HHS Awards $29M for Broad-Spectrum Antibody Therapeutic Against Flavivirus Infections to ABVIRO LLC

Contract Overview

Contract Amount: $29,175,011 ($29.2M)

Contractor: Abviro LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2016-09-19

End Date: 2022-09-30

Contract Duration: 2,202 days

Daily Burn Rate: $13.2K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 13

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF::OT::IGF - A BROAD-SPECTRUM ANTIBODY THERAPEUTIC AGAINST FLAVIVIRUS INFECTIONS.

Place of Performance

Location: BETHESDA, MONTGOMERY County, MARYLAND, 20814

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $29.2 million to ABVIRO LLC for work described as: IGF::OT::IGF - A BROAD-SPECTRUM ANTIBODY THERAPEUTIC AGAINST FLAVIVIRUS INFECTIONS. Key points: 1. The contract focuses on R&D in Biotechnology, a critical area for public health. 2. ABVIRO LLC is the sole awardee, raising questions about competition. 3. The contract duration is substantial (2202 days), indicating a long-term project. 4. The award mechanism is a Definitive Contract, suggesting a well-defined scope.

Value Assessment

Rating: fair

The total award is $29.17 million. Without specific unit costs or comparable contract data for similar antibody therapeutics, a precise pricing assessment is difficult. However, the cost-plus-fixed-fee structure requires careful monitoring of costs to ensure value.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, which theoretically allows for the best price discovery. However, the award to a single entity, ABVIRO LLC, warrants further examination to ensure the competitive process yielded optimal pricing.

Taxpayer Impact: Taxpayer funds are being invested in critical research for infectious diseases, potentially leading to significant public health benefits. The value for money depends on the successful development of the therapeutic.

Public Impact

Development of a broad-spectrum therapeutic could protect against multiple flavivirus threats, including Dengue, Zika, and West Nile Virus. Investment in biotechnology research is crucial for national biodefense and pandemic preparedness. The success of this therapeutic could reduce future healthcare burdens and economic impacts associated with flavivirus outbreaks.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Lack of specific performance metrics in provided data.
Potential for cost overruns in R&D contracts.
Dependence on a single contractor for critical research.

Positive Signals

Addresses a significant public health need.
Utilizes a competitive award process.
Long-term commitment suggests strategic importance.

Sector Analysis

This contract falls under the Research and Development in Biotechnology sector (NAICS 541711). Spending in this sector is vital for innovation and addressing emerging health threats. Benchmarks for similar R&D contracts can vary widely based on project scope and duration.

Small Business Impact

The provided data does not indicate whether small businesses were involved in this contract, either as prime contractors or subcontractors. Further analysis would be needed to assess small business participation.

Oversight & Accountability

The National Institutes of Health (NIH) is responsible for overseeing this contract. Standard oversight mechanisms for cost-plus-fixed-fee contracts, including regular progress reports and financial reviews, should be in place to ensure accountability and efficient use of funds.

Related Government Programs

Research and Development in Biotechnology
Department of Health and Human Services Contracting
National Institutes of Health Programs

Risk Flags

Contract duration is lengthy, increasing exposure to potential cost changes.
Cost-plus-fixed-fee contracts can incentivize higher spending if not closely monitored.
Reliance on a single awardee for critical R&D.
Lack of detailed performance metrics in the provided data.
Potential for scope creep in long-term research projects.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $29.2 million to ABVIRO LLC. IGF::OT::IGF - A BROAD-SPECTRUM ANTIBODY THERAPEUTIC AGAINST FLAVIVIRUS INFECTIONS.

Who is the contractor on this award?

The obligated recipient is ABVIRO LLC.

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 $29.2 million.

What is the period of performance?

Start: 2016-09-19. End: 2022-09-30.

What is the projected timeline for key development milestones and the expected efficacy of the antibody therapeutic?

The provided data indicates a contract duration of 2202 days (approximately 6 years), suggesting a long-term development process. Specific milestones and efficacy targets are not detailed. Further information from NIH would be required to understand the expected timeline for key development stages and the anticipated effectiveness of the therapeutic against various flaviviruses.

How will NIH ensure cost control and prevent potential overruns given the cost-plus-fixed-fee contract structure for this R&D project?

NIH will likely implement robust oversight, including regular reviews of ABVIRO LLC's financial expenditures and progress reports. Cost-plus-fixed-fee contracts require careful monitoring of direct costs and adherence to the fixed fee. Mechanisms such as established ceilings, performance incentives, and clear deliverables will be crucial for managing costs and ensuring value for taxpayer money.

What is the long-term strategy for transitioning this therapeutic from R&D to potential deployment and market availability?

The transition from R&D to deployment involves multiple phases, including clinical trials, regulatory approval (e.g., FDA), and manufacturing scale-up. NIH's long-term strategy likely includes follow-on contracts or partnerships to support these subsequent stages. The success of the R&D phase is critical for securing further investment and navigating the complex path to making the therapeutic available to the public.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: BASIC RESEARCH

Solicitation ID: NIAIDDMIDNIHAI2015037

Offers Received: 13

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 4800 HAMPDEN LN STE 200, BETHESDA, MD, 20814

Business Categories: Category Business, Limited Liability Corporation, Partnership or Limited Liability Partnership, Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $29,175,011

Exercised Options: $29,175,011

Current Obligation: $29,175,011

Actual Outlays: $6,363,671

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline