NIH awarded Battelle Memorial Institute $10.77M for preclinical drug toxicology and pharmacology research

Contract Overview

Contract Amount: $10,766,668 ($10.8M)

Contractor: Battelle Memorial Institute

Awarding Agency: Department of Health and Human Services

Start Date: 2004-04-01

End Date: 2011-07-31

Contract Duration: 2,677 days

Daily Burn Rate: $4.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 8

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS

Place of Performance

Location: COLUMBUS, FRANKLIN County, OHIO, 43201

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $10.8 million to BATTELLE MEMORIAL INSTITUTE for work described as: PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS Key points: 1. Contract awarded for essential preclinical research, supporting drug development pipelines. 2. Long-term contract duration suggests a sustained need for these specialized services. 3. Research and Development in Physical, Engineering, and Life Sciences sector is critical for innovation. 4. The contract's cost-plus-fixed-fee structure incentivizes efficient cost management by the contractor. 5. Performance occurred over a significant period, allowing for evaluation of contractor capabilities. 6. The definitive contract type indicates a clear scope of work for the research services.

Value Assessment

Rating: good

The contract value of $10.77 million over approximately 7 years for preclinical toxicology and pharmacology research appears reasonable given the specialized nature of the work. Benchmarking against similar R&D contracts in the life sciences sector would provide a more precise assessment, but the scale suggests a significant research undertaking. The cost-plus-fixed-fee (CPFF) pricing structure, while common for R&D, requires careful monitoring to ensure value for money.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple qualified bidders had the opportunity to submit proposals. This competitive process is expected to drive fair pricing and ensure the selection of the most capable contractor. The presence of 8 bidders suggests a healthy level of interest and competition for this type of specialized research service.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that can lead to more cost-effective solutions and prevent price inflation.

Public Impact

The primary beneficiaries are the National Institutes of Health (NIH) and the broader biomedical research community, who gain access to crucial preclinical data. Services delivered include essential toxicology and pharmacology studies necessary for advancing potential new drug candidates. The geographic impact is primarily within Ohio, where Battelle Memorial Institute is located, but the research findings have national and global implications for public health. Workforce implications include employment for scientists, researchers, and support staff involved in conducting these complex studies.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns inherent in cost-plus-fixed-fee contracts if not rigorously managed.
Long contract duration could lead to scope creep or evolving research needs not fully captured in initial pricing.
Reliance on a single contractor for a significant period may limit exposure to newer methodologies from other firms.

Positive Signals

Awarded through full and open competition, suggesting a robust selection process.
Contractor's extensive experience in R&D likely ensures high-quality research execution.
The definitive contract type implies a well-defined scope, reducing ambiguity.
The research directly supports NIH's mission to advance medical knowledge and improve health.

Sector Analysis

This contract falls within the Research and Development (R&D) sector, specifically focusing on the physical, engineering, and life sciences. This sector is characterized by significant investment in innovation and discovery, often involving long-term projects with uncertain outcomes. Comparable spending benchmarks in preclinical drug development can vary widely based on the complexity of the drug and the specific studies required, but contracts in the millions of dollars are typical for comprehensive toxicology and pharmacology assessments.

Small Business Impact

There is no indication that this contract involved small business set-asides, as Battelle Memorial Institute is a large research organization. However, large R&D contracts often involve subcontracting opportunities for specialized services, which could potentially benefit small businesses within the scientific support ecosystem. Further analysis would be needed to determine the extent of any small business subcontracting.

Oversight & Accountability

Oversight for this contract would have been managed by the contracting officers and program officials within the National Institutes of Health (NIH). The cost-plus-fixed-fee structure necessitates diligent monitoring of costs and performance to ensure adherence to the contract terms and to maximize value. Transparency is generally maintained through contract reporting requirements, though specific details of ongoing research may be proprietary.

Related Government Programs

NIH Research Grants
Pharmaceutical Development Contracts
Biomedical Research Services
Preclinical Drug Testing
Life Sciences R&D

Risk Flags

Cost Overrun Potential
Scientific Uncertainty
Long Contract Duration Risks
Data Integrity Concerns

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $10.8 million to BATTELLE MEMORIAL INSTITUTE. PRECLINICAL TOXICOLOGY AND PHARMACOLOGY OF DRUGS

Who is the contractor on this award?

The obligated recipient is BATTELLE MEMORIAL INSTITUTE.

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 $10.8 million.

What is the period of performance?

Start: 2004-04-01. End: 2011-07-31.

What is Battelle Memorial Institute's track record with federal R&D contracts, particularly with NIH?

Battelle Memorial Institute is a well-established research and development organization with a significant history of contracting with U.S. federal agencies, including the Department of Health and Human Services (HHS) and its components like the National Institutes of Health (NIH). Their extensive portfolio includes work across various scientific disciplines, often involving complex, large-scale research projects. Prior to this specific contract, Battelle would have undergone vetting processes for previous awards, demonstrating their capability to handle government research requirements. Their long-standing presence and numerous awards suggest a generally positive track record, though specific performance metrics for individual contracts would require deeper investigation into past performance evaluations and any associated contract disputes or awards.

How does the $10.77 million cost compare to similar preclinical toxicology and pharmacology research contracts?

The total award of $10.77 million over approximately 7 years for preclinical toxicology and pharmacology research is within a typical range for comprehensive studies supporting drug development. However, a precise comparison requires detailed analysis of the specific services rendered, the complexity of the compounds studied, and the duration and scope of the research. Factors such as the number of studies, types of assays performed (e.g., in vitro, in vivo), and the specific regulatory requirements (e.g., GLP compliance) significantly influence costs. Without access to detailed statements of work and performance metrics for comparable contracts, it is difficult to definitively benchmark this award. Generally, contracts of this magnitude suggest a substantial research effort rather than a small-scale feasibility study.

What are the primary risks associated with this type of R&D contract, and how were they mitigated?

The primary risks associated with this type of R&D contract include scientific uncertainty (research may not yield desired results), cost overruns (especially with cost-plus contracts), schedule delays, and potential issues with data integrity or reproducibility. For this specific contract, the use of a Cost Plus Fixed Fee (CPFF) structure aims to incentivize the contractor to control costs while allowing for flexibility in research direction. Mitigation strategies likely included rigorous project management by both Battelle and NIH, clear milestones, regular progress reviews, and adherence to Good Laboratory Practice (GLP) standards where applicable. The long duration also presents a risk of evolving research needs or technological obsolescence, which would require adaptive management and potentially contract modifications.

How effective was this contract in advancing NIH's mission to develop new therapies?

The effectiveness of this contract in advancing NIH's mission is directly tied to the scientific outcomes of the preclinical toxicology and pharmacology studies conducted by Battelle Memorial Institute. These studies are critical gatekeepers in the drug development process, providing essential safety and efficacy data required before a drug candidate can proceed to human clinical trials. If the research generated robust, reliable data that supported the progression of promising drug candidates or identified potential safety concerns early, thus preventing investment in non-viable therapies, the contract would be considered highly effective. Conversely, if the research yielded inconclusive results or faced significant delays, its effectiveness would be diminished. A full assessment would require reviewing the specific research outputs and their impact on subsequent drug development pipelines.

What were the historical spending patterns for preclinical toxicology and pharmacology research at NIH around the time of this award?

Historical spending patterns for preclinical toxicology and pharmacology research at NIH around the 2004-2011 period would likely show a consistent and significant investment in these areas, reflecting the agency's core mission. NIH's budget is substantial, with a considerable portion allocated to extramural research grants and contracts supporting various stages of biomedical research, including early-stage drug discovery and development. Spending on preclinical services is driven by the pipeline of potential therapeutics across numerous disease areas. While the specific amount dedicated solely to toxicology and pharmacology contracts can fluctuate based on research priorities and the number of active drug development programs, it represents a fundamental component of the drug development lifecycle funded by NIH. This $10.77 million award is indicative of the ongoing need for such specialized services.

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 › OTHER RESEARCH/DEVELOPMENT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation ID: N01CM3703919

Offers Received: 8

Pricing Type: COST PLUS FIXED FEE (U)

Contractor Details

Address: 505 KING AVE, COLUMBUS, OH, 43201

Business Categories: Category Business, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $91,567,452

Exercised Options: $91,567,452

Current Obligation: $10,766,668

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline