HHS awards $35.3M contract to INVSA, Inc. for mustard gas eye injury treatment research

Contract Overview

Contract Amount: $35,324,845 ($35.3M)

Contractor: Invirsa, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2020-09-28

End Date: 2028-11-16

Contract Duration: 2,971 days

Daily Burn Rate: $11.9K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST SHARING

Sector: R&D

Official Description: INV-102 FOR THE TREATMENT OF MUSTARD GAS KERATOPATHY UNDER BAA-18-100-SOL-00003, AREA OF INTEREST 5.3.

Place of Performance

Location: COLUMBUS, FRANKLIN County, OHIO, 43212

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $35.3 million to INVIRSA, INC. for work described as: INV-102 FOR THE TREATMENT OF MUSTARD GAS KERATOPATHY UNDER BAA-18-100-SOL-00003, AREA OF INTEREST 5.3. Key points: 1. Contract focuses on a critical unmet need in chemical warfare defense. 2. Research and Development in Biotechnology sector, specifically targeting rare medical conditions. 3. Long-term contract duration suggests a phased research and development approach. 4. Potential for significant public health impact in the event of chemical attacks. 5. Contract awarded under a broad agency announcement, indicating a focus on scientific merit. 6. Cost-sharing arrangement implies shared risk and investment between government and contractor.

Value Assessment

Rating: good

The contract value of $35.3 million over approximately 8 years represents a substantial investment in specialized research. Benchmarking this against similar R&D contracts for rare disease treatments or advanced medical countermeasures is challenging due to the unique nature of mustard gas keratitis. However, the cost-sharing mechanism suggests a potentially favorable arrangement for the government, as the contractor also bears some financial risk. The definitive contract award type, while not a fixed-price agreement, allows for flexibility in R&D which can be necessary for novel research.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under a full and open competition, likely through a Broad Agency Announcement (BAA) as indicated by the solicitation number. This suggests that multiple entities were potentially able to submit proposals based on specific research areas of interest. The specific number of bidders is not provided, but a full and open competition generally fosters a competitive environment, encouraging multiple proposals and potentially leading to better pricing and innovative solutions.

Taxpayer Impact: A full and open competition ensures that taxpayers benefit from the widest possible pool of talent and innovation, increasing the likelihood of securing the most effective and cost-efficient research for a critical national security need.

Public Impact

Military personnel and civilians potentially exposed to chemical warfare agents. Development of a novel treatment for mustard gas-induced eye damage (keratopathy). Enhancement of national biodefense capabilities. Advancement of scientific knowledge in the field of chemical injury treatment. Potential benefits for victims of industrial chemical accidents.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The long duration of the contract (nearly 8 years) could lead to scope creep or cost overruns if not managed effectively.
The success of the research is inherently uncertain, typical of R&D contracts, meaning the full value may not be realized.
Reliance on a single contractor for this specialized research could pose a risk if the contractor faces financial or operational difficulties.

Positive Signals

Focus on a critical and unique medical need with significant public health implications.
Cost-sharing arrangement indicates contractor commitment and shared risk.
Awarded under a broad agency announcement, suggesting a focus on scientific merit and innovation.
Long-term commitment allows for sustained research and development efforts.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, specifically focusing on advanced medical countermeasures. The market for treatments for chemical warfare injuries is highly specialized and often driven by government funding due to the limited commercial viability of such niche applications. Comparable spending benchmarks are difficult to establish precisely due to the unique nature of mustard gas keratitis, but investments in biodefense research and development by agencies like HHS and DoD are substantial, often ranging in the tens to hundreds of millions for advanced research programs.

Small Business Impact

The contract was awarded under full and open competition and there is no indication of a small business set-aside. Therefore, the direct impact on small businesses through this specific award is likely minimal. However, the prime contractor, INVSA, Inc., may engage small businesses as subcontractors for specialized services or supplies, contributing indirectly to the small business ecosystem. Further analysis would be needed to determine subcontracting plans.

Oversight & Accountability

Oversight for this contract will likely be managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS, which is responsible for biodefense preparedness. The contract type (cost sharing) and its long duration necessitate robust oversight to monitor research progress, expenditures, and adherence to the statement of work. Transparency will be maintained through regular reporting requirements from the contractor. The Inspector General's office for HHS would have jurisdiction for audits and investigations if any improprieties were suspected.

Related Government Programs

Biodefense Advanced Research Projects Agency (BARDA) programs
Chemical and Biological Defense Program (DoD)
National Institutes of Health (NIH) research grants
Medical Countermeasures Advanced Development and Manufacturing
Chemical Warfare Agent Decontamination Research

Risk Flags

Research and Development Uncertainty
Long-Term Contract Management
Contractor Performance Risk
Niche Market Viability

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $35.3 million to INVIRSA, INC.. INV-102 FOR THE TREATMENT OF MUSTARD GAS KERATOPATHY UNDER BAA-18-100-SOL-00003, AREA OF INTEREST 5.3.

Who is the contractor on this award?

The obligated recipient is INVIRSA, 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 $35.3 million.

What is the period of performance?

Start: 2020-09-28. End: 2028-11-16.

What is the specific scientific approach INVSA, Inc. will employ to develop a treatment for mustard gas keratitis?

The provided data does not detail the specific scientific approach INVSA, Inc. will employ. However, contracts awarded under Broad Agency Announcements (BAAs) like BAA-18-100-SOL-00003 typically solicit proposals for innovative research. Given the nature of mustard gas keratitis, potential approaches could involve regenerative medicine, advanced pharmaceutical interventions targeting cellular damage pathways, or novel drug delivery systems to protect and repair the ocular surface. The research would likely involve in-vitro studies, animal models, and potentially pre-clinical testing to assess efficacy and safety before human trials could be considered. The cost-sharing aspect suggests the contractor has a proprietary or well-researched methodology they are willing to invest in.

How does the $35.3 million contract value compare to other federal investments in chemical warfare countermeasures?

The $35.3 million contract value for this specific research is significant, particularly for a niche area like mustard gas keratitis. Federal investments in chemical warfare countermeasures are substantial and span various categories, including medical countermeasures, detection systems, and protective equipment. Agencies like the Department of Health and Human Services (HHS) and the Department of Defense (DoD) collectively invest billions annually in biodefense. While this single contract is a notable sum, it represents a focused investment within a much larger portfolio aimed at protecting against a range of threats. Direct comparisons are difficult as other countermeasure contracts might cover broader threat spectra, different stages of development (e.g., manufacturing scale-up vs. early research), or involve multiple therapeutic targets.

What are the primary risks associated with this research and development contract?

The primary risks associated with this R&D contract are inherent to the nature of scientific research. Firstly, there is a significant technical risk: the research may not yield a viable or effective treatment for mustard gas keratitis, despite the investment. Secondly, the long contract duration (nearly 8 years) introduces programmatic risks, including potential cost overruns if research proves more complex than anticipated, or schedule delays due to unforeseen scientific challenges. Thirdly, there is a contractor-specific risk; if INVSA, Inc. experiences financial instability, management issues, or a loss of key personnel, the project's progress could be severely hampered. Finally, the specialized nature of the threat means the market for the developed treatment is limited, primarily to government stockpiling, which could affect long-term sustainability if not managed strategically.

What is INVSA, Inc.'s track record in government contracting, particularly in R&D for biodefense?

Information regarding INVSA, Inc.'s specific track record in government contracting, especially within the biodefense R&D sector, is not detailed in the provided data. To assess their capabilities, one would need to review their past performance on similar contracts, including their success in meeting milestones, managing budgets, and delivering on technical objectives. Government contract databases (like SAM.gov or FPDS) would typically contain records of their awards, performance evaluations (if available), and any past performance issues. Without this specific data, it's difficult to definitively assess their suitability beyond the fact that they were selected through a full and open competition process for this significant award.

How does the cost-sharing arrangement impact the value proposition for the government?

The cost-sharing arrangement is a key factor in assessing the value proposition for the government. By requiring INVSA, Inc. to share in the research costs, the government effectively reduces its own financial exposure while simultaneously incentivizing the contractor to manage resources efficiently and prioritize research outcomes that are likely to succeed. This arrangement signals a strong commitment from INVSA, Inc. to the project's success and suggests they believe in the scientific merit and potential of their proposed solution. It shifts some of the inherent R&D risk from the government to the contractor, potentially leading to a more focused and cost-effective research effort. The exact ratio of cost sharing is crucial for a precise value assessment.

What are the potential long-term implications of this contract for national biodefense preparedness?

This contract has significant long-term implications for national biodefense preparedness by addressing a critical gap in medical countermeasures. Mustard gas, a persistent chemical warfare agent, can cause severe and long-lasting eye damage. Developing an effective treatment would significantly enhance the ability of military personnel and civilian first responders to recover from exposure, reducing long-term disability and improving readiness. Furthermore, the research could lead to advancements in treating other types of chemical burns or ocular injuries, broadening the applicability of the findings. Successful development would add a vital capability to the nation's strategic stockpile of medical countermeasures, bolstering overall resilience against chemical threats.

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 › OTHER RESEARCH/DEVELOPMENT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: BAA-18-100-SOL-00003

Offers Received: 1

Pricing Type: COST SHARING (T)

Evaluated Preference: NONE

Contractor Details

Address: 1275 KINNEAR RD, COLUMBUS, OH, 43212

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

Financial Breakdown

Contract Ceiling: $37,506,620

Exercised Options: $35,324,845

Current Obligation: $35,324,845

Actual Outlays: $16,179,208

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline