NIH awards $6.8M contract to Lovelace Biomedical for bioanalytical method validation, supporting drug development

Contract Overview

Contract Amount: $680,219 ($680.2K)

Contractor: Lovelace Biomedical Research Institute

Awarding Agency: Department of Health and Human Services

Start Date: 2021-11-15

End Date: 2026-04-15

Contract Duration: 1,612 days

Daily Burn Rate: $422/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: THE CONTRACTOR SHALL PERFORM THE TRANSFER, VALIDATION AND QUALIFICATION OF BIOANALYTICAL METHODS FOR DETECTION OF CABOTEGRAVIR AND LEVONORGESTREL IN RAT AND NONHUMAN PRIMATE PLASMA

Place of Performance

Location: ALBUQUERQUE, BERNALILLO County, NEW MEXICO, 87108

State: New Mexico Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $680,219 to LOVELACE BIOMEDICAL RESEARCH INSTITUTE for work described as: THE CONTRACTOR SHALL PERFORM THE TRANSFER, VALIDATION AND QUALIFICATION OF BIOANALYTICAL METHODS FOR DETECTION OF CABOTEGRAVIR AND LEVONORGESTREL IN RAT AND NONHUMAN PRIMATE PLASMA Key points: 1. Contract focuses on validating bioanalytical methods for detecting specific drug compounds in biological samples. 2. The work supports the development and testing of new pharmaceutical interventions. 3. Competition was full and open, suggesting a potentially competitive pricing environment. 4. The contract duration spans over four years, indicating a long-term research need. 5. The contractor, Lovelace Biomedical Research Institute, has a background in research and development. 6. The specific scientific area is bioanalytical method development for drug detection.

Value Assessment

Rating: good

The contract value of $6.8 million over approximately 4.5 years appears reasonable for specialized bioanalytical method validation services. Benchmarking against similar contracts for method development and validation in the life sciences sector would provide a more precise assessment. However, given the complexity of validating methods for specific compounds in biological matrices, the cost seems aligned with industry standards for contract research organizations performing such specialized work.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that multiple qualified bidders had the opportunity to submit proposals. The level of competition is a positive sign for price discovery and ensuring the government receives competitive pricing. The specific number of bidders is not provided, but the open competition framework suggests a robust process.

Taxpayer Impact: Full and open competition generally benefits taxpayers by fostering a competitive environment that can drive down costs and encourage innovation from a wider pool of contractors.

Public Impact

The primary beneficiaries are researchers and developers in the pharmaceutical and biomedical fields who rely on validated methods for accurate drug testing. The services delivered are crucial for the reliable detection and quantification of cabotegravir and levonorgestrel in preclinical studies. The geographic impact is primarily within New Mexico, where Lovelace Biomedical Research Institute is located, but the research findings have broader national and global implications for public health. The contract supports specialized scientific workforce in bioanalysis and pharmaceutical research.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for scope creep if research objectives evolve significantly beyond initial validation parameters.
Reliance on specialized scientific expertise means any loss of key personnel could impact project timelines.
The long-term nature of the contract requires continuous monitoring to ensure ongoing alignment with NIH research priorities.

Positive Signals

Contractor has a dedicated focus on biomedical research, suggesting relevant expertise.
Full and open competition indicates a potentially well-vetted and cost-effective solution.
The contract is for method validation, a critical step that enhances the reliability of future research findings.
Clear definition of deliverables (transfer, validation, qualification) provides a structured approach.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on bioanalytical services for drug development. The market for bioanalytical testing services is substantial, driven by the pharmaceutical and biotechnology industries' need for accurate and reliable data in preclinical and clinical trials. This contract represents a specific instance of federal investment in advancing drug discovery and safety through specialized scientific support, aligning with broader government initiatives to foster innovation in life sciences.

Small Business Impact

The contract data indicates that small business participation was not a specific set-aside requirement (ss: false, sb: false). Therefore, the primary focus is on the prime contractor's capabilities. There is no explicit information on subcontracting plans for small businesses within this award. The impact on the small business ecosystem is likely minimal unless the prime contractor actively engages small businesses for specialized support services not covered by their internal capabilities.

Oversight & Accountability

Oversight for this contract is likely managed by the National Institutes of Health (NIH), a component of the Department of Health and Human Services. The contract type (Cost Plus Fixed Fee) necessitates detailed financial reporting and review by the contracting officer to ensure costs are reasonable and allocable. Transparency is maintained through contract awards databases and reporting requirements. Inspector General jurisdiction would apply in cases of fraud, waste, or abuse.

Related Government Programs

Pharmaceutical Research and Development Support
Biomedical Research Services
Drug Efficacy and Safety Testing
Clinical Trial Support Services
Bioanalytical Laboratory Services

Risk Flags

Potential for scientific challenges impacting validation timelines.
Reliance on specialized scientific personnel.
Need for continuous monitoring of costs and progress under CPFF structure.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $680,219 to LOVELACE BIOMEDICAL RESEARCH INSTITUTE. THE CONTRACTOR SHALL PERFORM THE TRANSFER, VALIDATION AND QUALIFICATION OF BIOANALYTICAL METHODS FOR DETECTION OF CABOTEGRAVIR AND LEVONORGESTREL IN RAT AND NONHUMAN PRIMATE PLASMA

Who is the contractor on this award?

The obligated recipient is LOVELACE BIOMEDICAL RESEARCH 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 $680,219.

What is the period of performance?

Start: 2021-11-15. End: 2026-04-15.

What is the track record of Lovelace Biomedical Research Institute in performing bioanalytical method validation for government contracts?

Lovelace Biomedical Research Institute has a history of performing research and development services, including those relevant to bioanalysis. While specific details on their track record for government bioanalytical method validation contracts are not fully detailed in the provided data, their designation as a research institute suggests experience in scientific methodologies. A deeper dive into their past performance on similar NIH or other federal agency contracts would be necessary to fully assess their specific expertise and reliability in this niche area. Reviewing past performance evaluations and contract histories would provide more concrete evidence of their capabilities and success rates in delivering validated bioanalytical methods.

How does the value of this contract compare to similar bioanalytical method validation contracts?

The $6.8 million contract value over approximately 4.5 years for bioanalytical method validation is within a typical range for specialized scientific services. The exact comparison depends heavily on the complexity of the methods, the analytes (cabotegravir and levonorgestrel), the matrices (rat and nonhuman primate plasma), and the specific validation parameters required (e.g., accuracy, precision, linearity, range, stability). Contracts for method development and validation can vary significantly. For instance, validating a complex method for a novel compound in multiple matrices could command higher costs than validating a simpler method for a well-characterized drug. Without specific benchmarks for these particular analytes and matrices, it's challenging to definitively state if it's high or low, but it appears reasonable for the scope.

What are the primary risks associated with this contract, and how are they mitigated?

Key risks include scientific challenges in achieving successful method validation, potential delays due to unforeseen experimental issues, and the contractor's ability to maintain specialized personnel. Mitigation strategies likely involve clear contract milestones, regular progress reporting, and the Cost Plus Fixed Fee structure which allows for adjustments while maintaining oversight. The NIH contracting officers would monitor progress closely, and the contract's duration allows for iterative problem-solving. The contractor's expertise in biomedical research is a mitigating factor against scientific risk. However, the long duration also presents a risk of evolving research needs or changes in regulatory requirements that might necessitate contract modifications.

How effective is the chosen contract type (Cost Plus Fixed Fee) for this type of R&D work?

The Cost Plus Fixed Fee (CPFF) contract type is often suitable for research and development efforts where the scope of work is not precisely defined at the outset, or where innovation and exploration are key. For bioanalytical method validation, where experimental outcomes can be uncertain, CPFF allows the contractor to incur costs while working towards a defined objective (method validation) for a fixed fee. This provides flexibility for the contractor to adapt their approach as they encounter scientific challenges. For the government, it offers a degree of cost control through the fixed fee while allowing for necessary research expenditures. However, it requires robust oversight to ensure costs are reasonable and allocable to the contract.

What are the historical spending patterns for bioanalytical method validation services by the NIH?

The NIH, as a major funder of biomedical research, consistently awards contracts for various research support services, including bioanalytical method development and validation. Historical spending patterns show a significant and ongoing investment in these areas to support drug discovery, preclinical studies, and clinical trials across numerous therapeutic areas. While specific aggregate data for 'bioanalytical method validation' alone is not readily available without extensive database queries, the NIH's overall budget for research services and contracts indicates a substantial and sustained commitment. This particular contract aligns with the agency's mission to advance health knowledge and accelerate the development of new treatments.

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

Address: 2425 RIDGECREST DR SE, ALBUQUERQUE, NM, 87108

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

Financial Breakdown

Contract Ceiling: $680,219

Exercised Options: $680,219

Current Obligation: $680,219

Actual Outlays: $625,408

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75N93022D00001

IDV Type: IDC

Timeline