NIH awards $2.48M contract to Global Alliance for TB Drug Development for novel tuberculosis treatment

Contract Overview

Contract Amount: $2,475,623 ($2.5M)

Contractor: THE Global Alliance for TB Drug Development Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2024-05-10

End Date: 2026-11-09

Contract Duration: 913 days

Daily Burn Rate: $2.7K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 18

Pricing Type: COST NO FEE

Sector: R&D

Official Description: TO DEVELOP A NOVEL MODULATOR TARGETING PROTEOSTASIS FOR THE TREATMENT OF M. TUBERCULOSIS.

Place of Performance

Location: NEW YORK, NEW YORK County, NEW YORK, 10005

State: New York Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $2.5 million to THE GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT INC for work described as: TO DEVELOP A NOVEL MODULATOR TARGETING PROTEOSTASIS FOR THE TREATMENT OF M. TUBERCULOSIS. Key points: 1. Contract focuses on developing a novel modulator targeting proteostasis for tuberculosis treatment. 2. The contract duration of 913 days suggests a medium-term research and development effort. 3. Awarded under full and open competition, indicating a broad search for qualified contractors. 4. The 'Cost No Fee' contract type implies that the government will reimburse allowable costs. 5. The specific NAICS code 541715 points to research and development in life sciences. 6. The contractor, Global Alliance for TB Drug Development Inc., is likely specialized in this niche area.

Value Assessment

Rating: fair

The contract value of $2.48 million for a 913-day research and development project appears reasonable for its scope. However, without specific benchmarks for developing novel TB modulators, a precise value-for-money assessment is challenging. The 'Cost No Fee' structure means the government bears the financial risk of cost overruns, which is common in R&D but requires careful monitoring. Further analysis would involve comparing this to similar early-stage drug development contracts.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, suggesting that the agency actively sought proposals from a wide range of potential contractors. The number of bids received (18) indicates a healthy level of interest and a competitive environment for this specialized research area. This broad competition is generally favorable for price discovery and ensuring the government receives competitive proposals.

Taxpayer Impact: The full and open competition process is beneficial for taxpayers as it increases the likelihood of obtaining the best value by allowing multiple qualified entities to bid, potentially driving down costs and improving the quality of the research.

Public Impact

The primary beneficiaries are individuals suffering from tuberculosis, with the potential for a new, more effective treatment. The service delivered is critical research and development aimed at a significant global health challenge. The geographic impact is global, given the worldwide prevalence of tuberculosis. Workforce implications include employment for scientists, researchers, and support staff within the contractor's organization.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The 'Cost No Fee' contract type shifts cost overrun risk to the government, requiring diligent oversight.
The specialized nature of R&D means outcomes are uncertain, and success is not guaranteed.
Limited public information on the contractor's specific track record in developing proteostasis modulators.

Positive Signals

Awarded under full and open competition, suggesting a robust selection process.
The contractor is a specialized alliance focused on TB drug development, implying relevant expertise.
The project addresses a critical unmet medical need for tuberculosis treatment.

Sector Analysis

This contract falls within the Biotechnology and Life Sciences research sector, specifically focusing on infectious disease R&D. The market for developing novel therapeutics for diseases like tuberculosis is highly specialized, often involving public-private partnerships and global health initiatives. Comparable spending benchmarks would typically be found in grants and contracts awarded by agencies like NIH, BARDA, and global health organizations for early-stage drug discovery.

Small Business Impact

There is no indication of a small business set-aside for this contract. Given the specialized nature of developing novel therapeutics and the contractor being a global alliance, it is unlikely that small businesses would be primary awardees, though they may participate as subcontractors if the prime contractor opts for subcontracting opportunities.

Oversight & Accountability

Oversight for this contract 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 research milestones outlined in the contract. Transparency is generally maintained through contract databases, though specific research progress details may be proprietary. The Inspector General for HHS would have jurisdiction over potential fraud, waste, or abuse.

Related Government Programs

NIH Grants for Infectious Disease Research
Global TB Drug Development Initiatives
Biotechnology Research and Development Contracts
Proteostasis Modulator Research

Risk Flags

Cost overrun risk inherent in 'Cost No Fee' R&D contracts.
Scientific uncertainty and potential for research failure in novel drug development.
Dependence on contractor's specialized expertise for project success.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $2.5 million to THE GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT INC. TO DEVELOP A NOVEL MODULATOR TARGETING PROTEOSTASIS FOR THE TREATMENT OF M. TUBERCULOSIS.

Who is the contractor on this award?

The obligated recipient is THE GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT 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 $2.5 million.

What is the period of performance?

Start: 2024-05-10. End: 2026-11-09.

What is the specific scientific approach to developing a novel modulator targeting proteostasis for tuberculosis treatment?

The contract aims to develop a novel modulator targeting proteostasis for the treatment of Mycobacterium tuberculosis (M. tuberculosis). Proteostasis refers to the cellular process of maintaining protein homeostasis, including synthesis, folding, trafficking, and degradation. By targeting this process, the research seeks to disrupt essential functions within the M. tuberculosis bacterium, potentially leading to its death or inhibition. This could involve identifying specific proteins or pathways critical for the bacterium's survival that are amenable to modulation. The 'Cost No Fee' contract type suggests the government is funding the exploration and development of this scientific approach, with the contractor reimbursed for allowable costs incurred in pursuing the research objectives. The success of this approach hinges on identifying druggable targets within the proteostasis network of M. tuberculosis that can be effectively modulated without causing undue toxicity to the host.

How does the $2.48 million award compare to other NIH R&D contracts in infectious diseases?

The $2.48 million award for a 913-day research project is within a typical range for early-stage, specialized R&D contracts funded by the National Institutes of Health (NIH). NIH funds a vast array of research, from basic science to translational studies. Contracts for novel drug development, particularly for complex diseases like tuberculosis, often require significant investment over several years. While larger sums are awarded for later-stage clinical trials or manufacturing, this amount is consistent with foundational research and development phases. Benchmarking requires comparing it to similar projects targeting infectious diseases, specifically those focused on novel mechanisms of action rather than incremental improvements on existing therapies. The 'Cost No Fee' structure is common in R&D where the final costs are difficult to predict.

What are the key risks associated with this 'Cost No Fee' contract?

The primary risk associated with a 'Cost No Fee' contract is that the government bears the financial burden of any cost overruns. If the contractor incurs expenses exceeding the initially estimated costs, the government is obligated to reimburse these allowable costs, up to the contract's ceiling. This shifts the financial risk from the contractor to the government, which is common in research and development where the scope and duration of work can be unpredictable. For this specific contract, risks include potential delays in research, unexpected scientific challenges, or the need for additional resources not initially foreseen. Effective oversight by NIH is crucial to monitor expenditures, ensure progress aligns with objectives, and manage potential cost escalations. The absence of a fee means the contractor's profit is not directly tied to cost efficiency, potentially reducing incentives for strict cost control unless balanced by performance metrics.

What is the track record of The Global Alliance for TB Drug Development Inc. in similar projects?

The Global Alliance for TB Drug Development Inc. is an organization specifically established to accelerate the discovery and development of new drugs to combat tuberculosis. As such, its core mission aligns directly with the objectives of this contract. While specific details of their past projects and their success rates in developing proteostasis modulators are not provided in the basic contract data, their organizational focus suggests a relevant track record in the field of TB drug development. Further investigation into their published research, previous partnerships, and pipeline of drug candidates would be necessary to fully assess their capabilities and past performance in projects of similar scientific complexity and scope. Their existence as a dedicated alliance implies a commitment and likely experience in navigating the challenges of TB drug R&D.

What are the potential implications if this research is successful in developing a novel treatment?

If successful, the development of a novel modulator targeting proteostasis for tuberculosis treatment could have profound global health implications. Tuberculosis remains a major cause of death worldwide, and the emergence of drug-resistant strains necessitates new therapeutic strategies. A successful outcome from this research could lead to a new class of drugs that are more effective, have fewer side effects, or can overcome existing resistance mechanisms. This would significantly improve patient outcomes, reduce the burden of disease, and potentially contribute to the global effort to control and eventually eliminate tuberculosis. The 'Cost No Fee' nature of the contract means the government has invested in exploring this promising avenue, with the potential for significant public health returns if the research yields a viable treatment.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and 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: HHS-NIH-NIAID-BAA2023-1

Offers Received: 18

Pricing Type: COST NO FEE (S)

Evaluated Preference: NONE

Contractor Details

Address: 80 PINE ST FL 20, NEW YORK, NY, 10005

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

Financial Breakdown

Contract Ceiling: $9,851,406

Exercised Options: $2,475,623

Current Obligation: $2,475,623

Actual Outlays: $1,439,097

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline