HHS awarded $25.2M to Pfenex Inc. for anthrax vaccine component development

Contract Overview

Contract Amount: $25,241,192 ($25.2M)

Contractor: Pfenex Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2010-07-30

End Date: 2015-08-31

Contract Duration: 1,858 days

Daily Burn Rate: $13.6K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 100

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: TAS::75 0140::TAS PFENEX BIOPHARMACEUTICALS, INC. SHALL FURTHER DEVELOP A STRAIN AND PROCESS TO MANUFACTURE RECOMBINANT PROTECTIVE ANTIGEN (RPA) FOR USE IN ANTHRAX VACCINE DEVELOPMENT USING A MICROBIAL SYSTEM.

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 $25.2 million to PFENEX INC for work described as: TAS::75 0140::TAS PFENEX BIOPHARMACEUTICALS, INC. SHALL FURTHER DEVELOP A STRAIN AND PROCESS TO MANUFACTURE RECOMBINANT PROTECTIVE ANTIGEN (RPA) FOR USE IN ANTHRAX VACCINE DEVELOPMENT USING A MICROBIAL SYSTEM. Key points: 1. Contract focused on developing a specific strain and manufacturing process for recombinant protective antigen (RPA). 2. The contract utilized a Cost Plus Fixed Fee (CPFF) pricing structure. 3. Awarded by the Office of Assistant Secretary for Preparedness and Response (ASPR), indicating a focus on public health security. 4. The contract duration was substantial, spanning over 5 years. 5. Pfenex Inc. is the sole contractor for this specific effort. 6. The contract falls under Research and Development in Biotechnology (NAICS 541711).

Value Assessment

Rating: fair

Benchmarking the value of this contract is challenging without specific performance metrics or comparable development contracts. The $25.2 million awarded over five years for R&D in a critical area like anthrax vaccine development suggests a significant investment. However, the CPFF structure can sometimes lead to cost overruns if not managed tightly. Further analysis would require understanding the milestones achieved and the final efficacy of the developed strain and process.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, suggesting multiple entities had the opportunity to bid. However, the data does not specify the number of bidders or the evaluation process. Full and open competition is generally preferred as it allows for the widest possible pool of talent and potentially better pricing.

Taxpayer Impact: Taxpayers benefit from a competitive process that aims to secure the best value for critical national security and public health investments.

Public Impact

The primary beneficiaries are the U.S. public, through the development of a more robust anthrax vaccine. The service delivered is advanced research and development for a critical biodefense countermeasure. The geographic impact is national, focusing on improving U.S. biodefense capabilities. Workforce implications include specialized roles in biotechnology, research, and vaccine development.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee contracts can incentivize higher spending if not carefully monitored.
Long contract durations for R&D may present risks if scientific direction shifts or breakthroughs are not achieved.
Reliance on a single contractor for a critical development phase warrants close oversight.

Positive Signals

Awarded through full and open competition, indicating a potentially robust selection process.
Focus on a critical biodefense capability addresses a significant public health and national security need.
Contractor Pfenex Inc. has expertise in biopharmaceutical development.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a key area for biodefense and public health initiatives. The market for vaccine development, particularly for biothreat agents like anthrax, is specialized and often driven by government funding due to high R&D costs and uncertain commercial markets. Comparable spending benchmarks would typically involve other government-funded R&D contracts for novel vaccine platforms or specific biodefense agents.

Small Business Impact

The provided data indicates this contract was not set aside for small businesses (ss: false, sb: false). As a large-scale R&D effort, it is likely that the prime contractor, Pfenex Inc., would engage subcontractors. Analysis of subcontracting plans would be necessary to determine the extent of small business participation and its impact on the broader small business ecosystem in the biotech sector.

Oversight & Accountability

Oversight for this contract would typically be managed by the Department of Health and Human Services (HHS), specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). Accountability measures would be tied to the achievement of contract milestones and deliverables outlined in the Cost Plus Fixed Fee agreement. Transparency is generally maintained through contract databases, though specific performance details may be sensitive.

Related Government Programs

Anthrax Vaccine Development Programs
Biodefense Countermeasure Research
Biotechnology R&D Contracts
Department of Health and Human Services Contracts
Office of Assistant Secretary for Preparedness and Response Initiatives

Risk Flags

Potential for cost overruns due to CPFF structure
Risk of R&D failure or scientific challenges
Long contract duration may outpace technological relevance
Single point of failure risk for critical capability

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $25.2 million to PFENEX INC. TAS::75 0140::TAS PFENEX BIOPHARMACEUTICALS, INC. SHALL FURTHER DEVELOP A STRAIN AND PROCESS TO MANUFACTURE RECOMBINANT PROTECTIVE ANTIGEN (RPA) FOR USE IN ANTHRAX VACCINE DEVELOPMENT USING A MICROBIAL SYSTEM.

Who is the contractor on this award?

The obligated recipient is PFENEX 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 $25.2 million.

What is the period of performance?

Start: 2010-07-30. End: 2015-08-31.

What was the specific scientific objective of developing this strain and process for RPA?

The primary scientific objective was to develop a more effective and potentially scalable method for manufacturing Recombinant Protective Antigen (RPA), a key component of anthrax vaccines. This involved creating a specific microbial strain and optimizing the bioprocess to produce RPA efficiently. The goal was to enhance the vaccine's efficacy, stability, or manufacturability, thereby strengthening the nation's preparedness against anthrax attacks.

How does the Cost Plus Fixed Fee (CPFF) structure compare to other contract types for R&D in this sector?

The CPFF structure is common for R&D contracts where the scope of work is not precisely defined at the outset, allowing for flexibility as research progresses. It provides the contractor with reimbursement for allowable costs plus a fixed fee representing profit. Compared to Firm-Fixed-Price (FFP) contracts, CPFF offers less cost certainty for the government but allows for greater adaptability to research uncertainties. Cost-Plus-Incentive-Fee (CPIF) or Cost-Plus-Award-Fee (CPAF) contracts might offer better value by incentivizing performance and cost control, but CPFF is chosen when defining those incentives is difficult.

What are the potential risks associated with a five-year R&D contract for vaccine development?

A five-year R&D contract for vaccine development carries several risks. Scientific risk is paramount: the research may not yield the desired results, or breakthroughs may not occur within the timeframe. Technological obsolescence is another concern; new technologies could emerge that render the developed process outdated. Furthermore, changes in threat assessments or public health priorities could alter the need for the specific vaccine component. Finally, contractor performance and cost management over such a long period require continuous oversight to mitigate risks of inefficiency or budget overruns.

What is Pfenex Inc.'s track record in developing biopharmaceutical products, particularly for government contracts?

Pfenex Inc. (now part of Ligand Pharmaceuticals) has a history in developing microbial-based biopharmaceutical products. Their expertise includes strain development and fermentation processes. While specific details on their track record with government contracts for anthrax vaccine components require deeper investigation, their core business has centered on leveraging microbial platforms for therapeutic protein production. Past performance reviews and contract databases would offer more granular insights into their success rates and adherence to timelines and budgets on similar government R&D efforts.

How does the $25.2 million investment compare to overall federal spending on biodefense R&D?

The $25.2 million awarded to Pfenex Inc. represents a specific investment within the broader federal biodefense R&D portfolio. Federal spending in this area is substantial, often spanning billions of dollars annually across agencies like HHS (ASPR, BARDA), DoD, and DHS, aimed at developing countermeasures for a range of biological threats. This particular contract addresses a critical need for anthrax preparedness. To contextualize its size, it would need to be compared against the total budget allocated by ASPR or BARDA for vaccine development and biodefense initiatives in the fiscal years 2010-2015.

What are the implications of this contract being awarded to a single entity for a critical biodefense capability?

Awarding a critical biodefense capability development to a single entity like Pfenex Inc. concentrates expertise and streamlines project management. However, it also introduces a single point of failure risk. If the contractor encounters insurmountable technical challenges, faces financial instability, or experiences management issues, the entire development effort could be jeopardized. This necessitates robust government oversight, contingency planning, and potentially fostering alternative research pathways to ensure the nation's biodefense needs are ultimately met.

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: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 100

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 5501 OBERLIN DR, SAN DIEGO, CA, 92121

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

Financial Breakdown

Contract Ceiling: $25,241,192

Exercised Options: $25,241,192

Current Obligation: $25,241,192

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline