HHS awards $185M contract for Ebola, Sudan, and Marburg virus therapeutics, with R&D focus

Contract Overview

Contract Amount: $184,786,391 ($184.8M)

Contractor: Mapp Biopharmaceutical, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2022-09-30

End Date: 2030-09-30

Contract Duration: 2,922 days

Daily Burn Rate: $63.2K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 2

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: PROCUREMENT OF THERAPEUTICS FOR EBOLA, SUDAN AND MARBURG VIRUSES

Place of Performance

Location: SAN DIEGO, SAN DIEGO County, CALIFORNIA, 92121

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $184.8 million to MAPP BIOPHARMACEUTICAL, INC. for work described as: PROCUREMENT OF THERAPEUTICS FOR EBOLA, SUDAN AND MARBURG VIRUSES Key points: 1. Contract focuses on critical biodefense research and development, addressing potential public health threats. 2. The awardee, MAPP Biopharmaceutical, Inc., has a specific niche in developing countermeasures for emerging infectious diseases. 3. Long contract duration (8 years) suggests a phased approach to development and potential for follow-on work. 4. The contract type (Cost Plus Fixed Fee) is common for R&D where costs are uncertain. 5. This award represents a significant investment in national biosecurity and pandemic preparedness. 6. The geographic focus for the contractor is California, indicating a concentration of biotech expertise in that region.

Value Assessment

Rating: good

Benchmarking the value of this R&D contract is challenging due to its specialized nature and long-term objectives. However, the total award ceiling of $185 million over eight years for developing therapeutics against high-consequence pathogens like Ebola, Sudan, and Marburg viruses appears reasonable given the complexity and risk involved. The Cost Plus Fixed Fee (CPFF) structure allows for flexibility in research while providing the contractor with an incentive for efficient performance. Comparing this to other government investments in biodefense R&D, the funding level is consistent with the critical need for advanced medical countermeasures.

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 vendors had the opportunity to bid. The presence of two bidders suggests a competitive landscape for this specialized area of biopharmaceutical research. Full and open competition is generally expected to yield better pricing and innovation by allowing the government to select the most capable and cost-effective solution from a broad range of potential offerors.

Taxpayer Impact: Full and open competition ensures that taxpayer dollars are used efficiently by fostering a competitive environment that drives down costs and encourages the best possible research outcomes.

Public Impact

The primary beneficiaries are the citizens of the United States, who will gain access to potentially life-saving therapeutics in the event of an outbreak. The contract aims to deliver advanced therapeutics for treating and preventing infections caused by Ebola, Sudan, and Marburg viruses. The geographic impact is national, focusing on enhancing the nation's preparedness for biological threats. Workforce implications include supporting specialized jobs in biotechnology research and development, particularly in California.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The CPFF contract type can lead to cost overruns if not closely monitored, as the government bears the risk of actual costs incurred.
Long-term R&D projects inherently carry a high risk of failure, with no guarantee of a successful therapeutic outcome.
Reliance on a single contractor for such critical countermeasures could pose a supply chain risk if unforeseen issues arise.

Positive Signals

The contract is awarded through full and open competition, suggesting a robust selection process.
The contractor, MAPP Biopharmaceutical, Inc., specializes in this critical area, indicating relevant expertise.
The long-term nature of the contract allows for sustained focus and development of complex countermeasures.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a critical component of the broader healthcare and defense industries. The market for biodefense countermeasures is driven by government funding and the need to address emerging infectious diseases and bioterrorism threats. Spending in this area is often characterized by long development cycles, high R&D costs, and significant regulatory hurdles. Comparable spending benchmarks are difficult to establish due to the unique nature of pathogen-specific therapeutics, but government investment in biosecurity and pandemic preparedness has been increasing.

Small Business Impact

This contract does not appear to have specific small business set-aside provisions, as indicated by 'sb': false. However, the prime contractor, MAPP Biopharmaceutical, Inc., may engage small businesses for subcontracting opportunities to leverage specialized expertise or fulfill diversity goals. The impact on the small business ecosystem would depend on the extent to which MAPP Biopharmaceutical incorporates them into its supply chain for this significant R&D effort.

Oversight & Accountability

Oversight for this contract will likely be managed by the Department of Health and Human Services (HHS), specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). The CPFF contract type necessitates rigorous financial oversight to ensure costs are reasonable and allocable to the contract. Performance monitoring will focus on achieving R&D milestones. Transparency will be maintained through regular reporting requirements and potential reviews by HHS oversight bodies or the Government Accountability Office (GAO).

Related Government Programs

Biodefense Advanced Research Projects Agency (BARDA) programs
National Institutes of Health (NIH) research grants
Department of Defense (DoD) biosecurity initiatives
Strategic National Stockpile procurements

Risk Flags

Long-term R&D project risk
Potential for cost overruns with CPFF contract
Uncertainty of therapeutic development success
Reliance on specific contractor expertise

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $184.8 million to MAPP BIOPHARMACEUTICAL, INC.. PROCUREMENT OF THERAPEUTICS FOR EBOLA, SUDAN AND MARBURG VIRUSES

Who is the contractor on this award?

The obligated recipient is MAPP BIOPHARMACEUTICAL, INC..

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 $184.8 million.

What is the period of performance?

Start: 2022-09-30. End: 2030-09-30.

What is the track record of MAPP Biopharmaceutical, Inc. in developing therapeutics for high-consequence infectious diseases?

MAPP Biopharmaceutical, Inc. is a company specializing in the development of vaccines and therapeutics for emerging infectious diseases and biodefense threats. While specific details on their past successes in bringing products to market for Ebola, Sudan, or Marburg viruses are not readily available in the public domain without deeper investigation into their project history and regulatory filings, their focus on this niche suggests a dedicated effort in this area. Government contracts awarded to companies like MAPP often signify a level of vetting and confidence in their scientific capabilities and potential to deliver on complex R&D objectives. Further analysis would involve reviewing their portfolio of past government-funded projects, any published research, and their success in navigating the clinical trial and FDA approval processes for similar countermeasures.

How does the $185 million award compare to other government investments in Ebola and Marburg virus research?

The $185 million award for therapeutics against Ebola, Sudan, and Marburg viruses represents a substantial, but not unprecedented, investment in biodefense R&D. Government agencies like HHS (through ASPR and BARDA) and the Department of Defense have historically allocated significant funding towards developing countermeasures for these high-consequence pathogens. For instance, previous efforts to develop Ebola vaccines and treatments have involved hundreds of millions of dollars in research grants, development contracts, and advanced purchase agreements. The specific amount here is consistent with the long-term, high-risk nature of developing novel therapeutics for such diseases, which require extensive preclinical and clinical testing. It reflects a strategic commitment to bolstering national preparedness against these specific viral threats.

What are the primary risks associated with this Cost Plus Fixed Fee (CPFF) contract type for R&D?

The primary risks associated with a Cost Plus Fixed Fee (CPFF) contract type, especially for research and development, center on cost control and potential for scope creep. In a CPFF arrangement, the government agrees to pay the contractor's allowable costs plus a fixed fee representing profit. The main risk for the government is that the contractor may have less incentive to control costs rigorously, as the government bears the majority of the financial risk if actual costs exceed estimates. This can lead to cost overruns if the R&D process proves more complex or expensive than initially anticipated. Additionally, the fixed fee, while intended to provide incentive, might not always align perfectly with the contractor's efforts if the project's scope evolves significantly. Effective oversight and clear milestone definitions are crucial to mitigate these risks.

What is the expected timeline for delivering tangible results or therapeutics from this 8-year contract?

Given the 8-year duration and the nature of R&D for complex therapeutics like those targeting Ebola, Sudan, and Marburg viruses, tangible results are likely to be phased and may not culminate in a fully approved product until the latter stages of the contract, or potentially beyond. The contract likely involves milestones such as preclinical studies, formulation development, manufacturing process optimization, and multiple phases of clinical trials (Phase I, II, and III). Early phases might yield data on safety and efficacy, while later phases aim for regulatory approval. It is common for such long-term biodefense R&D contracts to have interim deliverables like research reports, optimized drug candidates, or manufacturing process validation, with the ultimate goal of a deployable therapeutic by the contract's end or through subsequent agreements.

How does this contract contribute to the broader U.S. strategy for pandemic preparedness and biosecurity?

This contract is a direct and critical component of the U.S. strategy for pandemic preparedness and biosecurity. By investing in the development of therapeutics for high-consequence pathogens like Ebola, Sudan, and Marburg viruses, the government is proactively building a defense against potential biological threats, whether naturally occurring or intentionally released. This aligns with national security objectives by reducing the vulnerability of the population to devastating outbreaks. Furthermore, it supports the broader goal of maintaining economic stability and public trust during health crises. The R&D funded through this contract aims to ensure that the U.S. has advanced medical countermeasures available, complementing efforts in surveillance, detection, and response.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: MEDICAL/DENTAL/VETERINARY EQPT/SUPP

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: 75A50121R00038

Offers Received: 2

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 4921 DIRECTORS PLACE STE 100, SAN DIEGO, CA, 92121

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Small Business, Special Designations, Subchapter S Corporation, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $906,651,398

Exercised Options: $184,786,391

Current Obligation: $184,786,391

Actual Outlays: $93,019,874

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline