Barda will implement a randomized, double-blind, placebo-controlled, multicenter phase 2 trial in the US to evaluate the safety and efficacy of novel host-directed therapeutic candidates in…

Active Definitive Contract Awarded Last action

Contract number
75A50124C00001
Awardee
Awarding agency
Obligated
$117,399,278

Award facts

Contract value 53% obligated
  • $117,399,278.00 Current, with exercised options
  • $222,126,308.00 Potential, with all options
Completion date 43% complete
Current and potential, with all options
Contracting staff
Set-aside
No set-aside
Competition
Full and Open Competition · 1 offer Negotiated Proposal / Quote
Pricing
Cost Plus Incentive
Place of performance
Cape Fear, NC 28401, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Other Administrative Action P00003 $0
Other Administrative Action P00002 $0
Other Administrative Action P00001 $0
Original award $117,399,278

About this award

The Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded a $222.1 million definitive contract to PPD Development LP on December 15, 2023, to implement a randomized, double-blind, placebo-controlled, multicenter Phase 2 clinical trial evaluating the safety and efficacy of novel host-directed therapeutic candidates in hospitalized adults with acute respiratory distress syndrome (ARDS). The contract, structured as cost-plus-incentive pricing with no set-aside designation, is scheduled for completion by September 30, 2030, and will be performed in Cape Fear, North Carolina. PPD Development LP, a global contract research organization and subsidiary of Thermo Fisher Scientific, brings extensive experience in clinical trial management, regulatory support, and research services across multiple federal agencies, including the National Institutes of Health, Department of Defense, and Department of Health and Human Services.

This award leverages PPD Development LP's established capabilities as a critical federal research partner, evidenced by its participation in multiple large Indefinite Delivery Vehicles including the $999 million OASIS+ contract, the $545 million Comprehensive and Rapid Response contract with the National Institute of Allergy and Infectious Diseases, and the $548 million Cancer Trials Support Unit contract. The ARDS clinical trial contract represents ASPR's continued investment in medical countermeasures and pandemic preparedness capabilities, aligning with the agency's mission to support research and development activities that strengthen the nation's health security infrastructure. PPD's expertise in infectious disease research, clinical site monitoring, and complex multi-site trial coordination positions it to successfully execute this critical Phase 2 study.

Description

Barda will implement a randomized, double-blind, placebo-controlled, multicenter phase 2 trial in the US to evaluate the safety and efficacy of novel host-directed therapeutic candidates in hospitalized adults with ards.

Quick answers

Who was awarded contract 75A50124C00001?

75A50124C00001 was awarded to PPD Development LP by Office of the Assistant Secretary for Preparedness and Response (Department of Health and Human Services) on December 15, 2023.

How much is contract 75A50124C00001 worth?

The government has obligated $117,399,278 on 75A50124C00001. Its potential value, with all options, is $222,126,308.

Was contract 75A50124C00001 competed?

The extent of competition for 75A50124C00001 was full and open competition. The government received 1 offer.

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