NIH awards $3.1M contract for advanced development of radiation countermeasure BBT-059

Contract Overview

Contract Amount: $3,079,369 ($3.1M)

Contractor: Bolder Biotechnology Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2023-07-01

End Date: 2026-06-30

Contract Duration: 1,095 days

Daily Burn Rate: $2.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 16

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: ADVANCED DEVELOPMENT OF BBT-059 AS A RADIATION MEDICAL COUNTERMEASURE FOR DOSING UP TO 48H POST EXPOSURE"

Place of Performance

Location: LOUISVILLE, BOULDER County, COLORADO, 80027

State: Colorado Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $3.1 million to BOLDER BIOTECHNOLOGY INC for work described as: ADVANCED DEVELOPMENT OF BBT-059 AS A RADIATION MEDICAL COUNTERMEASURE FOR DOSING UP TO 48H POST EXPOSURE" Key points: 1. Contract focuses on critical medical countermeasures for radiation exposure. 2. Research and Development in Biotechnology sector, specifically for medical applications. 3. Awarded via full and open competition, suggesting a competitive bidding process. 4. Contract duration of nearly three years indicates a substantial development phase. 5. Bolder Biotechnology Inc. is the sole awardee, highlighting specialized capabilities. 6. Cost Plus Fixed Fee contract type allows for flexibility in research and development.

Value Assessment

Rating: good

The contract value of $3.1 million for advanced development of a medical countermeasure appears reasonable given the specialized nature of the research and development involved. Benchmarking against similar R&D contracts in biotechnology, particularly those focused on radiation countermeasures, would provide a more precise assessment. However, the fixed fee component suggests that the contractor's profit margin is predetermined, which can offer some cost control.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple vendors had the opportunity to bid. This process is designed to foster price discovery and ensure that the government receives competitive pricing. The presence of multiple bidders, if applicable, would further strengthen the competitive aspect and potentially lead to a more favorable outcome for the government.

Taxpayer Impact: Full and open competition generally benefits taxpayers by driving down costs through a competitive bidding process, ensuring that public funds are used efficiently.

Public Impact

The primary beneficiaries are individuals potentially exposed to radiation, enhancing national security and public health preparedness. The contract supports the development of a novel medical countermeasure (BBT-059) for radiation emergencies. Geographic impact is national, focusing on preparedness for widespread or localized radiation events. Workforce implications include specialized roles in biotechnology research, development, and regulatory affairs.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns inherent in Cost Plus Fixed Fee R&D contracts.
Dependence on a single contractor for a critical countermeasure.
Long development timelines for novel medical countermeasures can pose risks.

Positive Signals

Addresses a critical national security and public health need.
Awarded through a competitive process, suggesting a well-vetted solution.
Focus on advanced development implies progress towards a deployable product.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a rapidly evolving field critical for national security and public health. The market for medical countermeasures, particularly for radiation exposure, is specialized and driven by government funding and preparedness initiatives. Comparable spending benchmarks would likely be found within NIH's broader R&D portfolio for medical countermeasures and advanced therapeutics.

Small Business Impact

The contract does not indicate any specific small business set-aside provisions. Given the specialized nature of advanced biotechnology development, it is common for such contracts to be awarded to established firms with proven capabilities. Subcontracting opportunities for small businesses may arise if Bolder Biotechnology Inc. identifies specific needs that can be met by smaller, specialized vendors.

Oversight & Accountability

Oversight will likely be managed by the National Institutes of Health (NIH), a component of the Department of Health and Human Services. Accountability measures will be tied to the achievement of milestones outlined in the Cost Plus Fixed Fee contract. Transparency is generally maintained through contract awards databases and public reporting requirements, though specific research details may be proprietary.

Related Government Programs

Biotechnology Research and Development
Medical Countermeasures
Radiation Health
National Preparedness Initiatives

Risk Flags

Research and Development timelines can be lengthy and subject to unforeseen challenges.
Dependence on a single contractor for a critical technology.
Cost overruns are a potential risk in CPFF contracts.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $3.1 million to BOLDER BIOTECHNOLOGY INC. ADVANCED DEVELOPMENT OF BBT-059 AS A RADIATION MEDICAL COUNTERMEASURE FOR DOSING UP TO 48H POST EXPOSURE"

Who is the contractor on this award?

The obligated recipient is BOLDER BIOTECHNOLOGY INC.

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 $3.1 million.

What is the period of performance?

Start: 2023-07-01. End: 2026-06-30.

What is the specific scientific basis for BBT-059's efficacy as a radiation medical countermeasure?

The provided data does not detail the specific scientific mechanism of action for BBT-059. However, as a radiation medical countermeasure, it is likely designed to mitigate cellular damage, promote DNA repair, or reduce the inflammatory response following radiation exposure. Advanced development contracts typically aim to move promising research candidates through preclinical and early clinical testing phases to validate efficacy and safety. Further details would be found in scientific publications, patent filings, or specific research proposals submitted by Bolder Biotechnology Inc. to NIH.

How does the $3.1 million contract value compare to similar R&D efforts for radiation countermeasures?

Benchmarking the $3.1 million contract value requires comparison with similar advanced development contracts for radiation medical countermeasures. Such contracts can vary significantly based on the stage of development, the specific threat addressed (e.g., acute radiation syndrome vs. chronic exposure), and the complexity of the countermeasure (e.g., small molecule drug vs. biologic). Contracts for early-stage research might be smaller, while those involving extensive clinical trials could be in the tens or hundreds of millions. This $3.1 million award appears to be for a focused, advanced development phase, suggesting it is within a reasonable range for progressing a specific candidate towards potential deployment.

What are the key performance indicators (KPIs) and milestones for this contract?

The specific Key Performance Indicators (KPIs) and milestones for this contract are not detailed in the provided data. However, for an advanced development contract of this nature, typical milestones would include successful completion of specific preclinical studies (e.g., toxicology, pharmacokinetics), formulation development, manufacturing process optimization, and potentially the initiation of early-phase human clinical trials. Performance would be assessed against the timely and successful achievement of these defined objectives within the Cost Plus Fixed Fee framework.

What is Bolder Biotechnology Inc.'s track record in developing medical countermeasures, particularly for radiation?

Information regarding Bolder Biotechnology Inc.'s specific track record in developing medical countermeasures, especially for radiation, is not provided in the contract data. A thorough assessment would require reviewing the company's history, previous government contracts, publications, and any existing products or pipeline candidates. Their selection for this contract suggests they possess relevant expertise and capabilities deemed necessary by the National Institutes of Health for this advanced development effort.

What is the projected timeline for BBT-059 to become a deployable countermeasure?

The contract duration is set at 1095 days (approximately three years), ending on June 30, 2026. This timeframe is allocated for the 'advanced development' phase. This suggests that BBT-059 is still in a developmental stage and not yet ready for immediate deployment. The subsequent phases, including extensive clinical trials, regulatory review (e.g., by the FDA), and large-scale manufacturing, would occur after the completion of this contract and would require additional funding and time. Therefore, a deployable countermeasure is likely several years beyond the current contract's end date.

How does the Cost Plus Fixed Fee (CPFF) contract structure influence risk and cost for this R&D project?

The Cost Plus Fixed Fee (CPFF) contract structure is common for research and development projects where the scope of work can be uncertain. In this structure, the government pays the contractor's actual allowable costs plus a predetermined fixed fee, which represents the contractor's profit. This structure incentivizes the contractor to control costs, as the fee remains constant regardless of the final cost. However, it also shifts some risk to the government, as they bear the actual cost incurred. For this R&D project, CPFF allows flexibility to adapt to research findings while providing a defined profit margin for Bolder Biotechnology Inc.

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: 75N93021R00019

Offers Received: 16

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 907 PIKES PEAK LN, LOUISVILLE, CO, 80027

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

Financial Breakdown

Contract Ceiling: $3,079,369

Exercised Options: $3,079,369

Current Obligation: $3,079,369

Actual Outlays: $3,018,999

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline