NIH awards $21.5M for botulism therapeutic R&D, with XOMA LTD. as contractor

Contract Overview

Contract Amount: $21,508,794 ($21.5M)

Contractor: Xoma Ltd.

Awarding Agency: Department of Health and Human Services

Start Date: 2011-09-27

End Date: 2016-09-29

Contract Duration: 1,829 days

Daily Burn Rate: $11.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 29

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: BROAD SPECTRUM MONOCLONAL ANTIBODY-BASED THERAPEUTIC FOR BOTULISM

Place of Performance

Location: BERKELEY, ALAMEDA County, CALIFORNIA, 94710

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $21.5 million to XOMA LTD. for work described as: BROAD SPECTRUM MONOCLONAL ANTIBODY-BASED THERAPEUTIC FOR BOTULISM Key points: 1. Contract value represents a significant investment in biodefense research. 2. The contract duration of nearly five years suggests a complex, multi-stage research and development process. 3. The 'Research and Development in Biotechnology' NAICS code indicates a focus on scientific advancement. 4. The definitive contract type suggests a commitment to a specific outcome or project. 5. The contractor, XOMA LTD., has a history in therapeutic development, though specific performance on this contract requires further review. 6. The contract was awarded under full and open competition, implying a broad search for qualified bidders.

Value Assessment

Rating: fair

Benchmarking the value of this R&D contract is challenging due to the specialized nature of therapeutic development and the inherent uncertainties in research outcomes. The total award of $21.5 million over approximately five years averages to about $4.3 million per year. This figure needs to be compared against similar R&D efforts for biodefense agents, which can vary widely based on the complexity of the pathogen and the stage of development. Without specific benchmarks for botulism therapeutic R&D, a precise value-for-money assessment is difficult, but the funding level appears consistent with the scope of developing novel therapeutics.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that the agency sought proposals from all responsible sources. The presence of 29 bids suggests a robust level of interest and a competitive environment for this research area. This broad competition is generally favorable for price discovery and ensuring the government receives competitive proposals, although the ultimate price is heavily influenced by the technical requirements and inherent risks of R&D.

Taxpayer Impact: A competitive bidding process for R&D contracts like this helps ensure taxpayer funds are used efficiently by driving down costs and encouraging innovative solutions.

Public Impact

The primary beneficiaries are public health and national security, through the development of a critical medical countermeasure against botulism. The service delivered is the research and development of a novel monoclonal antibody-based therapeutic. The geographic impact is national, aiming to bolster the U.S. biodefense capabilities. Workforce implications include employment for scientists, researchers, and technicians in the biotechnology sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The inherent risks and uncertainties of R&D can lead to cost overruns or failure to achieve desired outcomes.
The long duration of the contract may present challenges in adapting to evolving scientific knowledge or alternative technologies.
The cost-plus fixed-fee (CPFF) contract type, while common in R&D, can sometimes lead to less cost control compared to fixed-price contracts if not managed carefully.

Positive Signals

The contract was awarded through full and open competition, suggesting a strong initial proposal and competitive pricing.
The large number of bids (29) indicates significant interest and a healthy market for this type of research.
The focus on a critical biodefense agent addresses a significant public health threat.
The contractor, XOMA LTD., has experience in therapeutic development, potentially bringing valuable expertise to the project.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a sub-sector of the broader Health and Life Sciences industry. This area is characterized by high R&D investment, long development cycles, and significant regulatory hurdles. The market size for biodefense therapeutics is driven by government funding for national security and public health preparedness. Comparable spending benchmarks would involve looking at other government-funded R&D contracts for novel vaccines, antivirals, and antitoxins, which can range from tens to hundreds of millions of dollars depending on the scope and phase of development.

Small Business Impact

There is no indication that this contract included a small business set-aside. The nature of advanced biotechnology R&D often involves large, established firms or specialized research institutions. Subcontracting opportunities for small businesses might exist within specific research components or material supply chains, but the primary awardee is a larger entity. The impact on the small business ecosystem is likely indirect, potentially through innovation spillover or by demonstrating the viability of certain research avenues that smaller firms could later build upon.

Oversight & Accountability

Oversight for this contract would primarily reside with the National Institutes of Health (NIH), a component of the Department of Health and Human Services (HHS). Specific oversight mechanisms would include regular progress reports from the contractor, milestone reviews, and financial audits. Accountability is ensured through the contract terms and conditions, including performance metrics and deliverable requirements. Transparency is facilitated through contract award databases and public reporting requirements, although detailed R&D progress may be subject to proprietary or national security considerations.

Related Government Programs

Biodefense Countermeasures
Medical Countermeasures Advanced Development
National Institute of Allergy and Infectious Diseases (NIAID) Research
Biotechnology Research Grants
Therapeutic Development Programs

Risk Flags

Research and Development Uncertainty
Long-term Project Duration
Therapeutic Efficacy Risk
Manufacturing Scalability Challenges
Regulatory Approval Hurdles

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $21.5 million to XOMA LTD.. BROAD SPECTRUM MONOCLONAL ANTIBODY-BASED THERAPEUTIC FOR BOTULISM

Who is the contractor on this award?

The obligated recipient is XOMA LTD..

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 $21.5 million.

What is the period of performance?

Start: 2011-09-27. End: 2016-09-29.

What is XOMA LTD.'s track record with government R&D contracts, particularly in biodefense?

XOMA LTD. has a history of engaging in therapeutic development, including work relevant to infectious diseases and biodefense. While specific details on past government R&D contracts require deeper database searches, their experience in developing antibody-based therapeutics suggests a foundational capability. Assessing their track record on this specific botulism therapeutic contract would involve reviewing performance reports, milestone achievements, and any documented challenges or successes during the contract's lifespan (2011-2016). Publicly available information might highlight previous collaborations with agencies like NIH or BARDA, providing context for their ability to manage complex, long-term research projects and deliver on scientific objectives.

How does the $21.5 million award compare to other government investments in botulism countermeasures?

The $21.5 million awarded to XOMA LTD. for botulism therapeutic R&D represents a significant, but not necessarily outlier, investment in this specific area. Government agencies like the Department of Health and Human Services (HHS), through NIH and BARDA (Biomedical Advanced Research and Development Authority), frequently fund R&D for medical countermeasures against high-consequence pathogens, including botulinum neurotoxins. Funding levels for such projects can vary widely, from early-stage feasibility studies costing a few million dollars to late-stage development and manufacturing scale-up potentially reaching hundreds of millions. This particular award, spread over nearly five years, suggests a substantial commitment to advancing a specific therapeutic candidate through critical research phases.

What are the primary risks associated with developing a monoclonal antibody-based therapeutic for botulism?

Developing a monoclonal antibody-based therapeutic for botulism involves several key risks. Firstly, the inherent scientific risk is high: the antibody may not effectively neutralize the toxin, or it may have unforeseen immunogenicity or side effects in humans. Secondly, manufacturing challenges can arise, particularly in producing a consistent, high-quality biologic at scale. Thirdly, regulatory hurdles are significant; demonstrating safety and efficacy through rigorous clinical trials is a lengthy and expensive process. Finally, market viability and long-term funding can be uncertain, especially for countermeasures against rare or bioterrorism-related threats, which may have limited commercial demand outside of government stockpiling.

What was the intended outcome or program effectiveness goal for this contract?

The intended outcome of this contract was the research and development of a broad-spectrum monoclonal antibody-based therapeutic for botulism. The program effectiveness goal was to advance the development of a novel medical countermeasure that could neutralize the effects of botulinum neurotoxins, thereby providing a critical tool for public health and national security preparedness. Success would be measured by the successful completion of research phases, demonstration of the therapeutic's efficacy and safety in preclinical studies, and potentially its readiness for progression into human clinical trials. The ultimate goal is to have a deployable countermeasure available to treat botulism in the event of an outbreak, whether naturally occurring or intentionally caused.

How has federal spending on biotechnology R&D, specifically for biodefense, evolved since this contract was awarded?

Federal spending on biotechnology R&D, particularly for biodefense, has generally seen sustained or increased investment since this contract was awarded in 2011. Following events like the anthrax attacks and growing awareness of bioterrorism threats, agencies like HHS (NIH, BARDA) and the Department of Defense have prioritized funding for countermeasures against a range of biological agents, including botulinum toxin. Investments often fluctuate based on perceived threats, scientific breakthroughs, and shifts in national security priorities. However, the overall trend has been towards robust funding to maintain and advance the nation's biodefense capabilities, including the development of novel therapeutics and vaccines.

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

Solicitation ID: NIHAI2010097

Offers Received: 29

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 2910 7TH ST, BERKELEY, CA, 94710

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

Financial Breakdown

Contract Ceiling: $22,578,772

Exercised Options: $21,508,794

Current Obligation: $21,508,794

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline