NIH awards $25.1M contract for HIV-1 suppression research to Macrogenics, Inc

Contract Overview

Contract Amount: $25,119,949 ($25.1M)

Contractor: Macrogenics, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2015-09-14

End Date: 2024-10-31

Contract Duration: 3,335 days

Daily Burn Rate: $7.5K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 3

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF::OT::IGF DUAL AFFINITY RE-TARGETING MOLECULES FOR HIV-1 SUPPRESSION

Place of Performance

Location: ROCKVILLE, MONTGOMERY County, MARYLAND, 20850

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $25.1 million to MACROGENICS, INC. for work described as: IGF::OT::IGF DUAL AFFINITY RE-TARGETING MOLECULES FOR HIV-1 SUPPRESSION Key points: 1. Contract awarded through full and open competition, suggesting a competitive bidding process. 2. Research and Development in Physical, Engineering, and Life Sciences sector. 3. Definitive contract type with a Cost Plus Fixed Fee payment structure. 4. Long duration of 3335 days indicates a significant, multi-year research effort. 5. Contractor Macrogenics, Inc. is based in Maryland. 6. Potential for significant public health impact if research leads to effective HIV-1 suppression.

Value Assessment

Rating: fair

The contract value of $25.1 million over approximately 9 years represents a substantial investment in HIV-1 research. Benchmarking this specific contract's value is challenging without detailed cost breakdowns and comparisons to similar R&D efforts in HIV therapeutics. The Cost Plus Fixed Fee structure means costs are reimbursed plus a fixed fee, which can lead to cost overruns if not managed carefully. However, it also allows for flexibility in research scope.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under 'full and open competition,' indicating that all responsible sources were permitted to submit a bid. The presence of 3 bids suggests a moderate level of competition for this specific research area. While competition is present, the specialized nature of HIV-1 research might limit the number of highly qualified bidders.

Taxpayer Impact: Full and open competition generally benefits taxpayers by encouraging competitive pricing and innovation. However, the ultimate value for taxpayers depends on the successful outcome of the research and the cost-effectiveness of the contractor's performance.

Public Impact

The primary beneficiaries are individuals affected by HIV/AIDS, with the potential for new therapeutic interventions. The research aims to develop novel molecules for suppressing HIV-1. The geographic impact is primarily within Maryland, where the contractor is located, but the scientific advancements could have global implications. The contract supports scientific workforce development in biotechnology and biomedical research.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost overruns are a risk with Cost Plus Fixed Fee contracts if not closely monitored.
The long duration of the contract increases the risk of scope creep or changing research priorities.
Success is contingent on scientific breakthroughs, which are inherently uncertain in R&D.

Positive Signals

Awarded through full and open competition, suggesting a robust selection process.
Focus on a critical public health issue (HIV-1 suppression).
Contractor is likely specialized in relevant biotechnology and pharmaceutical research.

Sector Analysis

This contract falls within the Biotechnology and Pharmaceutical Research sector, a segment of the broader R&D industry. This sector is characterized by high innovation, significant investment, and long development cycles. Comparable spending benchmarks would involve looking at other NIH grants and contracts for HIV research and drug development, which can range from millions to hundreds of millions of dollars depending on the stage and scope.

Small Business Impact

The data indicates this contract was not set aside for small businesses (ss: false, sb: false). Therefore, there are no direct subcontracting implications for small businesses stemming from a set-aside. The primary focus is on large-scale research and development, likely involving specialized expertise.

Oversight & Accountability

Oversight for this contract would typically be provided by the National Institutes of Health (NIH), a component of the Department of Health and Human Services. Mechanisms likely include regular progress reports, financial reviews, and adherence to research protocols. Transparency is generally maintained through public databases of federal contracts, though specific research details may be proprietary.

Related Government Programs

NIH Research Grants
Biomedical Research Contracts
HIV/AIDS Therapeutic Development Programs
National Institute of Allergy and Infectious Diseases (NIAID) Funding

Risk Flags

Long contract duration may increase risk.
Cost Plus Fixed Fee structure requires careful cost monitoring.
R&D success is inherently uncertain.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $25.1 million to MACROGENICS, INC.. IGF::OT::IGF DUAL AFFINITY RE-TARGETING MOLECULES FOR HIV-1 SUPPRESSION

Who is the contractor on this award?

The obligated recipient is MACROGENICS, 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 $25.1 million.

What is the period of performance?

Start: 2015-09-14. End: 2024-10-31.

What is the track record of Macrogenics, Inc. in securing and performing on federal research contracts, particularly in the area of infectious diseases?

Macrogenics, Inc. is a biopharmaceutical company focused on developing antibody-based therapeutics. While specific details on their federal contract performance history are not provided in this data snippet, their ability to secure a significant contract from NIH suggests a level of established expertise and capability in relevant research areas. A deeper dive would involve reviewing their contract history with federal agencies, including performance evaluations, any past issues, and their success rate in similar R&D endeavors. Their primary focus on oncology and immunology suggests a strong foundation for infectious disease research, though HIV-1 may represent a specific area of focus for this particular contract.

How does the $25.1 million contract value compare to other federal investments in HIV-1 research over a similar timeframe?

The $25.1 million awarded to Macrogenics, Inc. represents a significant, but not exceptionally large, investment for a multi-year R&D project in a complex area like HIV-1 suppression. Federal agencies, particularly NIH, invest billions annually in HIV/AIDS research through various mechanisms including grants, cooperative agreements, and contracts. Individual research projects can vary widely in cost, from smaller pilot studies costing hundreds of thousands to large-scale clinical trials or drug development programs costing tens or hundreds of millions. This contract appears to be in the mid-to-high range for a specific R&D initiative focused on molecular targeting, suggesting a substantial commitment to this particular approach.

What are the primary risks associated with this Cost Plus Fixed Fee (CPFF) contract structure for HIV-1 research?

The primary risks associated with a CPFF contract for R&D, such as this HIV-1 suppression project, revolve around cost control and the inherent uncertainties of scientific discovery. For the government, the risk is that the contractor may not be able to complete the research within the estimated cost, potentially leading to cost overruns as the fixed fee is based on initial estimates. The contractor bears some risk if costs exceed estimates, but the government ultimately reimburses allowable costs. For the contractor, the risk lies in accurately estimating the costs and effort required for complex scientific research, which is prone to unforeseen challenges and delays. The fixed fee provides an incentive for efficiency, but the primary driver is often the successful completion of research objectives.

What are the potential program effectiveness indicators or metrics that NIH might use to evaluate the success of this contract?

NIH would likely evaluate the effectiveness of this contract based on a combination of scientific milestones and progress towards the ultimate goal of HIV-1 suppression. Key indicators could include the successful identification and characterization of dual-affinity re-targeting molecules, demonstration of these molecules' efficacy in preclinical models (e.g., in vitro assays, animal studies), achievement of specific viral load reduction targets, and assessment of the molecules' safety and pharmacokinetic profiles. Progress reports detailing experimental results, data analysis, and adherence to the research plan would be crucial. Ultimately, the long-term success would be measured by the potential for these molecules to advance into clinical trials and contribute to effective HIV-1 therapies.

How has federal spending on HIV/AIDS research, specifically related to therapeutic development, evolved over the past decade, and where does this contract fit?

Federal spending on HIV/AIDS research, primarily led by NIH, has been substantial and relatively consistent over the past decade, though priorities and funding levels can shift. The US government remains a leading global funder of HIV/AIDS research, allocating billions annually. Funding supports a broad spectrum of research, including basic science, prevention, vaccine development, and treatment/therapeutics. This $25.1 million contract for developing specific molecules for HIV-1 suppression fits within the therapeutic development category. It represents a focused investment in a particular scientific approach to treatment, complementing broader efforts in drug discovery, clinical trials, and understanding viral pathogenesis.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except 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: NIHAI2014011

Offers Received: 3

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 9640 MEDICAL CENTER DR, ROCKVILLE, MD, 20850

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

Financial Breakdown

Contract Ceiling: $25,119,949

Exercised Options: $25,119,949

Current Obligation: $25,119,949

Actual Outlays: $5,688,351

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline