Duke University awarded $8.78M for pediatric therapeutics trial designs and assay development

Contract Overview

Contract Amount: $8,783,682 ($8.8M)

Contractor: Duke University

Awarding Agency: Department of Health and Human Services

Start Date: 2023-09-28

End Date: 2027-09-27

Contract Duration: 1,460 days

Daily Burn Rate: $6.0K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST NO FEE

Sector: Healthcare

Official Description: BPCA INNOVATIVE TRIAL DESIGNS AND ASSAY DEVELOPMENTS IN PEDIATRIC THERAPEUTICS

Place of Performance

Location: DURHAM, DURHAM County, NORTH CAROLINA, 27705

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $8.8 million to DUKE UNIVERSITY for work described as: BPCA INNOVATIVE TRIAL DESIGNS AND ASSAY DEVELOPMENTS IN PEDIATRIC THERAPEUTICS Key points: 1. Contract focuses on advancing pediatric therapeutic research through innovative trial designs and assay development. 2. Funding supports critical early-stage research with potential long-term health benefits for children. 3. The contract is structured as a delivery order under a larger indefinite-delivery/indefinite-quantity (IDIQ) vehicle, suggesting a phased approach to research. 4. NIH's National Institute of Allergy and Infectious Diseases (NIAID) is the awarding agency, indicating a focus on infectious disease-related pediatric therapeutics. 5. The contract duration of approximately four years allows for sustained research efforts. 6. The 'COST NO FEE' contract type implies that the government will reimburse allowable costs incurred by the contractor, with no additional profit margin.

Value Assessment

Rating: good

The contract value of $8.78 million for a four-year research project in pediatric therapeutics appears reasonable given the specialized nature of the work. Benchmarking against similar NIH grants for early-stage R&D in rare diseases or pediatric populations suggests this funding level is within expected ranges. The 'COST NO FEE' structure indicates that the government aims to cover direct research expenses without additional profit, which can be cost-effective for foundational research where outcomes are uncertain.

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 specific competition dynamics for this delivery order are not detailed, but the initial award under an IDIQ likely involved a competitive process. Full and open competition generally promotes a wider range of innovative approaches and can lead to more competitive pricing.

Taxpayer Impact: Full and open competition ensures that taxpayer funds are used efficiently by allowing the government to select the most qualified offeror at the best value, fostering a competitive environment that can drive down costs for research services.

Public Impact

Children and pediatric patients will benefit from the development of new and improved therapeutic interventions. The research aims to enhance the design of clinical trials and develop more accurate diagnostic assays for pediatric diseases. Advancements in pediatric therapeutics can lead to better treatment outcomes and potentially reduce the burden of childhood illnesses. The project supports the scientific workforce involved in biomedical research, including researchers, technicians, and clinical trial specialists.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The 'COST NO FEE' contract type, while cost-effective for the government, may limit contractor incentive for efficiency beyond covering direct costs.
The specialized nature of pediatric therapeutics research means a limited pool of highly specialized contractors, potentially impacting future competition.
The success of the research is inherently uncertain, posing a risk to the timely development of effective treatments.

Positive Signals

Award to Duke University, a reputable research institution, suggests a high likelihood of scientific rigor and quality.
The contract's focus on innovative trial designs and assay development indicates a forward-looking approach to pediatric health research.
The full and open competition process suggests a robust evaluation of multiple proposals, leading to the selection of a strong candidate.

Sector Analysis

This contract falls within the broader Health and Biomedical Research sector, specifically focusing on the development of new treatments for pediatric conditions. The market for pediatric therapeutics is a critical but often underserved area of pharmaceutical and biotechnology research. Spending in this area is driven by unmet medical needs, regulatory requirements for pediatric drug testing, and public health initiatives. Comparable spending benchmarks would typically be found within NIH funding announcements for similar research grants and contracts, often in the millions of dollars for multi-year projects.

Small Business Impact

This contract does not appear to have a specific small business set-aside. Given the nature of advanced biomedical research and the requirement for specialized expertise, it is common for such contracts to be awarded to large research institutions or established companies. Subcontracting opportunities for small businesses might exist in areas such as specialized assay development, data analysis, or specific equipment provision, but this is not explicitly detailed in the provided data.

Oversight & Accountability

Oversight for this contract will likely be provided by the National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID). Mechanisms for oversight typically include regular progress reports, review of research findings, and adherence to ethical guidelines and federal regulations. The 'COST NO FEE' structure necessitates careful monitoring of expenditures to ensure costs are allowable and reasonable. Transparency is maintained through public databases like FPDS and SAM.gov, and research findings are often published in peer-reviewed journals.

Related Government Programs

Pediatric Research Initiative
National Center for Advancing Translational Sciences (NCATS) programs
NIH Common Fund initiatives
Clinical and Translational Science Awards (CTSAs)

Risk Flags

Potential for research delays
Uncertainty of research outcomes
Need for robust cost oversight in 'COST NO FEE' contracts

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $8.8 million to DUKE UNIVERSITY. BPCA INNOVATIVE TRIAL DESIGNS AND ASSAY DEVELOPMENTS IN PEDIATRIC THERAPEUTICS

Who is the contractor on this award?

The obligated recipient is DUKE UNIVERSITY.

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 $8.8 million.

What is the period of performance?

Start: 2023-09-28. End: 2027-09-27.

What is Duke University's track record in pediatric therapeutic research and clinical trials?

Duke University has a well-established reputation in biomedical research, including significant contributions to pediatric health. The Duke University School of Medicine and its affiliated Children's Health Center are actively involved in various research areas, from basic science to clinical trials. They have a history of securing substantial grant funding from agencies like the NIH for diverse research projects. Specifically in pediatric therapeutics, Duke researchers have been involved in studies related to rare diseases, infectious diseases, oncology, and developmental disorders. Their expertise in clinical trial design and assay development is supported by dedicated research infrastructure and experienced faculty, making them a strong candidate for contracts focused on advancing pediatric treatments.

How does the $8.78 million contract value compare to similar NIH-funded pediatric research projects?

The $8.78 million contract value for a four-year project focused on pediatric therapeutics trial designs and assay development is generally in line with significant NIH funding awards for complex research initiatives. NIH grants and contracts in areas like rare diseases, translational research, and early-stage drug development often range from several hundred thousand to several million dollars annually, depending on the scope, duration, and complexity. For a project involving innovative methodology and assay development over four years, this funding level suggests a comprehensive research effort. It is comparable to large R01 grants or specific program project grants that support multi-disciplinary teams and extensive research activities.

What are the primary risks associated with this type of research contract?

The primary risks associated with this research contract are inherent to the nature of scientific discovery and development. Firstly, there is a significant scientific risk: the innovative trial designs or assays may not prove effective or feasible, or the underlying scientific hypotheses may not be validated. Secondly, there is a timeline risk; research projects, especially in complex areas like pediatric therapeutics, can encounter unforeseen delays due to technical challenges, recruitment issues for trials, or the need for methodological adjustments. Thirdly, there is a funding risk, although this contract is funded, future research phases or follow-on projects would depend on continued appropriations and successful outcomes. Finally, regulatory hurdles or the need for ethical approvals can also introduce delays or complexities.

How effective are 'COST NO FEE' contracts in achieving research objectives compared to other contract types?

'COST NO FEE' contracts are primarily used when the scope of work is not precisely defined, or the outcome is highly uncertain, such as in basic research or early-stage development. Their effectiveness lies in allowing contractors to incur necessary costs to achieve the research objectives without the government needing to pre-approve every expense line item, provided they are allowable. This can foster flexibility and allow researchers to adapt to findings. However, a potential drawback is the lack of a direct profit incentive for the contractor to maximize efficiency or innovation beyond covering costs. For the government, effective oversight is crucial to ensure costs are reasonable and allocable to the contract. Compared to fixed-price contracts, they offer more flexibility but less cost certainty upfront. Compared to 'COST PLUS' contracts, they eliminate the profit margin, potentially making them more cost-effective for the government if managed well.

What is the historical spending pattern for NIH's National Institute of Allergy and Infectious Diseases (NIAID) in pediatric therapeutics R&D?

The National Institute of Allergy and Infectious Diseases (NIAID) historically allocates significant funding towards research aimed at preventing, diagnosing, and treating infectious diseases, including those affecting children. While specific figures for 'pediatric therapeutics R&D' as a distinct category can be complex to isolate due to overlapping research areas (e.g., vaccine development, antiviral research, immunology), NIAID consistently invests in research that has direct or indirect benefits for pediatric populations. Their portfolio includes funding for basic science, translational research, clinical trials, and the development of new diagnostic tools and therapies. Spending patterns reflect priorities in emerging infectious diseases, vaccine research, and the development of treatments for conditions like HIV/AIDS in children, influenza, and other public health threats. Analyzing NIAID's annual reports and funding data would reveal trends in their investment in pediatric-focused infectious disease research.

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 NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: 2200 W MAIN ST STE 710, DURHAM, NC, 27708

Business Categories: Category Business, Corporate Entity Tax Exempt, Educational Institution, Higher Education, Nonprofit Organization, Not Designated a Small Business, Higher Education (Private), Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $8,783,682

Exercised Options: $8,783,682

Current Obligation: $8,783,682

Actual Outlays: $3,044,456

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75N94018D00003

IDV Type: IDC

Timeline