HHS awards $118.6M for filovirus outbreak countermeasures, with a 10-year performance period

Contract Overview

Contract Amount: $118,563,679 ($118.6M)

Contractor: Emergent Product Development Gaithersburg Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2023-07-31

End Date: 2033-07-29

Contract Duration: 3,651 days

Daily Burn Rate: $32.5K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 2

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: MEDICAL COUNTERMEASURES (MCM) THAT CAN BE DEPLOYED IN THE EVENT OF A FILOVIRUS OUTBREAK ARE A CRUCIAL COMPONENT TO THE UNITED STATES GOVERNMENT?S (USG?S) OUTBREAK RESPONSE PLAN. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY (BARDA) IS SEEKIN

Place of Performance

Location: GAITHERSBURG, MONTGOMERY County, MARYLAND, 20879

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $118.6 million to EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC. for work described as: MEDICAL COUNTERMEASURES (MCM) THAT CAN BE DEPLOYED IN THE EVENT OF A FILOVIRUS OUTBREAK ARE A CRUCIAL COMPONENT TO THE UNITED STATES GOVERNMENT?S (USG?S) OUTBREAK RESPONSE PLAN. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY (BARDA) IS SEEKIN Key points: 1. Contract focuses on critical medical countermeasures for filovirus outbreaks, aligning with national response plans. 2. The awardee, Emergent Product Development, will conduct research and development in biotechnology. 3. A long performance period of 10 years suggests a need for sustained development and potential future needs. 4. The contract type is a firm-fixed-price definitive contract, indicating price certainty for the government. 5. The procurement was conducted under full and open competition, suggesting a broad search for qualified vendors. 6. The contract value of $118.6 million is significant for a single R&D award in this specialized area.

Value Assessment

Rating: good

The contract value of $118.6 million for a 10-year R&D effort in medical countermeasures appears reasonable given the critical nature of the work and the specialized field. Benchmarking against similar long-term biomedical R&D contracts would provide further context, but the duration and scope suggest a substantial investment. The firm-fixed-price structure helps manage cost certainty for the government over the contract's life.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded through full and open competition, indicating that the government sought proposals from all responsible sources. The fact that it is a definitive contract with a single awardee suggests that Emergent Product Development was selected as the most advantageous offer after a competitive process. The number of bidders is not specified, but full and open competition generally promotes price discovery and encourages multiple vendors to vie for the work.

Taxpayer Impact: Full and open competition is generally favorable for taxpayers as it aims to secure the best value by allowing a wide range of potential contractors to compete, potentially driving down prices and improving the quality of proposals.

Public Impact

The primary beneficiaries are the citizens of the United States, who will be better protected against filovirus outbreaks through the development of critical medical countermeasures. The services delivered include research and development in biotechnology, specifically focusing on countermeasures deployable during an outbreak. The geographic impact is national, as the development of these countermeasures contributes to the overall preparedness of the United States. Workforce implications may include specialized jobs in biotechnology research and development within the contractor's organization.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Long-term nature of the contract (10 years) could lead to cost overruns if development timelines are not met or if market conditions change significantly.
Dependence on a single contractor for critical countermeasures raises concerns about supply chain resilience and potential single-source issues if the contractor faces challenges.
The specialized nature of filovirus research means that the pool of qualified contractors might be limited, potentially impacting future competition.
The effectiveness of the developed countermeasures will depend on ongoing scientific advancements and the specific characteristics of future outbreaks.

Positive Signals

Focus on critical medical countermeasures addresses a significant public health and national security need.
The firm-fixed-price contract provides cost certainty for the government over the long performance period.
Award through full and open competition suggests a thorough evaluation process to select the most capable offeror.
The 10-year duration allows for sustained investment and development in a complex scientific field.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a critical area for national security and public health. The market for medical countermeasures is driven by government funding and the need for preparedness against emerging infectious diseases. BARDA, as the contracting agency, is a key player in funding advanced R&D for medical threats. Comparable spending benchmarks would involve looking at other long-term R&D contracts for vaccines, therapeutics, and diagnostics aimed at high-consequence pathogens.

Small Business Impact

The provided data indicates that this contract was not set aside for small businesses (ss: false, sb: false). Therefore, there are no direct subcontracting implications or specific impacts on the small business ecosystem stemming from a small business set-aside. The focus is on a large-scale R&D effort likely requiring significant infrastructure and expertise.

Oversight & Accountability

Oversight for this contract would typically be managed by the Biomedical Advanced Research and Development Authority (BARDA) within HHS. Accountability measures would be embedded in the contract's performance work statement, requiring regular reporting, milestone achievement, and adherence to scientific and regulatory standards. Transparency is facilitated through contract awards databases, though specific project details might be sensitive. Inspector General jurisdiction would apply to any allegations of fraud, waste, or abuse.

Related Government Programs

Biomedical Advanced Research and Development Authority (BARDA) Programs
National Biodefense Strategy
Medical Countermeasures Development
Infectious Disease Preparedness and Response
Filovirus Research Initiatives

Risk Flags

Long-term contract duration may present challenges in adapting to evolving scientific knowledge or threat landscapes.
Dependence on a single awardee for critical countermeasures could pose supply chain risks.
Past performance issues with contractors in the MCM space warrant close monitoring.
The specialized nature of the R&D may limit future competition if the technology path proves unsuccessful.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $118.6 million to EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.. MEDICAL COUNTERMEASURES (MCM) THAT CAN BE DEPLOYED IN THE EVENT OF A FILOVIRUS OUTBREAK ARE A CRUCIAL COMPONENT TO THE UNITED STATES GOVERNMENT?S (USG?S) OUTBREAK RESPONSE PLAN. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY (BARDA) IS SEEKIN

Who is the contractor on this award?

The obligated recipient is EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG 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 $118.6 million.

What is the period of performance?

Start: 2023-07-31. End: 2033-07-29.

What is the specific nature of the 'medical countermeasures' being developed under this contract?

The contract focuses on the development of medical countermeasures (MCMs) deployable in the event of a filovirus outbreak. Filoviruses include highly pathogenic viruses such as Ebola and Marburg. The specific countermeasures could encompass a range of products, including vaccines, therapeutics (antivirals or antibody treatments), or diagnostic tools designed to rapidly detect and respond to these threats. The contract's emphasis on 'biomedical advanced research and development' suggests that the work may involve early-stage research, preclinical testing, and potentially early clinical trials to advance these MCMs towards availability for public health stockpiles or emergency use.

How does this contract's value and duration compare to other BARDA or similar agency R&D awards for infectious disease countermeasures?

A $118.6 million award over 10 years for filovirus countermeasures is a substantial investment, reflecting the high-risk, high-reward nature of developing MCMs for rare but catastrophic threats. BARDA has awarded numerous contracts for MCM development, with values and durations varying significantly based on the pathogen, stage of development, and technological approach. For instance, contracts for vaccine development might range from tens to hundreds of millions of dollars over several years, while therapeutic development could follow similar patterns. The 10-year performance period is on the longer side, indicating a commitment to sustained development, potentially from early research through advanced testing phases, which is common for complex biological products targeting emerging threats.

What are the key performance indicators (KPIs) or milestones expected from Emergent Product Development under this contract?

While specific KPIs are not detailed in the provided summary, contracts of this nature typically include rigorous milestones tied to scientific and development progress. These would likely involve achieving specific research objectives, successful completion of preclinical studies (e.g., animal model efficacy and safety testing), progression through various phases of clinical trials (Phase I, II, III), manufacturing process development and validation, and regulatory submissions. Performance would be assessed against these defined milestones, with payments often contingent upon their successful achievement. Regular technical progress reports and reviews would be standard.

What is Emergent Product Development's track record in developing medical countermeasures, particularly for viral threats?

Emergent Product Development has a significant history in developing medical countermeasures, particularly for biodefense and emerging infectious diseases. The company has been involved in developing vaccines and therapeutics for various threats, including anthrax, smallpox, and more recently, COVID-19. Their experience spans research, development, manufacturing, and regulatory affairs. However, like many companies in this high-stakes field, they have also faced scrutiny and challenges related to product development timelines, manufacturing quality, and contract performance in the past. Their established presence in the MCM space suggests they possess the core capabilities, but ongoing performance under this new contract will be critical.

What are the potential risks associated with relying on a single contractor for such critical countermeasures?

Relying on a single contractor for critical medical countermeasures presents several risks. Firstly, there's the risk of contractor failure due to financial instability, scientific setbacks, manufacturing issues, or even acquisition by a foreign entity. Secondly, a single source can limit innovation and competition in the long run, potentially leading to higher costs or slower development if alternative approaches are not explored. Thirdly, supply chain disruptions affecting the sole contractor could jeopardize national preparedness. To mitigate these, the government often includes robust oversight, contingency planning, and potentially provisions for technology transfer or backup development efforts.

How does this contract align with the broader US government strategy for pandemic preparedness and biodefense?

This contract directly aligns with the US government's overarching strategy for pandemic preparedness and biodefense, as articulated in various national security and public health documents. The development of medical countermeasures against high-consequence pathogens like filoviruses is a cornerstone of these strategies. By investing in R&D through agencies like BARDA, the government aims to ensure that effective tools are available to prevent, detect, and respond to biological threats, whether naturally occurring or deliberately caused. This contract supports the goal of maintaining a robust pipeline of MCMs to protect the population and national security.

Industry Classification

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

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: 75A50122R000006

Offers Received: 2

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Parent Company: Emergent Biosolutions Inc.

Address: 300 PROFESSIONAL DR, GAITHERSBURG, MD, 20879

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

Financial Breakdown

Contract Ceiling: $1,525,625,390

Exercised Options: $237,127,358

Current Obligation: $118,563,679

Actual Outlays: $60,981,200

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline