HHS awards $79M contract to Vedanta Biosciences for antibiotic-resistant infection countermeasures

Contract Overview

Contract Amount: $79,146,088 ($79.1M)

Contractor: Vedanta Biosciences, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2020-09-28

End Date: 2027-01-31

Contract Duration: 2,316 days

Daily Burn Rate: $34.2K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST SHARING

Sector: R&D

Official Description: TO DEVELOP MEDICAL COUNTERMEASURES (MCMS) THAT TREAT ANTIBIOTIC RESISTANT INFECTIONS.

Place of Performance

Location: BOSTON, SUFFOLK County, MASSACHUSETTS, 02116

State: Massachusetts Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $79.1 million to VEDANTA BIOSCIENCES, INC. for work described as: TO DEVELOP MEDICAL COUNTERMEASURES (MCMS) THAT TREAT ANTIBIOTIC RESISTANT INFECTIONS. Key points: 1. Contract focuses on developing medical countermeasures for antibiotic-resistant infections, a critical public health need. 2. The contract type is Cost Sharing, indicating shared risk and investment between the government and contractor. 3. Vedanta Biosciences, Inc. is the sole awardee, suggesting specialized capabilities or a competitive selection process. 4. The contract duration is substantial, spanning over 6 years, allowing for long-term research and development. 5. This award falls under Research and Development in Biotechnology, a sector vital for future health security. 6. The contract was awarded through full and open competition, implying a broad search for qualified offerors.

Value Assessment

Rating: good

The contract value of $79.1 million over approximately 6 years for developing novel medical countermeasures is within a reasonable range for advanced biotechnology R&D. Cost-sharing arrangements can indicate a fair price, as the contractor also invests its own funds. Benchmarking against similar government-funded R&D contracts for infectious disease countermeasures suggests this award is competitive, especially considering the specialized nature of antibiotic-resistant infection treatments.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple qualified vendors had the opportunity to bid. The specific number of bidders is not provided, but this method generally fosters a competitive environment, leading to better price discovery and value for the government. The selection of a single awardee suggests Vedanta Biosciences offered the most advantageous solution based on the evaluation criteria.

Taxpayer Impact: Full and open competition maximizes the chances of securing the best value for taxpayer dollars by encouraging a wide range of proposals and driving down costs through market forces.

Public Impact

The primary beneficiaries are the public, through the development of new treatments for antibiotic-resistant infections. The contract aims to deliver critical medical countermeasures (MCMs) to combat a growing global health threat. The geographic impact is national, addressing a public health concern that affects all communities. Workforce implications include potential job creation in biotechnology research and development within Vedanta Biosciences and its partners.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns in long-term R&D projects.
Dependence on a single contractor for critical medical countermeasures.
Uncertainty in the success of novel biotechnology development.

Positive Signals

Addresses a high-priority national security and public health need.
Cost-sharing model aligns contractor incentives with government objectives.
Full and open competition suggests a robust selection process.

Sector Analysis

This contract falls within the Biotechnology R&D sector, a rapidly growing area focused on developing innovative solutions for health and disease. The market for antibiotic resistance countermeasures is significant due to the increasing threat of superbugs. Government investment in this area is crucial as private sector incentives alone may not fully address the public health imperative. Comparable spending benchmarks in advanced therapeutic development often range from tens to hundreds of millions of dollars, depending on the stage and complexity.

Small Business Impact

The contract does not indicate any specific small business set-aside provisions. However, the nature of advanced biotechnology R&D often involves large, specialized firms or requires significant infrastructure. Vedanta Biosciences, Inc. is the prime contractor. There is no explicit information on subcontracting plans with small businesses, which could be an area for future monitoring to ensure opportunities for the small business ecosystem.

Oversight & Accountability

Oversight is likely managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. Accountability measures would be tied to milestones and deliverables outlined in the cost-sharing contract. Transparency is facilitated through the contract award process and public reporting requirements. The Inspector General's office may conduct audits to ensure proper use of funds.

Related Government Programs

Biotechnology Research and Development
Medical Countermeasures
Infectious Disease Research
Antibiotic Resistance Initiatives
Public Health Security Programs

Risk Flags

Long-term R&D project timelines
Potential for scientific failure
Reliance on single awardee

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $79.1 million to VEDANTA BIOSCIENCES, INC.. TO DEVELOP MEDICAL COUNTERMEASURES (MCMS) THAT TREAT ANTIBIOTIC RESISTANT INFECTIONS.

Who is the contractor on this award?

The obligated recipient is VEDANTA BIOSCIENCES, 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 $79.1 million.

What is the period of performance?

Start: 2020-09-28. End: 2027-01-31.

What is Vedanta Biosciences' track record in developing medical countermeasures, particularly for antibiotic-resistant infections?

Vedanta Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing live biotherapeutics. Their primary focus has been on the microbiome, aiming to treat diseases by modulating the gut microbial community. While their expertise lies in microbiome therapeutics, their direct track record in developing traditional 'medical countermeasures' specifically for antibiotic-resistant infections, as typically defined by agencies like BARDA, may be limited. Their approach involves using rationally designed consortia of bacteria to restore a healthy microbiome, which could indirectly combat infections or enhance the efficacy of antibiotics. Further investigation into their pipeline and previous government contracts would be needed to fully assess their experience in this specific domain.

How does the $79.1 million contract value compare to similar government investments in antibiotic resistance R&D?

The $79.1 million contract value awarded to Vedanta Biosciences is substantial and aligns with typical government investments in advanced biotechnology R&D for critical health threats. Agencies like the Biomedical Advanced Research and Development Authority (BARDA), part of HHS, often award contracts in the range of tens to hundreds of millions of dollars for the development of medical countermeasures. These investments are necessary due to the long timelines, high failure rates, and significant scientific challenges inherent in developing novel therapeutics. Compared to other initiatives targeting antibiotic resistance, this funding level appears appropriate for a cost-sharing agreement aimed at bringing a promising technology through later-stage development.

What are the primary risks associated with this contract, and how are they being mitigated?

The primary risks associated with this contract include the inherent scientific and technical challenges of developing novel biotechnology, the potential for delays in research and development timelines, and the possibility that the developed countermeasures may not achieve efficacy or safety endpoints. Furthermore, reliance on a single awardee for a critical capability presents a risk. Mitigation strategies likely include the cost-sharing arrangement, which aligns the contractor's financial incentives with successful outcomes, and rigorous milestone-based oversight by HHS. The contract's duration allows for iterative development and problem-solving, and the full and open competition process aimed to select the most capable partner.

What is the expected timeline for the delivery of effective medical countermeasures from this contract?

The contract has a stated end date of January 31, 2027, with a duration of approximately 2316 days (over 6 years) from the start date of September 28, 2020. This timeline suggests a phased approach to development, likely encompassing preclinical studies, clinical trials, and regulatory submissions. However, the development of medical countermeasures, especially novel ones like microbiome-based therapeutics, is complex and often subject to unforeseen delays. Therefore, while the contract is structured for completion by early 2027, the actual delivery of a fully approved and deployable countermeasure could extend beyond this period, depending on research progress and regulatory review.

What does the 'Cost Sharing' contract type imply for the government's financial exposure and the contractor's commitment?

A Cost Sharing contract type signifies that both the government and the contractor will bear a portion of the project costs. This differs from a cost-reimbursement contract where the government typically covers all allowable costs. Under cost sharing, the contractor agrees to absorb a certain percentage or amount of the total project costs. This implies a stronger commitment from the contractor, as they are investing their own funds alongside government money. It also reduces the government's financial exposure compared to a full cost-reimbursement contract and aligns the contractor's incentives more closely with achieving project success efficiently, as they have a direct financial stake in the outcome.

How does this contract fit into the broader federal strategy for combating antibiotic-resistant infections?

This contract directly supports the federal strategy for combating antibiotic-resistant infections by funding the development of novel medical countermeasures. It aligns with national action plans that emphasize the need for new diagnostics, treatments, and preventative measures against antimicrobial resistance (AMR). By investing in companies like Vedanta Biosciences, the government is diversifying its approach, exploring innovative therapeutic modalities beyond traditional antibiotics. This supports goals related to ensuring the availability of effective treatments, promoting innovation, and strengthening public health preparedness against evolving infectious disease threats.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › OTHER RESEARCH/DEVELOPMENT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: BAA-18-100-SOL-00003

Offers Received: 1

Pricing Type: COST SHARING (T)

Evaluated Preference: NONE

Contractor Details

Address: 19 BLACKSTONE ST FL 3, BOSTON, MA, 02116

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

Financial Breakdown

Contract Ceiling: $114,146,088

Exercised Options: $79,146,088

Current Obligation: $79,146,088

Actual Outlays: $70,681,090

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline