NIH spent $14.4M on adjuvant lead development, with a 7-year contract for Coley Pharmaceutical Group

Contract Overview

Contract Amount: $14,456,405 ($14.5M)

Contractor: Coley Pharmaceutical Group Incorporated

Awarding Agency: Department of Health and Human Services

Start Date: 2004-06-30

End Date: 2011-06-29

Contract Duration: 2,555 days

Daily Burn Rate: $5.7K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 4

Pricing Type: COST NO FEE

Sector: R&D

Official Description: ESTABLISH A PIPELINE OF NEW ADJUVANT LEADS

Place of Performance

Location: WELLESLEY HILLS, NORFOLK County, MASSACHUSETTS, 02481

State: Massachusetts Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $14.5 million to COLEY PHARMACEUTICAL GROUP INCORPORATED for work described as: ESTABLISH A PIPELINE OF NEW ADJUVANT LEADS Key points: 1. Contract awarded through full and open competition, suggesting a competitive bidding process. 2. The contract duration of 2555 days (approx. 7 years) indicates a long-term research and development objective. 3. The contract type 'COST NO FEE' suggests that the government reimburses the contractor for allowable costs but does not pay a fee for profit. 4. The North American Industry Classification System (NAICS) code 541710 points to significant investment in physical, engineering, and life sciences research. 5. The contract's objective is to establish a pipeline of new adjuvant leads, crucial for vaccine development. 6. The awardee, Coley Pharmaceutical Group, was the sole awardee, but the initial competition was full and open.

Value Assessment

Rating: fair

The contract value of $14.4 million over approximately seven years averages to about $2 million per year. Without specific benchmarks for adjuvant lead development contracts, it's difficult to definitively assess value for money. The 'COST NO FEE' structure implies that the government bears the cost risk, and the value is tied to the successful development of leads rather than a fixed deliverable price. Further analysis would require comparing this to similar R&D efforts in the pharmaceutical sector.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under 'FULL AND OPEN COMPETITION,' indicating that all responsible sources were permitted to submit a bid. The presence of 4 bids suggests a moderate level of competition for this research and development effort. While not a large number of bidders, full and open competition generally provides a better opportunity for price discovery and selection of the most capable offeror compared to sole-source or limited competition scenarios.

Taxpayer Impact: A full and open competition, even with a moderate number of bidders, is generally favorable for taxpayers as it increases the likelihood of obtaining competitive pricing and selecting the most efficient solution.

Public Impact

The primary beneficiaries are the National Institutes of Health (NIH) and the broader public health community, through the potential development of new vaccine adjuvants. The service delivered is research and development focused on identifying and establishing a pipeline of novel adjuvant leads. The geographic impact is national, supporting the advancement of US public health initiatives. Workforce implications include employment for scientists, researchers, and support staff within Coley Pharmaceutical Group and potentially related research institutions.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The 'COST NO FEE' contract structure shifts cost risk to the government, which could lead to less incentive for cost control by the contractor.
The long duration of the contract (7 years) increases the risk of changing research priorities or technological obsolescence.
Limited information on the specific performance metrics or milestones makes it difficult to assess progress and contractor performance effectively.
The sole awardee status, despite full and open competition, might warrant a review of the bidding process or market dynamics.

Positive Signals

Awarded through full and open competition, suggesting a robust initial selection process.
The contract aims to address a critical need in vaccine development by establishing a pipeline of new adjuvant leads.
The long-term nature of the contract allows for sustained research and development efforts, potentially leading to significant breakthroughs.
The contractor, Coley Pharmaceutical Group, was selected to perform this important R&D work.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences and pharmaceutical innovation. The market for vaccine adjuvants is a critical component of the broader biotechnology and pharmaceutical industry, which is characterized by high R&D investment and long development cycles. Comparable spending benchmarks would typically be found within NIH's extramural research grants and contracts for similar early-stage drug and vaccine development projects.

Small Business Impact

There is no indication that this contract involved small business set-asides, as the awardee is Coley Pharmaceutical Group, Inc. The contract does not appear to have specific subcontracting requirements for small businesses mentioned in the provided data. Therefore, the direct impact on the small business ecosystem from this specific award is likely minimal, though the success of the R&D could indirectly benefit the broader biotech sector.

Oversight & Accountability

Oversight for this contract would primarily reside with the National Institutes of Health (NIH), a component of the Department of Health and Human Services. As a research and development contract, oversight would likely focus on scientific progress, adherence to research protocols, and responsible use of funds. Transparency is generally facilitated through contract databases and public reporting, though specific details of R&D progress may be proprietary. Inspector General jurisdiction would apply to any allegations of fraud, waste, or abuse.

Related Government Programs

NIH Research Grants
Biotechnology Research Contracts
Vaccine Development Programs
Pharmaceutical R&D Funding

Risk Flags

Long contract duration may increase risk of scope creep or changing requirements.
Cost-reimbursable contract type ('COST NO FEE') places cost risk on the government.
Limited number of bidders (4) in a full and open competition could indicate market concentration or specific technical requirements.
Lack of specific performance metrics in provided data hinders detailed performance assessment.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $14.5 million to COLEY PHARMACEUTICAL GROUP INCORPORATED. ESTABLISH A PIPELINE OF NEW ADJUVANT LEADS

Who is the contractor on this award?

The obligated recipient is COLEY PHARMACEUTICAL GROUP INCORPORATED.

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 $14.5 million.

What is the period of performance?

Start: 2004-06-30. End: 2011-06-29.

What is the track record of Coley Pharmaceutical Group in securing government contracts, particularly with NIH?

Based on the provided data, Coley Pharmaceutical Group, Inc. was awarded this definitive contract by the National Institutes of Health (NIH) for Research and Development in the Physical, Engineering, and Life Sciences. The contract, valued at approximately $14.4 million, spanned from June 30, 2004, to June 29, 2011, lasting for 2555 days. This indicates a significant engagement with the NIH for a substantial period. Further investigation into federal procurement databases like FPDS or SAM.gov would be necessary to ascertain the full extent of their contract history, including other agencies, contract types, values, and performance history. Understanding their broader track record would provide context for their capabilities and reliability in fulfilling government R&D objectives.

How does the $14.4 million contract value compare to other NIH R&D contracts for similar adjuvant development?

The $14.4 million contract value for adjuvant lead development over approximately seven years represents an average annual expenditure of roughly $2 million. To benchmark this effectively, a comparative analysis with other NIH contracts for similar early-stage pharmaceutical R&D, specifically focusing on vaccine adjuvants or related immunological research, would be required. Factors such as the scope of work, research phase (discovery vs. preclinical), specific scientific objectives, and the number of bidders in comparable solicitations would influence contract values. Without access to a broader dataset of similar NIH R&D contracts, it is challenging to definitively state whether this represents a high, low, or average investment for this type of research.

What are the key performance indicators (KPIs) or milestones associated with this contract, and how was performance measured?

The provided data indicates the contract's objective is to 'ESTABLISH A PIPELINE OF NEW ADJUVANT LEADS.' However, specific Key Performance Indicators (KPIs) or detailed milestones for measuring the contractor's success in achieving this objective are not included. For a 'COST NO FEE' contract, performance measurement often relies on the contractor's ability to conduct research, meet defined research objectives, and manage costs within the approved budget. Oversight by NIH program managers would typically involve regular reviews of scientific progress reports, data analysis, and potentially presentations of findings. A comprehensive assessment of performance would require access to the contract's statement of work and any associated performance management plans.

What is the historical spending pattern of the NIH on adjuvant research and development over the past decade?

The provided data pertains to a single contract awarded in 2004. To analyze the NIH's historical spending patterns on adjuvant research and development, a broader dataset encompassing multiple contracts and grants over the past decade would be necessary. This would involve querying federal procurement databases (like FPDS) and grant databases (like NIH RePORTER) for keywords related to 'adjuvants,' 'vaccine development,' and 'immunology research.' Analyzing trends in obligated amounts, number of awards, and funding mechanisms (contracts vs. grants) would reveal the NIH's strategic investment priorities and fluctuations in funding for this specific area of research over time.

What are the potential risks associated with a 'COST NO FEE' contract for R&D, and how were they mitigated?

A 'COST NO FEE' contract means the government reimburses the contractor for allowable costs incurred in performing the contract but does not pay an additional fee for profit. For R&D, this structure shifts the financial risk of research failure to the government. Potential risks include the contractor having less incentive to control costs, as their expenses will be reimbursed. Additionally, if the research is unsuccessful, the government has expended funds without achieving the desired outcome. Mitigation strategies typically involve robust oversight by the government, clear definition of allowable costs, stringent reporting requirements, and performance monitoring to ensure the contractor is diligently pursuing the research objectives. The NIH's role in managing the project and ensuring scientific rigor would be crucial in mitigating these risks.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Offers Received: 4

Pricing Type: COST NO FEE (S)

Contractor Details

Address: 93 WORCESTER ST, WELLESLEY, MA, 02481

Business Categories: Category Business, Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $21,387,536

Exercised Options: $14,705,841

Current Obligation: $14,456,405

Contract Characteristics

Multi-Year Contract: Yes

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline