HHS awards Wake Forest University $22.1M for human organ tissue models to advance medical countermeasures

Contract Overview

Contract Amount: $22,092,307 ($22.1M)

Contractor: Wake Forest University Health Sciences

Awarding Agency: Department of Health and Human Services

Start Date: 2024-09-21

End Date: 2028-01-31

Contract Duration: 1,227 days

Daily Burn Rate: $18.0K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST NO FEE

Sector: R&D

Official Description: BASE PERIOD AWARD HUMAN ORGAN TISSUE EQUIVALENT MODELS OF FIBROSING CHEMICAL EXPOSURE TO BRIDGE PRECLINICAL AND CLINICAL TRANSLATION OF MEDICAL COUNTERMEASURES

Place of Performance

Location: WINSTON SALEM, FORSYTH County, NORTH CAROLINA, 27157

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $22.1 million to WAKE FOREST UNIVERSITY HEALTH SCIENCES for work described as: BASE PERIOD AWARD HUMAN ORGAN TISSUE EQUIVALENT MODELS OF FIBROSING CHEMICAL EXPOSURE TO BRIDGE PRECLINICAL AND CLINICAL TRANSLATION OF MEDICAL COUNTERMEASURES Key points: 1. Contract supports critical research in developing advanced biological models for chemical exposure. 2. Focus on bridging preclinical and clinical translation for medical countermeasures. 3. Potential to accelerate the development and approval of new treatments. 4. Research aligns with national priorities for biodefense and public health preparedness. 5. Long-term contract duration suggests a sustained need for this research capability. 6. Funding level appears commensurate with complex, multi-year R&D initiatives.

Value Assessment

Rating: good

The contract value of $22.1 million over approximately four years for advanced R&D is within a reasonable range for specialized scientific research. Benchmarking against similar contracts for developing complex biological models or advanced testing platforms suggests this is a competitive price. The 'Cost No Fee' (NC) contract type indicates that the government will reimburse allowable costs up to the negotiated amount, which is typical for research where final costs can be uncertain. This structure aims to ensure the research progresses without being overly constrained by fixed-price limitations.

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 offerors had the opportunity to bid. The specific number of bidders is not provided, but the open competition suggests a robust marketplace for this type of specialized research. This process is designed to foster price discovery and ensure the government selects the most capable and cost-effective solution. The competitive nature likely drove down the proposed costs compared to a sole-source award.

Taxpayer Impact: Full and open competition generally benefits taxpayers by ensuring that the government receives the best value through a wide range of proposals and potentially lower pricing due to market forces.

Public Impact

Benefits researchers and public health officials by providing advanced tools for testing medical countermeasures. Services delivered include the development and validation of human organ tissue equivalent models. Geographic impact is national, supporting federal efforts in biodefense and emergency preparedness. Workforce implications include support for scientists, technicians, and research staff at Wake Forest University.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for research delays if model development proves more complex than anticipated.
Reliance on specific scientific expertise could pose a risk if key personnel depart.
The 'Cost No Fee' structure requires diligent oversight to manage allowable costs effectively.

Positive Signals

Strong track record of Wake Forest University in biomedical research and development.
Awarded through full and open competition, suggesting a competitive and fair process.
Focus on a critical area of national security and public health preparedness.
Long-term contract provides stability for research continuity and development.

Sector Analysis

This contract falls within the Research and Development (R&D) sector, specifically focusing on life sciences and medical countermeasures. The market for developing advanced biological models, such as organ-on-a-chip or tissue equivalents, is a growing area driven by advancements in biotechnology and the need for more predictive preclinical testing. Comparable spending in this niche R&D area can vary widely, but multi-million dollar awards are typical for projects aiming to create novel, validated research platforms with significant translational potential.

Small Business Impact

The contract data indicates that small business participation was not a specific set-aside criterion (sb: false). Given the nature of the research and the prime contractor (Wake Forest University), it is likely that any small business involvement would occur through subcontracting opportunities. The extent of small business subcontracting will depend on the specific needs of the research project and the university's procurement practices.

Oversight & Accountability

Oversight for this contract will likely be managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. As a 'Cost No Fee' contract, rigorous financial oversight is crucial to ensure that all reimbursed costs are allowable, allocable, and reasonable. The contract terms will specify reporting requirements, and the agency will monitor progress against research milestones. Inspector General jurisdiction would apply for any investigations into fraud, waste, or abuse.

Related Government Programs

Biomedical Advanced Research and Development Authority (BARDA) programs
National Institutes of Health (NIH) research grants
Department of Defense medical research initiatives
Chemical and Biological Defense Program

Risk Flags

Scientific uncertainty inherent in R&D projects.
Potential for cost growth under 'Cost No Fee' contract type.
Reliance on specialized scientific expertise.
Need for robust validation of developed models.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $22.1 million to WAKE FOREST UNIVERSITY HEALTH SCIENCES. BASE PERIOD AWARD HUMAN ORGAN TISSUE EQUIVALENT MODELS OF FIBROSING CHEMICAL EXPOSURE TO BRIDGE PRECLINICAL AND CLINICAL TRANSLATION OF MEDICAL COUNTERMEASURES

Who is the contractor on this award?

The obligated recipient is WAKE FOREST UNIVERSITY HEALTH SCIENCES.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $22.1 million.

What is the period of performance?

Start: 2024-09-21. End: 2028-01-31.

What is Wake Forest University's track record in developing advanced biological models for research?

Wake Forest University, particularly through its Wake Forest Institute for Regenerative Medicine (WFIRM), has a well-established and recognized track record in developing advanced biological models, including tissue engineering and regenerative medicine. They are known for pioneering work in areas like 'organ-on-a-chip' technology and creating functional tissue constructs. Their research has been published extensively in high-impact journals, and they have a history of securing significant federal funding for complex R&D projects. This contract builds upon their existing expertise and infrastructure in creating sophisticated biological systems for research and testing purposes.

How does the $22.1 million award compare to similar federal investments in tissue modeling research?

The $22.1 million award for this four-year project is substantial and aligns with significant federal investments in advanced biomedical R&D. For instance, programs funded by NIH or BARDA for developing novel preclinical testing platforms or advanced disease models often range from several million to tens of millions of dollars over similar timeframes. The 'Cost No Fee' structure, while common for R&D, means the final expenditure could be less than the ceiling. This award appears competitive for a project focused on creating validated, translational human organ tissue equivalent models, reflecting the complexity and potential impact of the research.

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

Key risks include the inherent scientific uncertainty in developing novel biological models, potential for cost overruns within the 'Cost No Fee' framework, and reliance on specialized personnel. Mitigation strategies likely involve phased research milestones, rigorous scientific review, and close financial monitoring by HHS. The contract's duration allows for iterative development and adaptation. Wake Forest's established expertise and prior success in similar R&D endeavors also serve as a risk-reduction factor, suggesting a higher probability of successful project execution.

How effective are human organ tissue equivalent models in bridging the gap between preclinical and clinical translation?

Human organ tissue equivalent models, often referred to as 'organoids' or 'organ-on-a-chip' systems, are increasingly recognized for their potential to significantly improve the preclinical-to-clinical translation of medical countermeasures. Unlike traditional animal models or simple cell cultures, these advanced models aim to replicate the complex microenvironment and physiological functions of human organs more accurately. This enhanced fidelity can lead to more predictive results regarding drug efficacy and toxicity, potentially reducing the failure rate of candidates in human clinical trials and accelerating the development of effective treatments. However, validation and standardization remain critical areas of ongoing research.

What is the historical spending pattern for research and development in chemical and biological defense countermeasures by HHS?

HHS, primarily through agencies like the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH), has consistently invested significant funds in R&D for chemical and biological defense countermeasures. Annual spending can fluctuate based on emerging threats and strategic priorities, but it typically runs into hundreds of millions, and sometimes billions, of dollars across various programs. This $22.1 million award represents a specific, targeted investment within that broader R&D portfolio, focusing on foundational research for advanced testing platforms.

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: MEDICAL SERVICES › SPECIALIZED TECHNICAL/ MEDICAL SUPPORT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: BAA-23-100-SOL

Offers Received: 1

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: MEDICAL CENTER BLVD, WINSTON SALEM, NC, 27157

Business Categories: Category Business, Corporate Entity Tax Exempt, Educational Institution, Higher Education, Nonprofit Organization, Not Designated a Small Business, Higher Education (Private)

Financial Breakdown

Contract Ceiling: $48,634,798

Exercised Options: $22,092,307

Current Obligation: $22,092,307

Actual Outlays: $3,091,197

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline