HHS awarded $52.4M for ZMapp Ebola countermeasure development to Mapp Biopharmaceutical

Contract Overview

Contract Amount: $52,369,282 ($52.4M)

Contractor: Mapp Biopharmaceutical, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2014-09-02

End Date: 2020-08-31

Contract Duration: 2,190 days

Daily Burn Rate: $23.9K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF::CL::IGF FOR OTHER FUNCTIONS ADVANCED DEVELOPMENT OF ZMAPP, AN EBOLA VIRUS CANDIDATE MEDICAL COUNTERMEASURE

Place of Performance

Location: WASHINGTON, DISTRICT OF COLUMBIA County, DISTRICT OF COLUMBIA, 20201

State: District of Columbia Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $52.4 million to MAPP BIOPHARMACEUTICAL, INC. for work described as: IGF::CL::IGF FOR OTHER FUNCTIONS ADVANCED DEVELOPMENT OF ZMAPP, AN EBOLA VIRUS CANDIDATE MEDICAL COUNTERMEASURE Key points: 1. Contract focused on advanced development of a promising Ebola virus candidate. 2. Significant investment in a critical public health medical countermeasure. 3. Long-duration contract suggests a complex and lengthy research and development process. 4. Sole contractor indicates a specialized capability or unique product. 5. Cost-plus-fixed-fee structure allows for flexibility but requires careful cost oversight. 6. Performance period spanned several years, encompassing critical development milestones.

Value Assessment

Rating: fair

The contract's value of $52.4 million over approximately six years for advanced development of a medical countermeasure is difficult to benchmark without specific details on the development stage and comparable projects. Cost-plus-fixed-fee contracts can sometimes lead to higher costs if not managed tightly. However, the nature of advanced R&D for novel therapeutics often involves significant uncertainty and high upfront investment, making direct price comparisons challenging. The fixed fee component provides some predictability for the contractor's profit.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, suggesting that multiple capable vendors had the opportunity to bid. The presence of only one awardee, however, might indicate that Mapp Biopharmaceutical was the only entity possessing the specific expertise, technology, or intellectual property required for the advanced development of ZMapp at that time. Further details on the number of proposals received would clarify the extent of competition.

Taxpayer Impact: Full and open competition is generally favorable for taxpayers as it aims to secure the best value through a competitive process. However, if only one viable bidder emerges, the potential for price negotiation is reduced.

Public Impact

The primary beneficiary is public health, with the development of a critical medical countermeasure against the Ebola virus. Services delivered include advanced research and development activities necessary to bring a promising therapeutic candidate closer to potential deployment. Geographic impact is national, focusing on enhancing U.S. preparedness for biological threats. Workforce implications include supporting specialized scientific and technical jobs in the biopharmaceutical R&D sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost-plus-fixed-fee contracts require diligent oversight to ensure costs remain reasonable and within scope.
The long duration of the contract could present challenges in adapting to evolving scientific knowledge or changing threat landscapes.
Reliance on a single contractor for a critical countermeasure may pose supply chain or continuity risks if the contractor faces unforeseen issues.

Positive Signals

Focus on developing a critical medical countermeasure addresses a significant public health need.
Awarding to a specialized firm like Mapp Biopharmaceutical suggests leveraging existing expertise for efficient development.
The contract's duration indicates a commitment to seeing the complex R&D process through to potential success.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a subset of the broader Health and Life Sciences industry. This sector is characterized by high innovation, significant R&D investment, and long development cycles for new therapies and countermeasures. Spending in this area is often driven by government priorities related to national security, public health emergencies, and the advancement of medical science. Comparable spending benchmarks would typically involve other government contracts for advanced development of vaccines, therapeutics, and diagnostics for infectious diseases.

Small Business Impact

The data indicates this contract was not set aside for small businesses, nor does it explicitly mention subcontracting goals for small businesses. Given the specialized nature of advanced biopharmaceutical R&D, it is possible that larger, more established firms or those with specific intellectual property were better positioned to compete. Further analysis would be needed to determine if any small business subcontracting opportunities were mandated or realized.

Oversight & Accountability

Oversight for this contract would primarily reside with the Department of Health and Human Services (HHS), specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). As a cost-plus-fixed-fee contract, regular financial and progress reporting would be expected. The Inspector General of HHS would have jurisdiction for audits and investigations into potential fraud, waste, or abuse. Transparency would be facilitated through contract award databases and potentially through public reports on the progress of the ZMapp development.

Related Government Programs

Biomedical Advanced Research and Development Authority (BARDA) contracts
National Institutes of Health (NIH) research grants
Department of Defense medical countermeasure development programs
Ebola preparedness and response initiatives

Risk Flags

Potential for cost overruns in CPFF contracts.
Long development timelines increase risk of obsolescence or changing needs.
Reliance on a single contractor for a critical countermeasure.
Uncertainty inherent in advanced R&D projects.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $52.4 million to MAPP BIOPHARMACEUTICAL, INC.. IGF::CL::IGF FOR OTHER FUNCTIONS ADVANCED DEVELOPMENT OF ZMAPP, AN EBOLA VIRUS CANDIDATE MEDICAL COUNTERMEASURE

Who is the contractor on this award?

The obligated recipient is MAPP BIOPHARMACEUTICAL, 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 $52.4 million.

What is the period of performance?

Start: 2014-09-02. End: 2020-08-31.

What was the specific stage of development for ZMapp when this contract was awarded, and what were the key milestones expected?

The contract, awarded in September 2014, focused on the 'advanced development' of ZMapp, an Ebola virus candidate. This typically implies moving beyond initial discovery and preclinical research into later stages, potentially including process development, scale-up manufacturing, and preparation for clinical trials. Key milestones would likely have involved demonstrating manufacturing feasibility at a larger scale, meeting specific quality control standards, and potentially initiating or completing Phase 1 clinical trials to assess safety and dosage in humans. The urgency surrounding Ebola at the time likely accelerated these development phases.

How does the $52.4 million contract value compare to other government investments in similar Ebola countermeasures during that period?

During the 2014-2016 Ebola epidemic, significant government funding was directed towards countermeasures. While $52.4 million is a substantial amount, it is comparable to, and in some cases less than, other large-scale investments made by agencies like BARDA and the Department of Defense. For instance, other contracts and grants for vaccine development, diagnostic tools, and therapeutic research often reached similar or higher figures, reflecting the high cost and urgency associated with developing effective responses to emerging infectious disease threats. The specific value is justified by the complexity and risk inherent in advanced biopharmaceutical R&D.

What were the primary risks associated with the development of ZMapp, and how did the contract structure aim to mitigate them?

The primary risks associated with ZMapp development included scientific uncertainty (whether the therapeutic would prove effective and safe), technical challenges (manufacturing scale-up and consistency), regulatory hurdles (meeting FDA requirements for approval), and market viability (ensuring a sustainable supply chain post-development). The cost-plus-fixed-fee (CPFF) contract structure aimed to mitigate some of these risks by providing flexibility for the contractor to incur necessary costs while pursuing development goals. The fixed fee provided the contractor with a defined profit margin, incentivizing completion. Government oversight was crucial to manage cost overruns and ensure progress against milestones.

What was Mapp Biopharmaceutical's track record prior to receiving this significant federal contract?

Prior to this contract, Mapp Biopharmaceutical was known for its work on developing antibody-based therapies for infectious diseases. They had been involved in the development of ZMapp, which gained significant attention during the 2014 Ebola outbreak due to its experimental use in treating infected aid workers. While ZMapp showed promising early results, it was still in the experimental stages. The company's track record demonstrated specialized expertise in monoclonal antibody development, particularly for viral threats, making them a logical, albeit perhaps not extensively proven at scale, candidate for advanced development funding.

How did the 'full and open competition' process result in a single awardee for this critical R&D effort?

The 'full and open competition' designation means that the solicitation was broadly advertised, allowing any responsible source to submit an offer. However, the selection of a single awardee, Mapp Biopharmaceutical, suggests that despite the open competition, only one offeror met all the required criteria to the highest degree. This could be due to several factors: Mapp Biopharmaceutical may have possessed unique intellectual property related to ZMapp, specialized manufacturing capabilities essential for its advanced development, a specific scientific approach deemed superior, or perhaps they were the only entity capable of meeting the stringent technical and performance requirements within the specified timeframe and budget constraints.

What is the historical spending pattern for developing medical countermeasures against viral hemorrhagic fevers by HHS?

HHS, primarily through agencies like the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH), has a history of significant investment in developing medical countermeasures against viral hemorrhagic fevers (VHFs), including Ebola. Spending patterns have historically fluctuated, often increasing sharply during or immediately following major outbreaks due to urgent public health needs. Investments cover a range of activities from basic research to late-stage development and manufacturing scale-up. The $52.4 million awarded to Mapp Biopharmaceutical for ZMapp development is consistent with the scale of funding typically allocated to promising, but still experimental, therapeutic candidates during critical development phases for high-consequence pathogens.

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: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 6160 LUSK BLVD STE 105, SAN DIEGO, CA, 92121

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

Financial Breakdown

Contract Ceiling: $52,369,282

Exercised Options: $52,369,282

Current Obligation: $52,369,282

Actual Outlays: $11,811

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline