Leidos Biomedical Research Inc. awarded $89.6M contract for COVID-19 clinical trials by NIH

Contract Overview

Contract Amount: $89,563,956 ($89.6M)

Contractor: Leidos Biomedical Research Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2020-04-01

End Date: 2028-07-31

Contract Duration: 3,043 days

Daily Burn Rate: $29.4K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: ON BEHALF OF NIAID-DCR, FACILITATE THE CONDUCT OF TWO, RANDOMIZED TRIALS AS DETAILED BELOW IN I AND II: I. A RANDOMIZED BLINDED CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF INVESTIGATIONAL THERAPEUTICS FOR THE TREATMENT OF COVID-19 (2,000 SUBJECTS

Place of Performance

Location: FREDERICK, FREDERICK County, MARYLAND, 21702

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $89.6 million to LEIDOS BIOMEDICAL RESEARCH INC for work described as: ON BEHALF OF NIAID-DCR, FACILITATE THE CONDUCT OF TWO, RANDOMIZED TRIALS AS DETAILED BELOW IN I AND II: I. A RANDOMIZED BLINDED CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF INVESTIGATIONAL THERAPEUTICS FOR THE TREATMENT OF COVID-19 (2,000 SUBJECTS Key points: 1. Contract aims to assess safety and efficacy of investigational therapeutics for COVID-19. 2. Significant duration of over 8 years suggests a long-term research commitment. 3. Cost Plus Fixed Fee contract type may incentivize cost overruns if not closely monitored. 4. The contract is a delivery order, indicating it's part of a larger indefinite-delivery contract. 5. Research and Development in Life Sciences is a critical area for public health. 6. The scale of 2,000 subjects highlights the substantial nature of the trials.

Value Assessment

Rating: good

The contract value of $89.6 million over approximately 8 years for a large-scale clinical trial is within a reasonable range for such complex research. Benchmarking against similar large, multi-year clinical trials for infectious diseases suggests this pricing is competitive. The Cost Plus Fixed Fee structure requires careful oversight to ensure value for money, but the fixed fee component provides some cost control.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple bidders had the opportunity to submit proposals. This competitive process is expected to yield fair pricing and innovative solutions. The specific number of bidders is not provided, but the 'full and open' designation suggests a robust competition.

Taxpayer Impact: Full and open competition generally benefits taxpayers by driving down costs through market forces and ensuring the government receives the best value for its investment.

Public Impact

The primary beneficiaries are patients participating in the trials and the broader public who will benefit from potential new COVID-19 treatments. The contract facilitates critical research into the safety and efficacy of investigational therapeutics for COVID-19. The geographic impact is national, focusing on subject recruitment across various research sites. Workforce implications include employment for researchers, clinicians, data analysts, and support staff involved in clinical trial operations.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee contracts can lead to higher costs if not managed diligently.
Long contract duration may require adjustments to research protocols or therapeutic focus over time.
Reliance on a single contractor for a significant research endeavor could pose risks if performance falters.

Positive Signals

Awarded through full and open competition, suggesting competitive pricing and quality.
Contract supports critical public health research for a global pandemic.
Leidos Biomedical Research Inc. has a track record in managing large-scale biomedical research contracts.
The contract's extensive duration allows for thorough and comprehensive trial execution.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences and clinical trials for infectious diseases. The market for clinical trial services is substantial, driven by pharmaceutical and biotechnology companies, as well as government health agencies. Comparable spending benchmarks for large-scale clinical trials can vary widely based on therapeutic area, trial phase, and subject population, but this contract appears to be of significant scale within its domain.

Small Business Impact

The provided data does not indicate any specific small business set-asides or subcontracting requirements for this contract. As a large-scale research and development award, it is likely that prime contractors would engage various specialized subcontractors, potentially including small businesses, for specific services. However, without explicit subcontracting plans or set-aside information, the direct impact on the small business ecosystem remains unclear.

Oversight & Accountability

Oversight for this contract would primarily reside with the National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID). Mechanisms likely include regular progress reports, financial reviews, and adherence to strict clinical trial protocols. The Cost Plus Fixed Fee structure necessitates close monitoring of expenditures against the fixed fee to ensure accountability and prevent cost overruns. Transparency is generally maintained through public reporting of trial results and contract awards.

Related Government Programs

COVID-19 Therapeutics Development
Clinical Trial Management
NIH Research Grants
Biomedical Research Services
Infectious Disease Research

Risk Flags

Potential for cost overruns due to CPFF contract type.
Evolving nature of COVID-19 variants may impact therapeutic efficacy over the contract duration.
Ensuring robust subject recruitment and retention across multiple sites.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $89.6 million to LEIDOS BIOMEDICAL RESEARCH INC. ON BEHALF OF NIAID-DCR, FACILITATE THE CONDUCT OF TWO, RANDOMIZED TRIALS AS DETAILED BELOW IN I AND II: I. A RANDOMIZED BLINDED CONTROLLED TRIAL OF THE SAFETY AND EFFICACY OF INVESTIGATIONAL THERAPEUTICS FOR THE TREATMENT OF COVID-19 (2,000 SUBJECTS

Who is the contractor on this award?

The obligated recipient is LEIDOS BIOMEDICAL RESEARCH INC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $89.6 million.

What is the period of performance?

Start: 2020-04-01. End: 2028-07-31.

What is Leidos Biomedical Research Inc.'s track record with similar large-scale, multi-year government contracts, particularly in infectious disease research?

Leidos Biomedical Research Inc. has a substantial track record in managing complex biomedical research and development contracts for government agencies, including significant work with the National Institutes of Health (NIH). They have been a key contractor for programs like the Frederick National Laboratory for Cancer Research, which involves extensive laboratory operations, clinical support, and data management. Their experience in handling large budgets, diverse scientific projects, and stringent regulatory requirements positions them well for managing the proposed COVID-19 trials. Specific to infectious diseases, their past performance would likely include managing research related to emerging threats and vaccine/therapeutic development, demonstrating capability in this critical area.

How does the $89.6 million contract value compare to other large-scale COVID-19 clinical trials funded by the government?

The $89.6 million contract value for this two-trial study appears to be within the expected range for large-scale, multi-year clinical trials focused on developing and testing therapeutics for a major public health crisis like COVID-19. Government funding for COVID-19 research has been substantial, with various initiatives supporting vaccine and therapeutic development. Contracts for Phase 3 trials, especially those involving thousands of subjects and multiple research sites, can easily reach tens or even hundreds of millions of dollars. Factors influencing cost include the number of subjects, trial duration, complexity of interventions, data collection requirements, and the specific therapeutic agents being investigated. This award reflects a significant investment commensurate with the scope and importance of the research.

What are the primary risks associated with a Cost Plus Fixed Fee (CPFF) contract for this type of research, and how are they mitigated?

The primary risk with a Cost Plus Fixed Fee (CPFF) contract is that the contractor may have less incentive to control costs compared to fixed-price contracts, as their allowable costs are reimbursed. This could potentially lead to cost overruns if not managed diligently. The 'fixed fee' component provides a profit incentive, but the risk of cost escalation remains. Mitigation strategies employed by the government typically include robust oversight, detailed cost monitoring, regular audits, and clear performance metrics. The contracting agency (NIAID/NIH) would closely scrutinize all incurred costs to ensure they are reasonable, allocable, and allowable under the contract terms. Strong project management and defined milestones are crucial for keeping the project on track and within budget expectations.

Given the contract's duration (ending July 2028), what are the potential implications for the evolving landscape of COVID-19 treatments and research?

The extended duration of this contract, ending in July 2028, suggests a long-term commitment to understanding and potentially treating COVID-19. This is significant because the virus continues to evolve, and new variants may emerge, requiring ongoing research into effective therapeutics. A multi-year timeline allows for comprehensive data collection, analysis, and potentially the investigation of treatments for long-COVID or chronic effects. It also provides flexibility to adapt the trials if initial findings warrant changes in therapeutic focus or patient populations. This foresight acknowledges that addressing a pandemic often requires sustained research efforts beyond the initial crisis phase.

How does the scale of 2,000 subjects for these randomized trials impact the statistical power and generalizability of the findings?

Enrolling 2,000 subjects across two randomized trials significantly enhances the statistical power of the study. This large sample size increases the likelihood of detecting statistically significant differences in treatment effects, even if those effects are modest. A higher number of participants also improves the generalizability of the findings to the broader population affected by COVID-19. Randomized controlled trials (RCTs) with substantial subject numbers are considered the gold standard for establishing causality and efficacy. This scale is crucial for providing reliable evidence to inform clinical practice guidelines and public health policy regarding the use of investigational therapeutics.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Parent Company: Leidos Holdings, Inc.

Address: 1050 BOYLES ST, FREDERICK, MD, 21702

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $136,722,003

Exercised Options: $89,563,956

Current Obligation: $89,563,956

Actual Outlays: $65,004,110

Subaward Activity

Number of Subawards: 1

Total Subaward Amount: $725,604

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Parent Contract

Parent Award PIID: 75N91019D00024

IDV Type: IDC

Timeline