HHS awards $12.5M contract for yellow fever antiviral drug development, with 10 bids received

Contract Overview

Contract Amount: $12,480,276 ($12.5M)

Contractor: Baruch S. Blumberg Institute

Awarding Agency: Department of Health and Human Services

Start Date: 2022-11-15

End Date: 2026-12-31

Contract Duration: 1,507 days

Daily Burn Rate: $8.3K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 10

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: TO DEVELOP AN ORALLY AVAILABLE SMALL MOLECULE ANTIVIRAL DRUG, WITH TREATMENT OF YELLOW FEVER VIRUS INFECTION AS THE PRIMARY INDICATION.

Place of Performance

Location: DOYLESTOWN, BUCKS County, PENNSYLVANIA, 18902

State: Pennsylvania Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $12.5 million to BARUCH S. BLUMBERG INSTITUTE for work described as: TO DEVELOP AN ORALLY AVAILABLE SMALL MOLECULE ANTIVIRAL DRUG, WITH TREATMENT OF YELLOW FEVER VIRUS INFECTION AS THE PRIMARY INDICATION. Key points: 1. Contract aims to develop an orally available small molecule antiviral for yellow fever. 2. The award represents a significant investment in pandemic preparedness and infectious disease research. 3. Competition was robust with 10 bids, suggesting a healthy market for this type of R&D. 4. The contract duration of approximately 4 years allows for substantial research and development. 5. Focus on yellow fever addresses a critical public health concern with potential for broader antiviral applications. 6. The chosen contract type (Cost Plus Fixed Fee) is common for R&D where scope may evolve.

Value Assessment

Rating: good

The contract value of $12.5 million for developing an orally available antiviral drug for yellow fever appears reasonable given the complexity and duration of R&D. Benchmarking against similar early-stage drug development contracts is challenging due to proprietary data, but the funding level is consistent with NIH investments in novel therapeutics. The Cost Plus Fixed Fee structure allows for flexibility while providing incentives for the contractor to manage costs effectively.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, with 10 bids received. This indicates a competitive marketplace for companies specializing in antiviral drug development. The high number of bidders suggests that the solicitation was widely disseminated and that multiple entities possessed the necessary capabilities and interest to pursue this research.

Taxpayer Impact: A competitive bidding process for R&D contracts like this generally leads to better price discovery and potentially more innovative solutions for taxpayers. It ensures that the government is not overpaying for the services and that the most capable contractor is selected.

Public Impact

The primary beneficiary is public health, with the development of a treatment for yellow fever virus infection. This contract supports the advancement of medical countermeasures against emerging infectious diseases. The research has the potential to reduce morbidity and mortality associated with yellow fever outbreaks. Successful development could lead to improved global health security and preparedness for future pandemics. The project may foster advancements in antiviral drug discovery technologies applicable to other diseases.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns inherent in early-stage R&D projects.
Uncertainty in drug development timelines and success rates.
Reliance on a single contractor for a critical public health objective.

Positive Signals

Robust competition indicates a healthy market and potential for innovation.
Contractor's focus on a specific, high-priority public health threat.
Clear performance period and defined objectives for drug development.

Sector Analysis

This contract falls within the Biotechnology and Pharmaceutical R&D sector, specifically focusing on infectious disease therapeutics. The market for antiviral drug development is highly specialized, driven by significant R&D investment from both government agencies and private pharmaceutical companies. Comparable spending benchmarks are difficult to ascertain due to the proprietary nature of drug development, but federal agencies like NIH frequently fund early-stage research to address unmet medical needs and public health threats.

Small Business Impact

There is no indication of a small business set-aside for this contract, nor is the primary contractor identified as a small business. The focus on specialized R&D in antiviral drug development may present barriers to entry for smaller firms. Subcontracting opportunities for small businesses could arise in areas such as specialized laboratory services, data analysis, or clinical trial support, depending on the contractor's strategy.

Oversight & Accountability

The contract is managed by the National Institutes of Health (NIH), a component of the Department of Health and Human Services (HHS). Oversight will likely involve regular progress reports, milestone reviews, and financial audits to ensure adherence to the contract terms and objectives. The Inspector General of HHS provides oversight for all HHS expenditures, including this contract, to prevent fraud, waste, and abuse.

Related Government Programs

NIH Antiviral Drug Development Programs
Biomedical Advanced Research and Development Authority (BARDA) funding
Centers for Disease Control and Prevention (CDC) infectious disease initiatives
National Institute of Allergy and Infectious Diseases (NIAID) research grants

Risk Flags

R&D Cost Overruns
Drug Development Failure
Long Development Timelines
Regulatory Hurdles

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $12.5 million to BARUCH S. BLUMBERG INSTITUTE. TO DEVELOP AN ORALLY AVAILABLE SMALL MOLECULE ANTIVIRAL DRUG, WITH TREATMENT OF YELLOW FEVER VIRUS INFECTION AS THE PRIMARY INDICATION.

Who is the contractor on this award?

The obligated recipient is BARUCH S. BLUMBERG 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 $12.5 million.

What is the period of performance?

Start: 2022-11-15. End: 2026-12-31.

What is the track record of the Baruch S. Blumberg Institute in developing antiviral drugs?

The Baruch S. Blumberg Institute, part of the Pennsylvania Biotechnology Center, has a history of research in virology and drug discovery. While specific publicly available data on their success in bringing orally available antiviral drugs to market is limited, their focus aligns with the contract's objectives. The institute benefits from a collaborative environment and access to specialized facilities. Their experience in basic and translational research in infectious diseases is a key factor in their selection for this R&D contract. Further assessment would require reviewing their specific project portfolios and any prior government contracts related to antiviral development.

How does the $12.5 million funding compare to similar R&D contracts for antiviral development?

The $12.5 million award for developing an orally available small molecule antiviral for yellow fever is within the typical range for early-stage drug discovery and development contracts funded by agencies like the NIH. Early-stage research, encompassing target identification, lead compound discovery, and preclinical testing, can cost millions of dollars over several years. More advanced clinical trials would require significantly higher funding. Benchmarking is difficult due to the proprietary nature of pharmaceutical R&D and the variability in project scope, but this amount suggests a focus on the initial phases of development rather than late-stage clinical trials.

What are the primary risks associated with this contract?

The primary risks associated with this contract are inherent to pharmaceutical R&D. These include scientific risk (the drug candidate may not be effective or safe), technical risk (challenges in synthesis, formulation, or delivery), regulatory risk (failure to meet FDA requirements), and market risk (changes in disease prevalence or availability of alternative treatments). Furthermore, the Cost Plus Fixed Fee structure, while common for R&D, carries a risk of cost overruns if not managed diligently. The long development timeline also introduces risks related to shifting research priorities or funding availability in future fiscal years.

What is the expected impact of this contract on yellow fever treatment availability?

This contract aims to develop a novel treatment for yellow fever, addressing a critical unmet medical need. Yellow fever is a serious viral hemorrhagic fever with no specific antiviral treatment currently approved, meaning current management is supportive. The successful development of an orally available antiviral drug would provide clinicians with a much-needed therapeutic option, potentially reducing the severity of illness, preventing deaths, and mitigating the impact of outbreaks. This could significantly improve patient outcomes and public health responses to yellow fever globally.

How has federal spending on antiviral drug development evolved in recent years?

Federal spending on antiviral drug development has seen a notable increase, particularly in response to emerging infectious disease threats like COVID-19. Agencies such as the NIH, NIAID, and BARDA have significantly boosted funding for research into broad-spectrum antivirals and specific pathogen-targeted therapies. This trend reflects a strategic shift towards pandemic preparedness and strengthening the nation's biodefense capabilities. While specific figures fluctuate annually based on emerging threats and budget allocations, the overall trajectory indicates a sustained commitment to advancing antiviral research and development.

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

Solicitation ID: BAA2022-1

Offers Received: 10

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 3805 OLD EASTON RD, DOYLESTOWN, PA, 18902

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

Financial Breakdown

Contract Ceiling: $32,348,261

Exercised Options: $12,480,276

Current Obligation: $12,480,276

Actual Outlays: $9,317,255

Subaward Activity

Number of Subawards: 4

Total Subaward Amount: $127,541

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline