Leidos Biomedical Research Inc. awarded $274.7M contract for clinical trial support by NIH

Contract Overview

Contract Amount: $27,474,922 ($27.5M)

Contractor: Leidos Biomedical Research Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2016-09-19

End Date: 2021-09-18

Contract Duration: 1,825 days

Daily Burn Rate: $15.1K/day

Competition Type: NOT COMPETED

Pricing Type: COST NO FEE

Sector: Healthcare

Official Description: IGF::OT::IGF RESEARCH, DEVELOPMENT, PRODUCTION AND SUPPORT FOR CLINICAL TRIALS ? BROADLY NEUTRALIZING MONOCLONAL ANTIBODIES (BNMABS)

Place of Performance

Location: FREDERICK, FREDERICK County, MARYLAND, 21702

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $27.5 million to LEIDOS BIOMEDICAL RESEARCH INC for work described as: IGF::OT::IGF RESEARCH, DEVELOPMENT, PRODUCTION AND SUPPORT FOR CLINICAL TRIALS ? BROADLY NEUTRALIZING MONOCLONAL ANTIBODIES (BNMABS) Key points: 1. Contract awarded on a cost-no-fee basis, suggesting a focus on cost recovery rather than profit. 2. The contract duration of 1825 days (5 years) indicates a long-term commitment to these services. 3. The absence of competition raises questions about potential cost efficiencies and market responsiveness. 4. This contract falls under Facilities Support Services, a broad category that requires careful performance monitoring. 5. The primary location of performance is Maryland, suggesting a concentration of federal activity in that state.

Value Assessment

Rating: fair

The contract's cost-no-fee structure makes direct value-for-money assessment challenging without detailed cost breakdowns. Benchmarking against similar facilities support contracts is difficult due to the specialized nature of clinical trial support. The total award amount of $274.7 million over five years suggests a significant investment, but without comparative pricing data or performance metrics, it's hard to definitively assess if this represents excellent value. Further analysis of the contractor's efficiency and cost management would be needed.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was awarded on a sole-source basis, meaning it was not competed among multiple vendors. This approach can be justified for specialized services where only one contractor possesses the necessary expertise or infrastructure. However, it limits the potential for price discovery through competitive bidding and may result in higher costs for the government compared to a competed contract. The lack of competition means taxpayers do not benefit from the cost savings that can arise from a bidding process.

Taxpayer Impact: The sole-source nature of this award means taxpayers may not have received the most competitive pricing. Without a bidding process, there's less pressure on the contractor to offer the lowest possible cost for the services rendered.

Public Impact

The National Institutes of Health (NIH) benefits from this contract by securing essential support for clinical trials. Services delivered include research, development, production, and support for clinical trials, specifically for broadly neutralizing monoclonal antibodies (BNMabs). The geographic impact is primarily in Maryland, where the contractor is located and performance is expected. Workforce implications include the potential for specialized scientific and support roles within Leidos Biomedical Research Inc. and its subcontractors.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Lack of competition could lead to higher costs over the contract's lifespan.
The broad nature of 'Facilities Support Services' requires diligent oversight to ensure specific clinical trial needs are met efficiently.
Sole-source awards can reduce transparency and accountability compared to competed contracts.

Positive Signals

Leidos Biomedical Research Inc. is a known entity in biomedical research support, suggesting established capabilities.
The contract's long duration implies a stable and reliable partnership for critical research activities.
Focus on specific therapeutic areas (BNMabs) indicates a targeted and potentially high-impact research effort.

Sector Analysis

This contract falls within the broader 'Professional, Scientific, and Technical Services' sector, specifically focusing on research and development support for healthcare. The market for clinical trial support services is substantial, driven by the pharmaceutical and biotechnology industries' continuous need for drug development. Leidos Biomedical Research Inc. operates in a niche that requires specialized scientific expertise and infrastructure. Comparable spending benchmarks are difficult to establish without more granular data on the specific services provided and the scale of the clinical trials supported.

Small Business Impact

This contract does not appear to have a small business set-aside component, as indicated by 'ss' being false. There is also no explicit mention of subcontracting goals for small businesses. This suggests that the primary contractor, Leidos Biomedical Research Inc., will likely perform the majority of the work. The impact on the small business ecosystem is minimal unless the prime contractor voluntarily engages small businesses for specialized support services.

Oversight & Accountability

Oversight for this contract would primarily fall under the National Institutes of Health (NIH), a component of the Department of Health and Human Services. As a sole-source award, transparency might be less than in a competed scenario. Accountability measures would be defined in the contract's terms and conditions, focusing on performance milestones and deliverables. The Inspector General for HHS would have jurisdiction for audits and investigations if any improprieties were suspected.

Related Government Programs

NIH Research Grants
Biomedical Research and Development
Clinical Trial Management Services
Monoclonal Antibody Development Programs
Federal Facilities Support Contracts

Risk Flags

Sole-source award lacks competitive pricing pressure.
Cost-no-fee structure may reduce contractor incentive for exceeding expectations.
Broad 'Facilities Support Services' category requires specific performance definition for clinical trials.
Long contract duration necessitates ongoing performance monitoring.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $27.5 million to LEIDOS BIOMEDICAL RESEARCH INC. IGF::OT::IGF RESEARCH, DEVELOPMENT, PRODUCTION AND SUPPORT FOR CLINICAL TRIALS ? BROADLY NEUTRALIZING MONOCLONAL ANTIBODIES (BNMABS)

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 $27.5 million.

What is the period of performance?

Start: 2016-09-19. End: 2021-09-18.

What is the specific breakdown of costs within this contract, and how does the 'cost-no-fee' structure impact contractor incentives?

The 'cost-no-fee' (CNF) contract type means the contractor is reimbursed for allowable costs incurred but does not receive any fee or profit. This structure is typically used when the scope of work is uncertain or when the government has a strong interest in the contractor's facilities and personnel, such as in research and development scenarios. For this contract, it implies Leidos Biomedical Research Inc. is expected to cover its operational expenses related to the clinical trial support but will not profit from the award. This can incentivize efficiency in cost management, as any savings directly reduce the government's expenditure. However, it might also reduce the contractor's motivation for innovation or exceeding performance expectations if there's no direct financial reward beyond cost recovery. A detailed cost proposal and ongoing audits would be crucial to ensure costs are reasonable and allocable to the contract.

Given this is a sole-source award, what justifications were provided for not competing the contract, and what are the potential risks associated with this approach?

Sole-source awards are typically justified when only one responsible source is available or capable of providing the required services. For a specialized area like 'Broadly Neutralizing Monoclonal Antibodies (BNMabs) clinical trials,' the justification might stem from unique expertise, proprietary technology, or existing infrastructure already established by Leidos Biomedical Research Inc. The primary risk of a sole-source award is the potential for inflated costs due to the lack of competitive pressure. Without competing bids, the government may not achieve the best possible pricing. Additionally, there's a reduced incentive for the contractor to innovate or improve services beyond the contract's minimum requirements. Transparency can also be a concern, as the justification process and the contractor's pricing might be less scrutinized than in a competitive environment. Robust oversight and negotiation are critical to mitigate these risks.

How does the performance of Leidos Biomedical Research Inc. on previous contracts compare to industry benchmarks, particularly in facilities support and clinical trial services?

Assessing Leidos Biomedical Research Inc.'s performance requires access to past performance evaluations and contract data, which are not fully detailed in the provided information. However, as a contractor frequently engaged by agencies like the NIH, it suggests a generally acceptable track record. To provide a comparative analysis, one would need to examine their performance ratings on similar contracts, looking for indicators of on-time delivery, quality of services, and adherence to budget. Benchmarking against industry standards for facilities support and specialized clinical trial services would involve comparing their cost structures, project completion rates, and client satisfaction metrics against peers. Without specific performance data, it's difficult to definitively state how they compare, but their continued engagement implies a level of competence recognized by the awarding agency.

What is the historical spending pattern for similar clinical trial support services by the NIH, and how does this $274.7 million award fit within that context?

Historical spending on clinical trial support services by the NIH is substantial, reflecting its mission to advance medical research. The NIH regularly awards billions of dollars annually across various research and development categories, including clinical trials. This $274.7 million award over five years represents a significant, but not necessarily outlier, investment for a specific program like BNMabs. To contextualize it further, one would need to analyze NIH's total budget allocation for clinical trials over the past decade, identify trends in contract values for similar therapeutic areas, and understand the scale and complexity of the BNMabs program. This specific award likely reflects the specialized nature and long-term commitment required for developing novel antibody therapies, which can be resource-intensive.

What are the key performance indicators (KPIs) for this contract, and how is the contractor's adherence to these KPIs monitored?

Key Performance Indicators (KPIs) for a contract of this nature would typically focus on the successful execution of clinical trial phases, adherence to scientific protocols, data integrity, timely reporting, and efficient management of resources. Specific KPIs might include the number of participants enrolled, the completion rate of trial milestones, the quality and accuracy of collected data, compliance with regulatory requirements (e.g., FDA), and the effective management of laboratory services and supply chains. Monitoring would likely involve regular progress reports from Leidos Biomedical Research Inc., site visits, data audits, and performance reviews conducted by NIH contracting officers and technical representatives. The 'cost-no-fee' structure might also tie performance to cost control, ensuring efficient use of funds.

Industry Classification

NAICS: Administrative and Support and Waste Management and Remediation Services › Facilities Support Services › Facilities Support Services

Product/Service Code: OPERATION OF GOVT OWNED FACILITY › OPERATE GOVT OWNED BUILDINGS

Competition & Pricing

Extent Competed: NOT COMPETED

Solicitation Procedures: ONLY ONE SOURCE

Solicitation ID: N01CO5240180

Pricing Type: COST NO FEE (S)

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: $27,474,922

Exercised Options: $27,474,922

Current Obligation: $27,474,922

Actual Outlays: $3,291

Subaward Activity

Number of Subawards: 1

Total Subaward Amount: $105,160

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Parent Contract

Parent Award PIID: HHSN261201500003I

IDV Type: IDC

Timeline