on safety and tolerability in pediatric patients aged 0 to 12 months with severe malaria. This procurement was executed as a total small business set-aside and was not awarded competitively under FAR 6.302-1(a)(2), as detailed in the associated Justification and Approval documentation. Performance of the contract is centered in Frederick, Maryland.

General Info

Agency

Department Of Defense → W4PZ USA Medical Rsch Acquis Act

Contract Value

$15,285,604

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Frederick, MD, 21702, USA

Set-Aside

SBA

Awardee

Amivas (US), LLC MD 21702-5958 USA

Award Issued Date

09/03/2021, 12:00:00 AM UTC

Documents

JA-21-02-00254 Justification for Other Than Full and Open Competition - Artesunate Studies

justification-and-authorization

Low

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Uniform Contract Format

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Timeline

PhaseAwarded

PostedSep 16

Award Notice

AwardedSep 3

Contract was awarded

Submission Closed

09/03/2021, 12:00:00 AM UTC

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Organization & Contact Information

AgencyDepartment Of Defense → W4PZ USA Medical Rsch Acquis Act

Contacts1 person available

OfficeFORT DETRICK, MD, 21702-5014, USA

Organization / AgencyDepartment Of Defense → W4PZ USA Medical Rsch Acquis Act

Office AddressFORT DETRICK, MD, 21702-5014, USA

Contacts

Matthew Teel

contact@example.gov

Full 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.